The decrease in external research and development ~~expense~~expenses in the nine months ended September 30, 2023 was primarily attributable to ~~the advancement of our~~decrease in Amgen co-development expense and lower external clinical trial costs for TEVIMBRA (tislelizumab) and ZW25 (zanidatamab), partially offset by increases in external clinical trial costs for BRUKINSA and sonrotoclax (BGB-11417) and preclinical ~~pipeline, and included:~~

·increases of approximately $33.4 million, $12.2 million and $11.4 million, respectively, for BGB-3111, BGB-A317 and BGB-290, offset by a decrease of approximately $2.1 million for BGB-283. The expense increases were primarily due to the expansion of our ongoing clinical development plan, including the initiation of two global Phase 1 and Phase 1b/2 combination trials of BGB-290, the continued enrollment of our three global registrational BGB-3111 trials, the initiation of a pivotal Phase 2 BGB-3111 trial and a Phase 2 BGB-3111 combination trial in China, and the initiation of a registrational trial and two Phase 2 combination trials of BGB-A317 in China; and

trial costs for certain assets in our portfolio.

·increase of approximately $3.8 million in external spending for our preclinical-stage programs, primarily related to costs associated with advancing our next preclinical candidate toward clinical trials.

~~The increase in internal~~

Internal research and development expense increased $104.4 million, or 14.1%, to $846.0 million and was primarily attributable to the expansion of our global development organization and our ~~pipeline,~~clinical and preclinical drug candidates, as well as our continued efforts to internalize research and clinical trial activities, and included the following:

·~~$20.7 million increase of employee salaries and benefits, which was primarily attributable to hiring more research and development personnel to support our expanding research and clinical activities;~~

·$14.5 million increase of share-based compensation expense ($19.7 million in the nine months ended September 30, 2017 compared to $5.2 million in the nine months ended September 30, 2016), primarily attributable to our increased headcount, as well as the increased valuation of non-employee grants;

·$3.6 million increase of materials and reagent expenses, mainly in connection with the in-house manufacture of drug candidates used for clinical purposes, that were previously outsourced and recorded as external cost; and

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•$62.3 million increase of employee salary and benefits, primarily attributable to hiring more research and development personnel to support our expanding research and development activities;

·~~$11.1 million increase of consulting fees, facilities, travel, rental fee and other expenses, primarily attributable to the global expansion of our company.~~

•$19.7 million increase of share-based compensation expense, primarily attributable to our increased headcount of research and development employees, resulting in more awards being expensed related to the growing research and development employee population;

•$21.8 million increase of facilities, depreciation, consulting, regulatory, office expense, rental fees, lab consumables and other expenses to support the growth of our organization, partially offset by a $6.3 million decrease in clinical inventory; and

•$6.9 million increase in meetings, seminars and travel expenses mainly attributable to increased meetings and conferences travel normalizing.

Selling, General and Administrative Expense

Selling, general and administrative expense increased by ~~$23.4~~$139.1 million, or ~~199.2%~~14.7%, to ~~$35.2~~$1.1 billion, for the nine months ended September 30, 2023, from $948.9 million for the nine months ended September 30, ~~2017~~2022. The increase was primarily attributable to the following:

•$73.0 million increase in external commercial-related expenses, including market research, sales and marketing, conference, meeting and seminar and travel related expenses related to the growth of our global commercial organization, including commercial expansion of BRUKINSA in CLL in the United States and Europe, as we continue to build our worldwide footprint and capabilities;

•$35.4 million increase in grants and donations;

•$30.4 million increase of employee salary and benefits, which was primarily attributable to the expansion of our commercial organizations in the United States, Europe, Canada, China and emerging markets, and the hiring of personnel to support our growing business;

•$30.0 million increase of share-based compensation expense, primarily attributable to our increased headcount of sales and administrative employees, resulting in more awards being expensed related to the growing sales and administrative employee population;

•$21.5 million decrease in consulting expenses due primarily to lower external commercial expenses in China; and

•$8.2 million decrease in general and administrative and other expenses primarily attributable to increased legal fees related to increased arbitration activities for the prior nine months period ended September 30, 2022.

Interest Income (Expense), Net

Interest income (expense), net increased by $23.5 million, or 68.5%, to $57.7 million of net interest income for the nine months ended September 30, 2023, from ~~$11.8~~$34.3 million of net interest income for nine months ended September 30, 2022. The increase in interest income was primarily attributable to higher interest rates earned on our cash, cash equivalents and short-term investments and lower interest expense due to an increase in interest capitalization related to Hopewell construction.

Other Income (Expense), Net

Other income, net was $291.1 million for the nine months ended September 30, ~~2016. The increase~~2023, primarily due to the noncash gain recorded for the receipt of ordinary shares as a result of the BMS settlement and government subsidy income, partially offset by foreign exchange losses resulting from the strengthening of the U.S. dollar compared to the RMB and the revaluation impact of RMB-denominated deposits held in U.S. functional currency subsidiaries and unrealized losses on equity investments.

For the nine months ended September 30, 2022, other expense, net was $243.3 million, which was primarily ~~attributable~~due to foreign exchanges losses resulting from the strengthening of the U.S. dollar compared to the ~~following:~~

·$7.7 million increase of professional fees for legal, consulting, recruiting and audit services, mainly in connection with our patent prosecution activities, consulting services, business development activities, including the Guangzhou joint venture and Celgene transactions, recruiting services and the preparation of periodic reports;

RMB and the revaluation impact of RMB-denominated deposits held in U.S. functional currency subsidiaries being greater in the prior-year period. Also contributing to the decrease in expense was decrease in the unrealized loss on our equity investment in Leap Therapeutics.

·$6.1 million increase of employee salaries and benefits, which was primarily attributable to hiring of more personnel to support our growing organization, including the acquired workforce in the acquisition of Celgen’s China operations;

Income Tax Expense

·~~$5.2 million increase of share-based compensation expense, primarily attributable to our increased headcount; and~~

·$4.4 million increase of office, travel, rental fee and other administrative expenses, primarily attributable to the global expansion of our company, including the post-combination operating costs of BeiGene Pharmaceutical (Shanghai).

~~Interest~~ Income ~~(Expense), Net~~

~~Net interest (expense) income decreased by $3.9~~tax expense increased to $39.1 million for the nine months ended September 30, ~~2017 as compared to the nine months ended September 30, 2016. The decrease was primarily attributable to increase of interest expense~~2023, from ~~the long-term bank loan and Shareholder Loan.~~

~~Changes in Fair Value of Financial Instruments~~

~~Loss from changes in fair value of financial instruments was nil for the nine months ended September 30, 2017, compared with $1.5~~$28.4 million for the nine months ended September 30, ~~2016.~~2022. The decrease in loss from changes in fair value of financial instruments was primarily attributable to change in the fair value of warrants and option liabilities, both of which were exercised in January 2016 and February 2016 in connection with the IPO.

~~Gain on Sale of Available-for-sale Securities~~

~~The gain on sale of available-for-sale securities was nominal~~income tax expense for the nine months ended September 30, ~~2017, compared to a loss of $1.1 million for the nine months ended~~2023 and September ~~30, 2016.~~

~~Other Income, Net~~

Net other income increased by $0.8 million to $1.5 million for the nine months ended September 30, 2017 from $0.7 million for the nine months ended September 30, 2016. Net other income primarily consisted of government grants received and foreign currency exchange gains/losses recognized.

~~Income Tax Expense~~

Income tax benefit was $2.7 million for the nine months ended September 30, 2017, compared with income tax expense of $0.3 million for the nine months ended September 30, 2016. The income tax benefit in the nine months ended

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~~September~~ 30, ~~2017~~2022 was primarily attributable to ~~the effect of estimated realized~~current China tax expense due to certain non-deductible expenses and current U.S. tax expense determined after other special deductions and research and development tax ~~credits and the U.S. Orphan Drug Credit~~ ~~related to BeiGene USA.~~

credits.

Liquidity and Capital Resources

~~Since inception,~~

The following table represents our cash, short-term investments, and debt balances as of September 30, 2023 and December 31, 2022:


	As of
	September 30,		December 31,
	2023		2022

	(dollars in thousands)
Cash, cash equivalents and restricted cash	$	3,080,892	$	3,875,037
Short-term investments	$	106,989	$	665,251
Total debt	$	531,051	$	538,117

With the exception of the periods in which we received upfront payments from out-licensing rights to tislelizumab to Novartis, and prior to that BMS, and the current quarter where we recorded a large noncash gain from the BMS settlement and accelerated deferred revenue recognition from the Novartis terminations, we have incurred net losses and negative cash flows from ~~our~~ operations ~~except for net income in~~since inception, resulting from the ~~current reporting period due to recognition~~funding of ~~an up-front license fee under our exclusive license agreement with Celgene. Substantially all of our losses have resulted from funding~~ our research and development programs and selling, ~~costs and~~ general and administrative ~~costs associated with~~expenses to support the commercialization of our products and our global operations. We ~~incurred~~recognized net income of ~~$117.3~~$215.4 million and ~~$6.0~~net loss of $514.2 million ~~respectively,~~ for the three and nine months ended September 30, ~~2017,~~2023, respectively, and net ~~loss~~losses of ~~$35.5~~$557.6 million and ~~$81.6 million, respectively,~~$1.6 billion for the three and nine months ended September 30, ~~2016.~~2022, respectively. As of September 30, ~~2017,~~2023, we had an accumulated deficit of $231.2 million. Our primary use of cash is to fund research and development costs. Our operating activities used $81.0 million and $63.4 million of cash flows during the nine months ended September 30, 2017 and 2016, respectively. Historically,$7.6 billion.

To date, we have financed our operations principally through proceeds from public and private offerings of our securities and proceeds from our ~~collaboration agreements, such as those with Merck KGaA, Darmstadt Germany~~ ~~and Celgene~~. During the three months ended September 30, 2017, we raised an aggregate of $601.4 million, consisting of $188.5 million in net proceeds from a public offering of our ordinary shares, $149.9 million in net proceeds from the sale of ordinary shares to Celgene in connection with our collaboration agreement, and $263.0 million in up-front license fees under our collaboration agreement with Celgene, of which $171.0 million is due in December 2017.

As of September 30, 2017, we had cash, cash equivalents and short-term investments of $757.4 million, including approximately $91.6 million of cash held by BeiGene Biologics to build a commercial biologics facility in Guangzhou, China and to fund research and development of biologics drug candidates in China. In addition, we had $10.5 million of accounts receivable related to product sales and $171.0 million of unbilled receivables related to the balance of the upfront fees from Celgene, payable to us in December 2017.

~~The following table provides information regarding our cash flows for the nine months ended September 30, 2017 and 2016:~~

Nine Months Ended September 30,


2017

2016


(in thousands)

Net cash used in operating activities

$
(80,997)

$
(63,373)

Net cash used in investing activities

(288,077)

(51,129)

Net cash provided by financing activities

487,308

182,210

Net effect of foreign exchange rate changes

2,762

(45)

Net increase in cash and cash equivalents

$
120,996

$
67,663

~~Net Cash Used in Operating Activities~~

The use of cash in all periods presented resulted primarily from our net losses adjusted for non-cash charges and changes in components of working capital. The primary use of our cash in all periods presented was to fund research and development, regulatory and other clinical trial costs, selling costs and related supporting administrative expenses. Our prepaid expenses and other current assets, accounts payable and accrued expense balances in all periods presented were affected by the timing of vendor invoicing and payments.

During the nine months ended September 30, 2017, operating activities used $81.0 million of cash, which resulted principally from our net income of $6.0 million, adjusted for non-cash charges of $28.1 million and by cash used in operations due to increased operating assets and liabilities of $115.1 million. Our operating assets increased $10.5 million for accounts receivable related to product sales and $171.0 million for unbilled receivables related to the balance of the upfront fees from Celgene due in December 2017. Operating liabilities increased $38.6 million related to deferred revenue under the Celgene collaboration and $45.1 million due to increased payables and accrued expenses from increased payroll-related costs, R&D external costs and selling, general and administrative expenses to support our growing business. Our net non-cash charges during the nine months ended September 30, 2017 primarily consisted of

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~~$26.4 million of share-based compensation expense, $4.8 million of non-cash interest expense and $2.7 million of depreciation expense, offset by $5.9 million related to deferred tax benefits.~~

During the nine months ended September 30, 2016, operating activities used $63.4 million of cash, which resulted principally from our net loss of $81.6 million, adjusting for non-cash charges of $10.7 million and ~~interest expense of $0.1 million, and~~ by cash provided by operations due to decreased operating assets and liabilities of $7.4 million. Our net non-cash charges during the nine months ended September 30, 2016 primarily consisted of a $1.4 million depreciation charge, a $6.7 million share-based compensation expense, a $1.1 million disposal loss on available-for-sale securities and a $1.5 million loss from changes in the fair value of financial instruments.

~~Net Cash Used in Investing Activities~~

Net cash used in investing activities was $288.1 million for the nine months ended September 30, 2017, compared to $51.1 million for the nine months ended September 30, 2016. The increase in cash used in investing activities was primarily due to $218.1 million of net purchases of available-for-sale securities, $50.1 million of investment in time deposits, $27.4 million paid to purchase property and equipment, primarily related to our Guangzhou and Suzhou manufacturing facilities, and $12.4 million paid to acquire land use rights in Guangzhou, China, partially offset by $19.9 million of cash acquired in the acquisition of BeiGene Pharmaceutical (Shanghai), net of cash paid.

~~Net Cash Provided by Financing Activities~~

Net cash provided by financing activities was $487.3 million for the nine months ended September 30, 2017, compared to $182.2 million for the nine months ended September 30, 2016. During the nine months ended September 30, 2017, we received $132.8 million of proceeds from the Shareholder Loan, $14.5 million from the capital contribution in BeiGene Biologics by GET, $188.5 million of net proceeds from our follow-on offering, net of underwriter discount and offering costs, $149.9 million from equity contribution by Celgene Switzerland, net of offering costs and $1.6 million from the exercise of employee options. During the nine months ended September 30, 2016, we received net proceeds of $167.9 million from our initial public offering, net of underwriter discount and offering costs, $12.2 million from a long-term bank loan and $2.1 million from the exercise of warrants and options.

~~Operating Capital Requirements~~

We do not expect to generate significant revenue from product sales of our internally developed drug candidates unless and until we obtain regulatory approval of and commercialize one of our current or future drug candidates. We ~~have exclusive rights to distribute and promote Celgene’s approved cancer therapies in China, for which we began recognizing revenue in the third quarter of 2017.~~ We anticipate that we will continue to generate losses for the foreseeable future, and we expect our losses to increase as we continue the development of, and seek regulatory approvals for, our drug candidates, and prepare for commercialization and begin to commercialize any approved products. As a growing public company, we will continue to incur additional costs associated with our operations. In addition, we expect to incur significant commercialization expenses for product sales, marketing and manufacturing of our in-licensed drug products in China and, subject to obtaining regulatory approval, our drug candidates. Accordingly, we anticipate that we will need substantial additional funding in connection with our continuing operations.

collaborations. Based on our current operating plan, we expect that our existing cash, cash equivalents and short-term investments as of September 30, ~~2017,~~2023 will enable us to fund our operating expenses and capital ~~expenditures~~expenditure requirements for at least the next 12 months after the date that the financial statements included in this report are issued. ~~We expect that~~

The following table provides information regarding our ~~expenses will continue to~~cash flows for the nine months ended September 30, 2023 and 2022:


	Nine Months Ended September 30,
	2023		2022

	(dollars in thousands)
Cash, cash equivalents and restricted cash at beginning of period	$	3,875,037	$	4,382,887
Net cash used in operating activities	(935,815)		(1,178,428)
Net cash provided by investing activities	122,588		1,038,587
Net cash provided by financing activities	69,430		91,395
Net effect of foreign exchange rate changes	(50,348)		(133,929)
Net decrease in cash, cash equivalents, and restricted cash	(794,145)		(182,375)
Cash, cash equivalents and restricted cash at end of period	$	3,080,892	$	4,200,512

Operating Activities

Cash flows from operating activities is net loss adjusted for certain non-cash items and changes in assets and liabilities.

Operating activities used $935.8 million of cash in the nine months ended September 30, 2023, principally from our net loss of $514.2 million, an increase ~~substantially as we fund clinical development~~in our net operating assets and liabilities of ~~BGB-3111, BGB-A317, BGB-290~~$387.6 million, and ~~BGB-283 as monotherapies~~non-cash charges of $34.1 million.

The increase in net operating assets and liabilities was primarily driven by increased working capital associated with our growth in ~~combination, fund new~~product sales. The non-cash charges were primarily the result of the BMS termination settlement and ~~ongoing~~amortization of the research and development ~~activities~~cost share liability, offset by share-based compensation expense, depreciation and working capital and other general corporate purposes. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our drug candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development and commercialization of our drug candidates.

amortization expense.

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~~Our future~~Operating activities used $1.2 billion of cash in the nine months ended September 30, 2022, which resulted principally from our net loss of $1.6 billion, partially offset by a decrease in our net operating assets and liabilities of $132.6 million and by non-cash charges of $247.5 million. Net loss for the three months ended September 30, 2022 includes $125.6 million of other losses due primarily to the strengthening of the U.S. dollar and the related revaluation of RMB-denominated deposits held by U.S. functional currency subsidiaries.

The decrease in working capital ~~requirements will depend~~was driven largely by decreases in accounts receivable (due to the receipt of the upfront from Novartis related to the ociperlimab collaboration), decreases in prepaid assets and other non-current assets, and an increase in taxes payable, partially offset by increases in inventories and decreases in accounts payable, accrued expenses, deferred revenue and other long-term liabilities. The non-cash charges were primarily driven by share-based compensation expense, depreciation and amortization expense, and unrealized loss on ~~many factors, including:~~

~~the costs, timing and outcome of regulatory reviews and approvals;~~

our Leap investment, offset by amortization of the research and development cost share liability and deferred income tax benefits.

~~the ability of our drug candidates to progress through clinical development successfully;~~

Investing Activities

~~the initiation, progress, timing, costs and results of nonclinical studies and clinical trials for our other programs and potential drug candidates;~~

Cash flows from investing activities consist primarily of capital expenditures, investment purchases, sales, maturities, and disposals, and upfront payments related to our collaboration agreements.

~~the number and characteristics of the drug candidates we pursue;~~

Investing activities provided $122.6 million of cash in the nine months ended September 30, 2023, consisting of sales and maturities of investment securities of $567.5 million, partially offset by capital expenditures of $404.9 million, purchase of IPR&D assets of $15.0 million, purchase of intangible assets of $9.4 million and $15.6 million in purchases of investment securities.

~~the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;~~

Investing activities provided $1.0 billion of cash in the nine months ended September 30, 2022, consisting of sales and maturities of investment securities of $1.4 billion, offset by $14.7 million in purchases of investment securities, capital expenditures of $204.1 million, and $95.0 million of acquired in-process research and development.

~~the costs of establishing and expanding our commercial operations;~~

Financing Activities

~~the extent to which we acquire or in-license other products and technologies; and~~

Cash flows from financing activities consist primarily of sale of ordinary shares, RMB Shares and ADSs through equity offerings, issuance and repayment of short-term and long-term debt, and proceeds from the sale of ordinary shares and ADSs through employee equity compensation plans.

~~our ability to maintain and establish collaboration arrangements on favorable terms, if at all.~~

Financing activities provided $69.4 million of cash in the nine months ended September 30, 2023, consisting primarily of $22.5 million of net proceeds from long-term bank loans, $162.6 million of proceeds from short-term bank loans and $52.4 million from the exercise of employee share options and proceeds from the issuance of shares through our employee share purchase plan, which were partially offset by $159.6 million in repayments of short-term bank loans and $8.5 million in repayments of long-term bank loans.

Financing activities provided $91.4 million of cash in the nine months ended September 30, 2022, consisting primarily of $163.8 million of proceeds from short-term bank loans, $37.4 million of proceeds from a long-term bank loan and $35.7 million from the exercise of employee share options and proceeds from the issuance of shares through our employee share purchase plan, which were partially offset by $145.4 million in repayment of short-term bank loans.

Effects of Exchange Rates on Cash

We have substantial operations in the PRC, which generate a significant amount of RMB-denominated cash from product sales and require a significant amount of RMB-denominated cash to pay our obligations. We hold a significant amount of RMB-denominated deposits at our China subsidiaries. Since the reporting currency of the Company is the U.S. dollar, periods of volatility in exchange rates may have a significant impact on our consolidated cash balances as they are translated into U.S. dollars. The impact of foreign currency deposits being translated into the U.S. dollar negatively impacted ending cash by $50.3 million in the nine months ended September 30, 2023, compared to a negative impact of $133.9 million in the prior-year period.

Future Liquidity and Material Cash Requirements

Until such time, if ever, as we can generate substantial product revenue sufficient to cover our costs and capital investments, we ~~expect~~may be required to finance our cash needs through a combination of equity offerings, debt financings, ~~collaborations,~~collaboration agreements, strategic alliances, licensing arrangements, government grants, and ~~government grants.~~ other available sources. Under the rules of the SEC, ~~rules,~~ we currently qualify as a “well-known seasoned issuer,” which allows us to file shelf registration statements to register an unspecified amount of securities that are effective upon filing. OnIn May ~~26, 2017,~~2023, we filed such a shelf registration statement with the SEC for the issuance of an unspecified amount of ordinary shares (including in the form of ADSs), preferred shares, various series of debt securities and/or warrants to purchase any of such securities, either individually or in units, from

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time to time at prices and on terms to be determined at the time of any such offering. This registration statement was effective upon filing and will remain in effect for up to three years from filing, prior to which time we may file another shelf registration statement that will be effective for up to three years from filing.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of ADSs, ordinary shares, or ~~ordinary shares.~~RMB Shares. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends, and may require the issuance of warrants, which could potentially dilute ~~your~~our investors' ownership interest. If we raise additional funds through ~~collaborations,~~collaboration agreements, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our ~~technologies,~~medicines or drug candidates, future revenue streams or research programs, or to grant licenses on terms that may not be favorable to us.

Furthermore, our ability to raise additional capital may be adversely impacted by worsening global economic conditions, with disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide resulting from the effects of inflationary pressures, recent and potential future bank failures and otherwise. If these conditions persist and deepen, we could experience an inability to access additional capital or our liquidity could otherwise be impacted, which could in the future negatively affect our capacity for certain corporate development transactions or our ability to make other important, opportunistic investments. If we are unable to raise additional funds through equity or debt financings, collaborations or other sources when needed, we may be required to delay, limit, reduce or terminate our product development or ~~future~~ commercialization efforts or grant rights to develop and market products or drug candidates that we would otherwise prefer to develop and market ourselves.

Our material cash requirements in the short- and long-term consist of the following operational, capital, and manufacturing expenditures, a portion of which contain contractual or other obligations. We plan to fund our material cash requirements with our current financial resources together with our anticipated receipts of accounts receivable, product sales and royalty revenues.

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Contractual and Other Obligations

~~Contractual Obligations and Commitments~~

The following table summarizes our significant contractual obligations as of the payment due date by period atas of September 30, ~~2017:~~

2023:


	Payments Due by Period
			Less Than							More Than		Payments Due by Period
	Total		1 Year		1–3 Years		3–5 Years			5 Years		Total		Short Term		Long Term
	(in thousands)											(dollars in thousands)
Contractual obligations											Contractual obligations
Operating lease commitments	$	23,081	$	5,960	$	9,884	$	5,290	$	1,947	Operating lease commitments	$	55,049	$	6,981	$	48,068
Purchase commitments											Purchase commitments	131,693		92,654		39,039
Debt obligations		158,347		9,018		9,018		—		140,311	Debt obligations	531,052		328,561		202,491
Interest on debt											Interest on debt	35,244		11,756		23,488
Co-development funding commitment											Co-development funding commitment	517,544		128,989		388,555
Funding commitment											Funding commitment	10,553		2,625		7,928
Research and development commitment											Research and development commitment	16,498		6,004		10,494

Capital commitments		36,149		36,149		—		—		—	Capital commitments	442,562		442,562		—
Total	$	217,577	$	51,127	$	18,902	$	5,290	$	142,258	Total	$	1,740,195	$	1,020,132	$	720,063

Operating Lease Commitments

We lease office or manufacturing facilities in Beijing,, Shanghai,, Suzhou and Guangzhou ~~PRC~~in China; office facilities in California, Massachusetts, Maryland, and New Jersey in the United States; and office facilities in ~~the United States in California, Massachusetts and New Jersey~~Basel, Switzerland under non-cancelable operating leases expiring on ~~different~~various dates. Payments under operating leases are expensed on a straight-line basis over the ~~periods of the~~ respective ~~leases.~~lease terms. The aggregate future minimum payments under these non-cancelable operating leases are summarized in the table above.

~~Long-term Debt Obligations~~

~~Long-term Bank Loan~~

On September 2, 2015, BeiGene (Suzhou) entered into a loan agreement with Suzhou Industrial Park Biotech Development Co., Ltd. and China Construction Bank, to borrow $18.0 million at a 7% fixed annual interest rate.

Purchase Commitments

As of September 30, ~~2017,~~2023, non-cancellable purchase commitments amounted to $131.7 million, of which $41.2 million related to minimum purchase requirements for supply purchased from contract manufacturers and $90.5 million related to

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binding purchase obligations of inventory from BMS and Amgen. We do not have any minimum purchase requirements for inventory from BMS or Amgen.

Debt Obligations and Interest

Total debt obligations coming due in the next twelve months is $328.6 million. Total long-term debt obligations are $202.5 million. See Note 10 in the Notes to the Financial Statements for further detail of our debt obligations.

Interest on bank loans is paid quarterly until the respective loans are fully settled. For the purpose of contractual obligations calculation, current interest rates on floating rate obligations were used for the remainder contractual life of the outstanding borrowings.

Co-Development Funding Commitment

Under the Amgen collaboration, we ~~have drawn down~~are responsible for co-funding global development costs for the ~~entire $18.0 million, which is secured by BeiGene (Suzhou)’s equipment with a carrying amount of $23.3 million and our rights~~licensed Amgen oncology pipeline assets up to a ~~PRC patent on a drug candidate. $9.0 million is repayable on each~~total cap of $1.25 billion. We are funding our portion of the co-development costs by contributing cash and development services. As of September 30, ~~2018~~2023, our remaining co-development funding commitment was $517.5 million.

Funding Commitment

Funding commitment represents our committed capital related to two equity method investments. As of September 30, 2023, our remaining capital commitment was $10.6 million and ~~2019.~~

~~Shareholder Loan~~

~~On March 7, 2017, BeiGene Biologics~~is expected to be paid from time to time over the investment period.

Research and Development Commitment

We entered into a ~~Shareholder Loan Contract with GET, pursuant~~long-term research and development agreement in June 2021, which includes obligations to ~~which, GET provided a Shareholder Loan~~make fixed quarterly payments over the next three years. As of September 30, 2023, the total research and development commitment amounted to BeiGene Biologics with the principal of RMB900 million at an 8% fixed annual interest rate. The term of the Shareholder Loan is 72 months, commencing from the actual drawdown date of April 14, 2017 and ending on April 13, 2023, unless converted earlier. On April 14, 2017, we drew down the entire RMB900 million from GET.

$16.5 million.

Capital Commitments

We had capital commitments amounting to ~~$36.1~~$442.6 million for the acquisition of property, plant and equipment as of September 30, ~~2017,~~2023, which ~~was primarily~~were mainly for ~~BeiGene~~our Hopewell facility, and additional capacity at the Guangzhou ~~Factory’s~~and Suzhou manufacturing ~~facility~~facilities.

We are making a significant investment in ~~Guangzhou, China.~~

~~Other Business Agreements~~

~~We enter into agreements~~our future manufacturing and clinical R&D center in the ~~normal course~~United States, a 42-acre site that is being constructed in Hopewell, NJ. We purchased this site for $75.2 million, announced its groundbreaking on April 29, 2022 and have $419.5 million of ~~business with CROs and institutions~~construction in process related to ~~license intellectual property.~~the project. We ~~have not included these future payments in~~expect continued significant capital expenditures as we build out the ~~table of contractual obligations above since~~Hopewell facility over the ~~contracts are cancelable at any time by us with prior written notice.~~

next several years.

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~~Off-Balance Sheet Arrangements~~

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules, such as relationships with unconsolidated entities or financial partnerships, which are often referred to as structured finance or special purpose entities, established for the purpose of facilitating financing transactions that are not required to be reflected on our balance sheets.

Critical Accounting Policies and Significant Judgments and Estimates

Our discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles ~~generally accepted in the United States of America, or GAAP.~~(“GAAP”). The preparation of these financial statements requires us to make estimates, assumptions and ~~assumptions~~judgments that affect the reported amounts of assets, liabilities, revenues, costs and ~~the disclosure of contingent assets and liabilities at the date of our financial statements and the reported amounts of revenues and expenses during the periods.~~expenses. We evaluate our estimates and judgments on an ongoing basis, ~~including~~and our actual results may differ from these estimates. These include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, estimating the incremental borrowing rate for operating lease liabilities, identifying separate accounting units and ~~estimating~~ the ~~best estimate~~standalone selling price of each ~~deliverable~~performance obligation in ~~our~~the Company's revenue arrangements, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets and the fair value of ~~warrant and option liabilities.~~financial instruments. We base our estimates on historical experience, known trends and events, contractual milestones and other various factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions.

There have been no material changes to our critical accounting policies ~~from~~as of and for the three and nine months ended September 30, 2023, as compared to those described in the section titled “Part ~~II—~~II – Item 7—7 – Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual ~~Report.~~ Report on Form 10-K for the year ended December 31, 2022.

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For ~~financial statement items relating to~~new accounting policies adopted during the three and nine months ended September 30, ~~2017,~~2023 , see ~~the accounting policies described in “Notes~~“Part I – Item 1 – Financial Statements—Notes to the Condensed Consolidated Financial Statements—~~2. Summary~~1. Description of ~~significant~~Business, Basis of Presentation and Consolidation and Significant Accounting Policies—Significant accounting policies” ofin this Quarterly Report on Form 10-Q.

~~Recent Accounting Pronouncements~~

~~See Note 2 to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for information regarding recent accounting pronouncements.~~

~~JOBS Act~~

Under Section 107(b) of the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, an “emerging growth company” can delay the adoption of new or revised accounting standards until such time as those standards would apply to private companies. We have irrevocably elected not to avail ourselves of this exemption and, as a result, we will adopt new or revised accounting standards at the same time as other public companies that are not emerging growth companies. For example, as an emerging growth company, we are exempt from Sections 14A(a) and (b) of the Exchange Act which would otherwise require us to (1) submit certain executive compensation matters to shareholder advisory votes, such as “say-on-pay,” “say-on-frequency” and “golden parachutes;” and (2) disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of our chief executive officer’s compensation to our median employee compensation. We also rely on an exemption from the rule requiring us to provide an auditor’s attestation report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and the rule requiring us to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis.

We have determined that, as of June 30, 2017, we have at least $700 million of equity securities held by non-affiliates, and as such we will no longer qualify as an emerging growth company as of December 31, 2017. As a result,

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~~we will no longer be able to take advantage of specified reduced disclosure and other requirements that are available to emerging growth companies after such date.~~

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Interest and Credit Risk

Financial instruments that are potentially subject to credit risk consist of cash, ~~and~~ cash equivalents, restricted cash and short-term investments. The carrying amounts of cash, ~~and~~ cash equivalents, restricted cash and short-term investments represent the maximum amount of loss due to credit risk. We had cash and cash equivalents of ~~$208.5~~$3.1 billion and $3.9 billion, restricted cash of $13.6 million and ~~$87.5~~$5.5 million, and short-term investments of ~~$548.9 million~~$0.1 billion and ~~$280.7 million at~~$0.7 billion as of September 30, ~~2017~~2023 and December 31, ~~2016,~~2022, respectively. ~~At September 30, 2017, our~~Our cash and cash ~~equivalents were~~equivalent are deposited with various major reputable financial institutions located ~~in the PRC and international financial institutions~~within or outside of the PRC. The deposits placed with these financial institutions are not protected by statutory or commercial insurance. In the event of bankruptcy of one of these financial institutions, we may be ~~unlikely~~unable to claim our deposits back in full. We believe that these financial institutions are of high credit quality, and we continually monitor the credit worthiness of these financial institutions. AtOn September 30, ~~2017,~~2023, our short-term investments consisted ~~primarily~~ of U.S. ~~Treasury securities and time deposits.~~treasury securities. We believe that the U.S. ~~Treasury~~treasury securities are of high credit quality and continually monitor the credit worthiness of these institutions.

The primary objectives of our investment activities are to preserve principal, provide liquidity, and maximize income without significant increasing risk. Our primary exposure to market risk relates to fluctuations in the interest rates, which are affected by changes in the general level of PRC and U.S. interest rates. Given the ~~short-term~~short‑term nature of our cash equivalents, we believe that a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operation. We estimate that a hypothetical 100-basis point ~~change~~increase or decrease in market interest rates would ~~impact the fair value~~result in a decrease of $0.2 million or an increase of ~~our investment portfolio~~$0.2 million, respectively, as of September 30, ~~2017 by $2.3 million.~~

2023.

We do not believe that our cash, cash equivalents and short-term investments have significant risk of default or illiquidity. While we believe our cash, ~~and~~ cash equivalents, and short-term investments do not contain excessive risk, we cannot provide absolute assurance that in the future investments will not be subject to adverse changes in market value.

We had accounts receivable, net of $309.1 million and $173.2 million as of September 30, 2023 and December 31, 2022, respectively. Accounts receivable, net represent amounts arising from product sales and amounts due from our collaboration partners. We monitor economic conditions to identify facts or circumstances that may indicate receivables are at risk of collection. To date, we have not experienced any significant losses with respect to the collection of our accounts receivable.

Foreign Currency Exchange Rate Risk

We are exposed to foreign exchange risk arising from various currency exposures. Our ~~functional~~reporting currency is the U.S. dollar, but a portion of our operating transactions and assets and liabilities are in other currencies, such as RMB, Euro, and Australian ~~dollar~~dollar. While we hold significant amounts of RMB, and ~~Euro. We do not believe that we currently have any significant direct~~are subject to foreign currency exchange risk upon revaluation or translation into our reporting currency, we expect to utilize our existing RMB cash deposits in the operation of our China business over the next several years, and as a result, have not used ~~any~~ derivative financial instruments to hedge exposure to such risk.

RMB is not freely convertible into foreign currencies for capital account transactions. The value of RMB against the U.S. dollar and other currencies is affected by, among other things, changes in China’s political and economic conditions and China’s foreign exchange prices. ~~From July 21,~~Since 2005, the RMB ishas been permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies. ~~For~~The RMB compared to the ~~RMB against~~ U.S. ~~dollars, there was appreciation of~~dollar depreciated approximately ~~4.4%~~5.5% in the nine months ended September 30, ~~2017~~2023 and ~~depreciation of~~depreciated approximately ~~6.3%~~8.2% in the year ended December 31, ~~2016,~~2022, respectively. It is difficult to predict how market forces or PRC or U.S. government policy may impact the exchange rate between the RMB and the U.S. dollar in the future.

To the extent that we need to convert U.S. dollars into RMB for capital expenditures, ~~and~~ working capital and other business ~~purpose,~~purposes, appreciation of RMB against the U.S. dollar would have an adverse effect on the RMB amount we would receive from the conversion. Conversely, if we decide to convert RMB into U.S. dollars for the purpose of making payments for dividends on our ordinary shares, strategic acquisitions or investments or other business purposes, appreciation of the U.S. dollar against RMB would have a negative effect on the U.S. dollar amount available to us.

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In addition, a significant depreciation of the RMB against the U.S. dollar may significantly reduce the U.S. dollar equivalent of our ~~earnings or losses.~~

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~~Currency Convertibility Risk~~

~~A majority of our expenses~~foreign cash balances and trade receivables. Further, volatility in exchange rate fluctuations may have a significant ~~portion of our assets and liabilities are denominated~~impact on the foreign currency translation adjustments recorded in RMB. On January 1, 1994, the PRC government abolished the dual rate system and introduced a single rate of exchange as quoted daily by the People’s Bank of China, or PBOC. However, the unification of exchange rates doesother comprehensive income (loss). We have not ~~imply that the RMB may be readily convertible into U.S. dollars or other foreign currencies. All~~used derivative financial instruments to hedge exposure to foreign exchange transactions continue to take place either through the PBOC or other banks authorized to buy and sell foreign currencies at the exchange rates quoted by the PBOC. Approvals of foreign currency payments by the PBOC or other institutions require submitting a payment application form together with suppliers’ invoices, shipping documents and signed contracts.

Additionally, the value of the RMB is subject to changes in central government policies and international economic and political developments affecting supply and demand in the PRC foreign exchange trading system market.

risk.

Effects of Inflation

Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our results of operations during the nine months ended September 30, ~~2017.~~

2023.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

~~Our management, with~~

Based on their evaluation, required by paragraph (b) of Rules 13a-15 or 15d-15, promulgated under the ~~participation~~Securities Exchange Act of 1934, as amended (the “Exchange Act”), our ~~Chief Executive Officer~~principal executive officer and ~~our Chief Financial Officer, evaluated the effectiveness of~~principal financial officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act are effective, at a reasonable assurance level, as of September 30, ~~2017. The term “disclosure controls and procedures,” as defined in Rule 13a‑15(e) under the Exchange Act means controls and other procedures of a company that are designed~~2023, to ensure that information required to be disclosed ~~by the company~~ in ~~the~~ reports that ~~it files~~we file or ~~submits~~submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in ~~the SEC’s~~U.S. Securities and Exchange Commission rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by ~~a company~~us in the reports that ~~it files~~we file or ~~submits~~submit under the Exchange Act is accumulated and communicated to ~~the company’s~~our management, including ~~its~~our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. ~~Management recognizes~~In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how ~~well-designed~~well designed and operated, can provide only reasonable ~~assurance~~assurances of achieving ~~their~~the desired control objectives, and management necessarily ~~applies~~was required to apply its judgment in designing and evaluating the ~~cost-benefit relationship of possible~~ controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2017, our management, including our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule ~~13a-15(d)~~13a‑15(d) and ~~15d-15(d)~~15d‑15(d) of the Exchange Act that occurred during the ~~three months~~quarter ended September 30, ~~2017,~~2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time we may become involved in legal proceedings or be subject to claims ~~arising in the~~of a nature considered ordinary course in our business, including the intellectual property litigation described herein. Most of ~~our business. We~~the issues raised by such claims are ~~not presently~~highly complex and subject to substantial uncertainties. For a ~~party~~description of risks relating to ~~any~~these legal proceedings, ~~that, if determined adversely~~see “Part II – Item 1A – Risk Factors” of this Quarterly Report, including the discussion under the headings entitled “Risks Related to ~~us, would individually or taken together have a material adverse effect on our business, results~~Our Intellectual Property.” The outcome of ~~operations, financial condition or cash flows.~~any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

ABRAXANE®

~~Table~~On June 26, 2020, following the suspension and recall of ~~Contents~~

ABRAXANE in China supplied to us by Celgene Logistics Sàrl, a Bristol-Myers Squibb Company (referred to elsewhere in this report as BMS, but for this paragraph only, “BMS-Celgene”), we initiated an arbitration proceeding at the International Chamber of Commerce against BMS-Celgene (the “Arbitration”) asserting that it had breached and continued to breach the terms and conditions of the License and Supply Agreement entered into by BeiGene and BMS-Celgene in July 2017 (the “LSA”) and the Amended and Restated Quality Agreement (the “QA” and collectively with the LSA, the “BMS-Celgene License”). Under the BMS-Celgene License, we alleged that BMS-Celgene was obligated, among other things, to ensure the continuity and adequacy of its supply of ABRAXANE to us. In the Arbitration, we sought (i) a declaration that BMS-Celgene was and continued to be in breach of the BMS-Celgene License, (ii) a declaration that BMS-Celgene acted with gross negligence and/or willful misconduct, (iii) an award of damages, and (iv) such other relief as the arbitrators deemed appropriate. BMS-Celgene responded in part by submitting a counterclaim against us seeking to recover approximately $30 million in costs that it contends it incurred as part of the ABRAXANE recall. In October 2021, BMS-Celgene delivered a notice to us purporting to terminate the BMS-Celgene License with respect to ABRAXANE® and providing 180-days' notice that it was withdrawing ABRAXANE from the range of products for sale or distribution in China pursuant to Section 2.6 of the BMS-Celgene License. Thereafter, we amended our claims to add a claim for wrongful termination of the BMS-Celgene License with respect to ABRAXANE. A hearing was held in the Arbitration in June 2022.

Prior to a decision being issued in the Arbitration, on August 1, 2023, we entered into a Settlement and Termination Agreement (the “Settlement Agreement”) with BMS-Celgene and certain of its affiliates relating to the termination of the parties’ ongoing contractual relationship, the Arbitration, the LSA, the QA, and the Share Subscription Agreement (the “SSA”), entered into by the parties in 2017 and 2018. Pursuant to the Settlement Agreement, the parties agreed to mutually dismiss the Arbitration and BMS-Celgene and its affiliates agreed to transfer 23,273,108 of our ordinary shares originally purchased in 2017, in each case subject to and in accordance with the terms and conditions of the Settlement Agreement. We have no payment obligation in exchange for the transferred shares pursuant to the Settlement Agreement. Furthermore, the parties agreed to terminate the LSA and QA on December 31, 2023, subject to our right to continue selling all inventory of REVLIMID® and VIDAZA® until sold out or December 31, 2024, whichever is earlier. The Settlement Agreement provides for a settlement and release by each party of claims arising from or relating to the Arbitration, the LSA, the QA and the SSA, as well as other disputes and potential disputes between the parties, in each case subject to and in accordance with the terms and conditions of the Agreement. The settlement closed on August 15, 2023, and the matter is concluded.

BRUKINSA®

On June 13, 2023, Pharmacyclics LLC (“Pharmacyclics”) filed a complaint in the U.S. District Court for the District of Delaware (the “Court”) against the Company and its subsidiary, BeiGene USA, Inc., alleging that BRUKINSA infringes Pharmacyclics’ U.S Patent No. 11,672,803 issued on June 13, 2023 (the “‘803 patent”). Pharmacyclics seeks a declaration of infringement, unspecified monetary damages and other relief. The Company intends to vigorously defend against the claims.

On October 12, 2023, the Court entered a joint stipulation filed by the parties to stay the infringement suit pending resolution of a petition for post-grant review (“PGR”) of the ‘803 Patent with the U.S. Patent and Trademark Office (“USPTO”) to be filed by the Company by November 3, 2023. On November 1, 2023, the Company filed a PGR petition against the ‘803 Patent with the USPTO.

Item 1A. Risk Factors.

The following section includes ~~the most significant~~material factors that we believe may adversely affect our business and operations. You should carefully consider the risks and uncertainties described below and all information contained in this Quarterly Report, including our financial statements and the related notes and “Part I—I – Item 2—2 – Management’s Discussion and Analysis of

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Financial Condition and Results of Operations,” before deciding to invest in ~~the ADSs.~~our ADSs, ordinary shares or RMB Shares. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of ~~the~~our ADSs, ordinary shares or RMB Shares could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Please refer to the explanation of the qualifications and limitation on forward-looking statements set forth at the outset of “Part I – Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

The risk factors denoted with a “*”, if any, are newly added or have been materially updated from our Annual ~~Report.~~

~~Risks Related~~Report on Form 10-K for the year ended December 31, 2022 (the “Annual Report”).

Summary of Risk Factors

Below is a summary of the material factors that make an investment in our American Depositary Shares (“ADSs”) listed on Nasdaq, our ordinary shares listed on The Stock Exchange of Hong Kong Limited, and our ordinary shares issued to permitted investors in China and listed and traded on the Science and Technology Innovation Board of the Shanghai Stock Exchange in Renminbi (“RMB Shares”) speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, are set forth herein and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the U.S. Securities and Exchange Commission (“SEC”), before making an investment decision regarding our ADSs, ordinary shares or RMB Shares.

•Our ~~Financial Position~~medicines may fail to achieve and ~~Need~~maintain the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for ~~Additional Capital~~

*commercial success.

•We have limited experience in launching and marketing our internally developed and in-licensed medicines. If we are ~~a globally focused biopharmaceutical company~~unable to further develop marketing and ~~have a limited operating history,~~sales capabilities or enter into agreements with third parties to market and sell our medicines, we may not be able to generate substantial product sales revenue.

•We face substantial competition, which may ~~make it difficult~~result in others discovering, developing, or commercializing competing medicines before or more successfully than we do.

•The market opportunities for our medicines may be limited to ~~evaluate~~those patients who are ineligible for or have failed prior treatments and may be small.

•If we or any third parties with which we may collaborate to market and sell our ~~current~~medicines are unable to achieve and maintain coverage and adequate levels of reimbursement, our commercial success and business operations could be adversely affected.

•We depend substantially on the success of the clinical development of our medicines and ~~predict~~drug candidates. If we are unable to successfully complete clinical development, obtain regulatory approvals and commercialize our ~~future performance.~~

~~We are~~medicines and drug candidates, or experience significant delays in doing so, our business will be materially harmed.

•Clinical development involves a ~~globally focused biopharmaceutical company formed in October 2010. Our operations to date have focused on organizing~~lengthy and ~~staffing our company, business planning, raising capital, establishing our intellectual property portfolio~~expensive process with an uncertain outcome, and ~~conducting preclinical~~results of earlier studies and trials may not be predictive of future trial results.

•If clinical trials of our ~~current~~ drug candidates ~~such as BGB-3111, BGB-A317, BGB-290~~fail to demonstrate safety and ~~BGB-283. We have~~efficacy to the satisfaction of regulatory authorities or do not yet demonstrated an ability to successfully complete large-scale, registrational clinical trials, obtain regulatory approvals, manufacture a commercial scale drug, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. We have not yet obtained regulatory approval for, or demonstrated an ability to commercialize, any of our internally developed drug candidates. We have no internally developed products approved for commercial sale and have not generated any revenue from internally developed product sales. Since September 2017, we have generated revenues from the sale of ABRAXANE®, REVLIMID®, and VIDAZA® under a license from Celgene Corporation as described in this Quarterly Report. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history. In addition, as an early-stage business,otherwise produce positive results, we may ~~encounter unforeseen expenses, difficulties, complications,~~incur additional costs or experience delays ~~and other known and unknown factors.~~

~~We are focused on~~in completing, or ultimately be unable to complete, the ~~discovery,~~ development and commercialization of ~~innovative, molecularly targeted and immuno-oncology drugs for the treatment of cancers. Our limited operating history, particularly~~our drug candidates.

•If we encounter difficulties enrolling patients in ~~light~~our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

•All material aspects of the ~~rapidly evolving cancer treatment field,~~research, development, manufacturing and commercialization of pharmaceutical products are heavily regulated, and we may ~~make it difficult~~face difficulties in complying with or be unable to ~~evaluate~~comply with such regulations, which could have a material adverse effect on our ~~current business~~business.

•The approval processes of regulatory authorities in the United States, China, Europe and ~~predict our future performance. Our short history makes any assessment of our future success or viability subject to significant uncertainty. We will encounter risks~~other comparable regulatory authorities are lengthy, time consuming, costly, and ~~difficulties frequently experienced by early-stage companies in rapidly evolving fields as we seek to transition to a company capable of supporting commercial activities.~~inherently unpredictable. If we ~~do not address these risks and difficulties successfully,~~experience delays or are ultimately unable to obtain regulatory approval for our drug candidates, our business will ~~suffer.~~

*be substantially harmed.

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•Our medicines and any future approved drug candidates will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our medicines and drug candidates.

•Even if we are able to commercialize our medicines and any approved drug candidates, the medicines may become subject to unfavorable pricing regulations or third-party reimbursement practices or healthcare reform initiatives, which could harm our business.

•We have ~~a history of incurring~~incurred significant net losses since our inception and anticipate that we will continue to incur net losses for the foreseeable ~~future.~~

Investment in pharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a drug candidate will fail to gain regulatory approval or become commercially viable. We have devoted most of our financial resources to research and development, including our nonclinical development activities and clinical trials. We continue to incur significant development and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred losses in each period since our inception in 2010, except in the third quarter of 2017, where we were profitable due to revenue recognized from up-front license fees in connection with our strategic collaboration with Celgene. As of September 30, 2017, we had a deficit accumulated of $231.2 million. Substantially all of our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations.

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~~We expect to continue to incur losses for the foreseeable~~ future and we expect these losses to increase as we continue our development of, and seek regulatory approvals for, our drug candidates, and begin to commercialize the approved drugs we have licensed from Celgene in China and any other drugs that we may successfully develop or license. Typically, it takes many years to develop one new drug from the time it is discovered to when it is available for treating patients. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses, our ability to generate revenues and the timing and amount of milestones and other required payments to third parties in connection with our potential future arrangements with third parties. If any of our drug candidates fail in clinical trials or do not gain regulatory approval, or if approved, fail to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our prior losses and expected future losses have had, and will continue to have, an adverse effect on our shareholders’ equity and working capital.

We expect our research and development expenses to continue to be significant in connection with our continued investment in our cancer biology platform and our ongoing and planned clinical trials for our drug candidates, such as BGB-3111, BGB-A317, BGB-290 and BGB-283. Furthermore, we expect to incur increased sales and marketing expenses for the approved drugs we have licensed from Celgene in China and any other drugs that we may successfully develop or license. In addition, we will continue to incur costs associated with operating as a public company and in support of our growth as a global biotechnology company. As a result, we expect to continue to incur significant and increasing operating losses and negative cash flows for the foreseeable future. These losses have had and will continue to have a material adverse effect on our shareholders’ deficit, financial position, cash flows and working capital.

*We may never become profitable.

Our ability to generate revenue and become profitable depends upon our ability to successfully complete the development of, and obtain the necessary regulatory approvals for, our drug candidates, such as BGB-3111, BGB-A317, BGB-290 and BGB-283 and successfully market our in-licensed drugs in China ~~and any other drugs that we may successfully develop or license~~. We expect to continue to incur substantial and increasing losses through the commercialization of our in-licensed drugs and internally developed drug candidates, if approved. None of our internally developed drug candidates have been approved for marketing in the United States, the European Union, the People’s Republic of China, or PRC, or any other jurisdiction and may never receive such approval. Our ability to achieve revenue and profitability is in part dependent on our ability to complete the development of our drug candidates, obtain necessary regulatory approvals, and have our drugs manufactured and successfully marketed.

Even if we receive regulatory approval of our drug candidates for commercial sale, we do not know when they will generate revenue, if at all. Our ability to generate product sales revenue depends on a number of factors, including our ability to continue:

~~completing research regarding, and nonclinical and clinical development of, our drug candidates;~~

~~obtaining regulatory approvals for drug candidates for which we complete clinical trials;~~

~~obtaining adequate reimbursement from third-party payors, including government payors;~~

developing a sustainable and scalable manufacturing process for our drugs and drug candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing our own manufacturing capabilities and infrastructure;

~~launching and commercializing our drugs and any drug candidates for which we obtain regulatory approvals, either directly or with a collaborator or distributor;~~

~~obtaining market acceptance of our drugs and drug candidates as viable treatment options;~~

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~~identifying, assessing, acquiring and/or developing new drugs and drug candidates;~~

~~addressing any competing technological and market developments;~~

negotiating and maintaining favorable terms in any collaboration, licensing or other arrangements into which we may enter, such as our collaboration arrangements with Celgene and Merck KGaA, Darmstadt Germany;

~~maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and~~

~~attracting, hiring and retaining qualified personnel.~~

In addition, because of the numerous risks and uncertainties associated with drug development, we are unable to predict the timing or amount of increased expenses, or when, or if, we will be able to achieve or maintain profitability. In addition, our expenses could increase beyond expectations if we are required by the FDA, the CFDA, the EMA, or other comparable regulatory authorities to perform studies in addition to those that we currently anticipate. Even if our drug candidates are approved for commercial sale, we anticipate incurring significant costs associated with the commercial launch of these drugs.

Our ability to become and remain profitable depends on our ability to generate revenue. Even if we are able to generate revenues from the sale of our in-licensed drugs and any other drugs that we may successfully develop or license, we may not become ~~profitable and~~profitable.

•We may need to obtain additional funding to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, expand our business or continue our operations. Failure to become and remain profitable may adversely affect the market price of the ADSs and our ability to raise capital and continue operations.

*We will need to obtain additional financing to fund our operations, and if we are unable to obtain such financing, we may be unable to complete the development ~~and commercialization~~ of ~~our primary drug candidates.~~

We have financed our operations with a combination of equity and debt offerings, collaboration and license agreements, and private and public grants. Since our inception through September 30, 2017, we have raised approximately $1.0 billion, consisting of an aggregate of $180.0 million in private financings prior to our IPO; an aggregate of $553.3 million in our IPO and follow-on public offerings, including most recently $188.5 million in net proceeds in August 2017; $150.0 million from an equity investment from Celgene in connection with our collaboration agreement; and an aggregate of $300.0 million from upfront and milestone payments through our collaboration arrangements with Merck KGaA, Darmstadt Germany and Celgene, including $171 million in upfront license fees expected to be received under our Celgene agreement in December 2017. In addition, under our collaboration with Celgene, we are eligible to receive up to $980 million in development, regulatory and sales milestone payments and royalties in the low-double digit to mid-twenty percentages on any future sales of BGB-A317, based on specified terms. While we have generated product revenue in China since September 2017 from sales of our approved drugs licensed from Celgene, our drug candidates ~~will require~~or achieve profitability.

•If we are unable to obtain and maintain patent protection for our medicines and drug candidates through intellectual property rights, or if the ~~completion~~scope of such intellectual property rights is not sufficiently broad, third parties may compete against us.

•We rely on third parties to manufacture some of our commercial and clinical ~~development, regulatory review, significant marketing efforts and substantial investment before they can~~drug supplies. Our business could be harmed if those third parties fail to provide us with sufficient quantities of product or fail to do so at acceptable quality levels or prices.

•We have entered into licensing and collaboration arrangements and may enter into additional ~~product~~collaborations, licensing arrangements, or strategic alliances in the future, and we may not realize the benefits of such arrangements.

•If we fail to maintain an effective distribution channel for our medicines, our business and sales ~~revenue.~~

~~Our operations~~could be adversely affected.

•If third-party manufacturers fail to comply with manufacturing regulations, our financial results and financial condition could be adversely affected.

•If we are not able to successfully develop and/or commercialize Amgen’s oncology products, the expected benefits of the collaboration will not materialize.

•We have ~~consumed substantial amounts of cash since inception. Our operating activities used $81.0 million~~significantly increased and ~~$63.4 million of net cash during the nine months ended September 30, 2017 and 2016, respectively. We~~ expect to continue to ~~spend substantial amounts~~increase our research, development, manufacturing, and commercial capabilities, and we may experience difficulties in managing our growth.

•Our future success depends on ~~drug discovery, advancing~~our ability to retain key executives and to attract, retain and motivate qualified personnel.

•Our business is subject to complex and evolving industry-specific laws and regulations regarding the ~~clinical development~~collection and transfer of personal data. These laws and regulations can be complex and stringent, and many are subject to change and uncertain interpretation, which could result in claims, changes to our data and other business practices, significant penalties, increased cost of operations, or otherwise adversely impact our business.

•We manufacture some of our ~~drug candidates, commercializing our approved drugs~~medicines and ~~launching and commercializing any drug candidates for which we receive regulatory approval, including building our own commercial organization~~intend to ~~address China and other markets.~~

We will need to obtain additional financing to fund our future operations, including completing the development and potential commercialization of our primary drug candidates: BGB-3111, BGB-A317, BGB-290 and BGB-283. We

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~~will need to obtain additional financing to conduct additional clinical trials for the approval~~manufacture some of our drug candidates, if ~~requested by~~approved. Failure to comply with regulatory ~~bodies,~~requirements could result in sanctions being imposed against us and delays in completing ~~the~~and receiving regulatory approvals for our manufacturing facilities, or damage to, destruction of or interruption of production at such facilities, could delay our development ~~of any additional drug candidates we might discover. Moreover, our fixed expenses such as rent, interest expense and other contractual commitments are substantial and are expected to increase~~plans or commercialization efforts.

•Changes in the ~~future.~~

~~Our forecast~~political and economic policies of the ~~period~~PRC government or in relations between China and the United States or other governments, and the significant oversight and discretion the PRC government has over the conduct of ~~time through~~the business operations of our PRC subsidiaries may materially and adversely affect our business, financial condition, and results of operations and may result in our inability to sustain our growth and expansion strategies.

•The audit reports included in our previous annual reports on Form 10-K filed with the SEC have historically been prepared by auditors who are not inspected fully by the Public Company Accounting Oversight Board, and as such, investors have previously been deprived of the benefits of such inspection.

•The trading prices of our ordinary shares, ADSs, and/or RMB Shares can be volatile, which could result in substantial losses to you.

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Risks Related to Clinical Development and Commercialization of Our Medicines and Drug Candidates

Our medicines may fail to achieve and maintain the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.

Our medicines may fail to achieve and maintain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community. For example, current cancer treatments like chemotherapy and radiation therapy are well established in the medical community, and doctors may continue to rely on these treatments to the exclusion of our ~~financial resources~~medicines. If our medicines do not achieve and maintain an adequate level of market acceptance, the sales of our medicines may be limited and we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of our medicines will ~~be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of~~depend on a number of factors, including: the clinical indications for which our medicines are approved; physicians, hospitals, cancer treatment centers, and patients considering our medicines safe and effective; government agencies, professional societies, practice management groups, insurance carriers, physicians’ groups, private health and science foundations, and organizations recommending our medicines and reimbursement; the perceived advantages and relative cost of alternative treatments; the prevalence and severity of any side effects; product labeling, including limitations or warnings, or product insert requirements of regulatory authorities; the ~~factors discussed elsewhere in this “Risk Factors” section. We have based this estimate on assumptions that may prove to be wrong,~~timing of market introduction of our medicines as well as competitive medicines; the availability of adequate coverage, reimbursement and ~~we could utilize~~pricing by third-party payors and government authorities; and the effectiveness of our ~~available capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including, but not limited to:~~

~~the progress, timing, scope and costs of our clinical trials, including the ability to timely enroll patients in our planned and potential future clinical trials;~~

the outcome, timing and cost of regulatory approvals by the FDA, CFDA, EMA and comparable regulatory authorities, including the potential that the FDA, CFDA, EMA or comparable regulatory authorities may require that we perform more studies than those that we currently expect;

~~the number and characteristics of drug candidates that we may in-license and develop;~~

~~our ability to successfully commercialize our drugs and drug candidates;~~

~~the amount of~~ sales ~~and other revenues from the drugs and drug candidates that we may commercialize, if any, including the selling prices for such products and the availability of adequate third-party reimbursement;~~

the amount and timing of the milestone and royalty payments we receive from our collaborators under our licensing arrangements, such as our collaborations with Merck KGaA, Darmstadt Germany and Celgene;

~~the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;~~

selling and marketing costs associated with our current drug products in China and any future drug candidates that may be approved, including the cost and timing of expanding our marketing and sales capabilities;

~~the terms and timing of any potential future collaborations, licensing or other arrangements that we may establish;~~

~~cash requirements of any future acquisitions and/or the development of other drug candidates;~~

~~the costs of operating as a public company;~~

~~the cost and timing of development and completion of commercial-scale internal or outsourced manufacturing activities;~~

~~the time and cost necessary to respond to technological and market developments; and~~

~~the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.~~

Until we can generate a sufficient amount of revenue, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing ~~or distribution arrangements. Additional funds~~efforts.

Even if our medicines achieve market acceptance, we may not be ~~available~~able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our medicines, are more cost effective or render our medicines obsolete.

We have limited experience in launching and marketing our internally developed and in-licensed medicines. If we are unable to further develop marketing and sales capabilities or enter into agreements with third parties to market and sell our medicines, we may not be able to generate substantial product sales revenue.

We became a commercial-stage company in 2017, when we ~~need them on terms that are acceptable~~entered into a license and supply agreement with Celgene Logistics Sàrl, now a Bristol-Myers Squibb Company (“BMS”), to ~~us,~~commercialize three of BMS’s approved cancer therapies, in the People's Republic of China (“PRC” or ~~at all. General~~“China”). In October 2019, we entered into a collaboration with Amgen for its commercial-stage oncology products and a portfolio of clinical- and late-preclinical-stage oncology pipeline products. We received the first approvals for our internally developed drug candidates in late 2019 in the United States, in 2020 in China, and in 2021 in Europe. Given this, we have limited experience in commercializing our internally developed and in-licensed medicines, including building and managing a commercial team, conducting a comprehensive market ~~conditions or the market price of the ADSs may not support capital raising transactions such as an additional public or private offering of the ADSs or other securities. In addition,~~analysis, obtaining state licenses and reimbursement, and managing distributors and a sales force for our medicines. As a result, our ability to ~~raise additional capital~~successfully commercialize our medicines may ~~be dependent upon~~involve more inherent risk, take longer, and cost more than it would if we were a company with substantial experience in launching medicines.

If we are unable to, or decide not to, further develop internal sales, marketing, and commercial distribution capabilities for any or all of our medicines in any country or region, we will likely pursue collaborative arrangements regarding the ~~ADSs being quoted on the NASDAQ or upon obtaining shareholder approval. There~~sales and marketing of our medicines. However, there can be

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no assurance that we will be able to ~~satisfy~~establish or maintain such collaborative arrangements, or if we are able to do so, that they will have effective sales forces. We would have little or no control over the ~~criteria for continued listing on the NASDAQ or~~marketing and sales efforts of such third parties, and our revenue from product sales may be lower than if we had commercialized our medicines ourselves.

There can be no assurance that we will be able to ~~obtain shareholder approval if it is necessary. If adequate funds are not available,~~further develop and successfully maintain internal sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any medicine, and as a result, we may be required to delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. In addition, if we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or drug candidates or to grant licenses on terms that may not be ~~favorable~~able to ~~us.~~

generate substantial product sales revenue.

We ~~believe~~face substantial competition, which may result in others discovering, developing, or commercializing competing medicines before or more successfully than we do.

The development and commercialization of new medicines is highly competitive. We face competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell medicines or are pursuing the development of medicines for the treatment of cancer for which we are commercializing our medicines or developing our drug candidates. For example, BRUKINSA, tislelizumab, and pamiparib face substantial competition, and some of our products face or are expected to face competition from generic therapies. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing, and commercialization.

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Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize medicines that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than our medicines. Our competitors also may obtain approval from regulatory authorities for their medicines more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market and/or slow our regulatory approval.

Many of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved medicines than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific, management and marketing personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

The market opportunities for our medicines may be limited to those patients who are ineligible for or have failed prior treatments and may be small.

In markets with approved therapies, we have and expect to initially seek approval of our drug candidates as a later stage therapy for patients who have failed other approved treatments. Subsequently, for those medicines that prove to be sufficiently beneficial, if any, we would expect to seek approval as a second-line therapy and potentially as a first-line therapy, but there is no guarantee that our ~~existing cash~~medicines and ~~cash equivalents, will not be sufficient to enable us to complete all global development or commercially launch our current~~ drug candidates, even if approved, would be approved for second-line or first-line therapy.

Our projections of both the ~~currently anticipated indications~~number of people who have the diseases we are targeting, as well as the subset of people with these diseases in a position to receive later stage therapy and who have the potential to ~~invest in additional programs. Accordingly, we will require further funding through other public~~benefit from treatment with our medicines and drug candidates, may prove to be inaccurate or ~~private offerings, debt financing, collaboration~~based on imprecise data. Further, new studies may change the estimated incidence or prevalence of these cancers. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for our medicines and ~~licensing arrangements~~drug candidates may be limited or ~~other sources. Adequate additional funding~~ may not be amenable to treatment with our medicines and drug candidates. Even if we obtain significant market share for our medicines and drug candidates, because the potential target populations are small, we may never achieve profitability without obtaining regulatory approval for additional indications, including use as a first- or second-line therapy.

*If we or any third parties with which we may collaborate to market and sell our medicines are unable to achieve and maintain coverage and adequate levels of reimbursement, our commercial success and business operations could be adversely affected.

Our ability or the ability of any third parties with which we collaborate to commercialize our medicines successfully will depend in part on the extent to which reimbursement for these medicines is available ~~to us~~ on ~~acceptable~~adequate terms, or at ~~all. If we are unable~~all, from government health administration authorities, private health insurers and other organizations. In the United States and markets in other countries, patients generally rely on third-party payors to ~~raise capital when needed~~reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Sales of our medicines will depend substantially, both domestically and abroad, on ~~attractive terms, we would~~the extent to which the costs of our medicines will be ~~forced to delay, reduce~~paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or ~~eliminate our research~~reimbursed by government health administration authorities, private health coverage insurers and ~~development programs or future commercialization efforts. Our inability~~other third-party payors. Without third-party payor reimbursement, patients may not be able to obtain or afford prescribed medications. Third-party payors also are seeking to encourage the use of generic or biosimilar products or entering into sole source contracts with healthcare providers, which could effectively limit the coverage and level of reimbursement for our medicines and have an adverse impact on the market access or acceptance of our medicines. In addition, reimbursement guidelines and incentives provided to prescribing physicians by third party payors may have a significant impact on the prescribing physicians’ willingness and ability to prescribe our products. For additional ~~funding when we need it~~information, please see the section of our Annual Report titled “Part I —Item 1 — Business — Government Regulation — Pharmaceutical Coverage, Pricing, and Reimbursement.”

A primary trend in the global healthcare industry is cost containment. Government authorities and these third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

In the United States, no uniform policy of coverage and reimbursement for drugs exists among third-party payors. As a result, obtaining coverage and reimbursement approval of a drug from a government or other third-party payor is a time-consuming and costly process that could ~~seriously harm our business.~~

~~Raising additional capital may cause dilution to our shareholders, restrict our operations or~~ require us to ~~relinquish rights~~provide to each payor supporting scientific, clinical and cost- effectiveness data for the use of our ~~technologies or drug candidates.~~

~~We may seek additional funding through~~medicines on a ~~combination of equity offerings, debt financings, collaborations~~payor-by-payor basis, with no assurance that coverage and ~~licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest~~adequate reimbursement will be ~~diluted,~~obtained. The principal decisions about reimbursement for new medicines are typically made by the

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Centers for Medicare and Medicaid Services (the “CMS”). They decide whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. Factors payors consider in determining reimbursement are based on whether the ~~terms may include liquidation or other preferences that adversely affect your rights as~~product is: a ~~holder of~~covered benefit under its health plan; safe, effective and medically necessary; appropriate for the ~~ADSs or our ordinary shares. The incurrence of additional indebtedness or the issuance of certain equity securities could result in increased fixed payment obligations~~specific patient; cost-effective; and could also result in certain additional restrictive covenants, such as limitations on our ability to incur additional debt or issue additional equity, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. In addition, issuance of additional equity securities, or the possibility of such issuance, may cause the market price of the ADSs to decline. In the event that we enter into collaborations or licensing arrangements in order to raise capital, weneither experimental nor investigational.

Coverage may be ~~required to accept unfavorable terms, including relinquishing~~more limited than the purposes for which the medicine is approved by the United States Food and Drug Administration (“FDA”) or ~~licensing to~~comparable regulatory authorities in other countries. Even if we obtain coverage for a ~~third party on unfavorable terms our rights to technologies or drug candidates that we otherwise would seek to develop or commercialize ourselves or potentially reserve~~given medicine, the resulting reimbursement rates might not be adequate for ~~future potential arrangements when we might be able~~us to achieve ~~more favorable terms.~~

~~Fluctuations in exchange rates could result in foreign currency exchange losses and could materially reduce~~or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the ~~value of your investment.~~

~~We incur portions~~use of our ~~expenses,~~medicines. Patients are unlikely to use our medicines unless coverage is provided and ~~may in the future derive revenues, in currencies other than the U.S. dollar, in particular, the RMB and Australian dollars. As a result, we are exposed~~reimbursement is adequate to ~~foreign currency exchange risk as our results of operations and cash flows are subject to fluctuations in foreign currency exchange rates. For example,~~cover a significant portion of the cost of the medicine. Because some of our ~~clinical trial activities~~medicines and drug candidates have a higher cost of goods than conventional therapies and may require long-term follow-up evaluations, the risk that coverage and reimbursement rates may be inadequate for us to achieve profitability may be greater.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Furthermore, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.

We cannot be sure that reimbursement will be available for any product candidate that we commercialize and, if reimbursement is available, the level of reimbursement. In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price and best price. Penalties may apply in some cases when such metrics are ~~conducted outside of~~not submitted accurately and timely.

In China, drug prices are typically lower than in the United States and ~~associated costs may~~Europe, and until recently, the market has been dominated by generic drugs. Government authorities regularly review the inclusion or removal of medicines from China’s National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance, or the National Reimbursement Drug List (the “NRDL”), or provincial or local medical insurance catalogues for the National Medical Insurance Program, and the tier under which a medicine will be ~~incurred~~classified, both of which affect the amounts reimbursable to program participants for their purchases of those medicines. There can be no assurance that our medicines and any approved drug candidates will be included in the ~~local currency~~NRDL or provincial reimbursements lists, or if they are, that they will be included at a price that allows us to be commercially successful. Products included in the NRDL have typically been generic and essential drugs. Innovative drugs similar to our medicines and drug candidates have historically been more limited on their inclusion in the NRDL due to the affordability of the ~~country~~Chinese government’s Basic Medical Insurance, although this has been changing in which the trial is being conducted, which costs could be subject to fluctuations in currency exchange rates. We currently do not engage in hedging transactions to protect against uncertainty in future exchange rates between particular foreign currenciesrecent years. For example, BRUKINSA, tislelizumab, pamiparib, XGEVA and ~~the U.S. dollar. A decline~~KYPROLIS have been included in the ~~value of~~NRDL. While the U.S. dollar against currencies in countries in which we conduct clinical trials could have a negative impact on our research and development costs. We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuationsdemand for these medicines has generally increased after inclusion in the ~~future may adversely affect our financial condition, results of operations~~NRDL, there can be no assurance that demand will continue to increase and ~~cash flows.~~

~~The value of~~such increases will be sufficient to offset the RMB against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in political and economic conditions and the foreign exchange policy adopted by the PRC, Australia and other non-U.S. governments. For instance, in August 2015, the People’s Bank of China, or PBOC, changed the way it calculates the mid-point price of Renminbi against the U.S. dollar, requiring the market-makers who submit for reference rates to consider the previous day’s closing spot rate, foreign-exchange demand and supply as well as changes in major currency rates. It is difficult to predict how market forces or PRC, Australia, other non-U.S. governments and U.S.

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~~government policies may impact the exchange rate of RMB and the U.S. dollar or any other currencies~~reduction in the future. There remains significant international pressure on the PRC government to adopt a more flexible currency policy, including from the U.S. government, which has threatened to label China as a “currency manipulator,” which could result in greater fluctuation of the RMB against the U.S. dollar.

It is difficult to predict how market forces or PRC, Australian, U.S. or other government policies may impact the exchange rate between the Australian dollar, RMB, U.S. dollar and other currencies in the future. There remains significant international pressure on the PRC government to adopt a more flexible currency policy, which could result in greater fluctuation of the RMB against the U.S. dollar. Substantially all of our revenues are denominated in U.S. dollarsprices and our costs are denominated in U.S. dollars, Australian dollars and RMB, and a large portion of our financial assets and a significant portion of our debt is denominated in U.S. dollars. Any significant revaluation of the RMB may materially reduce any dividends payable on the ADSs in U.S. dollars. To the extent that we need to convert U.S. dollars we received from our initial public offering and follow-on public offering into RMB for our operations, appreciation of the RMB against the U.S. dollar would have an adverse effect on the RMB amount we would receive. Conversely, if we decide to convert our RMB into U.S. dollars for the purpose of making payments for dividends on our ordinary shares or ADSs or for other business purposes, appreciation of the U.S. dollar against the RMB would have a negative effect on the U.S. dollar amount we would receive.

*Our investments are subject to risks thatmargins, which could ~~result in losses.~~

We had cash, cash equivalents and short-term investments of $757.4 million and $368.2 million at September 30, 2017 and December 31, 2016, respectively. In addition, we expect to receive $171 million in upfront license fees under our Celgene collaboration in December 2017. At September 30, 2017, our short-term investments mainly consisted of U.S. Treasury securities and time deposits. We may invest our cash in a variety of financial instruments, principally securities issued by the U.S. government and its agencies, investment grade corporate bonds, including commercial paper and money market instruments, which may not yield a favorable return to our shareholders. All of these investments are subject to credit, liquidity, market and interest rate risk. Such risks, including the failure or severe financial distress of the financial institutions that hold our cash, cash equivalents and investments, may result in a loss of liquidity, impairment to our investments, realization of substantial future losses, or a complete loss of the investments in the long-term, which may have a material adverse effect on our business, financial condition and results of ~~operations, liquidity~~operations. We prepare for the NRDL negotiations in China for our eligible medicines/indications annually. If any of these medicines/indications are not included in the NRDL or included at a significantly lower price, the revenues for such medicines could be limited, which could have a material adverse effect on our business, financial condition and results of operations.

Increasingly, third-party payors are requiring that companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be available for any medicine that we commercialize and, if reimbursement is available, what the level of reimbursement will be. Reimbursement may impact the demand for, or the price of, any medicine which we commercialize. Obtaining or maintaining reimbursement for our medicines may be particularly difficult because of the higher prices often associated with medicines administered under the supervision of a physician. If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any medicine and drug candidate that we in-license or successfully develop.

There may be significant delays in obtaining reimbursement for approved medicines, and coverage may be more limited than the purposes for which the medicine is approved by regulatory authorities. Moreover, eligibility for reimbursement does not imply that any medicine will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim payments for new medicines, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Payment rates may vary according to the use of the medicine and the clinical setting in which it is used, may be based on payments allowed for lower cost medicines that are already reimbursed, and may be incorporated into existing payments for other services. Net prices for medicines may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future weakening of laws that presently restrict imports of medicines from countries where they may be sold at lower prices than in the United States. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for our medicines and

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any new medicines that we develop could have a material adverse effect on our business, our operating results, and our overall financial condition. ~~Our primary exposure~~

We intend to seek approval to market ~~risk relates to fluctuations~~our medicines and drug candidates in the ~~interest rates~~United States, China, Europe and in other jurisdictions. In some countries, such as those in Europe, the pricing of drugs and biologics is subject to governmental control, which can take considerable time even after obtaining regulatory approval. Market acceptance and sales of our medicines will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for our medicines and may be affected by existing and future health care reform measures.

We have operations in the United States, China, Europe, and other markets and plan to expand in these and new markets on our own or with collaborators, which exposes us to risks of conducting business in international markets.

We are currently developing and commercializing or plan to commercialize our medicines in international markets, including China, Europe and other markets outside of the ~~PRC~~United States, either on our own or with third party collaborators or distributors. Our international business relationships subject us to additional risks that may materially adversely affect our ability to attain or sustain profitable operations, including:

•efforts to enter into collaboration or licensing arrangements with third parties in connection with our international sales, marketing and distribution efforts may increase our expenses or divert our management’s attention from the acquisition or development of drug candidates;

•difficulty of effective enforcement of contractual provisions in local jurisdictions;

•potential third-party patent rights or potentially reduced protection for intellectual property rights;

•unexpected changes in tariffs, trade barriers and regulatory requirements, including the loss of normal trade status between China and the United ~~States. In order~~States or actions taken by U.S. or China governmental authorities on companies with significant operations in the U.S. and China, such as us;

•economic weakness, including inflation;

•compliance with tax, employment, immigration and labor laws for employees traveling abroad;

•the effects of applicable non-U.S. tax structures and potentially adverse tax consequences;

•currency fluctuations, which could result in increased operating expenses and reduced revenue;

•workforce uncertainty and labor unrest;

•failure of our employees and contracted third parties to ~~manage~~comply with Office of Foreign Asset Control rules and regulations and the ~~risk~~Foreign Corrupt Practices Act and other anti-bribery and corruption laws;

•business interruptions resulting from geo-political actions, including trade disputes, war and terrorism, public health crises, such as the COVID-19 pandemic, or natural disasters, including earthquakes, volcanoes, typhoons, floods, hurricanes and fires; and

•international military conflicts and related sanctions.

These and other risks, including the risks described in “Risks Related to Our Doing Business in the PRC”, may materially adversely affect our ~~investments, we maintain an investment policy that, among other things, limits the amount that we may invest~~ability to attain or sustain revenue in ~~any one issue~~international markets.

The illegal distribution and sale by third parties of counterfeit versions of our medicines or ~~any single issuer~~stolen products could have a negative impact on our reputation and ~~requires us to only invest in high credit quality securities. While we believe~~business.

Third parties might illegally distribute and sell counterfeit or unfit versions of our ~~cash and cash equivalents~~medicines, which do not ~~contain excessive~~meet our or our collaborators’ rigorous manufacturing and testing standards. A patient who receives a counterfeit or unfit medicine may be at risk ~~we cannot provide absolute assurance that in the future investments will~~for a number of dangerous health consequences. Our reputation and business could suffer harm as a result of counterfeit or unfit medicines sold under our or our collaborators’ brand name(s). In addition, thefts of inventory at warehouses, plants or while in- transit, which are not ~~be subject to adverse changes in market value.~~

~~Risks Related to Clinical Development~~properly stored and which are sold through unauthorized channels, could adversely impact patient safety, our reputation and our business.

Table of ~~Our Drug Candidates~~

*Contents

We depend substantially on the success of ~~our drug candidates, particularly BGB-3111, BGB-A317, BGB‑290 and BGB-283, which are in~~the clinical ~~development. Clinical trials~~development of our medicines and drug ~~candidates may not be successful.~~candidates. If we are unable to successfully complete clinical development, obtain regulatory approvals and commercialize our medicines and drug candidates, or experience significant delays in doing so, our business will be materially harmed.

Our business ~~will depend~~depends on the successful development, regulatory approval and commercialization of our ~~drug candidates for the treatment of patients with cancer, particularly BGB‑3111, BGB-A317, BGB‑290 and BGB‑283, which are still in development,~~medicines and other ~~drugs~~drug candidates we may develop. We have invested a significant portion of our efforts and financial resources in the development of our ~~existing~~medicines and drug candidates. The success of our medicines and drug candidates ~~including BGB‑3111, BGB-A317, BGB‑290 and BGB‑283, will depend~~depends on several factors, including:

~~successful enrollment in, and completion of, clinical trials, as well as completion of preclinical studies;~~

~~receipt of regulatory approvals from the FDA, CFDA, EMA and other comparable regulatory authorities for our drug candidates, including our companion diagnostics;~~

•successful enrollment in, and completion of, clinical trials, as well as completion of preclinical studies;

•favorable safety and efficacy data from our clinical trials and other studies;

•receipt of regulatory approvals;

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their duties to us in a manner that complies with our protocols and applicable laws and that protects the integrity of the resulting data;

~~establishing commercial manufacturing capabilities, either by building facilities ourselves or making arrangements with third-party manufacturers;~~

•obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity;

~~relying on third parties to conduct our clinical trials safely and efficiently;~~

•ensuring that we do not infringe, misappropriate or otherwise violate the valid patent, trade secret or other intellectual property rights of third parties;

~~obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity;~~

•successfully launching our medicines and drug candidates, if and when approved;

~~protecting our rights in our intellectual property;~~

•obtaining favorable reimbursement from third-party payors for our medicines and drug candidates, if and when approved;

~~ensuring we do not infringe, misappropriate or otherwise violate the patent, trade secret or other intellectual property rights of third parties;~~

•competition with other products;

~~launching commercial sales of our drug candidates, if and when approved;~~

•continued acceptable safety profile following regulatory approval; and

~~obtaining reimbursement from third-party payors for drug candidates, if and when approved;~~

•manufacturing or obtaining sufficient supplies of our medicines, drug candidates and any competing drug products that may be necessary for use in clinical trials for evaluation of our drug candidates and commercialization of our medicines.

~~competition with other drug candidates and drugs;~~

~~continued acceptable safety profile for our drug candidates following regulatory approval, if and when received; and~~

~~obtaining sufficient supplies of any competitor drug products that may be necessary for use in clinical trials for evaluation of our drug candidates.~~

If we do not achieve and maintain one or more of these factors in a timely manner or at all, we could experience significant delays in our ability or be unable to obtain ~~approval~~additional regulatory approvals for and/or to successfully commercialize our medicines and drug candidates, which would materially harm our business and we may not be able to generate sufficient revenues and cash flows to continue our operations.

We may not be successful in our efforts to identify or discover additional drug candidates. Due to our limited resources and access to capital, we must and have in the past decided to prioritize development of certain drug candidates; these decisions may prove to have been wrong and may adversely affect our business.

Although we intend to explore other therapeutic opportunities with our cancer biology platform in addition to the drug candidates that we are currently developing, we may fail to identify other drug candidates for clinical development for a number of reasons. For example, our research methodology may be unsuccessful in identifying potential drug candidates or those we identify may be shown to have harmful side effects or other characteristics that make them unmarketable or unlikely to receive regulatory approval. Specifically, we have focused on developing our cancer biology platform, which enables us to test a large panel of tumor models for sensitivity to the drug candidates we generated, identify targets to pursue, identify drug-resistance mechanisms, explore combination strategies and regimens, and improve our understanding of the contributions of tumor micro, or macro-environment in cancer treatments. If our cancer biology platform fails to identify potential drug candidates, our business could be materially harmed.

Research programs to pursue the development of our drug candidates for additional indications and to identify new drug candidates and disease targets require substantial technical, financial and human resources whether or not we ultimately are successful. Our research programs may initially show promise in identifying potential indications and/or drug candidates, yet fail to yield results for clinical development for a number of reasons, including:

~~the research methodology used may not be successful in identifying potential indications and/or drug candidates;~~

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~~potential drug candidates may, after further study, be shown to have harmful adverse effects or other characteristics that indicate they are unlikely to be effective drugs; or~~

it may take greater human and financial resources to identify additional therapeutic opportunities for our drug candidates or to develop suitable potential drug candidates through internal research programs than we will possess, thereby limiting our ability to diversify and expand our drug portfolio.

Because we have limited financial and managerial resources, we focus on research programs and drug candidates for specific indications. As a result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.

Accordingly, there can be no assurance that we will ever be able to identify additional therapeutic opportunities for our drug candidates or to develop suitable potential drug candidates through internal research programs, which could materially adversely affect our future growth and prospects. We may focus our efforts and resources on potential drug candidates or other potential programs that ultimately prove to be unsuccessful.

~~If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.~~

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:

~~the size and nature of the patient population;~~

~~the patient eligibility criteria defined in the protocol;~~

~~the size of the study population required for analysis of the trial’s primary endpoints;~~

~~the proximity of patients to trial sites;~~

~~the design of the trial;~~

~~our ability to recruit clinical trial investigators with the appropriate competencies and experience;~~

~~competing clinical trials for similar therapies or other new therapeutics;~~

clinicians’ and patients’ perceptions as to the potential advantages and side effects of the drug candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are investigating;

~~our ability to obtain and maintain patient consents;~~

~~the risk that patients enrolled in clinical trials will not complete a clinical trial; and~~

~~the availability of approved therapies that are similar in mechanism to our drug candidates.~~

Our clinical trials will compete with other clinical trials for drug candidates that are in the same therapeutic areas as our drug candidates, such as BGB‑3111, BGB-A317, BGB‑290 and BGB‑283, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Because the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our

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~~competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.~~

Even if we are able to enroll a sufficient number of patients in our clinical trials, delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our drug candidates.

Some of our drug candidates represent a novel approach to cancer treatment that could result in delays in clinical development, heightened regulatory scrutiny, or delays in our ability to achieve regulatory approval or commercialization of our drug candidates.

Some of our drug candidates represent a departure from more commonly used methods for cancer treatment, and therefore represent a novel approach that carries inherent development risks. The need to further develop or modify in any way the protocols related to our drug candidates to demonstrate safety or efficacy may delay the clinical program, regulatory approval or commercialization, if approved. In addition, potential patients and their doctors may be inclined to use conventional standard-of-care treatments rather than enroll patients in any current or future clinical trial. This may have a material impact on our ability to generate revenues from our drug candidates. Further, given the novelty of our drug candidates, the end users and medical personnel may require a substantial amount of education and training.

*Clinical ~~drug~~ development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

Clinical ~~testing~~development is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of our drug candidates may not be predictive of the results of later-stage clinical ~~trials.~~trials, and initial or interim results of a trial may not be predictive of the final results. Drug candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. In some instances, there can be significant variability in safety and/or efficacy results between different trials of the same drug candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, including genetic differences, patient adherence to the dosing regimen and other trial protocol elements and the rate of dropout among clinical trial participants. In the case of any trials we conduct, results may differ from earlier trials due to the larger number of clinical trial sites and additional countries ~~and languages~~ involved in such trials. A number of companies in ~~the pharmaceutical and biotechnology industries~~our industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Our future clinical trial results may not be favorable.

Even if our future clinical trial results show favorable efficacy and durability of anti-tumor responses, not all patients may benefit. For certain drugs, including checkpoint inhibitors, and in certain indications, it is likely that the majority of patients may not respond to the agents at all, some responders may relapse after a period of response, and certain tumor types may appear particularly resistant.

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If clinical trials of our drug candidates fail to demonstrate safety and efficacy to the satisfaction of ~~the FDA, CFDA, EMA or other comparable~~ regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates.

Before obtaining regulatory approval for the sale of our drug candidates, ~~such as BGB‑3111, BGB-A317, BGB‑290 and BGB‑283,~~ we must conduct extensive clinical trials to demonstrate the safety and efficacy of our drug candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and successful interim results of a clinical trial do not necessarily predict successful final results.

We may experience numerous unexpected events during, or as a result of, clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize our drug candidates, ~~including:~~

~~regulators, IRBs or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;~~

including but not limited to: regulators, institutional review boards (“IRBs”), or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; our inability to reach agreements on acceptable terms with CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly; manufacturing issues, including problems with manufacturing, supply quality, compliance with good manufacturing practice (“GMP”), or obtaining sufficient quantities of a drug candidate for use in a clinical trial or for commercialization; clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs; the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment may be insufficient or slower than we anticipate or patients may drop out at a higher rate than we anticipate; our third-party contractors, including clinical investigators, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; we might have to suspend or terminate clinical trials of our drug candidates for various reasons, including a finding of a lack of clinical response or other unexpected characteristics or a finding that participants are being exposed to unacceptable health risks; regulators, IRBs or ethics committees may require that we or our investigators suspend or terminate clinical research or not rely on the results of clinical research for various reasons, including noncompliance with regulatory requirements; the cost of clinical trials of our drug candidates may be greater than we anticipate; and the supply or quality of our medicines and drug candidates, companion diagnostics or other materials necessary to conduct clinical trials of our drug candidates or commercialization of our medicines may be insufficient or inadequate.

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clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs;

the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment may be insufficient or slower than we anticipate or patients may drop out at a higher rate than we anticipate;

~~our third-party contractors, including clinical investigators, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;~~

we might have to suspend or terminate clinical trials of our drug candidates for various reasons, including a finding of a lack of clinical response or a finding that participants are being exposed to unacceptable health risks;

~~regulators, IRBs or ethics committees may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;~~

~~the cost of clinical trials of our drug candidates may be greater than we anticipate;~~

~~the supply or quality of our drug candidates, companion diagnostics or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate; and~~

~~our drug candidates may cause adverse affects, have undesirable side effects or other unexpected characteristics, causing us or our investigators to suspend or terminate the trials.~~

If we are required to conduct additional clinical trials or other testing of our drug candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our drug candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if they raise safety concerns, we ~~may:~~

may be delayed in obtaining regulatory approval for ~~our drug candidates;~~

~~not obtain regulatory approval at all;~~

~~obtain approval for indications that are not as broad as intended;~~

~~have the drug removed from the market after obtaining regulatory approval;~~

~~be subject to additional post-marketing testing requirements;~~

~~be subject to restrictions on how the drug is distributed or used; or~~

~~be unable to obtain reimbursement for use of the drug.~~

~~Delays in testing or approvals may result in increases in~~ our drug ~~development costs. We do~~candidates, or not ~~know whether any clinical trials will begin~~obtain regulatory approval at all; obtain approval for indications that are not as ~~planned, will need~~broad as intended; have the drug removed from the market after obtaining regulatory approval; be subject to additional post-marketing testing requirements; be ~~restructured~~subject to warning labels or ~~will~~restrictions on how the drug is distributed or used; or be ~~completed on schedule,~~unable to obtain reimbursement or obtain reimbursement at ~~all.~~

a commercially viable level for use of the drug.

Significant clinical trial delays may also increase our development costs and could shorten any periods during which we have the exclusive right to commercialize our drug candidates or allow our competitors to bring drugs to market before we ~~do and~~do. This could impair our ability to commercialize our drug candidates and may harm our business and results of operations.

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~~Risks Related to Obtaining Regulatory Approval for Our Drug Candidates~~

The regulatory approval processes of the FDA, CFDA, EMA and other comparable regulatory authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed.

The time required to obtain approval by the FDA, CFDA, EMA and other comparable regulatory authorities is unpredictable but typically takes many years following the commencement of preclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a drug candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any drug candidate, and it is possible that none of our existing drug candidates or any drug candidates we may discover, in-license or acquire and seek to develop in the future will ever obtain regulatory approval.

~~Our drug candidates could fail to receive regulatory approval from the FDA, CFDA, EMA or a comparable regulatory authority for many reasons, including:~~

~~disagreement with the design or implementation of our clinical trials;~~

~~failure to demonstrate that a drug candidate is safe and effective or that a biologic drug candidate is safe, pure, and potent for its proposed indication;~~

~~failure of clinical trial results to meet the level of statistical significance required for approval;~~

~~failure to demonstrate that a drug candidate’s clinical and other benefits outweigh its safety risks;~~

~~data integrity issues related to our clinical trials;~~

~~disagreement with our interpretation of data from preclinical studies or clinical trials;~~

the insufficiency of data collected from clinical trials of our drug candidates to support the submission and filing of a New Drug Application, or NDA; Biologics License Application, or BLA; or other submission or to obtain regulatory approval;

the FDA, CFDA, EMA or comparable regulatory authority’s finding of deficiencies related to the manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and commercial supplies; and

~~changes in approval policies or regulations that render our preclinical and clinical data insufficient for approval.~~

The FDA, CFDA, EMA or a comparable regulatory authority may require more information, including additional preclinical or clinical data, to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program. If we were to obtain approval, regulatory authorities may approve any of our drug candidates for fewer or more limited indications than we request, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a drug candidate with a label that is not desirable for the successful commercialization of that drug candidate. In addition, if our drug candidate produces undesirable side effects or safety issues, the FDA may require the establishment of a Risk Evaluation Mitigation Strategy, or REMS, or the CFDA, EMA or a comparable regulatory authority may require the establishment of a similar strategy, that may, for instance, restrict distribution of our drugs and impose burdensome implementation requirements on us. Any of the foregoing scenarios could materially harm the commercial prospects of our drug candidates.

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*Regulatory approval may be substantially delayed or may not be obtained for one or all of our drug candidates if regulatory authorities require additional time or studies to assess the safety and efficacy of our drug candidates.

We may be unable to initiate or complete development of our drug candidates, such as BGB‑3111, BGB-A317, BGB‑290 and BGB‑283, on schedule, if at all. If regulatory authorities require additional time or studies to assess the safety or efficacy of our drug candidates, we may not have or be able to obtain adequate funding to complete the necessary steps for approval for any or all of our drug candidates. Preclinical studies and clinical trials required to demonstrate the safety and efficacy of our drug candidates are time consuming and expensive and together take several years or more to complete. Delaysencounter difficulties enrolling patients in clinical trials, regulatory approvals or rejections of applications for regulatory approval in the United States, Australia, New Zealand, the PRC, Europe or other markets may result from many factors, including:

~~our inability to obtain sufficient funds required for a clinical trial;~~

~~regulatory requests for additional analyses, reports, data, nonclinical studies and clinical trials;~~

~~regulatory questions regarding interpretations of data and results and the emergence of new information regarding our drug candidates or other products;~~

clinical holds, other regulatory objections to commencing or continuing a clinical trial or the inability to obtain regulatory approval to commence a clinical trial in countries that require such approvals;

~~failure to reach agreement with the FDA, CFDA, EMA or other regulators regarding the scope or design of our clinical trials;~~

~~delay or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial;~~

~~our inability to enroll a sufficient number of patients who meet the inclusion and exclusion criteria in a clinical trial;~~

~~our inability to conduct a clinical trial in accordance with regulatory requirements or our clinical trial protocols;~~

~~clinical sites and investigators deviating from a trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial;~~

~~withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials;~~

~~inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication;~~

~~failure of our third-party contract research organizations, or CROs, to satisfy their contractual duties or regulatory requirements or meet expected deadlines;~~

~~delay or failure in adding new clinical trial sites;~~

~~ambiguous or negative interim results, or results that are inconsistent with earlier results;~~

~~unfavorable or inconclusive results of clinical trials and supportive nonclinical studies, including unfavorable results regarding effectiveness of drug candidates during clinical trials;~~

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feedback from the FDA, CFDA, EMA, an IRB, data safety monitoring boards, or comparable entities, or results from earlier stage or concurrent preclinical studies and clinical trials, that might require modification to the protocol;

~~unacceptable risk-benefit profile or unforeseen safety issues or adverse side effects;~~

decision by the FDA, CFDA, EMA, an IRB, comparable entities, or us, or recommendation by a data safety monitoring board or comparable regulatory entity, to suspend or terminate clinical trials at any time for safety issues or for any other reason;

~~failure to demonstrate a benefit from using a drug or biologic;~~

~~lack of adequate funding to continue the clinical trial due to unforeseen costs or other business decisions;~~

our inability to reach agreements on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

~~our inability to obtain approval from IRBs or ethics committees to conduct clinical trials at their respective sites;~~

~~manufacturing issues, including problems with manufacturing or timely obtaining from third parties sufficient quantities of a drug candidate for use in a clinical trial; and~~

~~difficulty in maintaining contact with patients after treatment, resulting in incomplete data.~~

Changes in regulatory requirements and guidance may also occur, and we may need to amend clinical trial protocols submitted to applicable regulatory authorities to reflect these changes. Amendments may require us to resubmit clinical trial protocols to IRBs or ethics committees for re-examination, which may impact the costs, timing or successful completion of a clinical trial.

If we experience delays in the completion of, or the termination of, a clinical trial, of any of our drug candidates, the commercial prospects of our drug candidates will be harmed, and our ability to generate product sales revenues from any of those drug candidates will be delayed. In addition, any delays in completing our clinical trials, ~~will increase~~ our ~~costs, slow down our drug candidate~~clinical development and approval process, and jeopardize our ability to commence internally developed product sales and generate related revenues. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause,activities could be delayed or ~~lead to, a delay in the commencement or~~otherwise adversely affected.

The timely completion of clinical trials ~~may also ultimately lead to the denial of regulatory approval of our drug candidates.~~

~~If we are required to conduct additional clinical trials or~~in accordance with their protocols depends, among other studies with respect to any of our drug candidates beyond those that we initially contemplated, if we are unable to successfully complete our clinical trials or other studies or if the results of these studies are not positive or are only modestly positive, we may be delayed in obtaining regulatory approval for that drug candidate, we may not be able to obtain regulatory approval at all or we may obtain approval for indications that are not as broad as intended. Our drug development costs will also increase if we experience delays in testing or approvals, and we may not have sufficient funding to complete the testing and approval process. Significant clinical trial delays could allow our competitors to bring drugs to market before we do and impair our ability to commercialize our drugs, if and when approved. If any of this occurs, our business will be materially harmed.

*Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics could harm our drug development strategy.

As one of the key elements of our clinical development strategy, we seek to identify patient subsets within a disease category who may derive selective and meaningful benefit from the drug candidates we are developing. In collaboration

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with partners, we plan to develop companion diagnostics to help us to more accurately identify patients within a particular subset, both during our clinical trials and in connection with the commercialization of our drug candidates, if approved. Companion diagnostics are subject to regulation by the FDA, CFDA, EMA and other comparable regulatory authorities and require separate regulatory approval or clearance prior to commercialization. We do not develop companion diagnostics internally, and thus we are dependent on the sustained cooperation and effort of our third-party collaborators in developing and obtaining approval or clearance for these companion diagnostics. We and our collaborators may encounter difficulties in developing and obtaining approval or clearance of the companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility or clinical validation. Any delay or failure by our collaborators to develop or obtain regulatory approval or clearance of the companion diagnostics could delay or prevent approval of our drug candidates. In addition, our collaborators may encounter production difficulties that could constrain the supply of the companion diagnostics, and both they and we may have difficulties gaining acceptance of the use of the companion diagnostics in the clinical community. A failure of such companion diagnostics to gain market acceptance would have an adverse effectthings, on our ability to ~~derive revenues~~enroll a sufficient number of patients who remain in the trial until its conclusion. We have and may continue to experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including the size and nature of the patient population and the patient eligibility criteria defined in the protocol, competition from ~~sales of our drugs. In addition, the diagnostic company~~competing companies, and natural disasters or public health epidemics.

Our clinical trials will likely compete with ~~whom we contract may decide to discontinue selling or manufacturing the diagnostic we anticipate using in connection with development and commercialization of our~~other clinical trials for drug candidates or our relationship with such diagnostic company may otherwise terminate. We may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic test for usethat are in ~~connection with~~ the development and commercialization of our drug candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the development or commercialization of our drug candidates.

*Our drug candidates may cause undesirable adverse events or have other properties that could interrupt, delay or halt clinical trials, delay or prevent regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any regulatory approval.

Undesirable adverse events, or AEs, caused by our drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, CFDA, EMA or other comparable regulatory authority. Results of our trials could reveal a high and unacceptable severity or prevalence of AEs. In such an event, our trials could be suspended or terminated and the FDA, CFDA, EMA or other comparable regulatory authorities could order us to cease further development of, or deny approval of, our drug candidates for any or all targeted indications.

~~Treatment-related serious adverse events, or SAEs, that have been reported in our monotherapy clinical trials include the following: (i) for BGB-3111, petechiae (spots that appear on the skin~~same therapeutic areas as a result of bleeding), purpura (subcutaneous bleeding), bruising, other serious hemorrhage (grade 3 hemorrhage or central nervous system, or CNS, hemorrhage of any grade), atrial fibrillation, diarrhea, haemothorax, colitis, febrile neutropenia, neutropenia, anemia, thrombocytopenia, pneumonia, renal hematoma, urinary tract infection, pneumonitis, leukocytosis, lymphocytosis, toxic epidermal necrolsysis and headache; (ii) for BGB-A317, colitis, hypotension, diarrhea, diabetes mellitus, diabetic ketoacidosis, dyspnea, hypoxia, pneumonitis, fatigue, alanine aminotransferase, or ALT, increase, aspartate aminotransferase, or AST, increase, gamma-glutamyl transferase, or GGT, increase, autoimmune pancreatitis, back pain, dermatitis, hyperglycaemia, hyperthyroidism, nausea, proteinuria, stomatitis, bilirubin increase, leukopenia, neutropenia, pyrexia, mucosal inflammation and hepatitis; (iii) for BGB-290, anemia, neutropenia, nausea, vomiting, thrombocytopenia, diarrhea, fatigue, neutropenia and acute myeloid leukemia / myelodysplastic syndrome; and (iv) for BGB-283, thrombocytopenia, fatigue, nausea, anemia, neutropenia, vomiting, hepatitis, ALT increase, AST increase, GGT increase, pyrexia, decreased appetite, hypophosphataemia, hand-foot syndrome, hypertension, weight decrease, lymphopenia, leukopenia, and constipation.

In addition, treatment-related SAEs that have been reported in our combination clinical trials include the following: (i) for the BGB-3111 and obinutuzumab combination, neutropenia, thrombocytopenia, pneumonia, infusion-related reaction, and serious hemorrhage, including one report of a grade 3 intracranial hemorrhage SAE, which is possibly drug related, in one Diffuse Large B-Cell Lymphoma patient that caused the patient’s treatment with BGB-3111 to be interrupted; (ii) for the BGB-3111 and BGB-A317 combination, haemolytic anaemia, pneumonia, pneumonitis, anemia, autoimmune encephalitis, dyspnea, ALT increase, GGT increase, infusion-related reaction, peripheral edema, pyrexia, thrombocytopenia, limb abscess, ulcerative keratitis, catheter site hemorrhage, hemolytic transfusion reaction, nausea,

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lymph gland infection and eczema; and (iii) for the BGB-290 and BGB-A317 combination, nausea, vomiting, hepatitis, ALT increase, AST increase, GGT increase, fatigue, anemia, liver injury, hypophysitis, and neutropenia.

Drug-related AEs or SAEs could affect patient recruitment or the ability of enrolled subjects to complete the trial, and could result in potential product liability claims. Any of these occurrences may harm our reputation, business, financial condition and prospects significantly.

Additionally, if we or others identify undesirable side effects caused by our drugs or any future approved drug candidates, a number of potentially significant negative consequences could result, including:

~~we may suspend marketing of the drug;~~

~~regulatory authorities may withdraw approvals or revoke licenses of the drug;~~

~~regulatory authorities may require additional warnings on the label;~~

we may be required to develop a REMS for the drug, as is the case with REVLIMID®, or, if a REMS is already in place, to incorporate additional requirements under the REMS, or to develop a similar strategy as required by a comparable regulatory authority;

~~we may be required to conduct post-market studies;~~

~~we could be sued and held liable for harm caused to subjects or patients; and~~

~~our reputation may suffer.~~

Any of these events could prevent us from achieving or maintaining market acceptance of the particular drug or drug candidate, and could significantly harm our business, results of operations and prospects.

Further, combination therapy, such as using our wholly-owned drug candidates as well as third-party products, involves unique AEs that could be exacerbated compared to AEs from monotherapies. These types of AEs could be caused by our drug candidates, and ~~could also cause~~this competition will reduce the number and types of patients available to us, ~~or regulatory authorities~~because some patients who might have opted to ~~interrupt, delay or halt clinical~~enroll in our trials ~~and could result~~may instead opt to enroll in a ~~more restrictive label or the delay or denial of regulatory approval~~trial being conducted by ~~the FDA, CFDA, EMA or other comparable regulatory authority. Results of our trials could reveal a high and unacceptable severity or prevalence of AEs.~~

A Fast Track Designation by the FDA, even if granted for any of our drug candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our drug candidates will receive regulatory approval.

We do not currently have Fast Track Designation for any of our drug candidates, but may seek such designation in the future. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical need for that condition, the drug sponsor may apply for FDA Fast Track Designation. The FDA has broad discretion whether or not to grant this designation. Even if we believe a particular drug candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we do receive Fast Track Designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw a Fast Track Designation if it believes that the designation is no longer supported by data from our clinical development program. Many drugs that have received Fast Track Designation have failed to obtain approval from the FDA.

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A Breakthrough Therapy Designation by the FDA, even if granted for any of our drug candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our drug candidates will receive regulatory approval.

We do not currently have Breakthrough Therapy Designation for any of our drug candidates, but may seek it in the future. A Breakthrough Therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs that have been designated as Breakthrough Therapies, interaction and communication between the FDA and the sponsor can help to identify the most efficient path for development.

~~Designation as a Breakthrough Therapy is within the discretion of the FDA. Accordingly, even if we believe, after completing early clinical trials, that~~ one of our ~~drug candidates meets~~competitors. Because the ~~criteria for designation as a Breakthrough Therapy, the FDA may disagree~~number of qualified clinical investigators and ~~instead decide not~~clinical trial sites is limited, we expect to grant that designation. In any event, the receipt of a Breakthrough Therapy Designation for a drug candidate may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of our drug candidates qualify as Breakthrough Therapies, the FDA may later decide that such drug candidates no longer meet the conditions for qualification.

*We may seek orphan drug designation and exclusivity forconduct some of our ~~drug candidates, and we may be unsuccessful.~~

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a disease with a patient population of fewer than 200,000 individuals in the United States, or that affects more than 200,000 individuals in the United States and for which there is no reasonable expectation that costs of research and development of the product for the indication can be recovered by sales of the product in the United States. BGB‑3111 received orphan drug designation from the FDA for CLL, MCL and WM in 2016.

Generally, if a drug with an orphan drug designation subsequently receives the first regulatory approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the FDA or EMA, from approving another marketing application for the same drug for the same indication during the period of exclusivity. The applicable period is seven years in the United States and 10 years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

Even if we obtain orphan drug exclusivity for a drug candidate, that exclusivity may not effectively protect the drug candidate from competition because different drugs can be approved for the same condition and the same drugs can be approved for a different condition but used off-label for any orphan indication we may obtain. Even after an orphan drug is approved, the FDA can subsequently approve a drug that is otherwise the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

*Our drugs and any future approved drug candidates will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our drug candidates.

Our in-licensed drugs in China and any additional drug candidates that are approved will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information,

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~~including both federal and state requirements in the United States and requirements of comparable regulatory authorities in China and other countries.~~

Manufacturers and manufacturers’ facilities are required to comply with extensive FDA, CFDA, EMA and comparable regulatory authority requirements, including, in the United States, ensuring that quality control and manufacturing procedures conform to cGMP regulations. As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any NDA or BLA, other marketing application, and previous responses to any inspection observations. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

The regulatory approvals for our in-licensed drugs and any approvals that we receive for our drug candidates may be subject to limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the drug candidate. The FDA or comparable regulatory authorities may also require a REMS program as a condition of approval of our drug candidates or following approval, as is the case with REVLIMID®, which could entail requirements for long-term patient follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA, CFDA, EMA or a comparable regulatory authority approves our drug candidates, we will have to comply with requirements including, for example, submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP and GCP for any clinical trials that we conduct post-approval.

The FDA or comparable regulatory authorities may seek to impose a consent decree or withdraw marketing approval if compliance with regulatory requirements is not maintained or if problems occur after the drug reaches the market. Later discovery of previously unknown problems with our drug candidates, including AEs of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

~~restrictions on the marketing or manufacturing of our drugs, withdrawal of the product from the market, or voluntary or mandatory product recalls;~~

~~fines, untitled or warning letters, or holds on clinical trials;~~

refusal by the FDA or comparable regulatory authorities to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals or withdrawal of approvals;

~~product seizure or detention, or refusal to permit the import or export of our drug candidates; and~~

~~injunctions or the imposition of civil or criminal penalties.~~

The FDA and other regulatory authorities strictly regulate the marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for their approved indications and for use in accordance with the provisions of the approved label. The FDA, CFDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. The policies of the FDA, CFDA, EMA and of other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our drug candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any regulatory approval that we may have obtained and we may not achieve or sustain profitability.

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In addition, if we were able to obtain accelerated approval of any of our drug candidates, the FDA would require us to conduct a confirmatory study to verify the predicted clinical benefit and additional safety studies. Other comparable regulatory authorities outside the United States, such as the CFDA or EMA, may have similar requirements. The results from the confirmatory study may not support the clinical benefit, which would result in the approval being withdrawn. While operating under accelerated approval, we will be subject to certain restrictions that we would not be subject to upon receiving regular approval.

~~Risks Related to Commercialization of Our Drug Candidates~~

*If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our drug candidates, and our ability to generate revenue will be materially impaired.

We currently do not have any drug candidates that have gained regulatory approval for sale in the United States, European Union, China or any other country, and we cannot guarantee that we will ever have marketable drugs that we are currently developing or may develop in the future. Our business is substantially dependent on our ability to complete the development of, obtain regulatory approval for and successfully commercialize drug candidates in a timely manner. We cannot commercialize drug candidates without first obtaining regulatory approval to market each drug from the FDA, CFDA, EMA and/or comparable regulatory authorities. BGB‑3111, BGB-A317, BGB‑290 and BGB‑283 are each currently undergoing clinical trials. We cannot predict whether these trials and future trials will be successful or whether regulators will agree with our conclusions regarding the preclinical studies and clinical trials we have conducted to date.

Before obtaining regulatory approvals for the commercial sale of any drug candidate for a target indication, we must demonstrate in preclinical studies and well-controlled clinical trials, and, with respect to approval in the United States, to the satisfaction of the FDA, that the drug candidate is safe and effective, or the biologic product candidate is safe, pure, and potent, for use for that target indication and that the manufacturing facilities, processes and controls are adequate. In the United States, we have not submitted an NDA or BLA for any of our drug candidates. An NDA or BLA must include extensive preclinical and clinical data and supporting information to establish, in the case of an NDA, the drug candidate’s safety and effectiveness or, in the case of a BLA, safety, purity and potency for each desired indication. The NDA or BLA must also include significant information regarding the chemistry, manufacturing and controls for the drug candidate. Obtaining approval of an NDA or BLA is a lengthy, expensive and uncertain process, and approval may not be obtained. If we submit an NDA or BLA to the FDA, the FDA decides whether to accept or reject the submission for filing. We cannot be certain that any submissions will be accepted for filing and review by the FDA.

Regulatory authorities outside of the United States, such as the CFDA and EMA, also have requirements for approval of drugs for commercial sale with which we must comply prior to marketing in those areas. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our drug candidates. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and obtaining regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking non-U.S. regulatory approval could require additional nonclinical studies or clinical trials, which could be costly and time consuming. The non-U.S. regulatory approval process may include all of the risks associated with obtaining FDA approval. For all of these reasons, we may not obtain non-U.S. regulatory approvals on a timely basis, if at all.

Specifically, in China, the CFDA categorizes domestically-manufactured innovative drug applications as Category 1 and imported innovative drug applications as Category 5. To date, most of local companies’ domestically-manufactured drug applications are filed in Category 1 if the drug has not already been approved by the FDA or EMA. Most multinational pharmaceutical companies’ drug registration applications are filed in Category 5 applicable to imported drugs, formerly known as Category 3 prior to the reclassification implemented by CFDA in 2016. These two categories have distinct approval pathways, as described in the section of our Annual Report titled “Item 1—Business—Regulatory Framework and Structural Advantages of Being a China-Based Research and Development Organization.” We believe the local drug registration pathway, Category 1, is a faster and more efficient path to approval in the Chinese market than Category 5. Companies are required to obtain Clinical Trial Application approval before conducting clinical trials in China. This registration pathway has a fast track review and approval mechanism if the drug candidate is on a national

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priority list. The imported drug registration pathway, Category 5, is more complex and is evolving. China Category 5 registration applications for certain drugs may only be submitted after a drug has obtained an NDA approval and received the Certificate of Pharmaceutical Product, or CPP, granted by a major drug regulatory authority, such as the FDA or EMA.

~~Further, in August 2015, the Chinese State Council issued a statement,~~ ~~Opinions on Reforming the Review and Approval Process for Pharmaceutical Products and Medical Devices~~ ~~that contained several potential policy changes that could benefit the pharmaceutical industry:~~

A plan to accelerate innovative drug approval with a special review and approval process, with a focus on areas of high unmet medical needs, including drugs for HIV, cancer, serious infectious diseases and orphan diseases, drugs on national priority lists.

~~A plan to adopt a policy which would allow companies to act as the marketing authorization holder and to hire contract manufacturing organizations to produce drug products.~~

~~A plan to improve the review and approval of clinical trials, and to allow companies to conduct~~ clinical trials at the same ~~time as they are being conducted in other countries and encourage local clinical trial organizations to participate in international multi-center clinical trials.~~

~~In November 2015, the CFDA released the~~ ~~Circular Concerning Several Policies on Drug Registration Review and Approval, which further clarified the following policies potentially simplifying and accelerating the approval process of clinical trials:~~

A one-time umbrella approval procedure allowing approval of all phases of a new drug’s clinical trials at once, rather than the current phase-by-phase approval procedure, will be adopted for new drugs’ clinical trial applications.

A fast track drug registration or clinical trial approval pathway will be available for the following applications: (1) registration of innovative new drugs treating HIV, cancer, serious infectious diseases and orphan diseases; (2) registration of pediatric drugs; (3) registration of geriatric drugs and drugs treating China-prevalent diseases in elders; (4) registration of drugs sponsored by national science and technology grants; (5) registration of innovative drugs using advanced technology, using innovative treatment methods, or having distinctive clinical benefits; (6) registration of foreign innovative drugs to be manufactured locally in China; and (7) concurrent applications for new drug clinical trials which are already approved in the United States or European Union or concurrent drug registration applications for drugs which have applied for marketing authorization and passed onsite inspections in the United States or European Union and are manufactured using the same production line in China; and (8) clinical trial applications for drugs with urgent clinical need and patent expiry within three years, and marketing authorization applications for drugs with urgent clinical need and patent expiry within one year.

~~In February 2016, the CFDA released the~~ ~~Opinions on Priority Review and Approval for Resolving Drug Registration Applications Backlog, which further clarified the following policies potentially accelerating the approval process of certain clinical trials or drug registrations:~~

A fast track drug registration or clinical trial approval pathway will be available for the following drug registration applications with distinctive clinical benefits: (1) registration application of innovative drugs not sold within or outside China; (2) registration application of innovative drugs transferred to be manufactured in China; (3) registration application of drugs using advanced technology, using innovative treatment methods, or having distinctive treatment advantages; (4) clinical trial applications for drugs with patent expiry within three years, and marketing authorization applications for drugs with patent expiry within one year; (5) concurrent applications for new drug clinical trials which are already approved in the United States or European Union, or concurrent drug registration applications for drugs which have applied for marketing authorization and passed onsite inspections in the United States or European Union and are manufactured using

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the same production line in China; (6) traditional Chinese medicines (including ethnic medicines) with clear clinical position in prevention and treatment of serious diseases; and (7) registration application of new drugs sponsored by national key technology projects or national key development projects.

A fast track drug registration approval pathway will be available for drug registration applications with distinctive clinical benefits for prevention and treatment of HIV, phthisis, viral hepatitis, orphan diseases, cancer, malignant neoplasms, children’s diseases, and geriatrics.

In March 2016, the CFDA released a circular, CFDA Announcement on Reforms of Pharmaceutical Registration Classification, which outlined the re-classifications of drug applications. Under the new categorization, innovative drugs that have not been marketed either within or outside China remain Category 1, while drugs marketed outside China seeking marketing approval in China are now Category 5.

However, because these laws and regulations in relation to such above-mentioned fast track clinical trial approval and drug registration pathway were newly issued and constantly evolving, uncertainty remains with respect to their implementation. We expect that the CFDA review and approval process will improve over time. However, how and when this approval process will be changed is still subject to further policies to be issued by the CFDA and is currently uncertain.

The process to develop, obtain regulatory approval for and commercialize drug candidates is long, complex and costly both inside and outside the United States and China, and approval is never guaranteed. Even if our drug candidates were to successfully obtain approval from the regulatory authorities, any approval might significantly limit the approved indications for use, or require that precautions, contraindications or warnings be included on the product labeling, or require expensive and time-consuming post-approval clinical trials or surveillance as conditions of approval. Following any approval for commercial sale of our drug candidates, certain changes to the drug, such as changes in manufacturing processes and additional labeling claims, may be subject to additional review and approval by the FDA, CFDA and EMA and comparable regulatory authorities. Also, regulatory approval for any of our drug candidates may be withdrawn. If we are unable to obtain regulatory approval for our drug candidates in one or more jurisdictions, or any approval contains significant limitations, our target market will be reduced and our ability to realize the full market potential of our drug candidates will be harmed. Furthermore, we may not be able to obtain sufficient funding or generate sufficient revenue and cash flows to continue the development of any other drug candidate in the future.

n April 2017, the NHFPC, Ministry of Finance, the National Development and Reform Commission and four other four government agencies jointly issued the Notice on Overall Implementation of Public Hospital Comprehensive Reform, or the Public Hospital Reform Notice. The Public Hospital Reform Notice requires all prefecture-level cities to formulate plans for full implementation of the urban public hospital reforms by July 31, 2017. According to the Public Hospital Reform Notice, the public hospital reform plans were to be implemented by September 30, 2017. Under the public hospital reform plan, public hospitals will no longer be able to sell all drugs, except for traditional Chinese medicines, at prices higher than they paid for purchasing the drugs, also known as a zero-markup policy. The Public Hospital Notice also provides that the first four batches of public hospital reform cities should reduce the proportion of their drug sales-related income to around 30%. Because the zero-markup policy proposed by the Public Hospital Reform Notice has not taken effect nationwide, there is still substantial uncertainty with respect to the interpretation and implementation in different cities. However, the implementation of a zero-markup policy may disincentivize public hospitals to purchase and sell new drugs with high prices, which may negatively affect our business operations and financial performance.

In May 2017, the CFDA issued four draft policies for public comment, proposing further reforms in the current drug regulatory regime, including 2017 CFDA Circular 52, 2017 CFDA Circular 53, 2017 CFDA Circular 54 and 2017 CFDA Circular 55. These draft policies propose significant reforms in the areas of the new drug approval process, clinical trial regulation, life-cycle management and post-marketing, and regulatory data protection and patent linkage. These draft policies, if adopted as currently proposed, will further streamline and accelerate the market access of novel drugs, including domestic and foreign drug candidates. For example, 2017 CFDA Circular 52 proposes an accelerated approval regime for drugs meeting urgent clinical needs, under which drugs that meet urgent clinical needs may receive conditional approval, if the early and middle stage clinical trials show positive results and there is anticipated clinical

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value. Also, the National Health and Family Planning Commission, or NHFPC, will publish a list of orphan diseases. Applicants with drugs treating such orphan diseases may apply for a clinical trial waiver. If a new drug for orphan diseases has been approved outside China, the CFDA may grant a conditional approval, and the applicant must complete a trial in China within a prescribed timeframe after such approval. 2017 CFDA Circular 53 proposes to streamline the clinical trial approval process by adoption of a notification system for clinical trial applications, under which the applicants only need to wait for 60 business days before proceeding with the protocol, unless the Center for Drug Evaluation rejects the application or issues a deficiency notice during the 60-day period. 2017 CFDA Circular 53 also proposes that foreign clinical data be admitted to support registration of drugs in China, as long as (1) the clinical trial data satisfy the requirements under PRC regulations, (2) the trials pass the CFDA’s on-site inspection, and (3) applicants can provide clinical data to prove that no ethnicity difference affects the drug candidates’ safety and efficacy.

~~Based on the draft policies, in October 2017, the General Office of the State Council of China announced~~ ~~The Opinions on Deepening Review and Approval System Reform and Encouraging the Innovation of Drugs and Medical Devices~~, or the Opinions on Reform. The Opinions on Reform upholds the draft policies’ proposal to improve clinical trial approval procedures by adopting a notification system for clinical trial applications under which applicants may proceed with the protocol unless the drug evaluation authority issues a negative opinion or queries within a prescribed period. In addition, the Opinions on Reform upholds the draft policies’ proposal of conditional approval for drugs treating life-threatening diseases or meeting urgent public health needs. According to the Opinions on Reform, the marketing authorization holder system will roll out nationwide in China and marketing authorization holders will be held ultimately responsible for pre-approval and post-approval compliance obligations, as well as for the activities of their contracted research organizations, manufacturers and distributors. The Opinions on Reform are recently announced high-level opinions to be further supplemented and implemented with the adoption of the detailed draft policies proposed by the CFDA.

~~In October 2017, the CFDA issued the~~ ~~Decisions Concerning the Adjustment of Imported Drug Registration, or the~~ Imported Drug Registration Adjustment Decisions. The Imported Drug Registration Adjustment Decisions (1) allow drugs to launch synchronized Phase 1 international multi-center clinical trials within and outside China, (2) allow applicants to apply for drug marketing approval upon completion of international multi-center clinical trials, and (3) remove the requirement of marketing authorization in the country or region of the foreign pharmaceutical manufacturers for new chemical drugs and therapeutic biological innovative drugs applying for imported drug clinical trials and imported drug marketing. Although the Imported Drug Registration Adjustment Decisions are newly issued and uncertainty remains with respect to their implementation, we expect the advantage of our conduct clinical trials as domestic drugs in China over imported drugs could be reduced with the implementation of Imported Drug Registration Adjustment Decisions.

A Category 1 designation by the CFDA may be revoked or may not be granted for any of our drug candidates or may not lead to faster development or regulatory review or approval process and does not increase the likelihood that our drug candidates will receive regulatory approval.

We believe the local drug registration pathway, Category 1, is a faster and more efficient path to approval in the Chinese market than the drug registration pathway for imported drugs under Category 5. Companies are required to obtain Clinical Trial Application approval before conducting clinical trials in China. This registration pathway has a fast track review and approval mechanism if the drug candidate is on a national priority list. Imported drug candidates under Category 5 cannot qualify for the national priority list to benefit from fast track reviews. Our drug candidates are all new therapeutic agents and we have built research and development, clinical trial capacities, and manufacturing facilities in China. As a result, we expect all of our current drug candidates to fall within the Category 1 application process, but cannot be sure we will be granted or be able to maintain Category 1 designation.

*Our drugs and any future approved drug candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

Our drugs and any future approved drug candidates may fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. For example, current cancer treatments like chemotherapy and radiation therapy are well established in the medical community, and doctors may continue to rely on

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these treatments to the exclusion of our drugs and drug candidates. In addition, physicians, patients and third-party payors may prefer other novel products to ours. If our drugs and drug candidates do not achieve an adequate level of acceptance, we may not generate significant product sales revenues and we may not become profitable. The degree of market acceptance of our drugs and drug candidates, if approved for commercial sale, will depend on a number of factors, including:

~~the clinical indications for which our drugs and drug candidates are approved;~~

~~physicians, hospitals, cancer treatment centers and patients considering our drugs and drug candidates as a safe and effective treatment;~~

~~the potential and perceived advantages of our drugs and drug candidates over alternative treatments;~~

~~the prevalence and severity of any side effects;~~

~~product labeling or product insert requirements of the FDA, CFDA, EMA or other comparable regulatory authorities;~~

~~limitations or warnings contained in the labeling approved by the FDA, CFDA, EMA or other comparable regulatory authorities;~~

~~the timing of market introduction of our drugs and drug candidates as well as competitive drugs;~~

~~the cost of treatment in relation to alternative treatments;~~

~~the amount of upfront costs or training required for physicians to administer our drugs and drug candidates;~~

~~the availability of adequate coverage, reimbursement and pricing by third-party payors and government authorities;~~

~~the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payors and government authorities;~~

~~relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and~~

~~the effectiveness of our sales and marketing efforts.~~

If our drugs and any approved drug candidates fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical community, we will not be able to generate significant revenue. Even if our drugs achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our drugs, are more cost effective or render our drugs obsolete.

* If we are unable to further develop marketing and sales capabilities or enter into agreements with third parties to market and sell our drug candidates and third-party drugs, we may not be able to generate product sales revenue.

Prior to the closing of our transaction with Celgene, we had no sales, marketing or commercial product distribution capabilities and had no experience in marketing drugs. On August 31, 2017, we closed a strategic collaboration with Celgene in which we were granted an exclusive license in China, excluding Hong Kong, Macau and Taiwan, to commercialize Celgene’s approved cancer therapies, ABRAXANE®, REVLIMID®, and VIDAZA®, and Celgene’s investigational agent CC-122 in clinical development, and acquired Celgene’s commercial operations in China, excluding certain functions. We plan to further build our salesforce in China to market these in-licensed drugs and our

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internally developed drug candidates, in the event they receive commercial approval, and any additional drugs or drug candidates that we may in-license, which will require significant capital expenditures, management resources and time. We will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

If we are unable to, or decide not to, further develop internal sales, marketing and commercial distribution capabilities for any or all drugs we develop or in-license, we will likely pursue collaborative arrangements regarding the sales and marketing of our drugs. However, there can be no assurance that we will be able to establish or maintain such collaborative arrangements, or if we are able to do so, that they will have effective sales forces. Any revenue we receive will depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the marketing and sales efforts of such third parties, and our revenue from product sales may be lower than if we had commercialized our drug candidates ourselves. We also face competition in our search for third parties to assist us with the sales and marketing efforts of our drug candidates.

There can be no assurance that we will be able to further develop and successfully maintain in-house sales and commercial distribution capabilities or establish or maintain relationships with third-party collaborators to successfully commercialize any product, and as a result, we may not be able to generate product sales revenue.

*We face substantial competition, which may result in others discovering, developing or commercializing competing drugs before or more successfully than we do.

The development and commercialization of new drugs is highly competitive. We face competition with respect to our current drugs and drug candidates and any future drugs that we may develop or in-license from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell drugs or are pursuing the development of drugs for the treatment of cancer for which we are commercializing our in-licensed drugs or developing our drug candidates. Some of these competitive drugs and therapies are based on scientific approaches that are the same as or similar to our approach, and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Specifically, there are a large number of companies developing or marketing treatments for cancer, including many major pharmaceutical and biotechnology companies. See the section titled “Item 1—Business—Competition” of our 2016 Annual Report.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize drugs that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any drugs that we commercialize or may develop. Our competitors also may obtain approval from the FDA, CFDA, EMA or other comparable regulatory authorities for their drugs more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market and or slow our regulatory approval.

Many of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved drugs than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites ~~and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.~~

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*Our drugs and drug candidates for which we intend to seek approval as biological or drug products may face competition sooner than expected.

With the enactment of the Biologics Price Competition and Innovation Act of 2009, or BPCIA, as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or, collectively the ACA, an abbreviated pathway for the approval of biosimilar and interchangeable biological products was created in the United States. The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilars, including the possible designation of a biosimilar as “interchangeable,” based on their similarity to existing reference product. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA. The BPCIA is complex and is only beginning to be interpreted and implemented by the FDA. As a result, its ultimate impact, implementation and meaning are subject to uncertainty, and it could have a material adverse effect on the future commercial prospects for our biological products, including BGB-A317, if approved.

~~We believe~~ that ~~any~~some of our ~~drugs approved as a biological product under a BLA should qualify for~~competitors use, which will reduce the ~~12-year period of exclusivity. However:~~

~~a potential competitor could seek and obtain approval of its own BLA during our exclusivity period instead of seeking approval of a biosimilar version; and~~

the FDA could consider a combination therapy which contains both drug and biological product components, to be a drug subject to review pursuant to an NDA, and therefore eligible for a significantly shorter marketing exclusivity period as provided under the Drug Price Competition and Patent Term Restoration Act of 1984.

Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear and will depend on a number of ~~marketplace and regulatory factors that are still developing.~~

In addition, a drug product approved under an NDA, such as BGB‑3111, BGB‑290 or BGB‑283, if they were to be approved, could face generic competition earlier than expected. We do expect competition from generic drugs with our in-licensed drugs in China but currently do not know the actual impact. In the United States, the enactment of the Generic Drug User Fee Amendments of 2012 as part of the Food and Drug Administration Safety and Innovation Act of 2012 established a user fee program that will generate hundreds of millions of dollars in funding for the FDA’s generic drug review program. Funding from the user fee program, along with performance goals that the FDA negotiated with the generic drug industry, could significantly decrease the timeframe for FDA review and approval of generic drug applications.

*The market opportunities for our drugs and drug candidates may be limited to those patients who are ~~ineligible~~available for ~~or have failed prior treatments and may be small.~~

Cancer therapies are sometimes characterized as first line, second line or third line, and the FDA often approves new therapies initially only for third line use. When cancer is detected early enough, first line therapy is sometimes adequate to cure the cancer or prolong life without a cure. Whenever first line therapy, usually chemotherapy, hormone therapy, surgery or a combination of these, proves unsuccessful, second line therapy may be administered. Second line therapies often consist of more chemotherapy, radiation, antibody drugs, tumor targeted small molecule drugs or a combination of these. Third line therapies can include bone marrow transplantation, antibody and small molecule targeted therapies, more invasive forms of surgery and new technologies. In markets with approved therapies, we expect to initially seek approval of our drug candidates as a later stage therapy for patients who have failed other approved treatments. Subsequently, for those drugs that prove to be sufficiently beneficial, if any, we would expect to seek approval as a second line therapy and potentially as a first line therapy, but there is no guarantee that our drug candidates, even if approved, would be approved for second line or first line therapy. In addition, we may have to conduct additional clinical trials ~~prior to gaining approval for second line or first line therapy.~~

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Our projections of both the number of people who have the cancers we are targeting, as well as the subset of people with these cancers in a position to receive later stage therapy and who have the potential to benefit from treatment with our drug candidates, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these cancers. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for our drugs and drug candidates may be limited or may not be amenable to treatment with our drugs and drug candidates. Even if we obtain significant market share for our drug candidates, because the potential target populations are small, we may never achieve profitability without obtaining regulatory approval for additional indications, including use as a first or second line therapy.

Our market opportunities may also be limited by competitor treatments that may enter the market. See “—We face substantial competition, which may result in others discovering, developing or commercializing competing drugs before or more successfully than we do.”

*at such clinical trial sites. Even if we are able to ~~commercialize~~enroll a sufficient number of patients in our ~~drugs and any approved drug candidates,~~clinical trials, delays in patient enrollment may result in increased costs or may affect the ~~drugs may become subject to unfavorable pricing regulations, third party reimbursement practices~~timing or ~~healthcare reform initiatives,~~outcome of the planned clinical trials, which could ~~harm our business.~~

~~The regulations that govern regulatory approvals, pricing~~delay or prevent completion of these trials and reimbursement for new therapeutic products vary widely from country to country. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or licensing approval is granted. In some non-U.S. markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain regulatory approval for a drug in a particular country, but then be subject to price regulations that delay our commercial launch of the drug and negatively impact the revenues we are able to generate from the sale of the drug in that country. Adverse pricing limitations may hinderadversely affect our ability to ~~recoup our investment in one or more drugs or any drug candidates, even if~~advance the development of our drug ~~candidates obtain regulatory approval.~~

Our ability to commercialize any drugs successfully also will depend in part on the extent to which reimbursement for these drugs and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. A primary trend in the global healthcare industry is cost containment. Government authorities and these third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are requiring that companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be available for any drug that we commercialize and, if reimbursement is available, what the level of reimbursement will be. Reimbursement may impact the demand for, or the price of, any drug which we commercialize. Obtaining or maintaining reimbursement for our drugs may be particularly difficult because of the higher prices often associated with drugs administered under the supervision of a physician. If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any drug candidate that we in-license or successfully develop.

There may be significant delays in obtaining reimbursement for approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or other comparable regulatory authorities outside the United States. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim payments for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Payment rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on payments allowed for lower cost drugs that are already reimbursed, and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future weakening of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for our drugs and any new drugs that we

candidates.

In addition to the similar manufacturing risks described in ~~“—Risks~~“Risks Related to Our Reliance on Third Parties,” our manufacturing facilities ~~will be~~are subject to inspection in connection with clinical development and new drug approvals and ongoing, periodic inspection by the FDA, ~~CFDA,~~NMPA, EMA or other comparable regulatory agencies to ensure compliance with ~~cGMP.~~GMP and other regulatory requirements. Historically, some manufacturing facilities in China have had difficulty meeting the FDA’s, NMPA's or EMA's standards. Our failure to follow and document our adherence to such ~~cGMP~~GMP regulations or other regulatory requirements may lead to significant delays in the availability of products for clinical or ~~in the future,~~ commercial use, may result in the termination of or a hold on a clinical trial, or may delay or prevent filing or approval of marketing applications for our ~~drugs.~~drug candidates or the commercialization of our medicines. We also may encounter problems with the following:

~~achieving adequate or clinical-grade materials that meet FDA, CFDA, EMA or other comparable regulatory agency standards or specifications with consistent and acceptable production yield and costs;~~

~~shortages of qualified personnel, raw materials or key contractors; and~~

•achieving adequate or clinical-grade materials that meet FDA, NMPA, EMA or other comparable regulatory agency standards or specifications with consistent and acceptable production yield and costs;

~~ongoing compliance with cGMP regulations and other requirements of the FDA, CFDA, EMA or other comparable regulatory agencies.~~

•shortages of qualified personnel, raw materials or key contractors; and

•ongoing compliance with GMP regulations and other requirements of the FDA, NMPA, EMA or other comparable regulatory agencies.

Failure to comply with applicable regulations could also result in sanctions being imposed on us, including fines, injunctions, civil penalties, a requirement to suspend or put on hold one or more of our clinical trials, failure of regulatory authorities to grant marketing approval of our drug candidates, delays, suspension or withdrawal of approvals, supply disruptions, license revocation, seizures or recalls of drug candidates or ~~drugs,~~medicines, operating restrictions and criminal prosecutions, any of which could harm our business.

Developing advanced manufacturing techniques and process controls is required to fully utilize our facilities. Advances in manufacturing techniques may render our facilities and equipment inadequate or obsolete.

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To supply commercial quantities for our marketed products, produce our ~~drugs~~medicines in the quantities that we believe will be required to meet anticipated market demand, ~~of any~~and to supply clinical drug material to support the continued growth of our ~~drug candidates if approved,~~clinical programs, we will need to increase, or “scale up,” the production process by a significant factor over the initial level of ~~production.~~production, which will require substantial additional expenditures and various regulatory approvals and permits. If we are unable to do so, are delayed, or if the cost of this scale up is not economically feasible for us or we cannot find a third-party supplier, we may not be able to produce our ~~drugs~~medicines in a sufficient quantity to meet future demand.

If our manufacturing facilities, including our Suzhou manufacturing facility once completed, are damaged or destroyed or production at such facilities is otherwise interrupted, our business and prospects would be negatively affected.

~~In addition to the similar manufacturing risks described in “—Risks Related to Our Reliance on Third Parties,” if~~ our manufacturing facilities or the equipment in them is damaged or destroyed, we may not be able to quickly or inexpensively replace our manufacturing capacity or replace it at all. In the event of a temporary or protracted loss of the

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facilities or equipment, we might not be able to transfer manufacturing to a third party. Even if we could transfer manufacturing to a third party, the shift would likely be expensive and time-consuming, particularly since the new facility would need to comply with the necessary regulatory requirements and we would need ~~FDA, CFDA, EMA or and other comparable~~ regulatory agency approval before selling any ~~drugs~~medicines manufactured at that facility. ~~Such an event could delay our clinical trials or reduce our product sales if and when we are able to successfully commercialize one or more of our drug candidates.~~

Any interruption in manufacturing operations at our manufacturing facilities could result in our inability to satisfy the demands of our clinical trials or commercialization. ~~A number of factors could cause interruptions, including:~~

~~equipment malfunctions or failures;~~

~~technology malfunctions;~~

~~work stoppages;~~

~~damage to or destruction of either facility due to natural disasters;~~

~~regional power shortages;~~

~~product tampering; or~~

~~terrorist activities.~~

Any disruption that impedes our ability to manufacture our drug candidates or medicines in a timely manner could materially harm our business, financial condition and operating results.

Currently, we maintain insurance coverage against damage to our property, plant and equipment in ~~the amount of up to RMB 100 million.~~amounts we believe are reasonable. However, our insurance coverage may not reimburse us, or may not be sufficient to reimburse us, for any expenses or losses we may suffer. We may be unable to meet our requirements for our drug candidates and medicines if there were a catastrophic event or interruption or failure of our manufacturing facilities or processes.

*The Celgene Transaction could disrupt

We incur significant costs as a result of operating as a public company, and our ~~business~~management is required to devote substantial time to compliance requirements, including establishing and ~~harm our~~maintaining internal controls over financial ~~condition~~reporting. We may be exposed to potential risks if we are ~~not able~~unable to ~~successfully integrate Celgene’s commercial business~~comply with these requirements.

As a public company listed in ~~China into ours,~~the United States, Hong Kong and Shanghai, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the ~~expected benefits~~listing rules of the ~~acquisition may not materialize.~~

~~On August 31, 2017, we closed the Celgene Transaction~~ ~~pursuant to which we were granted the right to exclusively distribute and promote three~~Nasdaq Stock Market (Nasdaq), The Stock Exchange of ~~Celgene’s drugs and one of Celgene’s drug candidates in China, excluding~~ Hong Kong ~~Macau~~Limited (the “HKEx”) and ~~Taiwan,~~the STAR Market of the Shanghai Stock Exchange (the “SSE”), and ~~acquired Celgene’s commercial operations~~incur significant legal, accounting and other expenses to comply with applicable requirements. These rules impose various requirements on public companies, including requiring certain corporate governance practices. Our management and other personnel devote a substantial amount of time to these requirements. Moreover, these rules and regulations increase our legal and financial compliance costs and make some activities more time-consuming and costly.

For example, the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. In particular, we must perform system and process evaluations and testing of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. Such compliance may require that we incur substantial accounting expenses and expend significant management efforts. Our testing may reveal deficiencies in ~~China. We also have specified~~our internal controls over financial reporting that are deemed to be material weaknesses. In the event we identify significant deficiencies or material weaknesses in our internal controls that we cannot remediate in a timely manner, the market price of our shares could decline if investors and others lose confidence in the reliability of our financial statements, we could be subject to sanctions or investigations by the SEC, HKEx, China Securities Regulatory Commission (the “CSRC”), SSE or other applicable regulatory authorities, and our business could be harmed.

If we engage in acquisitions or strategic collaborations, this may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.

From time to time, we may evaluate various acquisitions and strategic collaborations, including licensing or acquiring complementary products, intellectual property rights, ~~to future oncology drugs that Celgene~~technologies or businesses. Any completed, in-process or potential acquisition or strategic collaboration may ~~seek to commercialize in China~~.

~~The Celgene Transaction involves~~entail numerous risks, including:

•increased operating expenses and cash requirements;

•the assumption of additional indebtedness or contingent or unforeseen liabilities;

•the issuance of our equity securities;

•assimilation of operations, intellectual property and products of an acquired company, including ~~problems combining the purchased operations~~difficulties associated with integrating new personnel;

Table of ~~Celgene’s commercial operations in China with our own operations and unanticipated costs and~~Contents

•the diversion of our management’s attention from our ~~drug discovery~~existing product programs and ~~development business. There can be no assurance~~initiatives in pursuing such a strategic merger or acquisition;

•retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;

•risks and uncertainties associated with the other party to such a transaction, including the prospects of that ~~we will be able to successfully manage~~party and ~~integrate Celgene’s commercial operations in China and its personnel into our business, which could disrupt our business and harm our financial results.~~

Moreover, we may not achieve the revenue and cost synergies expected from the Celgene Transaction. These synergies are inherently uncertain, and are subject to significant business, economic and competitive uncertainties and contingencies, many of which are difficult to predict and are beyond our control. If we achieve the expected benefits, they may not be achieved within the anticipated time frame. Also, the synergies from the Celgene Transaction may be offset by costs incurred in integrating Celgene’s commercial operations in China, increases in other expenses, operating

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~~losses~~their existing drugs or ~~problems in the business unrelated to the Celgene Transaction. As a result, there can be no assurance that such synergies will be achieved.~~

~~Risks Related to Our Doing Business in the PRC~~

*The pharmaceutical industry in China is highly regulated and such regulations are subject to change which may affect approval and commercialization of our drugs.

Our research operations and manufacturing facilities are in China. The pharmaceutical industry in China is subject to comprehensive government regulation and supervision, encompassing the approval, registration, manufacturing, packaging, licensing and marketing of new drugs. See the section of our 2016 Annual Report titled “Item 1—Business—Regulatory Framework and Structural Advantages of Being a China-Based Research and Development Organization” for a discussion of regulatory requirements that are applicable to our current and planned business activities in China. In recent years, the regulatory framework in China regarding the pharmaceutical industry has undergone significant changes, and we expect that it will continue to undergo significant changes. Any such changes or amendments may result in increased compliance costs on our business or cause delays in or prevent the successful development or commercialization of our drug candidates ~~or drugs in China~~ and ~~reduce the current benefits we believe are available to us from developing~~regulatory approvals; and manufacturing drugs in China. Chinese authorities have become increasingly vigilant in enforcing laws in the pharmaceutical industry and any failure by us or our partners to maintain compliance with applicable laws and regulations or obtain and maintain required licenses and permits may result in the suspension or termination of our business activities in China. We believe our strategy and approach is aligned with the Chinese government’s policies, but we cannot ensure that our strategy and approach will continue to be aligned.

~~Changes in the political and economic policies of the PRC government may materially and adversely affect our business, financial condition and results of operations and may result in~~

•our inability to ~~sustain~~generate revenue from acquired technology and/or products sufficient to meet our ~~growth~~objectives in undertaking the acquisition or even to offset the associated acquisition and ~~expansion strategies.~~

Amaintenance costs.

In addition, if we undertake acquisitions or strategic collaborations, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant ~~portion~~future amortization expense. For example, in connection with our transaction with Amgen, we issued to Amgen a total of 206,635,013 ordinary shares in the form of ADSs in January 2020, representing 20.5% of the then issued share capital of the Company after giving effect to the share issuance, which resulted in Amgen becoming our largest shareholder and the ownership of our ~~operations are in the PRC. Accordingly, our financial condition and results of operations are affected to a large extent by economic, political and legal developments in the PRC.~~

The PRC economy differs from the economies of most developed countries in many respects, including the extent of government involvement, level of development, growth rate, control of foreign exchange and allocation of resources. Although the PRC government has implemented measures emphasizing the utilization of market forces for economic reform, the reduction of state ownership of productive assets, and the establishment of improved corporate governance in business enterprises, a substantial portion of productive assets in China is still owned by the government. In addition, the PRC government continues to play a significant role in regulating industry development by imposing industrial policies. The PRC government also exercises significant control over China’s economic growth by allocating resources, controlling payment of foreign currency-denominated obligations, setting monetary policy, regulating financial services and institutions and providing preferential treatment to particular industries or companies.

While the PRC economy has experienced significant growth in the past three decades, growth has been uneven, both geographically and among various sectors of the economy. The PRC government has implemented various measures to encourage economic growth and guide the allocation of resources. Some of these measures may benefit the overall PRC economy, but may also have a negative effect on us. Our financial condition and results of operation could be materially and adversely affected by government control over capital investments or changes in tax regulations that are applicable to us and consequently have a material adverse effect on our businesses, financial condition and results of operations.

~~There are uncertainties regarding the interpretation and enforcement of PRC laws, rules and regulations.~~

A large portion of our operations are conducted in the PRC through our PRC subsidiaries, and are governed by PRC laws, rules and regulations. Our PRC subsidiaries are subject to laws, rules and regulations applicable to foreign investment in China. The PRC legal system is a civil law system based on written statutes. Unlike the common law system, prior court decisions may be cited for reference but have limited precedential value.

existing shareholders being diluted.

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In 1979, the PRC government began to promulgate a comprehensive system of laws, rules and regulations governing economic matters in general. The overall effect of legislation over the past three decades has significantly enhanced the protections afforded to various forms of foreign investment in China. However, China has not developed a fully integrated legal system, and recently enacted laws, rules and regulations may not sufficiently cover all aspects of economic activities in China or may be subject to significant degrees of interpretation by PRC regulatory agencies. In particular, because these laws, rules and regulations are relatively new, and because of the limited number of published decisions and the nonbinding nature of such decisions, and because the laws, rules and regulations often give the relevant regulator significant discretion in how to enforce them, the interpretation and enforcement of these laws, rules and regulations involve uncertainties and can be inconsistent and unpredictable. In addition, the PRC legal system is based in part on government policies and internal rules, some of which are not published on a timely basis or at all, and which may have a retroactive effect. As a result, we may not be aware of our violation of these policies and rules until after the occurrence of the violation.

Any administrative and court proceedings in China may be protracted, resulting in substantial costs and diversion of resources and management attention. Since PRC administrative and court authorities have significant discretion in interpreting and implementing statutory and contractual terms, it may be more difficult to evaluate the outcome of administrative and court proceedings and the level of legal protection we enjoy than in more developed legal systems. These uncertainties may impede our ability to enforce the contracts we have entered into and could materially and adversely affect our business, financial condition and results of operations.

Substantial uncertainties exist with respect to the enactment timetable, the final version, interpretation and implementation of draft PRC Foreign Investment Law and how it may impact the viability of our current corporate governance.

The Ministry of Commerce published a discussion draft of the proposed Foreign Investment Law in January 2015 aiming to, upon its enactment, replace the trio of existing laws regulating foreign investment in China, namely, the Sino-foreign Equity Joint Venture Enterprise Law, the Sino-foreign Cooperative Joint Venture Enterprise Law and the Wholly Foreign-invested Enterprise Law, together with their implementation rules and ancillary regulations. The draft Foreign Investment Law embodies an expected PRC regulatory trend to rationalize its foreign investment regulatory regime in line with prevailing international practice and the legislative efforts to unify the corporate legal requirements for both foreign and domestic investments. The Ministry of Commerce has solicited comments on this draft and substantial uncertainties exist with respect to its enactment timetable, the final version, interpretation and implementation. The draft Foreign Investment Law, if enacted as proposed, may materially impact the viability of our current corporate governance if we, in the future, have PRC shareholders.

Among other things, the draft Foreign Investment Law expands the definition of foreign investment and introduces the principle of “actual control” in determining whether a company is considered a foreign-invested enterprise, or an FIE. The draft Foreign Investment Law specifically provides that entities established in China but “controlled” by foreign investors will be treated as FIEs, whereas an entity set up in a foreign jurisdiction would nonetheless be, upon market entry clearance by the Ministry of Commerce or its local counterparts, treated as a PRC domestic investor provided that the entity is “controlled” by PRC entities and/or citizens. In this connection, “control” is broadly defined in the draft law to cover the following summarized categories: (1) holding 50% of more of the shares, equity or voting rights of the subject entity; (2) holding less than 50% of the voting rights of the subject entity but having the power to secure at least 50% of the seats on the board or other equivalent decision making bodies, or having the voting power to exert material influence on the board, the shareholders’ meeting or other equivalent decision making bodies; or (3) having the power to exert decisive influence, via contractual or trust arrangements, over the subject entity’s operations, financial matters or other key aspects of business operations. Once an entity is determined to be an FIE, it will be subject to the foreign investment restrictions or prohibitions, if the FIE is engaged in the industry listed in the “negative list” which will be separately issued by the Chinese State Council later. Unless the underlying business of the FIE falls within the negative list, which calls for market entry clearance by the Ministry of Commerce or its local counterparts, prior approval from the government authorities as mandated by the existing foreign investment legal regime would no longer be required for establishment of the FIE.

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The draft Foreign Investment Law, if enacted as proposed, may also materially impact our corporate governance practice and increase our compliance costs. For instance, the draft Foreign Investment Law imposes stringent ad hoc and periodic information reporting requirements on foreign investors and the applicable FIEs. Aside from investment implementation report and investment amendment report that are required at each investment and alteration of investment specifics, an annual report is mandatory, and large foreign investors meeting certain criteria are required to report on a quarterly basis. Any company found to be non-compliant with these information reporting obligations may potentially be subject to fines and/or administrative or criminal liabilities, and the persons directly responsible may be subject to criminal liabilities.

*PRC regulations establish complex procedures for some acquisitions of Chinese companies by foreign investors, which could make it more difficult for us to pursue growth through acquisitions in China.

PRC regulations and rules concerning mergers and acquisitions, including the Regulations on Mergers and Acquisitions of Domestic Companies by Foreign Investors ~~or the M~~(the “M&A ~~Rules,~~Rules”), and other ~~recently adopted~~ regulations and rules with respect to mergers and acquisitions established additional procedures and requirements that could make merger and acquisition activities by foreign investors more time consuming and complex. For example, the M&A Rules require that the ~~MOFCOM~~Ministry of Commerce of the PRC (the “MOFCOM”) be notified in advance of any change-of-control transaction in which a foreign investor takes control of a PRC domestic enterprise, if (i) any important industry is concerned, (ii) such transaction involves factors that have or may have impact on the national economic security, or (iii) such transaction will lead to a change in control of a domestic enterprise which holds a famous trademark or PRC time-honored brand. Moreover, according to the Anti-Monopoly Law of the PRC, ~~promulgated on~~which was amended in June 2022 and became effective as of August ~~30, 2007~~1, 2022, and the Provisions on Thresholds for Prior Notification of Concentrations of Undertakings ~~or the Prior Notification Rules~~ issued by the State Council, ~~in August 2008,~~ the concentration of business undertakings by way of mergers, acquisitions or contractual arrangements that allow one market player to take control of or to exert decisive impact on another market player must also be notified in advance to the ~~MOFCOM~~State Administration for Market Regulation (the “SAMR”) when the threshold is crossed and such concentration shall not be implemented without the clearance of prior notification. In addition, the Measures for Security Review of Foreign Investment jointly issued by the National Development and Reform Commission and MOFCOM and the Regulations on Implementation of Security Review System for the Merger and Acquisition of Domestic Enterprise by Foreign ~~Lenders, or the Security~~Investors (the “Security Review ~~Rules~~Rules”) issued by the MOFCOM ~~that became effective in September 2011~~ specify that mergers and acquisitions by foreign investors that raise “national defense and security” concerns and mergers and acquisitions through which foreign investors may acquire the de facto control over domestic enterprises that raise “national security” concerns are subject to strict review by the MOFCOM, and the rules prohibit any activities attempting to bypass a security review by structuring the transaction through, among other things, trusts, entrustment or contractual control arrangements.

We may also be subject to similar review and regulations in other jurisdictions, such as the laws and regulations on foreign investment in the United States under the jurisdiction of the Committee on Foreign Investment in the United States (the “CFIUS”) and other agencies, including the Foreign Investment Risk Review Modernization Act (the “FIRRMA”), which became effective in February 2020.

Furthermore, according to the Overseas Listing Trial Measures, if a Chinese overseas listed company issues overseas listed securities to acquire assets, such issuance would be subject to filing requirements with the CSRC.

In the future, we may grow our business by acquiring complementary businesses. Complying with the requirements of the above-mentioned regulations and other relevant rules to complete such transactions could be time consuming, and any required approval or filing processes, including obtaining approval from or filing with CFIUS, the SAMR, the MOFCOM, the CSRC or ~~its local counterparts~~other agencies may delay or inhibit our ability to complete such transactions. It is unclear whether ~~our business~~those complementary businesses we may acquire in the future would be deemed to be in an industry that raises “national defense and security” or “national security” concerns.

However, ~~the~~CFIUS, SAMR, MOFCOM, CSRC or other government agencies may publish explanations in the future determining that ~~our~~certain complementary business is in an industry subject to the security review, in which case our future acquisitions in the United States and the PRC, including those by way of entering into contractual control arrangements with target entities, may be closely scrutinized or prohibited. Our ability to expand our business or maintain or expand our market share through future acquisitions would as such be materially and adversely affected.

PRC regulations relating to investments in offshore companies by PRC residents may subject our future PRC-resident beneficial owners or our PRC subsidiaries to liability or penalties, limit our ability to inject capital into our PRC subsidiaries or limit our PRC subsidiaries’ ability to increase their registered capital or distribute profits.

SAFE promulgated the Circular on Relevant Issues Concerning Foreign Exchange Control on Domestic Residents’ Offshore Investment and Financing and Roundtrip Investment through Special Purpose Vehicles, or SAFE Circular 37, on July 4, 2014, which replaced the former circular commonly known as “SAFE Circular 75” promulgated by SAFE on October 21, 2005. SAFE Circular 37 requires PRC residents to register with local branches of SAFE in connection with their direct establishment or indirect control of an offshore entity, for the purpose of overseas investment and financing, with such PRC residents’ legally owned assets or equity interests in domestic enterprises or offshore assets or interests, referred to in SAFE Circular 37 as a “special purpose vehicle.” SAFE Circular 37 further requires amendment to the registration in the event of any significant changes with respect to the special purpose vehicle, such as increase or

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decrease of capital contributed by PRC individuals, share transfer or exchange, merger, division or other material event. In the event that a PRC shareholder holding interests in a special purpose vehicle fails to fulfill the required SAFE registration, the PRC subsidiaries of that special purpose vehicle may be prohibited from making profit distributions to the offshore parent and from carrying out subsequent cross-border foreign exchange activities, and the special purpose vehicle may be restricted in its ability to contribute additional capital into its PRC subsidiary. Moreover, failureIf we fail to comply with the ~~various SAFE registration requirements described above could result in liability under PRC law for evasion of foreign exchange controls.~~

~~We believe that four of~~U.S. Foreign Corrupt Practices Act or other anti-bribery and corruption laws, our shareholders, each of whom owns our ordinary shares as a result of exercising share options, are PRC residents under SAFE Circular 37. These four shareholders have undertaken to (i) apply to register with local SAFE branch or its delegated commercial bank as soon as possible after exercising their options, and (ii) indemnify and hold harmless us and our subsidiaries against any loss suffered arising from their failure to complete the registration. We do not have control over the four shareholders and our other beneficial owners and cannot assure you that all of our PRC-resident beneficial owners have complied with, and will in the future comply with, SAFE Circular 37 and subsequent implementation rules. The failure of PRC-resident beneficial owners to register or amend their SAFE registrations in a timely manner pursuant to SAFE Circular 37 and subsequent implementation rules, or the failure of future PRC-resident beneficial owners of our company to comply with the registration procedures set forth in SAFE Circular 37 and subsequent implementation rules,reputation may subject such beneficial owners or our PRC subsidiaries to fines and legal sanctions. Furthermore, SAFE Circular 37 is unclear how this regulation, and any future regulation concerning offshore or cross-border transactions, will be ~~interpreted, amended and implemented by the relevant PRC government authorities,~~harmed and we ~~cannot predict how these regulations will affect our business operations or future strategy. Failure~~could be subject to ~~register or comply with relevant requirements may also limit our ability to contribute additional capital to our PRC subsidiaries~~penalties and ~~limit our PRC subsidiaries’ ability to distribute dividends to us. These risks could in the future~~significant expenses that have a material adverse effect on our business, financial condition and results of operations.

~~Any failure~~

We are subject to the U.S. Foreign Corrupt Practices Act (the “FCPA”). The FCPA generally prohibits us from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business. We are also subject to the anti-bribery and corruption laws of other jurisdictions, particularly China. The anti-bribery laws in China generally prohibit companies and their intermediaries from making payments to government officials for the purpose of obtaining or retaining business or securing any other improper advantage. As our business has expanded, the applicability of the FCPA and other anti-bribery and corruption laws to our operations has increased.

We do not fully control the interactions our employees, distributors and third-party promoters have with hospitals, medical institutions and doctors, and they may try to increase sales volumes of our products through means that constitute violations of United States, PRC or other countries’ anti-corruption and related laws. Although we have policies and procedures designed to ensure that we, our employees and our agents comply with anti- bribery laws, there is no assurance that such policies or procedures will prevent our agents, employees and intermediaries from engaging in bribery activities. If we, due to either our own deliberate or inadvertent acts or those of others, fail to comply with ~~PRC regulations regarding~~applicable anti-bribery and corruption laws, our ~~employee equity incentive plans may subject the PRC plan participants~~reputation could be harmed and we could incur criminal or ~~us to fines and other legal or administrative sanctions.~~

We and our directors, executive officers and other employees who are PRC residents have participated in our employee equity incentive plans. Upon completion of our initial public offering, we became an overseas listed company. Pursuant to SAFE Circular 37, PRC residents who participate in share incentive plans in overseas non-publicly-listed companies may submit applications to SAFE or its local branches for the foreign exchange registration with respect to offshore special purpose companies. Our directors, executive officers and other employees who are PRC citizens or who have resided in the PRC for a continuous period of not less than one year and who have been granted restricted shares or options may follow SAFE Circular 37 to apply for the foreign exchange registration before our company became an overseas listed company. However, in practice, different local SAFE branches may have different views and procedures on the application and implementation of SAFE regulations, and there remains uncertainty with respect to its implementation. If we or our directors, executive officers or other employees who are PRC citizens or who have resided in the PRC for a continuous period of not less than one year and who have been granted restricted shares or options,civil penalties, including but not limited to imprisonment, criminal and civil fines, suspension of our ability to do business with the ~~four shareholders referred to above,~~government, denial of government reimbursement for our products and/or exclusion from participation in government healthcare programs, other sanctions and/or significant expenses, which could have a material adverse effect on our business.

If we or our CROs or contract manufacturing organizations (“CMOs”) fail to ~~register~~comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.

We and third parties, such as our CROs or CMOs, are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the ~~employee equity incentive plans~~handling, use, storage, treatment and disposal of hazardous materials and waste. In addition, our construction projects can only be put into operation after certain regulatory procedures with the relevant administrative authorities in charge of environmental protection, health and safety have been completed. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and waste. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and such liability could exceed our insurance coverage. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance to cover us for costs and expenses that we may incur due to injuries to our employees resulting from the use of or exposure to hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage, use or disposal of biological or hazardous materials.

In addition, we may be required to incur substantial costs to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development, manufacturing or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

*Our information technology systems, or those used by our contractors or collaborators, may fail or suffer security breaches, which could result in a material disruption of our product development and commercialization efforts.

Despite the implementation of security measures, our information technology systems and those of our contractors and collaborators, are vulnerable to damage from internal or external events, such as computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures, which can compromise the confidentiality, integrity and availability of the systems. Although to our knowledge we have not experienced any material system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our research, development, manufacturing, regulatory and commercialization efforts and our business operations.

In the ordinary course of our business, we collect and store sensitive data, including, among other things, legally protected patient health information, personally identifiable information about our employees, intellectual property, and proprietary business information. We manage and maintain our applications and data utilizing on-site systems and outsourced vendors. These applications and data encompass a wide variety of business-critical information, including research and development information, commercial information and business and financial information. Because information systems, networks and other

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technologies are critical to many of our operating activities, shutdowns or service disruptions at our company or vendors that provide information systems, networks, or other services to us pose increasing risks. Such disruptions may be caused by events such as computer hacking, phishing attacks, ransomware, dissemination of computer viruses, worms and other destructive or disruptive software, denial of service attacks and other malicious activity, as well as power outages, natural disasters (including extreme weather), terrorist attacks or other similar events. Such events could cause loss of data, damage to systems and data and leave us unable to utilize key business systems or access important data needed to operate our business. Our contractors and collaborators have faced, and in the future may face, similar risks, and service disruptions or security breaches of their systems could adversely affect our security, leave us without access to important systems, products, raw materials, components, services or information or expose our confidential data. In addition, system redundancy may be ineffective or inadequate, and our disaster recovery planning may not be sufficient to cover all eventualities. Significant events could result in a disruption of our operations, damage to our reputation or a loss of revenues. In addition, we may not have adequate insurance coverage to compensate for any losses associated with such events.

We could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in the information systems and networks of our company and our vendors, including personal information of our employees and patients, and company and vendor confidential data. In addition, outside parties may attempt to penetrate our systems or those of our vendors or fraudulently induce our personnel or the personnel of our vendors to disclose sensitive information in order to gain access to our data and/or systems. Like other companies, we and our third-party vendors have on occasion experienced, and will continue to experience, threats to our or their ~~exercise~~data and systems, including malicious codes and viruses, phishing, email compromise attacks, ransomware, or other cyber-attacks. For example, one of ~~options,~~our third-party vendors experienced a business email compromise which results in us sending payment to a fraudulent bank account. Funds were successfully recovered in this case, but it is possible that to the extent a similar future event occurs, funds will not be recoverable. The number and complexity of these threats continue to increase over time. If a material breach of our information technology systems or those of our vendors occurs, we could be required to expend significant amounts of money and other resources to respond to these threats or breaches and to repair or replace information systems or networks and could suffer financial loss or the loss of valuable confidential information. In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices. Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have processes to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated. Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely. It is possible that the risk of cyber-attacks or other privacy or data security incidents may be heightened as a result of our remote working environment, which may be less secure and more susceptible to hacking attacks. As we outsource more of our information systems to vendors, engage in more electronic transactions with payors and patients, and rely more on cloud-based information systems, the related security risks will increase and we will need to expend additional resources to protect our technology and information systems. In addition, there can be no assurance that our internal information technology systems or those of our contractors and collaborators, as well as our and their efforts to implement adequate security and control measures, will be sufficient to protect us against breakdowns, service disruptions, data deterioration or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, ransomware, industrial espionage attack or insider threat attack that could adversely affect our business and operations and/or result in the loss or exposure of critical, proprietary, private, confidential or otherwise sensitive data, which could result in financial, legal, business or reputational harm to us.

*The increasing use of artificial intelligence-based software (including machine learning) and social media platforms may result in reputation harm or liability or could otherwise adversely affect our business.

The use of artificial intelligence-based software is increasingly being used in the biopharmaceutical and global healthcare industries. As with many developing technologies, artificial intelligence-based software presents risks and challenges that could affect its further development, adoption, and use, and therefore our business. For example, algorithms may be flawed; data sets may be insufficient, of poor quality, or contain biased information; and inappropriate or controversial data practices by data scientists, engineers, and end-users could impair results. If the analyses that artificial intelligence applications assist in producing are deficient or inaccurate, we could be subjected to competitive harm, potential legal liability, and brand or reputational harm. Furthermore, use of artificial intelligence-based software may lead to the release of confidential information which may impact our ability to realize the benefit of our intellectual property.

Relatedly, social media platforms are increasingly being used to communicate about our products and the diseases our medicines and drug candidates are designed to treat. Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such ~~employees~~use are not always clear and create uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media channels to comment on the effectiveness of

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a product or to report an alleged adverse event. When such disclosures occur, there is a risk that we may fail to monitor and comply with applicable adverse event reporting obligations. There is also a risk of negative or inaccurate posts about us on social media, including criticism regarding our medicines or drug candidates. The immediacy of social media precludes us from having real-time control over postings made regarding our company, medicines or drug candidates. Our reputation could be damaged by negative publicity posted on social media platforms which we may not be able to timely reverse. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face restrictive regulatory actions or incur other harm to our business.

Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.

In the United States, Europe, China, and many other jurisdictions where we operate, we are subject to laws and regulations that address privacy, personal information protection and data security at both the federal and State levels. Numerous laws and regulations, including, without limitation, privacy laws (such as the European Union's General Data Protection Regulation (“GDPR”) or similar laws), security breach notification laws (such as Australia's amendment to the Privacy Act), health information privacy laws (such as the United States' Health Insurance Portability and Accountability Act (“HIPAA”) and the Human Genetic Resources Administration of China's rules), and consumer protection laws (such as the United States' Federal Trade Commission's unfair or deceptive practices rules or California's Consumer Privacy Act and California's Privacy Rights Act), govern the collection, use, disclosure and protection of health-related and other personal information. A subset of these laws also have strict requirements governing the cross-border transmission of personal information (see the risk factor entitled “Compliance with the Data Security Law of the People’s Republic of China (the “Data Security Law”), Cybersecurity Review Measures, Personal Information Protection Law of the People’s Republic of China (the “PIPL”), regulations and guidelines relating to the multi-level protection scheme (the “MLPS”) and any other future laws and regulations may entail significant expenses and could materially affect our business.”).

The legal and regulatory landscape around data privacy is rapidly changing with countries, states and other localities passing new laws and regulations every year. Tracking and complying with these laws and regulations requires significant time and expenses and could materially affect our business. By way of example and without limitation, these laws may require updating of contracts, informed consent forms, clinical trial protocols and privacy notices; changes to company procedures; limiting what personal information we collect, who has access to it and how/where we use it; performing internal assessments; changes to the security and hosting solution of our systems; specific reporting and remediation efforts in the event of a data breach; and even opening our business up for external assessments by government bodies.

Given the variability and evolving state of these laws, we face uncertainty as to the exact interpretation of the new requirements, and we may face challenges in implementing all measures required by regulators or courts in their interpretation. Additionally, we may experience a reportable data breach (see the risk factor entitled “Our information technology systems, or those used by our contractors or collaborators, may fail or suffer security breaches, which could result in a material disruption of our product development and commercialization efforts”). Any failure or perceived failure by us to comply with applicable laws and regulations could subject us to significant administrative, civil or criminal fines or other penalties and negatively impact our reputation. For severe violations, in some countries these laws even allow courts and government agencies to delay or halt transfer of personal information, require deletion of personal information, or even order we stop collection, use or other processing of personal information in that country. All of these could materially harm our business, prospects, and financial condition or even disrupt our operations.

These laws apply not just to us, but also to those vendors working on our behalf, as well as our business partners. Any actual or perceived failure of them to comply with these laws and regulations could impact the services they provide to us, our collaborations with them and our reputation; additionally, there is a risk of liability flowing to us under certain contractual and/or legal conditions.

Compliance with the Data Security Law of the People’s Republic of China (the “Data Security Law”), Cybersecurity Review Measures, Personal Information Protection Law of the People’s Republic of China (the “PIPL”), regulations and guidelines relating to the multi-level protection scheme (the “MLPS”) and any other future laws and regulations may entail significant expenses and could materially affect our business.

China has implemented extensive data protection, privacy and information security rules and is considering a number of additional proposals relating to these subject areas. We face significant uncertainties and risks related to these laws, regulations and policies, some of which were only recently enacted, and the interpretation of these legal requirements by government regulators as applied to biotechnology companies like us. For example, we do not maintain, nor do we intend to maintain in the future, personally identifiable health information of patients in China. We do, however, collect and maintain de-identified or pseudonymized health data for clinical trials in compliance with local regulations. This data could be deemed “personal data” or

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“important data” by government regulators. With China’s growing emphasis of its sovereignty over data derived from China, the outbound transmission of de-identified or pseudonymized health data for clinical trials may be subject to ~~(i)~~the new national security legal ~~or administrative sanctions imposed by~~regime, including the ~~SAFE or other PRC authorities, including fines; (ii) to restrictions~~Data Security Law, the Cyber Security Law of the People’s Republic of China (the “Cyber Security Law”), the PIPL, and various implementing regulations and standards.

China’s Data Security Law provides that the data processing activities must be conducted based on ~~our cross-border investment activities; (iii) to limits on~~“data classification and hierarchical protection system” for the ~~ability~~purpose of ~~our wholly owned subsidiaries~~data protection and prohibits entities in China from transferring data stored in China to ~~distribute dividends~~foreign law enforcement agencies or judicial authorities without prior approval by the relevant PRC authority. The classification of data is based on its importance in economic and social development, as well as the degree of harm expected to be caused to national security, public interests, or the ~~proceeds~~legitimate rights and interests of individuals or organizations if such data is tampered with, destroyed, leaked, or illegally acquired or used.

The Cyber Security Law requires companies to take certain measures to ensure the security of their networks and data stored on their networks. Specifically, the Cyber Security Law provides that companies adopt an MLPS, under which network operators are required to perform obligations of security protection to ensure that the network is free from interference, disruption or unauthorized access, and prevent network data from being disclosed, stolen or tampered. The CAC released draft amendments to the Cyber Security Law in September 2022, which propose to impose more stringent legal liabilities for violations. Under the MLPS, entities operating information systems must have a thorough assessment of the risks and the conditions of their information and network systems to determine the level to which the entity’s information and network systems belong, from the lowest Level 1 to the highest Level 5 pursuant to a series of national standards on the grading and implementation of the classified protection of cybersecurity. The grading result will determine the set of security protection obligations that entities must comply with and when relevant government authority examination and approval is required.

Under the Cyber Security Law and Data Security Law, we are required to establish and maintain a comprehensive data and network security management system that will enable us to monitor and respond appropriately to data security and network security risks. We are obligated to notify affected individuals and appropriate Chinese regulators of and respond to any ~~reduction~~data security and network security incidents. Establishing and maintaining such systems takes substantial time, effort and cost, and we may not be able to establish and maintain such systems as fully as needed to ensure compliance with our legal obligations. Despite our investment, such systems may not adequately protect us or enable us to appropriately respond to or mitigate all data security and network security risks or incidents we may face.

Furthermore, under the Data Security Law, data categorized as “important data,” which will be determined by governmental authorities in ~~capital, share transfer~~the form of catalogs, is to be processed and handled with a higher level of protection. The notion of important data is not clearly defined by the Cyber Security Law or ~~liquidation to us; and (iv) to prohibitions on our ability to inject additional capital into these subsidiaries. Moreover, failure~~the Data Security Law. In order to comply with the statutory requirements, we will need to determine whether we possess important data, monitor the important data catalogs that are expected to be published by local governments and departments, perform risk assessments and ensure we are complying with reporting obligations to applicable regulators. We may also be required to disclose to regulators business sensitive or network security-sensitive details regarding our processing of important data and may need to pass the government security review or obtain government approval in order to share important data with offshore recipients, which can include foreign licensors, or share data stored in mainland China with judicial and law enforcement authorities outside of mainland China. If judicial and law enforcement authorities outside mainland China require us to provide data stored in mainland China, and we are not able to pass any required government security review or obtain any required government approval to do so, we may not be able to meet the foreign authorities’ requirements and may be unable to share information outside of China which may disrupt the operation of our business. The potential conflicts in legal obligations could have adverse impacts on our operations in and outside of mainland China. PRC regulatory authorities have also enhanced the supervision and regulation of cross-border data transmission. The Data Security Law prohibits entities and individuals in China from providing any foreign judicial or law enforcement authority with any data stored in China without approval from competent PRC authority, and sets forth the legal liabilities of entities and individuals found to be in violation of their data protection obligations, including rectification order, warning, fines, suspension of relevant business, and revocation of business permits or licenses. Moreover, the CAC promulgated the Measures for the Security Assessment of Cross-border Data Transmission, which became effective as of September 1, 2022. According to these measures, personal data processors are subject to security assessment prior to any cross-border transfer of data if the transfer involves (i) important data; (ii) personal information transferred overseas by operators of critical information infrastructure or a data processor that has processed personal data of more than one million persons; (iii) personal information transferred overseas by a data processor who has already provided personal data of 100,000 persons or sensitive personal data of 10,000 persons overseas since January 1 of last year; or (iv) other circumstances as requested by the CAC. Any cross-border data transfer activities conducted in violation of the Measures for the Security Assessment of Cross-border Data Transmission before the effectiveness of these measures were required to be rectified by March 2023. Though these measures have already taken effect, substantial uncertainties still exist with respect to the interpretation and implementation of these measures in practice and how they will affect our business operation.

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The CAC has taken action against several Chinese internet companies listed on U.S. securities exchanges for alleged national security risks and improper collection and use of the personal information of Chinese data subjects. According to the official announcement, the action was initiated based on the National Security Law of the People’s Republic of China (the “National Security Law”), the Cyber Security Law and the Cybersecurity Review Measures. Effective February 15, 2022, the CAC, together with 12 other PRC governmental authorities, promulgated the Revised Cybersecurity Review Measures, pursuant to which critical information infrastructure operators procuring network products and services and online platform operators carrying out data processing activities, which affect or may affect national security, shall conduct a cybersecurity review. In addition, online platform operators possessing personal information of more than one million users seeking to be listed on foreign stock markets must apply for a cybersecurity review. The relevant competent governmental authorities may also initiate a cybersecurity review against the relevant operators if the authorities believe that the network product or service or data processing activities of such operators affect or may affect national security. There are still uncertainties as to the exact scope of network product or service or data processing activities that will or may affect national security, and the PRC government authorities may have discretion in the interpretation and enforcement of these measures.

Additionally, the CAC published the draft Administrative Regulations on Cyber Data Security (“Draft Cyber Data Security Regulations”), pursuant to which data processors shall apply for cybersecurity review if they engage in (i) merger, reorganization or division of internet platform operators with significant data resources related to national security, economic development or public interests that affects or may affect national security; (ii) overseas listing while processing over one million users’ personal information; (iii) Hong Kong listing that affects or may affect national security; or (iv) other data processing activities that affect or may affect national security. The Draft Cyber Data Security Regulations further require data processors processing important data or going public overseas to conduct annual data security self-assessment and submit an assessment report to the CAC before January 31 each year. As the Draft Cyber Data Security Regulations were released only for public comment, the final version and the effective date thereof may be subject to change with substantial uncertainty.

It is unclear how widespread the cybersecurity review requirement and the enforcement action will be and what effect they will have on the life sciences sector generally and the Company in particular. China’s regulators may impose penalties for non-compliance ranging from fines or suspension of operations, and the imposition of any such penalties on our business could cause a material adverse effect on our business, financial condition, results of operations, prospects and the trading price of our ordinary shares, ADSs and RMB Shares, and could lead to our delisting from the Nasdaq. As of the date of this report, we have not received any notice from any Chinese regulatory authority identifying us as a “critical information infrastructure operator,” “online platform operator” or “data processor,” or requiring us to go through the cybersecurity review procedures pursuant to the Revised Cybersecurity Review Measures and the Draft Cyber Data Security Regulations. However, there remains uncertainty as to how the regulations if enacted as currently proposed, will be interpreted or implemented and whether the Chinese regulatory authorities will adopt additional regulations. We intend to closely monitor the evolving laws and regulations in this area and take all reasonable measures to mitigate compliance risks, we cannot guarantee that our business and operations will not be adversely affected by the potential impact of the Revised Cybersecurity Review Measures, the Draft Cyber Data Security Regulations or other laws and regulations related to privacy, data protection and information security.

Additionally, the Standing Committee of the National People’s Congress of the PRC promulgated the PIPL, which expands data protection compliance obligations to cover the processing of personal information of persons by organizations and individuals in China, and the processing of personal information of persons in China outside of China if such processing is for purposes of providing products and services to, or analyzing and evaluating the behavior of, persons in China. The PIPL also provides that critical information infrastructure operators and personal information processing entities that process personal information meeting a volume threshold are also required to store in China personal information generated or collected in China, and to pass a security assessment for any export of such personal information. Lastly, the PIPL contains proposals for significant fines for serious violations of up to RMB50 million, or 5% of annual revenues from the prior year, and penalties, including that companies found to have violated the PIPL may be ordered to suspend any related activity.

Interpretation, application and enforcement of these laws, rules and regulations evolve from time to time and their scope may continually change, through new legislation, amendments to existing legislation or changes in enforcement. Compliance with the Cyber Security Law, the Data Security Law and the PIPL could significantly increase the cost to us of providing our service offerings, require significant changes to our operations or even prevent us from providing certain service offerings in jurisdictions in which we currently operate or in which we may operate in the future. Despite our efforts to comply with applicable laws, regulations and other obligations relating to privacy, data protection and information security, it is possible that our practices, offerings or platform could fail to meet all of the requirements imposed by the Cyber Security Law, the Data Security Law and/or related implementing regulations. Any failure on our part to comply with such law or regulation, or any compromise of security that results in unauthorized access, use or release of personally identifiable information or other data, or the perception or allegation that any of the foregoing types of failure or compromise has occurred, could damage our reputation, discourage new and existing counterparties from contracting with us or result in investigations, fines, suspension or other penalties by Chinese government authorities and private claims or litigation, any of which could materially adversely affect our

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business, financial condition and results of operations. Even if our practices are not subject to legal challenge, the perception of privacy concerns, whether or not valid, may harm our reputation and adversely affect our business, financial condition and results of operations. Moreover, the legal uncertainty created by the Data Security Law and the recent Chinese government actions could materially adversely affect our ability, on favorable terms, to raise capital in the U.S. and other markets in the future.

If we or parties on whom we rely fail to maintain the necessary licenses for the development, manufacture, sale and distribution of our products, our ability to conduct our business could be materially impaired.

We are required to obtain, maintain and renew various ~~foreign exchange registration requirements described above~~permits, licenses and certificates to develop, manufacture, promote and sell our products. Third parties, such as distributors, third-party promoters and third-party manufacturers, on whom we may rely to develop, manufacture, promote, sell and distribute our products may be subject to similar requirements. We and third parties on whom we rely may be also subject to regular inspections, examinations, inquiries or audits by the regulatory authorities, and an adverse outcome of such inspections, examinations, inquiries or audits may result in the loss or non-renewal of the relevant permits, licenses and certificates. Moreover, the criteria used in reviewing applications for, or renewals of permits, licenses and certificates may change from time to time, and there can be no assurance that we or the parties on whom we rely will be able to meet new criteria that may be imposed to obtain or renew the necessary permits, licenses and certificates. Many of such permits, licenses and certificates are material to the operation of our business, and if we or parties on whom we rely fail to maintain or renew material permits, licenses and certificates, our ability to conduct our business could be materially impaired. Furthermore, if the interpretation or implementation of existing laws and regulations change, or new regulations come into effect, requiring us or parties on whom we rely to obtain any additional permits, licenses or certificates that were previously not required to operate our business, there can be no assurance that we or parties on whom we rely will successfully obtain such permits, licenses or certificates.

*Our financial and operating performance may be adversely affected by government shutdowns, public health crises, natural catastrophes, or other business interruptions outside of our control.

Our global operations and those of our third-party contractors and collaborators expose us to natural or man-made disasters, such as earthquakes, hurricanes, floods, fires, explosions, public health crises, such as epidemics or pandemics, terrorist activity, wars, or other business interruptions outside of our control. Furthermore, we do not maintain any insurance other than property insurance for some of our buildings, vehicles and equipment. Accordingly, unexpected business interruptions resulting from disasters could disrupt our operations and thereby result in substantial costs and diversion of resources. For example, our Guangzhou manufacturing facility was hit by a typhoon in 2019 and although the typhoon did not cause material damage to the facility, the boundary area and the adjacent land were flooded, causing a power outage for a few days. Afterwards, we built a gutter along the boundary and installed waterproof electricity cables to fortify the facility and to help prevent future interruptions. A significant disruption at either our Guangzhou or Suzhou manufacturing facilities, even on a short-term basis, could impair our ability to timely produce products, which could have a material adverse effect on our business, financial position and results of operations.

Our production process requires a continuous supply of electricity. We have encountered power shortages historically in China due to restricted power supply to industrial users during summers when the usage of electricity is high and supply is limited or as a result of damage to the electricity supply network. Because the duration of those power shortages was brief, they had no material impact on our operations. Longer interruptions of electricity supply could result in lengthy production shutdowns, increased costs associated with restarting production and the loss of production in progress. Any major suspension or termination of electricity or other unexpected business interruptions could have a material adverse impact on our business, financial condition and results of operations.

We also rely in part on third-party manufacturers to produce and process our medicines and drug candidates. Our ability to obtain supplies of our medicines and drug candidates could be disrupted if the operations of these suppliers are affected by man-made or natural disasters, public health epidemics or other business interruptions which could cause us to delay or cease development or commercialization of some or all of our medicines and drug candidates. In addition, we partially rely on our third-party research institution collaborators for conducting research and development of our drug candidates, and they may be affected by such business interruptions, government shutdowns or withdrawn funding. For example, the ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. If a prolonged government shutdown occurs, it could significantly impact the ability of the

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FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

In particular, the COVID-19 pandemic negatively impacted our business and our financial performance, and future global pandemics or other public health crises could have similar negative impacts, including causing a delay in or the inability of health authorities to complete regulatory inspections of our development activities, regulatory filings, manufacturing operations, or clinical trial recruitment. Additionally, the commercial or clinical supply of our medicines and drug candidates could be negatively impacted due to reduced operations or a shutdown of our or our third-party manufacturing facilities, distribution channels and transportation systems, or shortages of raw materials and drug product.

The COVID-19 pandemic also resulted in significant governmental measures being implemented to control the spread of the virus, including quarantines, travel restrictions, social distancing and business shutdowns. To the extent similar measure are enacted in the future, such measures may negatively affect our business by inducing absenteeism or employee turnover, disrupting our operations, or increasing the risk of a cybersecurity incident.

Climate change manifesting as physical or transition risks, included related environmental regulation, could have a material adverse impact on our business operations, clients and customers.

The long-term effects of climate change are difficult to assess and predict. Our business and the activities of our clients and customers could be impacted by climate change. Climate change could manifest as a financial risk either through changes in the physical climate or from the process of transitioning to a low-carbon economy, including related environmental regulation of companies with respect to risks posed by climate change.

The physical impacts of climate change may include physical risks (such as rising sea levels or frequency and severity of extreme weather conditions), social and human effects (such as population dislocations or harm to health and well-being), compliance costs and transition risks (such as regulatory or technology changes) and other adverse effects. The effects could impair, for example, the availability and cost of certain products, commodities and energy (including utilities), which in turn may impact our ability to procure goods or services required for the operation of our business at the quantities and levels we require. Furthermore, related environmental regulation as a response to climate change could result in additional costs in the form of taxes and investments of capital to maintain complacent with such laws. We bear losses incurred as a result of, for example, physical damage to or destruction of our facilities, loss or spoilage of inventory, and business interruption due to weather events that may be attributable to climate change and could materially adversely affect our business operations, financial position or results of operation.

Product liability claims or lawsuits could cause us to incur substantial liabilities.

We face an inherent risk of product liability as a result of the commercialization of our medicines in the United States, China, Europe and other markets, and for the clinical testing and any future commercialization of our drug candidates globally. For example, we may be sued if our medicines or drug candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the medicine, negligence, strict liability or a breach of warranties. Claims could also be asserted under applicable consumer protection acts. If we cannot successfully defend ourselves against or obtain indemnification from our collaborators for product liability claims, we may incur substantial liabilities or be required to limit commercialization of our medicines and drug candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in: decreased demand for our medicines; injury to our reputation; withdrawal of clinical trial participants and inability to continue clinical trials; initiation of investigations by regulators; costs to defend the related litigation; a diversion of our management’s time and resources; substantial monetary awards to trial participants or patients; product recalls, withdrawals or labeling, marketing or promotional restrictions; loss of revenue; exhaustion of any available insurance and our capital resources; the inability to commercialize any medicine or drug candidate; and a decline in our share price.

Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of our medicines and drug candidates. Although we currently hold product liability coverage which we believe to be sufficient in light of our current products and clinical programs, the amount of such insurance coverage may not be adequate, and we may be unable to maintain such insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise, or we may not be able to obtain additional or replacement insurance at a reasonable cost, if at all. Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to

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obtain, sufficient capital to pay such amounts. Even if our agreements with any future collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

*We are subject to the risks and challenges of doing business globally, which may adversely affect our business operations.

Our business is subject to risks and challenges associated with doing business globally. Accordingly, our business and financial results could be adversely affected due to a variety of factors, including: changes in a specific country’s or region’s political and cultural climate or economic condition; unexpected changes in laws and regulatory requirements in local jurisdictions; challenges in replicating or adapting our company policies and procedures to operating environments different from that of the United States; difficulty of effective enforcement of contractual provisions in local jurisdictions; inadequate intellectual property protection in certain countries; enforcement of anti-corruption and anti-bribery laws, such as the FCPA; trade-protection measures or disputes, import or export licensing requirements, and fines, penalties or suspension or revocation of export privileges; laws and regulations on foreign investment in the United States under the jurisdiction of the CFIUS and other agencies; the effects of applicable local tax regimes and potentially adverse tax consequences; the impact of public health epidemics on employees, our operations and the global economy; restrictions on international travel and commerce; and significant adverse changes in local currency exchange rates. In addition, in 2017 the United Kingdom Financial Conduct Authority (“UKFCA”), which regulates the London Interbank Offered Rate (“LIBOR”), announced that it would no longer require banks to submit rates for the calculation of LIBOR to the LIBOR administrator. Following June 30, 2023, the UKFCA ceased to publish one month, three month and six month USD LIBOR settings. In the United States, the Alternative Reference Rate Committee (“ARRC”), a steering committee assembled by the Federal Reserve Board and the Federal Reserve Bank of New York, was tasked with identifying alternative reference rates to replace LIBOR. The AARC selected, and the Federal Reserve Bank of New York has recommended, the Secured Overnight Finance Rate (“SOFR”) as an alternative to LIBOR. SOFR is a broad measure of the cost of borrowing cash in the overnight United States treasury market. LIBOR and SOFR have significant differences: LIBOR was an unsecured lending rate and SOFR is a secured lending rate, and SOFR is an overnight rate while LIBOR is a forward-looking rate that reflected term rates at different maturities. At this time, it is not possible to predict how markets will respond to SOFR or other alternative reference rates, and as such, the replacement of LIBOR could have an adverse effect on the market for, or value of, LIBOR-linked financial instruments. Failure to manage these risks and challenges could negatively affect our ability to expand our businesses and operations as well as materially and adversely affect our business, financial condition and results of operations.

Future operating results could be negatively affected by changes in tax rates, the adoption of new tax legislation in the jurisdictions in which we operate, or exposure to additional tax liabilities.

The nature of our international operations subjects us to local, state, regional and national tax laws in jurisdictions around the world. Our future tax expense could be affected by changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities or changes in tax laws or their interpretation. Additionally, tax rules governing cross-border activities are continually subject to modification intended to address concerns over base erosion and profit shifting (BEPS) and other perceived international tax avoidance techniques as a result of both coordinated actions by governments, such as the OECD/G20 Inclusive Framework on BEPS, and unilateral measures designed by individual countries. For example, the Cayman Islands has enacted the International Tax Co-operation (Economic Substance) Law (2020 Revision) (the “Economic Substance Law”), which originally took effect on January 1, 2019, and which is accompanied by Guidance on Economic Substance for Geographically Mobile Activities (Version 2.0; April 30, 2019) published by the Cayman Islands Tax Information Authority. The Economic Substance Law embraces a global initiative to combat BEPS and demonstrates the continued commitment of the Cayman Islands to international best practice. The Economic Substance Law provides that relevant entities that existed before January 1, 2019 and that had been conducting relevant activities by that date must comply with the economic substance requirements from July 1, 2019, and relevant entities that are established from January 1, 2019 onwards must comply with the requirements from the date they commence the relevant activity. Although we believe that we currently are not obliged to meet the economic substance requirements under the Economic Substance Law, we cannot predict any changes to the legislation or its interpretation in the future. If we are obliged to meet certain economic substance requirements in the future, our business and results of operations could be negatively impacted if we are required to make changes to our business in order to gain compliance or if we fail to comply.

We have received tax rulings from various governments that have jurisdictional authority over our operations. If we are unable to meet the requirements of such agreements, or if they expire or are renewed on less favorable terms, the result could negatively impact our future earnings. Additionally, the European Commission has opened formal investigations into specific tax rulings granted by several countries to specific taxpayers. While we believe that our rulings are consistent with accepted tax ruling practices, the ultimate resolution of such activities cannot be predicted and could also have an adverse impact on future operating results.

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Risks Related to Our Doing Business in the PRC

*Changes in the political and economic policies of the PRC ~~law~~government or in relations between China and the United States or other governments and the oversight and discretion the PRC government has over the conduct of the business operations of our PRC subsidiaries may materially and adversely affect our business, financial condition, and results of operations and may result in our inability to sustain our growth and expansion strategies.

Due to our operations in China, our business, results of operations, financial condition and prospects may be influenced by economic, legal and social conditions in the PRC or changes in government relations between China and the United States or other governments. There is significant uncertainty about the future relationship between the United States and China with respect to trade policies, treaties, government regulations and tariffs. China’s economy differs from the economies of other countries in many respects, including with respect to the level of development, growth rate, amount of government involvement and oversight upon foreign exchange. While China's economy has experienced significant growth over the past four decades, growth has been uneven across different regions and among various economic sectors. The Chinese government has implemented various measures to encourage economic development and guide the allocation of resources. Some of these measures may benefit the overall Chinese economy, but may have a negative effect on us. For example, our financial condition and results of operations may be adversely affected by government oversight of capital investments or changes in tax regulations that are currently applicable to us. In addition, in the past the Chinese government implemented certain measures, including interest rate increases, to manage the pace of economic growth and prevent the economy from overheating. These measures may cause decreased economic activity in China, which may adversely affect our business and results of operations.

*The PRC government has the ability to exert oversight over any offering of securities conducted overseas and/or foreign investment in China-based issuers, and, as a result, may limit or completely hinder our ability to offer or continue to offer securities to investors, and may cause the value of such securities to significantly decline or be worthless.

The PRC government has indicated its intent to exert more oversight over securities offerings and other capital markets activities that are conducted overseas and foreign investment in China-based companies. If the PRC authorities attempt to exercise such oversight or administration through regulation over our PRC subsidiaries, we could be required to restructure our operations to comply with such regulations or potentially cease operations in the PRC entirely, which could adversely affect our business, results of operations and financial condition. Any such action, once taken by the PRC government, could significantly limit or completely hinder our ability to offer or continue to offer securities to investors and cause the value of such securities to significantly decline or in extreme cases, become worthless.

For example, the PRC government initiated a series of regulatory actions and statements to regulate business operations in China, including cracking down on illegal activities in the securities market, enhancing supervision over China-based companies listed overseas using the variable interest entity structure, adopting new measures to extend the scope of cybersecurity reviews, and expanding the efforts in anti-monopoly enforcement. For example, in July 2021, the relevant PRC government authorities made public the Opinions on Intensifying Crack Down on Illegal Securities Activities (the “Securities Opinions”), which emphasized the need to strengthen the administration over illegal securities activities and the supervision on overseas listings by China-based companies and proposed to take effective measures, such as promoting the construction of relevant regulatory systems to deal with the risks and incidents faced by China-based overseas listed companies.

Furthermore, in July 2021, the PRC government provided guidance on China-based companies raising capital outside of China, including through arrangements called variable interest entities (“VIEs”). In light of such developments, the SEC has imposed enhanced disclosure requirements on China-based companies seeking to register securities with the SEC. In February 2023, the CSRC released the Overseas Listing Trial Measures and five relevant guidelines which became effective as of March 31, 2023. According to the Overseas Listing Trial Measures, where Chinese companies that have directly or indirectly listed securities in overseas markets conduct follow-on offering of equity securities in such overseas markets, they shall fulfill the filing procedures with and report relevant information to the CSRC. As the Overseas Listing Trial Measures have recently been promulgated and are subject to changes and may continue to evolve, we cannot assure you that we would not be deemed as an indirect overseas listed Chinese company under the Overseas Listing Trial Measures. If we are deemed as an indirect overseas listed Chinese company but fail to complete the filing procedures with the CSRC for ~~circumventing applicable~~any of our follow-on offerings or follow relevant reporting requirements thereunder, we may be subject to penalties, sanctions and fines imposed by the CSRC and relevant departments of the State Council. See also the section of our Annual Report titled “Part I —Item 1 — Business — Government Regulation – PRC Regulation – Regulations Relating to Overseas Listing”. We are currently evaluating the implications and potential impact of the Overseas Listing Trial Measures and will continue to closely monitor the interpretation and implementation of the Overseas Listing Trial Measures. Due to our operations in China and stock listings in and outside of China, the Overseas Listing Trial Measures and any future PRC, U.S. or other rules and regulations that place restrictions on capital raising could adversely affect our business and results of operations and could significantly limit or completely hinder

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our ability to offer or continue to offer our ADSs or ordinary shares to investors, and could cause the value of our ADSs or ordinary shares to significantly decline or become worthless.

In February 2023, the CSRC and other PRC governmental authorities jointly issued the revised Provisions on Strengthening Confidentiality and Archives Administration of Overseas Securities Offering and Listing by Domestic Companies (the “Revised Confidentiality Provisions”), which became effective as of March 31, 2023. According to the Revised Confidentiality Provisions, Chinese companies that directly or indirectly conduct overseas offerings and listings, shall strictly abide by the laws and regulations on confidentiality when providing or publicly disclosing, either directly or through their overseas listed entities, materials to securities services providers. In the event such materials contain state secrets or working secrets of government agencies, the Chinese companies shall first obtain approval from authorities, and file with the secrecy administrative department at the same level with the approving authority; in the event that such materials, if divulged, will jeopardize national security or public interest, the Chinese companies shall comply with procedures stipulated by national regulations. The Chinese companies shall also provide a written statement of the specific sensitive information provided when providing materials to securities service providers, and such written statements shall be retained for inspection. As the Revised Confidentiality Provisions recently took effect, their interpretation and implementation remain substantially uncertain.

Currently, these statements and regulatory actions have had no impact on our daily business operations, the ability to accept foreign ~~exchange restrictions.~~investments and list our securities on a U.S. or other foreign exchange. However, since these statements and regulatory actions are new, it is highly uncertain how the legislative or administrative regulation making bodies will further respond and what existing or new laws or regulations or detailed implementations and interpretations will be further modified or promulgated, if any, and the potential impact such modified or new laws and regulations will have on our daily business operations, the ability to accept foreign investments and list our securities on a U.S., Hong Kong, or other stock exchanges. There are still substantial uncertainties as to how PRC governmental authorities will regulate overseas listing in practice and whether we are required to obtain any specific regulatory approvals from PRC governmental authorities for our offshore offerings. If PRC regulatory agencies later promulgate new rules or explanations requiring that we obtain their approvals for our future offshore offerings, we may be unable to obtain such approvals in a timely manner, or at all, and such approvals may be rescinded even if obtained. Any such circumstance could significantly limit or completely hinder our ability to continue to offer securities to investors and cause the value of such securities to significantly decline or be worthless. In addition, implementation of industry-wide regulations directly targeting our operations could cause the value of our securities to significantly decline. Therefore, investors of our company face potential uncertainty from actions taken by the PRC government affecting our business.

*The audit reports included in our previous annual reports on Form 10-K filed with the SEC have historically been prepared by auditors who are not inspected fully by the Public Company Accounting Oversight Board (the “PCAOB”), and as such, investors have previously been deprived of the benefits of such inspections.

Ernst & Young Hua Ming LLP, our auditor from fiscal year 2014 to fiscal year 2021, is required to undergo regular inspections by the PCAOB as an auditor of companies that are publicly traded in the United States and a firm registered with the PCAOB. Since Ernst & Young Hua Ming LLP is located in China, a jurisdiction where the PCAOB had been unable to conduct inspections without the approval of the Chinese authorities, Ernst & Young Hua Ming LLP was not previously inspected by the PCAOB. Additionally, because we have substantial operations within the PRC, a jurisdiction where the PCAOB was previously unable to conduct inspections without the approval of the Chinese government authorities, Ernst & Young Hua Ming LLP and the audit work that it has carried out for us in the PRC has not historically been able to be inspected independently and fully by the PCAOB.

Inspections of other auditors conducted by the PCAOB outside the PRC have at times identified deficiencies in those auditors’ audit procedures and quality control procedures, which may be addressed as part of the inspection process to improve future audit quality. The lack of PCAOB inspections of audit work undertaken in the PRC prevents the PCAOB from regularly evaluating auditors’ audits and their quality control procedures. As a result, to the extent that any components of our auditor’s work papers had been located in China, such work papers had not been subject to inspection by the PCAOB. As a result, we and investors of our ADSs, ordinary shares and RMB Shares had been deprived of the benefits of such PCAOB inspections, which could cause investors and potential investors of our securities to lose confidence in our audit procedures and reported financial information and the quality of our financial statements.

*To the extent the Holding Foreign Companies Accountable Act is further revised or similar legislation is enacted, our ADSs may be at risk of delisting and our ADSs and ordinary shares potentially prohibited from trading in the over-the-counter market. The delisting of our ADSs, or the threat of their being delisted, may materially and adversely affect the value of your investment.

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In December 2020, the Holding Foreign Companies Accountable Act (“HFCAA”), was signed into law as part of a continued regulatory focus in the United States on access to audit and other information currently protected by national law. The HFCAA states if the SEC determines that we have filed audit reports issued by a registered public accounting firm that has not been subject to inspection by the PCAOB for three consecutive years beginning in 2021, the SEC shall prohibit securities from being traded on a national securities exchange or in the over-the-counter trading market in the U.S. Following the filing of our annual report on Form 10-K for fiscal year ended December 31, 2021, which was audited by Ernst & Young Hua Ming LLP, the SEC added us to its list of Commission-Identified Issuers identified under HFCAA. In December 2022, the Accelerating Holding Foreign Companies Accountable Act (“AHFCAA”) was signed into law, which amended the HFCAA to shorten the three-year period to two years.

However, as our global business expanded, we built substantial organizational capabilities outside of the PRC and we evaluated, designed and implemented business processes and control changes which enabled us to engage Ernst & Young LLP, located in Boston, Massachusetts, United States, as our independent registered public accounting firm for the audits of our financial statements and internal control over financial reporting for the fiscal year ended December 31, 2022. We expect that this will satisfy the PCAOB inspection requirements for the audit of our consolidated financial statements, subject to compliance with SEC and other requirements prior to the two-year deadline of the AHFCAA.

Given that Ernst and Young LLP (United States) now serves as the principal accountant to audit our consolidated financial statements, we expect to be able to comply with the HFCAA and AHFCAA and certify that we have retained a registered public accounting firm that the PCAOB has determined it is able to inspect or investigate which would preclude a further finding by the SEC that we are a Commission-Identified Issuer and therefore the delisting of our ADSs from the Nasdaq Global Select Market.

Furthermore, in August 2022, the PCAOB signed a Statement of Protocol with the CSRC and the Ministry of Finance of the People's Republic of China, for opening access for the PCAOB to inspect and investigate completely registered public accounting firms in mainland China and Hong Kong. The PCAOB staff members conducted on-site inspections and investigations in late 2022. In December 2022, the PCAOB announced that it has secured complete access to inspect and investigate registered public accounting firms headquartered in mainland China and Hong Kong, which would include Ernst & Young Hua Ming LLP, and confirmed that until such time as the PCAOB issues any new determination, there are no Commission-Identified Issuers at risk of having their securities subject to a trading prohibition under the HFCAA.

Additionally, in October 2021, Nasdaq adopted additional listing criteria applicable to companies that primarily operate in jurisdictions where local regulators impose secrecy laws, national security laws or other laws that restrict U.S. regulators from accessing information relating to the issuer (a “Restrictive Market”). Under this rule, whether a jurisdiction permits PCAOB inspection would be a factor in determining whether a jurisdiction is deemed by Nasdaq to be a Restrictive Market. China may be considered to be a Restrictive Market and, as a result, Nasdaq may impose on us additional continued listing criteria or deny continued listing of our securities on Nasdaq, and we cannot assure you whether Nasdaq or regulatory authorities would apply additional and more stringent criteria to us after considering the effectiveness of our auditor’s audit procedures and quality control procedures, adequacy of personnel and training, or sufficiency of resources, geographic reach or experience as it relates to our audit.

We may be subject to enforcement under the HFCAA, the rules implementing the act that may be adopted by the SEC, and any other similar legislation that may be enacted into law or executive orders that may be adopted in the future. Although we are committed to complying with the rules and regulations applicable to listed companies in the United States, we are currently unable to predict the potential impact on our listed status by any rules that may be adopted by the SEC under the HFCAA in the future. If we failed to comply with those rules, it is possible that our ADSs would be delisted. The risk and uncertainty associated with a potential delisting would have a negative impact on the price of our ADSs, ordinary shares and RMB Shares. Delisting of our ADSs would force holders of our ADSs to sell their ADSs or convert them into our ordinary shares, which are listed for trading on the HKEx. Although our ordinary shares are listed in Hong Kong, investors may face difficulties in converting their ADSs into ordinary shares and migrating the ordinary shares to Hong Kong or may have to incur increased costs or suffer losses in order to do so. Failure to adopt effective contingency plans may also have a material adverse impact on our business and the price of our ADSs, ordinary shares and RMB Shares.

*There are uncertainties regarding the interpretation and enforcement of Chinese laws, rules and regulations.

A large portion of our operations are conducted in China through our Chinese subsidiaries. Our Chinese subsidiaries are subject to laws, rules and regulations applicable to foreign investment in China. The Chinese legal system is a civil law system based on written statutes. Unlike the common law system, prior court decisions may be cited for reference but have limited precedential value.

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Furthermore, China's legal system is still developing. The laws, rules and regulations are subject to interpretation and enforcement by PRC regulatory agencies and courts. In particular, on account of the relatively new implementation of certain laws, rules and regulations, the non-precedential nature of court decisions, and the discretion such laws, rules and regulations give to the relevant regulator in enforcement, the interpretation and enforcement of these laws, rules and regulations involve uncertainties and can be inconsistent. In addition, the legal system is based in part on government policies and rules which may quickly be amended from time to time. As a result, we may not be aware of our violation of these policies and rules until after the occurrence of the violation.

China's Foreign Investment Law and its implementing rule came into force in January 2020. The Foreign Investment Law and its implementing rules embody an expected regulatory trend to rationalize China’s foreign investment regulatory regime in line with prevailing international practice and the legislative efforts to unify the legal requirements for both foreign and domestic investments. There are still uncertainties with respect to the interpretation and implementation of the Foreign Investment Law and its implementing rules. For example, the Foreign Investment Law and its implementing rules provide that foreign invested entities established according to the previous laws regulating foreign investment prior to its implementation may maintain their structure and corporate governance for a five-year transition period. It is uncertain whether governmental authorities may require us to adjust the structure and corporate governance of certain of our Chinese subsidiaries in such transition period. Failure to take timely and appropriate measures to meet any of these or similar regulatory requirements could materially affect our current corporate governance practices and business operations and our compliance costs may increase significantly. In addition, the Security Review Rules, effective as of January 18, 2021, embody China's continued efforts to provide a legal regime for national security review comparable to similar procedures in other jurisdictions, such as CFIUS review in the United States. There are still uncertainties with respect to the interpretation, implementation and enforcement of the Security Review Rules. For example, national security remains undefined and there is no clear guidance on whether the biotechnology industry requires security review and what factors the regulatory authority may consider in determining whether there are security concerns. It is difficult to evaluate the impact of the Security Review Rules on our existing investments or potential investments in China.

It may be difficult for overseas regulators to conduct investigations or collect evidence within China. In China, there are legal and other obstacles to providing information needed for regulatory investigations or litigations initiated outside China. According to Article 177 of the PRC Securities Law, which became effective in March 2020, no overseas securities regulator is allowed to directly conduct investigation or evidence collection activities within the PRC territory, which may increase the difficulties you face in protecting your interests. According to the Revised Confidentiality and Archives Administration Provisions, where overseas securities regulators or relevant competent authorities request to inspect, investigate or collect evidence from Chinese domestic companies concerning their overseas offering and listing or their securities firms and securities service providers that undertake securities business for such Chinese domestic companies, such inspection, investigation and evidence collection must be conducted under the cross-border regulatory cooperation mechanism, and the CSRC or competent authorities of the Chinese government will provide necessary assistance pursuant to bilateral and multilateral cooperation mechanism. Although the authorities in China may establish a regulatory cooperation mechanism with the securities regulatory authorities of another country or region to implement cross-border supervision and administration, such cooperation with the securities regulatory authorities in the Unities States may not be efficient in the absence of a mutual and practical cooperation mechanism. For risks associated with investing in us as a Cayman Islands company, see also the risk factor entitled “—Risks Related to Our Ordinary Shares, ADSs, and RMB Shares—We are a Cayman Islands company. Because judicial precedent regarding the rights of shareholders is more limited under Cayman Islands law than under Hong Kong law, Chinese law or U.S. law, our shareholders may have fewer shareholder rights than they would have under Hong Kong law, Chinese law or U.S. law and may face difficulties in protecting their interests.”

Any administrative and court proceedings in the jurisdictions in which we operate, including China may be protracted, resulting in substantial costs and diversion of resources and management attention. Since administrative and court authorities have discretion in interpreting and implementing statutory and contractual terms, it may be difficult to evaluate the outcome of administrative and court proceedings and the level of legal protection. These uncertainties may impede our ability to ~~distribute profits~~enforce the contracts we have entered and could materially and adversely affect our business, financial condition and results of operations.

In addition, the PRC government has announced its plans to ~~you~~enhance its regulatory oversight of China-based companies listed overseas and cross-border law enforcement cooperation. The Securities Opinions called for:

•tightening oversight of data security, cross-border data flow and administration of classified information, as well as amendments to relevant regulation to specify responsibilities of overseas listed China-based companies with respect to data security and information security;

•enhanced oversight of overseas listed companies as well as overseas equity fundraising and listing by China-based companies; and

•extraterritorial application of China’s securities laws.

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There are uncertainties with respect to the interpretation and implementation of the Securities Opinions and the Overseas Listing Trial Measures. The PRC government may promulgate relevant laws, rules and regulations to impose additional obligations and liabilities on overseas listed China-based companies regarding data security, cross-border data flow, and compliance with China’s securities laws. As a company with operations in China and stock listings in and outside of China, it is uncertain whether or how these laws, rules and regulations and their interpretation and implementation may affect us. However, among other things, our ability to obtain external financing through the issuance of equity securities overseas could be adversely affected if restrictions on overseas fundraising are imposed on companies like us.

*The filing or other procedures with, the CSRC or other Chinese regulatory authorities may be required in connection with issuing our equity securities to foreign investors under Chinese law, and, if required, we cannot predict whether we will be able, or how long it will take us, to complete such filing or other procedures.If we fail to complete a filing with the CSRC, our future offering application may be impacted and we may be subject to penalties, sanctions and fines imposed by the CSRC and relevant departments of the State Council.

Pursuant to the Securities Opinions, Chinese regulators are required to accelerate rulemaking related to the overseas issuance and listing of securities outside of China, and update the existing laws and regulations related to data security, cross-border data flow, and administration of classified information. The Securities Opinions emphasized the need to strengthen the administration over illegal securities activities and the need to strengthen the supervision over overseas listings by Chinese companies.

Numerous regulations, guidelines and other measures have been or are expected to be adopted under the umbrella of or in addition to the Cyber Security Law and Data Security Law. As the relevant regulations, guidelines and measures are subject to change and continue to evolve, we cannot assure investors that we will be able to comply with new regulatory requirements relating to our future overseas capital-raising activities outside of China and we may become subject to more stringent requirements with respect to matters including data privacy and cross-border investigation and enforcement of legal claims.

Furthermore, in February 2023, the CSRC released the Overseas Listing Trial Measures and five relevant guidelines, which took effect on March 31, 2023, requiring Chinese companies that have already directly or indirectly offered and listed securities in overseas markets to fulfil their filing obligations and report relevant information to the CSRC within three working days after conducting a follow-on offering of equity securities on the same overseas market. The Overseas Listing Trial Measures may continue to evolve. We may have to go through the filing process for any follow-on offerings we conduct on the NASDAQ Global Select Market or Hong Kong Stock Exchange within three working days of the completion of our follow-on offerings. If we fail to complete a filing with the CSRC for any of our follow-on offerings, we may be subject to penalties, sanctions and fines imposed by the CSRC and relevant departments of the State Council.

As of the date of this report, we have not received any inquiry, notice, warning or sanction regarding completing filing or other procedures in connection with offering our equity securities on the Nasdaq Global Select Market or Hong Kong Stock Exchange from the CSRC or any other Chinese regulatory authorities that have jurisdiction over our operations. However, there remains uncertainty as to the interpretation and implementation of regulatory requirements related to securities offerings and other capital markets activities outside of China. If it is determined in the future that the filing or other procedure with the CSRC or any other regulatory authority is required for issuing our equity securities on the Nasdaq Global Select Market or Hong Kong Stock Exchange, it is uncertain whether we will be able to and how long it would take for us to complete the filing or other procedure, despite our best efforts. If we, for any reason, are unable to complete, or experience significant delays in completing, the requisite relevant filing or other procedure(s), we may face sanctions by the CSRC or other Chinese regulatory authorities. These regulatory authorities may impose fines and penalties on our operations in China, limit our ability to pay dividends outside of China, limit our operations in China, delay or restrict the repatriation of funds into China or take other actions that could have a material adverse effect on our business, financial condition, results of operations and prospects, as well as the trading price of our ADSs, ordinary shares, and RMB Shares. In addition, if the CSRC or other regulatory authorities later promulgate new rules requiring that we obtain their approvals or complete filing or other procedures for any future public offerings on the Nasdaq Global Select Market or Hong Kong Stock Exchange, we may be unable to obtain a waiver of such requirements, if and when procedures are established to obtain such a waiver. Any uncertainties and/or negative publicity regarding such a requirement could have a material adverse effect on the trading price of our ADSs, ordinary shares, and RMB Shares.

To operate our general business activities currently conducted in China, each of our Chinese subsidiaries is required to obtain a business license from the local counterpart of the SAMR. Each of our Chinese subsidiaries has obtained a valid business license from the local counterpart of the SAMR, and no application for any such license has been denied. The pharmaceutical industry in which we operate is also highly regulated in China. Our Chinese subsidiaries are required to obtain applicable licenses from competent Chinese government authorities for our operations in China, including drug manufacturing licenses, drug trade license, clinical trial authorizations, drug registration certificates, licenses for use of experimental animals,

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pollutant discharge licenses and permits for urban sewage discharge into drainage pipe network. We believe our PRC subsidiaries have obtained all applicable licenses and permits which are material to our business operations in China.

PRC regulations establish complex procedures for some acquisitions conducted by foreign investors, which could make it more difficult for us to pursue growth through acquisitions in China.

PRC regulations and rules concerning mergers and acquisitions set forth additional procedures and requirements that could make merger and acquisition activities of PRC-based companies by foreign investors more time-consuming and complex. See also the risk factor entitled “—Risks Related to Our Industry, Business and Operations—We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to compliance requirements, including establishing and maintaining internal controls over financial reporting. We may be exposed to potential risks if we are unable to comply with these requirements.” These rules, among others, specify that mergers and acquisitions by foreign investors that raise “national defense and security” concerns and mergers and acquisitions through which foreign investors may acquire the de facto control over domestic enterprises that raise “national security” concerns are subject to strict review by the MOFCOM, and the rules prohibit any activities attempting to bypass a security review by structuring the transaction through, among other things, trusts, entrustment or contractual control arrangements. Although we believe that our business is not in an industry related to national security, we cannot preclude the possibility that the competent PRC government authorities may publish explanations contrary to our understanding or broaden the scope of such security reviews in the future, in which case our future acquisitions and investment in the PRC, including those by way of entering into contractual control arrangements with target entities, may be closely scrutinized or prohibited. Moreover, according to the Anti-Monopoly Law, the SAMR shall be notified in advance of any concentration of undertaking if certain filing thresholds are triggered. We may grow our business in part by acquiring complementary businesses in China. Complying with the requirements of the laws and regulations mentioned above and other PRC regulations to complete such transactions could be time-consuming, and any required approval processes, including obtaining approval from the SAMR, may delay or inhibit our ability to complete such transactions, which could affect our ability to expand our business or maintain or expand our market share. Our ability to expand our business or maintain or expand our market share through future acquisitions would as such be materially and adversely affected. ~~Upon completion of our initial public offering, we became an overseas listed company,~~

In December 2020, the NDRC and ~~therefore, we and our directors, executive officers and other employees who are PRC citizens or who have resided in~~ the ~~PRC for a continuous period of not less than one year and who have been granted restricted shares or options are subject to the Notice on Issues Concerning~~MOFCOM promulgated the Foreign ~~Exchange Administration for Domestic Individuals Participating~~Investment Security Review Measures, which came into effect on January 18, 2021. Under the Foreign Investment Security Review Measures, investments in ~~Stock Incentive Plan~~military, national defense-related areas or in locations in proximity to military facilities, or investments that would result in acquiring the actual control of ~~Overseas Publicly Listed Company, issued by SAFE~~assets in ~~February 2012, according to which, employees, directors, supervisors~~certain key sectors, such as critical agricultural products, energy and other management members participating in any share incentive plan of an overseas publicly listed company who are PRC citizens or who are non-PRC citizens residing in China for a continuous period of not less than

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~~one year, subject to limited exceptions,~~resources, equipment manufacturing, infrastructure, transport, cultural products and services, IT, Internet products and services, financial services and technology sectors, are required to ~~register with SAFE through a domestic qualified agent, which could~~ be ~~a PRC subsidiary~~approved by designated governmental authorities in advance. Official guidance for these measures has not been issued by the designated office in charge of such ~~overseas listed company,~~security review yet, therefore there are great uncertainties with respect to the interpretation and ~~complete certain other procedures. Failure~~implementation of the Foreign Investment Security Review Measures. If any of our business operations were to ~~complete~~fall under the ~~SAFE registrations~~foregoing categories, we would need to take further actions in order to comply with these laws, regulations and rules, which may ~~subject them to fines~~materially and ~~legal sanctions~~adversely affect our current corporate structure, business, financial condition and may also limit our ability to make payments under our equity incentive plans or receive dividends or sales proceeds related thereto, or our ability to contribute additional capital into our wholly-foreign owned enterprises in China and limit our wholly-foreign owned enterprises’ ability to distribute dividends to us. We also face regulatory uncertainties that could restrict our ability to adopt additional equity incentive plans for our directors and employees under PRC law.

In addition, the SAT has issued circulars concerning employee share options or restricted shares. Under these circulars, employees working in the PRC who exercise share options, or whose restricted shares vest, will be subject to PRC individual income tax. The PRC subsidiariesresults of an overseas listed company have obligations to file documents related to employee share options or restricted shares with relevant tax authorities and to withhold individual income taxes of those employees related to their share options or restricted shares. If the employees fail to pay, or the PRC subsidiaries fail to withhold applicable income taxes, the PRC subsidiaries may face sanctions imposed by the tax authorities or other PRC government authorities.

*In the future, weoperations.

We may rely ~~to some extent~~ on dividends and other distributions on equity ~~from~~paid by our ~~principal operating~~PRC subsidiaries to fund ~~offshore~~any cash and financing ~~requirements.~~

requirements we may have, and any limitation on the ability of our PRC subsidiaries to make payments to us could have a material and adverse effect on our ability to conduct our business.

We are a holding company incorporated in the Cayman Islands, and we may ~~in the future~~ rely ~~to some extent~~ on dividends and other distributions on equity ~~from~~paid by our ~~principal operating~~PRC subsidiaries for our ~~offshore~~ cash and financing requirements, including the funds necessary to pay dividends and other cash distributions to our shareholders ~~fund inter-company loans,~~or to service any debt we may ~~incur outside China and pay our expenses. The laws, rules and regulations applicable to~~incur. If any of our PRC subsidiaries incur debt on their own behalf in the future, the instruments governing the debt may restrict their ability to pay dividends or make other distributions to us. Under PRC laws and ~~certain other~~regulations, our PRC subsidiaries ~~permit payments of~~may pay dividends only out of their ~~retained earnings, if any,~~respective accumulated profits as determined in accordance with ~~applicable~~PRC accounting standards and regulations.

~~Under PRC laws, rules and regulations, each of our subsidiaries incorporated in China~~ In addition, a wholly foreign- owned enterprise is required to set aside at least 10% of its accumulated after-tax profits each year, if any, to fund a certain statutory reserve fund, until the aggregate amount of such fund reaches 50% of its registered capital. Such reserve funds cannot be distributed to us as dividends until the liquidation of the enterprise. At its discretion, a wholly foreign-owned enterprise may allocate a portion of its ~~net income each year~~after-tax profits based on PRC accounting standards to an enterprise expansion fund, ~~certain statutory reserves. These reserves, together with the registered equity, are not distributable as cash dividends. As~~or a ~~result of these laws, rules~~staff welfare and ~~regulations, our subsidiaries incorporated in China are restricted in their ability to transfer a portion of their respective net assets to their shareholders as dividends.~~bonus fund. In addition, registered share capital and capital reserve accounts are also restricted from withdrawal in the PRC, up to the amount of net assets held in each operating subsidiary. As of September 30, ~~2017,~~2023 and December 31, 2022, these restricted assets totaled ~~RMB166.6 million.~~

$3.8 billion and $3.5 billion, respectively.

Our PRC subsidiaries generate primarily all of their revenue in RMB, which is not freely convertible into other currencies. As a result, any restriction on currency exchange may limit the ability of our PRC subsidiaries to use their RMB revenues to pay dividends to us.

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In response to the persistent capital outflow in the PRC and RMB’s depreciation against the U.S. dollar in the fourth quarter of 2016, the People’s Bank of China (“PBOC”) and China's State Administration of Foreign Exchange (“SAFE”) promulgated a series of measures relating to oversight of capital flow, including stricter vetting procedures for domestic companies to remit foreign currency for overseas investments, dividends payments and shareholder loan repayments.

The PRC government may continue to strengthen its oversight of capital flow, and more regulations and substantial vetting process may be put forward by the SAFE for cross-border transactions. Any limitation on the ability of our PRC subsidiaries to pay dividends or make other kinds of payments to us could materially and adversely limit our ability to grow, make investments or acquisitions that could be beneficial to our business, pay dividends, or otherwise fund and conduct our business.

The PRC Enterprise Income Tax Law ~~or the EIT Law~~(the “EIT Law”) and its implementation rules ~~both of which became effective on January 1, 2008,~~ provide that China-sourced income of foreign enterprises, such as dividends paid by a PRC subsidiary to its equity holders that are non-PRC resident enterprises, will normally be subject to PRC withholding tax at a rate of 10%, unless any such foreign investor’s jurisdiction of ~~incorporation~~tax residency has a tax treaty with China that provides for a ~~different~~reduced withholding ~~arrangement. As a result, dividends paid to us by our PRC subsidiaries are expected to be subject to PRC withholding tax at a~~ rate arrangement and such non-PRC resident enterprises constitute the beneficiary of ~~10%.~~

such income.

Pursuant to ~~the Arrangement~~an arrangement between ~~Mainland~~mainland China and the Hong Kong Special Administrative Region ~~for the Avoidance of Double Taxation and Prevention of Fiscal Evasion with respect to Taxes on Income, or the~~(the “Hong Kong Tax ~~Treaty,” BeiGene HK,~~Treaty”) and relevant tax regulations of the ~~shareholder of our~~ PRC, ~~subsidiaries, may be subject to a withholding tax at a rate of 5% on dividends received from our PRC operating subsidiaries as a Hong Kong tax resident. Pursuant to the Hong Kong Tax Treaty,~~ subject to certain conditions, ~~this~~a reduced withholding tax rate of 5% will be available for dividends from PRC entities provided that the recipient holds at least 25% shares of the PRC entities and can demonstrate it is a Hong Kong tax resident and it is the beneficial owner of the dividends. The China government has adopted multiple regulations which stipulate that in determining whether a non-resident enterprise has the status as a beneficial owner, comprehensive analysis shall be conducted based on the factors listed therein and the actual circumstances of the specific case shall be taken into consideration. Specifically, it expressly excludes an agent or a designated payee from being considered as a “beneficial owner.” We own the PRC subsidiaries through BeiGene (Hong Kong) Co., Limited (“BeiGene HK”), a company incorporated under the laws of Hong Kong on November 22, 2010 and a wholly owned subsidiary of the Company. BeiGene HK currently does not hold a Hong Kong tax resident certificate from the Inland Revenue Department of Hong Kong, and there is no assurance that the reduced withholding tax rate will be available.

Furthermore, if our subsidiaries in China incur debt on their own behalf in the future, the instruments governing the debt may restrict their ability to pay dividends or make other payments to us. Any limitation on the ability of our subsidiaries to distribute dividends or other payments to us in the future could materially and adversely limit our ability

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~~to make investments or acquisitions that could be beneficial to our businesses, pay dividends, or otherwise fund and conduct our business.~~

We may be treated as a resident enterprise for PRC tax purposes under the EIT Law and we may therefore be subject to PRC income tax on our worldwide taxable ~~income at a rate~~income. Dividends payable to foreign investors and gains on the sale of ~~25%.~~

our ADSs or ordinary shares by our foreign investors may become subject to PRC tax.

Under the EIT Law, an enterprise established outside ~~China~~the PRC with “de facto management bodies” within ~~China~~the PRC is considered a “resident enterprise,” meaning that it is treated in a manner similar to a Chinese enterprise for PRC enterprise income tax ~~or EIT,~~ purposes. The implementing rules of the EIT Law define “de facto management bodies” as “management bodies that exercise substantial and overall management and control over the production and operations, personnel, accounting, and properties” of the enterprise. In addition, ~~the Notice Regarding the Determination of Chinese-Controlled Offshore Incorporated Enterprises as~~ PRC ~~Tax Resident Enterprises on the Basis of De Facto Management Bodies, or Circular 82, specifies~~regulations specify that certain Chinese-controlled offshore incorporated enterprises, defined as enterprises incorporated under the laws of foreign countries or territories and that have PRC enterprises or enterprise groups as their primary controlling shareholders, will be classified as resident enterprises if all of the following are located or resident in China: (i) senior management personnel and departments that are responsible for daily production, operation and management; (ii) financial and personnel decision-making bodies; (iii) key properties, accounting books, company seal, and minutes of board meetings and shareholders’ meetings; and (iv) half or more of senior management or directors having voting rights. On July 27, 2011, the SAT issued Administrative Measures of Enterprise Income Tax of Chinese-Controlled Offshore Incorporated Resident Enterprises (Trial), or Bulletin 45, which became effective on September 1, 2011 and was most recently amended on October 1, 2016, to provide further guidance on the implementation of Circular 82. Bulletin 45 clarifies certain issues related to determining PRC resident enterprise status, including which competent tax authorities are responsible for determining offshore incorporated PRC resident enterprise status, as well as post-determination administration. In 2014, the SAT, released the Announcement of the SAT on Issues Concerning the Recognition of Chinese-Controlled Enterprises Incorporated Overseas as Resident Enterprises on the Basis of Their Actual Management Bodies and supplemented some provisions on the administrative procedures for the recognition of resident enterprise, while the standards used to classify resident enterprises in Circular 82 remain unchanged.

Although BeiGene, Ltd. does not have a PRC enterprise or enterprise group as ~~our~~its primary controlling shareholder and is therefore not a Chinese-controlled offshore incorporated enterprise within the meaning of ~~Circular 82,~~these regulations, in the absence of guidance specifically applicable to us, we have applied the guidance set forth in ~~Circular 82~~the regulations to evaluate the tax residence status of BeiGene, Ltd. and its subsidiaries organized outside of the PRC.

We are not aware of any offshore holding company with a corporate structure similar to ours that has been deemed a PRC “resident enterprise” by the PRC tax authorities. Accordingly, we do not believe that our company or any of our overseas subsidiaries should be treated as a PRC resident enterprise.

However, the tax resident status of an enterprise is subject to determination by the PRC tax authorities and uncertainties remain with respect to the interpretation of the term “de facto management body.” If the PRC tax authorities determine that our Cayman Islands holding company is a resident enterprise for PRC ~~EIT~~enterprise income tax purposes, a number of unfavorable PRC tax consequences could follow and we may be subject to ~~EIT~~enterprise income tax at a rate of 25% on our worldwide taxable income, as well as to PRC ~~EIT~~enterprise income tax reporting obligations. ~~In that case, it is possible that dividends paid to us by our PRC subsidiaries will not be subject to PRC withholding tax.~~

~~Dividends payable to our foreign investors may be subject to PRC withholding tax and gains on the sale of the ADSs or ordinary shares by our foreign investors may be subject to PRC tax.~~

If we are deemed a PRC resident enterprise, ~~as described under “—We may be treated as a resident enterprise for PRC tax purposes under the EIT Law and be subject to PRC tax on our worldwide taxable income at a rate of 25%,”~~ dividends paid on our ~~ordinary~~ shares ~~or ADSs,~~ and any gain realized from the transfer of our ordinary shares ~~or ADSs,~~ may be treated as income derived from sources within the PRC. As a result, dividends paid to non-PRC resident enterprise ADS holders or shareholders may be subject to PRC withholding tax at a rate of 10% (or 20% in the case of non-PRC individual ADS holders or shareholders) and gains realized by non-PRC resident enterprises ADS holders or

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shareholders from the transfer of our ordinary shares or ADSs may be subject to PRC tax at a rate of 10% (or 20% in the case of non-PRC individual ADS holders or shareholders)~~. It is unclear whether if we~~, which may be reduced or ~~any of our subsidiaries~~

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~~established outside China are considered a PRC resident enterprise, holders of the ADSs or ordinary shares would be able~~exempted according to ~~claim the benefit of income~~relevant tax treaties between PRC and the non-PRC resident enterprise/individual ADS holders' or agreements entered into between China and other countries or areas. If dividends payable to our non-PRC investors, or gains from the transfer of the ADSs or ordinary shares by such investors are subject to PRCshareholders' tax ~~the value of your investment in the ADSs or ordinary shares may decline significantly.~~

resident jurisdictions.

We and our shareholders face uncertainties with respect to indirect transfers of equity interests in PRC resident enterprises or other assets attributed to a PRC establishment of a non-PRC company, or other assets attributable to a PRC establishment of a non-PRC company.

On February 3, 2015, the SAT issued the Bulletin on Issues of Enterprise Income Tax and Indirect Transfers of Assets by Non-PRC Resident Enterprises, or Bulletin 7, which replaced or supplemented certain previous rules under the Notice on Strengthening Administration of Enterprise Income Tax for Share Transfers by Non-PRC Resident Enterprises, or Circular 698, issued by the SAT, on December 10, 2009.

Pursuant to ~~this Bulletin,~~Chinese regulations, an “indirect transfer” of “PRC taxable assets,” including equity interests in a PRC resident enterprise, by non-PRC resident enterprises may be recharacterized and treated as a direct transfer of PRC taxable assets, if such arrangement does not have a reasonable commercial purpose and was established for the purpose of avoiding payment of PRC enterprise income tax. As a result, gains derived from such indirect transfer may be subject to PRC enterprise income tax. When determining whether there is a “reasonable commercial purpose” of the transaction arrangement, factors to be taken into consideration include: whether the main value of the equity interest of the relevant offshore enterprise derives from PRC taxable assets; whether the assets of the relevant offshore enterprise mainly consists of direct or indirect investment in ~~China~~the PRC or if its income mainly derives from ~~China;~~the PRC; whether the offshore enterprise and its subsidiaries directly or indirectly holding PRC taxable assets have real commercial nature which is evidenced by their actual function and risk exposure; the duration of existence of the business model and organizational structure; the replicability of the transaction by direct transfer of PRC taxable assets; and the tax situation of such indirect transfer and applicable tax treaties or similar arrangements. In respect of an indirect offshore transfer of assets of a PRC establishment, the resulting gain is to be reported on with the enterprise income tax filing of the PRC establishment or place of business being transferred and would consequently be subject to PRC enterprise income tax at a rate of 25%. Where the underlying transfer relates to equity investments in a PRC resident enterprise, which is not related to a PRC establishment or place of business of a non-resident enterprise, a PRC enterprise income tax at the rate of 10% would apply, subject to available preferential tax treatment under applicable tax treaties or similar arrangements. Late payment of applicable tax will subject the transferor to default interest. Gains derived from the sale of shares by investors through a public stock exchange are not subject to the PRC enterprise income tax ~~pursuant to Bulletin 7~~ where such shares were acquired in a transaction through a public stock exchange. As such, the sale of the ADSs or ordinary shares on a public stock exchange will not be subject to PRC enterprise income ~~tax pursuant to Bulletin 7.~~tax. However, the sale of our ordinary shares or ADSs originally purchased from a stock exchange by a non-PRC resident enterprise outside a public stock exchange may be subject to PRC enterprise income tax under ~~Bulletin 7.~~

these regulations.

There are uncertainties as to the application of ~~Bulletin 7. Bulletin 7~~these regulations, which may be determined by the tax authorities to be applicable to sale of the shares of our offshore subsidiaries or investments where PRC taxable assets are involved. The transferors and transferees may be subject to the tax filing and withholding or tax payment obligation, while our PRC subsidiaries may be requested to assist in the filing. Furthermore, we, our non-resident enterprises and PRC subsidiaries may be required to spend valuable resources to comply with ~~Bulletin 7~~these regulations or to establish that we and our non-resident enterprises should not be taxed under ~~Bulletin 7,~~these regulations, for our previous and future restructuring or disposal of shares of our offshore subsidiaries, which may have a material adverse effect on our financial condition and results of operations.

The PRC tax authorities have the discretion ~~under Bulletin 7~~ to make adjustments to the taxable capital gains based on the difference between the fair value of the taxable assets transferred and the cost of investment. If the PRC tax authorities make adjustments to the taxable income of the transactions under ~~Circular 698/Bulletin 7,~~these regulations, our income tax costs associated with such potential acquisitions or disposals will increase, which may have an adverse effect on our financial condition and results of operations.

~~Restrictions~~

*Regulations on currency exchange may limit our ability to utilize our revenue effectively.

The PRC government ~~imposes controls~~exerts oversight on the ~~convertibility~~conversion of RMB into foreign currencies and, in certain cases, the remittance of currency out of ~~China.~~the PRC. A portion of our revenue ~~may in the future be~~is denominated in RMB. Shortages

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in availability of foreign currency may ~~then~~ restrict the ability of our PRC subsidiaries to remit sufficient foreign currency to our offshore entities for our offshore entities to pay dividends or make other payments or otherwise to satisfy our foreign currency denominated obligations. The RMB is currently convertible under the “current account,” which includes dividends, trade and service-related foreign exchange transactions, but not under the “capital account,” which includes foreign direct investment and loans, including loans we may secure from our onshore subsidiaries. Currently, our PRC subsidiaries ~~which are wholly-foreign owned enterprises,~~ may purchase foreign currency for settlement of “current account transactions,” including payment of dividends to us, without the approval of SAFE by complying with certain procedural requirements. ~~However, the relevant PRC governmental authorities may limit or eliminate our ability to purchase foreign currencies in the future for current account transactions.~~ Since a portion of our ~~future~~ revenue ~~may be~~is denominated in RMB, any existing and future ~~restrictions~~regulations on currency exchange may limit our ability to utilize revenue generated in RMB to fund our business activities outside of the PRC or pay dividends in foreign currencies to ~~our shareholders, including~~ holders of our ordinary shares and the ADSs. Foreign exchange transactions under the capital account remain subject to limitations and require approvals from, or registration with, SAFE and other relevant PRC governmental ~~authorities.~~authorities or designated banks. This could affect our ability to obtain foreign currency through debt or equity financing for our subsidiaries.

~~The audit report included in~~

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Our business benefits from certain financial incentives and discretionary policies granted by local governments. Expiration of, or changes to, these incentives or policies would have an adverse effect on our ~~Annual Report is prepared by auditors who are not inspected fully by the Public Company Accounting Oversight Board, or the PCAOB, and, as such, our shareholders are deprived~~results of ~~the benefits of such inspection.~~

~~As an auditor of companies that are publicly traded~~operations.

Local governments in the ~~United States and a firm registered with the PCAOB, Ernst & Young Hua Ming LLP is required under the laws of the United States~~PRC have granted certain financial incentives from time to ~~undergo regular inspections by the PCAOB. However, because we have substantial operations within the~~time to our PRC a jurisdiction where the PCAOB is currently unable to conduct inspections without the approval of the Chinese government authorities, our auditor and its audit work is not currently inspected fully by the PCAOB.

~~Inspections of other auditors conducted by the PCAOB outside China have at times identified deficiencies in those auditors’ audit procedures and quality control procedures, which may be addressed~~subsidiaries as part of their efforts to encourage the ~~inspection process~~development of local businesses. The timing, amount and criteria of government financial incentives are determined within the discretion of the local government authorities and cannot be predicted with certainty before we actually receive any financial incentive. We generally do not have the ability to ~~improve future audit quality. The lack~~influence local governments in making these decisions. Local governments may decide to reduce or eliminate incentives at any time. In addition, some of ~~PCAOB inspections~~the government financial incentives are granted on a project basis and subject to the satisfaction of ~~audit work undertaken in China prevents~~certain conditions, including compliance with the ~~PCAOB from regularly evaluating our auditor’s audits~~applicable financial incentive agreements and ~~its quality control procedures. As a result, shareholders~~completion of the specific project therein. We cannot guarantee that we will satisfy all relevant conditions, and if we do so we may be deprived of the ~~benefits~~relevant incentives. We cannot assure you of ~~PCAOB inspections,~~the continued availability of the government incentives currently enjoyed by us. Any reduction or elimination of incentives would have an adverse effect on our results of operations.

Any failure to comply with PRC regulations regarding our employee equity plans and investments in offshore companies by PRC residents may ~~lose confidence~~subject the PRC plan participants and PRC-resident beneficial owners or us to fines and other legal or administrative sanctions.

We and our directors, executive officers and other employees who are PRC residents have participated in our ~~reported financial information~~employee equity plans. We are an overseas listed company, and ~~procedures~~therefore, we and our directors, executive officers and other employees who are PRC citizens or who have resided in the ~~quality~~PRC for a continuous period of not less than one year and who have been granted restricted share units, restricted shares, options or other forms of equity incentives or rights to acquire equity are subject to the PRC regulations, according to which, employees, directors, supervisors and other management members participating in any share incentive plan of an overseas publicly listed company who are PRC citizens or who are non-PRC citizens residing in the PRC for a continuous period of not less than one year, subject to limited exceptions, are required to register with the SAFE through a domestic qualified agent, which could be a PRC subsidiary of such overseas listed company, and complete certain other procedures. We also face regulatory uncertainties that could restrict our ~~financial statements.~~

~~Proceedings instituted by~~ability to adopt additional equity incentive plans for our directors and employees under PRC law. Moreover, failure to comply with the ~~SEC against five PRC-based accounting firms, including our independent registered public accounting firm,~~various foreign exchange registration requirements could result in liability under PRC law for circumventing applicable foreign exchange restrictions.

The pharmaceutical industry in China is highly regulated, and such regulations are subject to change, which may affect approval and commercialization of our ~~financial statements being determined~~medicines and drug candidates.

A large portion of our business is conducted in China. The pharmaceutical industry in China is subject to ~~not be~~comprehensive government regulation and supervision, encompassing the approval, registration, manufacturing, packaging, licensing and marketing of new medicines. In recent years, the regulatory framework in China for pharmaceutical companies has undergone significant changes, which we expect will continue. While we believe our strategies regarding research, development, manufacturing and commercialization in China are aligned with the Chinese government's policies, they may in the future diverge, requiring a change in our strategies. Any such change may result in increased compliance costs on our business or cause delays in or prevent the successful research, development, manufacturing or commercialization of our drug candidates or medicines in China and reduce the current benefits we believe are available to us from developing and manufacturing medicines in China.

Chinese authorities have become increasingly active in enforcing laws affecting the pharmaceutical industry. Specifically, the Chinese authorities have recently increased anti-bribery efforts to address improper payments and other benefits received by physicians, staff and hospital administrators in connection with the sales, marketing and purchase of pharmaceuticals products. Any failure by us or our partners to maintain compliance with ~~the requirements of the Exchange Act.~~

In December 2012, the SEC brought administrative proceedings against five accounting firms in China, including our independent registered public accounting firm, alleging that they had refused to produce audit work papersapplicable laws and ~~other documents related to certain other PRC-based companies under investigation by the SEC. On January 22, 2014, an initial administrative law decision was issued, censuring these accounting firms~~regulations or obtain and ~~suspending four of these firms from practicing before the SEC for a period of six months. The decision is neither final nor legally effective unless~~maintain required licenses and until reviewed and approved by the SEC. On February 12, 2014, four of these PRC-based accounting firms appealed to the SEC against this decision. In February 2015, each of the four PRC-based accounting firms agreed to a censure and to pay a fine to the SEC to settle the dispute and avoid suspension of their ability to practice before the SEC. These firms’ ability to continue to serve all their respective clients is not affected by the settlement. The settlement requires these firms to follow detailed procedures to seek to provide the SEC with access to Chinese firms’ audit documents via the China Securities Regulatory Commission. If these firms do not follow these procedures, the SEC could impose penalties such as suspensions, or it could restart the administrative proceedings. The settlement did not require these firms to admit to any violation of law and preserves these firms’ legal defensespermits may result in the suspension or termination of our business activities in China. Reports of what have come to be viewed as significant quality-control failures by Chinese vaccine manufacturers have led to enforcement actions against officials responsible for implementing national reforms favorable to innovative drugs (such as ours). While not directly affecting us, this macro-industry event the administrative proceeding is restarted. In the event that the SEC restarts the administrative proceedings, depending upon the final outcome, listed companies in the United States with major PRC operations may find it difficultcould cause state or ~~impossible~~private resources to ~~retain auditors in respect of their operations in the PRC,~~be diverted away from fostering innovation and be redirected toward regulatory enforcement, which could ~~result in financial statements being determined to not be in compliance with the requirements of the Exchange Act, including possible delisting. Moreover, any negative news about the proceedings~~

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~~against these audit firms may cause investor uncertainty regarding PRC-based, United States-listed companies and the market price of the ADSs may be adversely affected.~~

If our independent registered public accounting firm was denied, even temporarily, the ability to practice before the SEC and we were unable to timely find another registered public accounting firm to audit and issue an opinion on our financial statements, our financial statements could be determined not to be in compliance with the requirements of the Exchange Act. Such a determination could ultimately lead to deregistration from the SEC, which would substantially reduce or effectively terminate the trading of the ADSs in the United States. Moreover, any negative news about the proceedings against these audit firms may adversely affect ~~investor confidence in companies with substantial mainland China-based operations listed in the United States. All these would materially~~our research, development, manufacturing and ~~adversely affect the market price of the ADSs~~commercialization activities and ~~substantially reduce or effectively terminate the trading of the ADSs in the United States.~~

increase our compliance costs.

Risks Related to ~~the American Depositary~~Our Ordinary Shares,

* ADSs, and RMB Shares

The trading prices of ~~the~~our ordinary shares, ADSs, ~~are likely to~~and/or RMB Shares can be volatile, which could result in substantial losses to you.

~~We completed our initial public offering on February 8, 2016, and there has been a public market for the ADSs since that time.~~

The trading price of ~~the~~our ordinary shares, ADSs, ~~is likely to~~and/or RMB Shares can be volatile and ~~could~~ fluctuate widely in response to a variety of factors, many of which are beyond our ~~control. In addition,~~control, including: announcements of regulatory approval or a complete

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response letter, or specific label indications or patient populations for its use, or changes or delays in the regulatory review process; announcements of therapeutic innovations, new products, acquisitions, strategic relationships, joint ventures or capital commitments by us or our competitors; adverse actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities; any adverse changes to our relationship with manufacturers or suppliers; the results of our testing and clinical trials; the results of our efforts to acquire or license additional medicines or drug candidates; variations in the level of expenses related to our existing medicines and drug candidates or preclinical, clinical development and commercialization programs; any intellectual property infringement actions in which we may become involved; announcements concerning our competitors or the pharmaceutical industry in general; the performance and fluctuation of the market prices of other companies with significant business operations ~~located mainly~~ in China that have listed their securities in Hong Kong, Shanghai or the United ~~States may affect~~States; fluctuations in product revenue, sales and marketing expenses and profitability; manufacture, supply or distribution shortages; variations in our results of operations; announcements about our results of operations that are not in line with analyst expectations, the ~~volatility~~risk of which is enhanced because it is our policy not to give guidance on results of operations; publication of operating or industry metrics by third parties, including government statistical agencies, that differ from expectations of industry or financial analysts; changes in financial estimates by securities research analysts; media reports, whether or not true, about our business, our competitors or our industry; additions to or departures of our management; fluctuations of exchange rates between the ~~price~~RMB, the U.S. dollar and Hong Kong dollar; release or expiry of lock-up or other transfer restrictions on our outstanding ordinary shares, ADSs or RMB Shares; sales or perceived potential sales of additional ordinary shares, ADSs or RMB Shares by us, our executive officers and trading volumes for the ADSs. Some of these companies have experienced significant volatility, including significant price declines after their initial public offerings. The trading performances of these PRC companies’ securities at the time ofdirectors or ~~after their offerings may affect the~~our shareholders; general economic and market conditions and overall ~~investor sentiment towards other PRC companies listed~~fluctuations in the United States, ~~and consequently may impact the trading performance of the ADSs.~~

~~In addition to market and industry factors, the price and trading volume for the ADSs may be highly volatile for specific business reasons, including:~~

~~announcements of regulatory approval or a complete response letter, or specific label indications or patient populations for its use, or changes or delays in the regulatory review process;~~

~~announcements of therapeutic innovations or new products by us or our competitors;~~

~~adverse actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities;~~

~~any adverse changes to our relationship with manufacturers or suppliers;~~

~~the results of our testing and clinical trials;~~

~~the results of our efforts to acquire or license additional drug candidates;~~

~~variations in the level of expenses related to our existing drug candidates or preclinical, clinical development and commercialization programs;~~

~~any intellectual property infringement actions in which we may become involved;~~

~~announcements concerning our competitors or the pharmaceutical industry in general;~~

~~fluctuations in product revenue, sales and marketing expenses and profitability;~~

~~manufacture, supply or distribution shortages;~~

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~~variations in our results of operations;~~

~~announcements about our results of operations that are not in line with analyst expectations, the risk of which is enhanced because it is our policy not to give guidance on results of operations;~~

~~publication of operating or industry metrics by third parties, including government statistical agencies, that differ from expectations of industry or financial analysts;~~

~~changes in financial estimates by securities research analysts;~~

~~announcements made by us or our competitors of new product and service offerings, acquisitions, strategic relationships, joint ventures or capital commitments;~~

~~media reports, whether or not true, about our business;~~

~~additions to or departures of our management;~~

~~fluctuations of exchange rates between the RMB and the U.S. dollar;~~

~~release or expiry of lock-up or other transfer restrictions on our outstanding ordinary shares or ADSs;~~

~~sales or perceived potential sales of additional ordinary shares or ADSs;~~

~~sales of the ADSs by us, our executive officers and directors or our shareholders in the future;~~

~~general economic and market conditions and overall fluctuations in the U.S.~~Hong Kong or Shanghai equity markets;

~~changes in accounting principles;~~

~~changes or developments in the PRC or global regulatory environment; and~~

~~the outcome of proceedings recently instituted by the SEC against five PRC-based accounting firms, including the affiliate of our independent registered public accounting firm.~~

~~Any of these factors may result in large and sudden~~ changes in ~~the volume~~accounting principles; trade disputes or U.S.-China government relations; and ~~trading price of the ADSs. In the past, following periods of volatility~~changes or developments in the ~~market price of a company’s securities, shareholders have often instituted securities class action litigation against that company. If we were involved in a class action suit, it could divert~~United States, PRC, the ~~attention of management, and, if adversely determined, have a material adverse effect on our financial condition and results of operations.~~

European Union or global regulatory environment.

In addition, the stock market, in general, and ~~small~~ pharmaceutical and biotechnology companies, in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of ~~the~~our ordinary shares, ADSs, and/or RMB Shares, regardless of our actual operating performance. ~~Further, the current decline~~

The characteristics of capital markets in the ~~financial markets~~United States, Hong Kong and ~~related factors beyond our control~~Shanghai are different, which may cause volatility in the market price of our ordinary shares, ADSs, and RMB Shares.

Our ordinary shares are listed on the HKEx in Hong Kong under the stock code “06160”, our ADSs are listed on the Nasdaq in the United States under the symbol “BGNE”, and our RMB Shares are listed on the STAR Market in the PRC under the stock code “688235”. Under current PRC laws and regulations, our ADSs and ordinary shares listed on the Nasdaq and the HKEx are not interchangeable or fungible with the RMB Shares listed on the STAR Market, and there is no trading or settlement between either the Nasdaq or the HKEx on the one hand, and the STAR Market on the other hand. The three markets have different trading hours, trading characteristics (including trading volume and liquidity), trading and listing rules, and investor bases (including different levels of retail and institutional participation). As a result of these major differences, the trading prices of our ordinary shares, ADSs, and RMB Shares might not be the same, even allowing for currency differences. Fluctuations in the price of our ADSs due to ~~decline rapidly~~circumstances peculiar to its home capital market could materially and ~~unexpectedly.~~

adversely affect the price of the ordinary shares and/or RMB Shares, and vice versa. Because of the different characteristics of the U.S., Hong Kong and Shanghai equity markets, the historic market prices of our ordinary shares, ADSs, and RMB Shares may not be indicative of the performance of our securities going forward.

We may be subject to securities litigation, which is expensive and could divert management attention.

~~The ADS price may be volatile, and in the past companies~~

Companies that have experienced volatility in the volume and market price of their ~~ADSs~~shares have been subject to an increased incidence of securities class action ~~litigation.~~litigation, particularly in our industry in recent years. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, ~~which~~and, if adversely determined, could ~~seriously harm~~have a material adverse effect on our ~~business.~~

business, financial condition, and results of operations.

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*Future sales of ~~the~~our ordinary shares, ADSs, and/or RMB Shares in the public market could cause the ordinary share, ADS, and/or RMB Share price to fall.

The ~~ADS~~ price of our ordinary shares, ADSs, and/or RMB Shares could decline as a result of sales of a large number of the ordinary shares, ADSs, and/or RMB Shares or the perception that these sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

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As of November ~~8, 2017, we had 591,072,330~~1, 2023, 1,359,497,624 ordinary shares, par value $0.0001 per share, were outstanding, of which ~~377,568,555~~871,833,599 ordinary shares were held in the form of ~~29,043,735 ADSs. Of this amount, 32,746,416~~67,064,123 ADSs, each representing 13 ordinary shares, ~~issued~~and 115,055,260 were RMB Shares.

We filed a registration statement on Form S-3 with the SEC on behalf of certain shareholders on May 11, 2020, registering 300,197,772 ordinary shares, including 224,861,338 ordinary shares in the form of 17,297,026 ADSs to ~~Celgene at~~be resold by the ~~closing~~selling shareholders identified therein and in any related prospectus supplement from time to time. Amgen also has specified registration rights upon expiration of ~~the Celgene Transaction are subject to~~ a ~~one-year lock-up.~~

lock-up period. Furthermore, we have registered or plan to register the offer and sale of all ~~ordinary shares~~securities that we have issued and may issue in the future under our equity compensation plans, including upon the exercise of share options and vesting of restricted share ~~units.~~units and under our employee share purchase plan. If these additional ~~ordinary shares~~securities are sold, or if it is perceived that they will be sold, in the public market, the trading price of our ordinary shares, ADSs and/or RMB Shares could decline.

On May 26, 2017, we filed a registration statement on behalf of certain shareholders, registering 299,279,370 ordinary shares in the form of 23,021,490 ADSs to be resold by the selling shareholders identified therein and in any related prospectus supplement from time to time. As of September 30, 2017, the holder of approximately 224,372 of our then-outstanding ordinary shares, had rights, subject to some conditions, to include its ordinary shares in registration statements we may file for ourselves or other shareholders. We have also agreed to grant certain registration rights with respect to the shares to be issued to Celgene in the event that they are not eligible for sale under Rule 144.

In addition, in the future, we may issue additional ordinary shares, ADSs, RMB Shares, or other equity or debt securities convertible into ordinary shares, ADSs, or RMB Shares in connection with a financing, acquisition, license, litigation settlement, employee arrangements or otherwise. Any such issuance could result in substantial dilution to our existing shareholders and could cause the ordinary share, ADS, and/or RMB Share price to decline.

*We

The triple listing of our ADSs, ordinary shares and RMB Shares may adversely affect the liquidity and value of our ADSs, ordinary shares and/or RMB Shares.

Our ADSs are ~~currently~~traded on the Nasdaq, our existing ordinary shares maintained on our Cayman register in Cayman Islands and Hong Kong register in Hong Kong, are traded on the HKEx, and our RMB Shares are traded on the STAR Market. The triple listing of our ADSs, ordinary shares and RMB Shares may dilute the liquidity of these securities in one or all three markets and may adversely affect the maintenance of an ~~“emerging growth company.” As a result of the reduced disclosure requirements applicable to emerging growth companies, the ADSs may be less attractive to investors.~~

We are currently an “emerging growth company,” as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on some of the exemptions from certain reporting requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include but are not limited to not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.

~~We cannot predict whether investors will find the ADSs less attractive because we will rely on these exemptions. If some investors find the ADSs less attractive as a result, there may be a less~~ active trading market for ADSs in the United States, the ordinary shares in Hong Kong, and/or the RMB Shares in the PRC. The price of our ADSs, ordinary shares and/or RMB Shares could also be adversely affected by trading of our securities on other markets. We may decide at some point in the future to delist our RMB Shares from the STAR Market, and our shareholders may approve such delisting. We cannot predict the ~~ADS~~effect such delisting of our RMB Shares on the STAR Market would have on the market price of our ADSs on the Nasdaq or our ordinary shares on the HKEx.

We face increased regulatory scrutiny and compliance costs due to our listing on the STAR Market of the SSE.

We are subject to the applicable laws, rules and regulations governing public companies listed on the STAR Market in addition to the various laws, rules and regulations that we are subject to in the United States and Hong Kong. The listing and trading of our equity securities in multiple jurisdictions and multiple markets will lead to increased compliance obligations and costs for us, and we may face the risk of significant intervention by regulatory authorities in these jurisdictions and markets, such as inquiries, investigations, enforcement actions and other regulatory proceedings by regulatory authorities. In addition, we may be ~~more volatile.~~

~~We have determined that, as of June 30, 2017, we have at least $700 million of equity~~subject to securities ~~held~~litigation filed with the courts in China by ~~non-affiliates, and as such we will no longer qualify as an emerging growth company as of December 31, 2017. As a result, we will no longer be able~~the investors with respect to ~~take advantage of specified reduced disclosure and other requirements that are available to emerging growth companies after such date.~~

the RMB Shares traded on the STAR Market.

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Because we do not expect to pay dividends in the foreseeable future, you must rely on price appreciation of the ordinary shares, ADSs and/or RMB Shares for return on your investment.

We intend to retain most, if not all, of our available funds and earnings to fund the development and growth of our business. As a result, we do not expect to pay any cash dividends in the foreseeable future. Therefore, you should not rely on an investment in the ordinary shares, ADSs and/or RMB Shares as a source for any future dividend income.

Our board of directors has significant discretion as to whether to distribute dividends. Even if our board of directors decides to declare and pay dividends, the timing, amount and form of future dividends, if any, will depend on, among other things, our future results of operations and cash flow, our capital requirements and surplus, the amount of distributions, if any, received by us from our subsidiaries, our financial condition, contractual and regulatory restrictions and other factors deemed relevant by our board of directors. Accordingly, the return on your investment in the ordinary shares, ADSs and/or RMB Shares will likely depend entirely upon any future price appreciation of the ~~ADSs.~~ordinary shares, ADSs and/or RMB Shares. There is no guarantee that the ordinary shares, ADSs and/or RMB Shares will appreciate in value or even maintain the price at which you purchased the ~~ADSs.~~ordinary shares, ADSs and/or RMB Shares. You may not realize a return on your investment in the ordinary shares, ADSs and/or RMB Shares and you may even lose your entire investment in the ~~ADSs.~~

ordinary shares, ADSs and/or RMB Shares.

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If securities or industry analysts do not continue to publish research or publish inaccurate or unfavorable research about our business, the market price for the ordinary shares, ADSs and/or RMB Shares and trading volume could decline.

The trading market for the ordinary shares, ADSs and RMB Shares relies in part on the research and reports that equity research analysts publish about us or our business. We do not control these analysts. If research analysts do not ~~establish and~~ maintain adequate research coverage or if one or more of the analysts who covers us downgrades the ordinary shares, ADSs and/or RMB Shares or publishes inaccurate or unfavorable research about our business, the market price for the ordinary shares, ADSs and/or RMB Shares would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for the ordinary shares, ADSs and/or RMB Shares to decline significantly.

Because we are a Cayman Islands ~~company. Because judicial precedent regarding the rights of shareholders is more limited under Cayman Islands law than under U.S. law,~~company, our shareholders may have fewer shareholder rights than they would have under Hong Kong law, Chinese law or U.S. ~~law.~~

law and may face difficulties in protecting their interests.

We are an exempted company with limited liability incorporated in the Cayman Islands. Our corporate affairs are governed by our amended and restated memorandum and articles of association (as may be further amended from time to time), the Companies Law (as amended) of the Cayman Islands, and the common law of the Cayman Islands. The rights of shareholders to take action against the directors, actions by minority shareholders and the fiduciary responsibilities of our directors are to a large extent governed by the common law of the Cayman Islands. This common law is derived in part from comparatively limited judicial precedent in the Cayman Islands as well as from English common law, which has persuasive, but not binding, authority on ~~a court~~courts in the Cayman Islands. The rights of our shareholders and the fiduciary responsibilities of our directors under Cayman Islands law are not as clearly established as they would be under statutes or judicial precedent in some jurisdictions in Hong Kong, mainland China and the United States. In particular, the Cayman Islands has a less developed body of securities law than Hong Kong, mainland China or the United States. In addition, some states in the United States, such as Delaware, have more fully developed and judicially interpreted bodies of corporate law than the Cayman Islands.

In addition, as a Cayman Islands exempted company, our shareholders have no general rights under Cayman Islands law to inspect corporate records and accounts or to obtain copies of lists of shareholders, ~~of these companies~~ with the exception that ~~the~~ shareholders may request a copy of the current amended and restated memorandum and articles of association. Our directors have discretion under our amended and restated articles of association to determine whether or not, and under what conditions, our corporate records may be inspected by our shareholders, but are not obliged to make them available to our shareholders. This may make it more difficult for ~~you~~shareholders to obtain the information needed to establish ~~any~~ facts necessary for a shareholder ~~motion~~action or to solicit proxies from other shareholders in connection with a proxy contest. As a Cayman Islands company, we may not have standing to initiate a derivative action in a Hong Kong, mainland China or U.S. federal ~~court of the United States.~~court. As a result, ~~you~~shareholders may be limited in ~~your~~their ability to protect ~~your~~their interests if ~~you~~they are harmed in a manner that would otherwise enable ~~you~~them to sue in a United States federal court. In addition, shareholders of Cayman Islands companies may not have standing to initiate a shareholder derivative action in Hong Kong, mainland China or U.S. federal courts.

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As a result of all of the above, public shareholders may have more difficulty in protecting their interests in the face of actions taken by management, members of the board of directors or controlling shareholders than they would as public shareholders of a U.S. company.

*You may face difficulties in protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited because we are incorporated under Cayman Islands law, we currently conduct substantially all of our operations outside the United States and someSome of our directors and executive officers reside outside ~~the United States.~~

~~We are incorporated in the Cayman Islands~~of Hong Kong and ~~currently conduct a substantial amount of our operations outside the United States through our subsidiaries. Some of our directors and executive officers reside outside~~ the United States and a substantial portion of their assets are located outside of Hong Kong and the United States. As a result, it may be difficult or impossible for ~~you~~shareholders to bring an action against us or against these individuals in ~~the Cayman Islands~~Hong Kong or in ~~China~~the United States in the event that ~~you~~shareholders believe that ~~your~~their rights have been infringed under the securities laws of Hong Kong, the United States or otherwise. In addition, some of our directors and executive officers reside outside of China. To the extent our directors and executive officers reside outside of China or their assets are located outside of China, it may not be possible for investors to effect service of process upon us or our management inside China. Even if ~~you~~shareholders are successful in bringing an action, ~~of this kind,~~ the laws of the Cayman Islands and China may render ~~you~~them unable to enforce a judgment against our assets or the assets of our directors and officers. There is no statutory recognition in the Cayman Islands of judgments obtained in the United States, Hong Kong or China, although the courts of the Cayman Islands will generally recognize and enforce a non-penal judgment of a foreign court of competent jurisdiction without retrial on the merits.

~~Your voting rights as~~

As a ~~holder~~result of the ~~ADSs~~above, shareholders may have more difficulty protecting their interests in the face of actions taken by management, members of the board of directors or controlling shareholders than they would as shareholders of a Hong Kong company, a Chinese company or a U.S. company.

Voting rights of our ADS holders are limited by the terms of the deposit ~~agreement, as amended.~~

~~You~~agreement. The depositary for the ADSs will give us a discretionary proxy to vote the ordinary shares underlying our ADS holders' ADSs if they do not vote at shareholders’ meetings, except in limited circumstances, which could adversely affect their interests.

Holders of our ADSs may exercise ~~your~~their voting rights with respect to the ordinary shares underlying ~~your~~their ADSs only in accordance with the provisions of the deposit ~~agreement, as amended.~~agreement. Upon receipt of voting instructions from ~~you~~ADS holders in the manner set forth in the deposit agreement, the depositary for the ADSs will endeavor to vote ~~your~~the holder's underlying ordinary shares in

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accordance with these instructions. Under our articles of association, the minimum notice period required for convening aan annual general meeting is ~~seven~~21 calendar days and the minimum notice period required for convening an extraordinary general meeting is 14 calendar days. When a general meeting is convened, ~~you~~ADS holders may not receive sufficient notice of a shareholders’ meeting to permit ~~you~~them to withdraw ~~your~~their ordinary shares to allow ~~you~~them to cast ~~your~~their vote with respect to any specific matter at the meeting. In addition, the depositary and its agents may not be able to send voting instructions to ~~you~~ADS holders or carry out ~~your~~their voting instructions in a timely manner. We will make ~~all~~ reasonable efforts to cause the depositary to extend voting rights to ~~you~~our ADS holders in a timely manner, but ~~you~~our ADS holders may not receive the voting materials in time to ensure that ~~you~~they can vote or instruct ~~the depositary~~their agent to vote ~~your~~their shares.

Furthermore, the depositary and its agents will not be responsible for any failure to carry out any instructions to vote, for the manner in which any vote is cast or for the effect of any such vote. As a result, ~~you~~ADS holders may not be able to exercise ~~your~~their right to vote and ~~you~~they may lack recourse if ~~your~~the ordinary shares underlying their ADSs are not voted as they requested.

Under the deposit agreement for the ADSs, the depositary will give us a discretionary proxy to vote the ordinary shares underlying ADS holders' ADSs at shareholders’ meetings if such holders do not give voting instructions to the depositary, unless:

•we have failed to timely provide the depositary with our notice of meeting and related voting materials;

•we have instructed the depositary that we do not wish a discretionary proxy to be given;

•we have informed the depositary that there is substantial opposition as to a matter to be voted on at the meeting; or

•a matter to be voted on at the meeting would have a material adverse impact on shareholders.

The effect of this discretionary proxy is that, if ADS holders fail to give voting instructions to the depositary, they cannot prevent the ordinary shares underlying their ADSs from being voted, absent the situations described above, and it may make it more difficult for such ADS holders to influence our management. Holders of our ordinary shares are not ~~voted as you requested.~~

subject to this discretionary proxy.

Anti-takeover provisions in our ~~charter~~constitutional documents may discourage our acquisition by a third party, which could limit our shareholders’ opportunity to sell their shares ~~including ordinary shares represented by the ADSs,~~ at a premium.

Our amended and restated memorandum and articles of association include provisions that could limit the ability of others to acquire control of our company, could modify our structure or could cause us to engage in change-of-control transactions. These provisions could have the effect of depriving our shareholders of an opportunity to sell their shares, ~~including ordinary shares represented by ADSs,~~ at a premium over prevailing market prices by discouraging third parties from seeking to obtain control in a tender offer or similar transaction.

For example, our board of directors has the authority, without further action by our shareholders, to issue preferred shares in one or more series and to fix the powers and rights of these shares, including dividend rights, conversion rights, voting rights, terms of redemption and liquidation preferences, any or all of which may be greater than the rights associated with our ordinary shares. ~~preferred~~Preferred shares could thus be issued quickly with terms calculated to delay or prevent a change in control or make removal of management more difficult. In addition, if our board of directors authorizes the issuance of preferred shares, the market price of the ordinary shares and/or ADSs may fall and the voting and other rights of the holders of our ordinary shares and/or ADSs may be materially and adversely affected.

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Furthermore, ~~the~~our amended and restated articles of association permit ~~the~~our directors to vary all or any of the rights attaching to any class of shares in issue without the consent of ~~the shareholder~~shareholders but only if such variation is considered by the directors not to have a material adverse effect upon such ~~holder. The directors cannot vary the rights of shares if such variation would have a material adverse effect of the holder.~~holders. The amended and restated articles of association provide that the holders must consent to any such material adverse changes in the manner set out therein.

Because our directors are divided into three classes with staggered terms of three years each, shareholders can only elect or remove a limited number of our directors in any given year. The length of these terms could present an obstacle to certain actions, such as a merger or other change of control, which could be in the interest of our shareholders.

Our amended and restated memorandum and articles of association designate specific courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our shareholders, which could limit our shareholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

Our amended and restated memorandum and articles of association provide that, unless we consent in writing to the selection of an alternative forum, the courts of Cayman Islands will be the sole and exclusive forum for any derivative action or proceeding brought on behalf of us, any action asserting a claim of breach of a fiduciary duty owed by any director, officer or

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other employee of us to us or our shareholders, any action asserting a claim arising pursuant to any provision of the Companies Law of the Cayman Islands as amended from time to time, or the amended and restated memorandum and articles of association, or any action asserting a claim governed by the internal affairs doctrine (as such concept is recognized under the U.S. laws). Our amended and restated memorandum and articles of association further state that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall be the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended (the “Securities Act”) and provide that any person or entity purchasing or otherwise acquiring any interest in any of our securities is deemed to have notice of and consented to these provisions; provided, however, that shareholders cannot and will not be deemed to have waived our compliance with U.S. federal securities laws and rules and regulations thereunder.

These provisions may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits. Alternatively, if a court were to find these provisions of our amended and restated memorandum and articles of association inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions.

Our amended and restated memorandum and articles of association provide that any shareholder bringing an unsuccessful action against us may be obligated to reimburse us for any costs we have incurred in connection with such unsuccessful action.

Our amended and restated memorandum and articles of association provide that under certain circumstances the fees, costs, and expenses that we incur in connection with actions or proceedings brought by any person or entity, which we refer to as claiming parties, may be shifted to such person or entity. If a claiming party asserts any claim; initiates any proceeding; or joins, offers substantial assistance to, or has a direct financial interest in any claim or proceeding against us, ~~(including any proceeding purportedly filed on behalf of us or any shareholder),~~ and such claiming party ~~(or~~or the third party that received substantial assistance from athe claiming party or in ~~whose~~whole claim ~~or proceeding such~~the claiming party ~~has~~had a direct financial ~~interest)~~interest is unsuccessful in obtaining a judgment on the merits in which the claiming party prevails, then such claiming party ~~may, to~~shall (to the fullest extent ~~permissible~~permitted by ~~law,~~law) be obligated ~~jointly and severally~~ to reimburse us for all fees, costs, and expenses, including but not limited to all reasonable attorneys’ fees and other litigation expenses, that we may incur in connection with such claim ~~suit, action,~~ or proceeding.

Fee-shifting articles are relatively new and untested in ~~both~~ the Cayman Islands, ~~and~~ the United ~~States.~~States, Hong Kong and mainland China. The case law and potential legislative action on fee-shifting articles are evolving and there exists considerable uncertainty regarding the validity of, and potential judicial and legislative responses to, such articles. ~~For example, it is unclear whether our ability to invoke~~The application of our fee-shifting article in connection with claims under the ~~federal~~Cayman Islands, the United States, Hong Kong or Chinese securities laws, including claims related to any of our public offerings, would be preempted by federal law. Similarly, it is unclear how courts might apply the standard that a claiming party must obtain a judgment that substantially achieves, in substance and amount, the full remedy sought. The application of our fee-shifting article in connection with such claims, if any, will depend in part on future developments of the law. We cannot assure you that we will or will not invoke our fee-shifting article in any particular ~~dispute, including any claims related to our public offerings.~~dispute. Consistent with our directors’ fiduciary duties to act in the best interests of the ~~company,~~Company, the directors may in their sole discretion from time to time decide whether or not to enforce this article. In addition, given the unsettled state of the law related to fee-shifting articles, such as ours, we may incur significant additional costs associated with resolving disputes with respect to such articles, which could adversely affect our business and financial condition.

If a shareholder that brings any such claim ~~suit, action~~ or proceeding is unable to obtain the judgment sought, the attorneys’ fees and other litigation expenses that might be shifted to a claiming party ~~are potentially~~may be significant. This fee-shifting article, therefore, may dissuade or discourage current or former shareholders (and their attorneys) from initiating lawsuits or claims against us. In addition, it may impact the fees, contingency or otherwise, required by potential plaintiffs’ attorneys to represent our shareholders or otherwise discourage plaintiffs’ attorneys from representing our shareholders at all. As a result, this article may limit the ability of shareholders to affect the management and direction of our company, particularly through litigation or the threat of litigation.

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The depositary for the ADSs will give us a discretionary proxy to vote our ordinary shares underlying your ADSs if you do not vote at shareholders’ meetings, except in limited circumstances, which could adversely affect your interests.

Under the deposit agreement, as amended, for the ADSs, the depositary will give us a discretionary proxy to vote our ordinary shares underlying your ADSs at shareholders’ meetings if you do not give voting instructions to the depositary, unless:

~~we have failed to timely provide the depositary with our notice of meeting and related voting materials;~~

~~we have instructed the depositary that we do not wish a discretionary proxy to be given;~~

~~we have informed the depositary that there is substantial opposition as to a matter to be voted on at the meeting; or~~

~~a matter to be voted on at the meeting would have a material adverse impact on shareholders.~~

The effect of this discretionary proxy is that, if you fail to give voting instructions to the depositary, you cannot prevent our ordinary shares underlying your ADSs from being voted, absent the situations described above, and it may make it more difficult for shareholders to influence our management. Holders of ~~our ordinary shares are not subject to this discretionary proxy.~~

~~Holders of the~~ ADSs may be subject to limitations on transfer of their ADSs.

~~Your~~

ADSs are transferable only on the books of the depositary. However, the depositary may close its books at any time or from time to time when it deems expedient in connection with the performance of its duties. The depositary may refuse to deliver, transfer or register transfers of ~~your~~ ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, as amended, or for any other reason, subject to ~~your~~ADS holders' right to cancel ~~your~~their ADSs and withdraw the underlying ordinary shares. Temporary delays in the cancellation of ~~your~~ ADSs and withdrawal of the underlying ~~common~~ordinary shares may arise because the depositary has closed its transfer books or we have closed our transfer books, the transfer of ordinary shares is blocked to permit voting at a shareholders’ meeting or we are paying a dividend on our ordinary shares.

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In addition, ~~you~~holders of ADSs may not be able to cancel ~~your~~their ADSs and withdraw the underlying ordinary shares when ~~you~~they owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities.

The depositary for the ADSs is entitled to charge holders fees for various services, including annual service fees.

The depositary for the ADSs is entitled to charge holders fees for various services, including for the issuance of ADSs upon deposit of ordinary shares, cancellation of ADSs, distributions of cash dividends or other cash distributions, distributions of ADSs pursuant to share dividends or other free share distributions, distributions of securities other than ADSs, and annual service fees. In the case of ADSs issued by the depositary into The Depository Trust Company ~~or DTC,~~(“DTC”), the fees will be charged by the DTC participant to the account of the applicable beneficial owner in accordance with the procedures and practices of the DTC participant as in effect at the time.

~~You~~

Dealings in ordinary shares registered in our Hong Kong register of members will be subject to Hong Kong stamp duty. There is uncertainty as to whether Hong Kong stamp duty will apply to the trading or conversion of the ADSs.

In connection with our Hong Kong public offering in 2018, we established a branch register of members in Hong Kong (the “Hong Kong share register”). Our ordinary shares that are traded on the HKEx, including those that may be converted from ADSs, are registered on the Hong Kong share register, and the trading of these ordinary shares on the HKEx are subject to Hong Kong stamp duty. To facilitate ADS to ordinary share conversion and trading between the Nasdaq and the HKEx, we moved a portion of our issued ordinary shares from our Cayman share register to our Hong Kong share register.

Under the Hong Kong Stamp Duty Ordinance, any person who effects a sale or purchase of Hong Kong stock, defined as stock the transfer of which is required to be registered in Hong Kong, is required to pay Hong Kong stamp duty. The stamp duty is currently set at a total rate of 0.2% of the greater of the consideration for, or the value of, shares transferred, with 0.1% payable by each of the buyer and the seller.

To the best of our knowledge, Hong Kong stamp duty has not been levied in practice on the trading or conversion of ADSs of companies that are listed in both the United States and Hong Kong and that have maintained all or a portion of their ordinary shares, including ordinary shares underlying ADSs, in their Hong Kong share registers. However, it is unclear whether, as a matter of Hong Kong law, the trading or conversion of ADSs of these dual-listed companies constitutes a sale or purchase of the underlying Hong Kong registered ordinary shares that is subject to Hong Kong stamp duty. We advise investors to consult their own tax advisors on this matter. If Hong Kong stamp duty is determined by the competent authority to apply to the trading or conversion of the ADSs, the trading price and the value of your investment in our ADSs or ordinary shares may be affected.

Holders of ADSs may not receive distributions on our ordinary shares or any value for them if it is illegal or impractical to make them ~~available to you.~~

available.

The depositary of the ADSs has agreed to ~~pay you~~ADS holders the cash dividends or other distributions it or the custodian for the ADSs receives on our ordinary shares or other deposited securities after deducting its fees and expenses. ~~You~~ADS holders will

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receive these distributions in proportion to the number of our ordinary shares that ~~your~~their ADSs represent. However, the depositary is not responsible for making such payments or distributions if it is unlawful or impractical to make a distribution available to any holders of ADSs. For example, it would be unlawful to make a distribution to a holder of ADSs if it consists of securities that require registration under the Securities Act, but that are not properly registered or distributed pursuant to an applicable exemption from registration. The depositary is not responsible for making a distribution available to any holders of ADSs if any government approval or registration required for such distribution cannot be obtained after reasonable efforts made by the depositary. We have no obligation to take any other action to permit the distribution of the ADSs, ordinary shares, rights or anything else to holders of the ADSs. This means that ~~you~~holders of ADSs may not receive the distributions we make on our ordinary shares or any value for them if it is illegal or impractical for us to make them available to ~~you.~~such holders. These restrictions may materially reduce the value of ~~your~~our ADSs.

Holders of ~~the~~ ADSs may not be able to participate in rights offerings and may experience dilution of their holdings.

From time to time, we may distribute rights to our shareholders, including rights to acquire securities. Under the deposit agreement, the depositary will not distribute rights to holders of ADSs unless the distribution and sale of rights and the securities to which these rights relate are either exempt from registration under the Securities Act with respect to all holders of ADSs or are registered under ~~the provisions of~~ the Securities Act. The depositary may, but is not required to, attempt to sell these undistributed rights to third parties and may allow the rights to lapse. We may be unable to establish an exemption from registration under the Securities Act, and we are under no obligation to file a registration statement with respect to these rights or underlying securities or to try to have a registration statement declared effective. Accordingly, holders of ADSs may be unable to participate in our rights offerings and may experience dilution of their holdings as a result.

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Our corporate actions are substantially controlled by our directors, executive officers and other principal shareholders, who can exert significant influence over important corporate matters, which may reduce the price of ~~the~~our ordinary shares, ADSs, and/or RMB Shares and deprive ~~you~~shareholders of an opportunity to receive a premium for ~~your ADSs.~~

their ordinary shares, ADSs, and/or RMB Shares.

Our directors, executive officers and principal shareholders beneficially owned approximately ~~66.7%~~54% of our outstanding ordinary shares as of November 1, ~~2017.~~2023. These shareholders, if acting together, could exert substantial influence over matters such as electing directors and approving material mergers, acquisitions or other business combination transactions. This concentration of ownership may also discourage, delay or prevent a change in control of our company, which could have the dual effect of depriving our shareholders of an opportunity to receive a premium for their shares as part of a sale of our company and reducing the price of ~~the ADSs.~~our ordinary shares, ADSs, and/or RMB Shares. These actions may be taken even if they are opposed by our other ~~shareholders, including the holders of the ADSs.~~shareholders. In addition, these persons could divert business opportunities away from us to themselves or others.

*We have incurred increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, we have incurred and will continue to incur significant legal, accounting and other expenses that we did not incur as a private company. For example, as a public company, we are now subject to the reporting requirements of the Exchange Act, which requires, among other things, that we file with the SEC annual, quarterly and current reports with respect to our business and financial condition. We have incurred and will continue to incur costs associated with the preparation and filing of these reports. The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the NASDAQ Stock Market and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified members of our board of directors.

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We continue to evaluate these rules and regulations, and cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, we were first required to furnish a report by our management on our internal control over financial reporting for the year ending December 31, 2016. Because we remain an emerging growth company, we are not currently required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. However, we will no longer qualify as an emerging growth company as of December 31, 2017, and will be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm after such date.

To achieve compliance with Section 404 within the prescribed period, we will continue to be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

*We determined that we were a “passive foreign investment company” in 2016 and we may be a passive foreign investment company in future taxable years, which may have adverse U.S. federal income tax consequences for U.S. shareholders.

~~U.S. investors should~~

A non-U.S. corporation will be ~~aware that~~classified as a “passive foreign investment company” (“PFIC”) for any taxable year if either (1) 75% or more of its gross income consists of certain types of passive income or (2) 50% or more of the average quarterly value of its assets during such year produce or are held for the production of passive income. Based upon the composition of our income and assets, we ~~determined~~believe that we were a passive foreign investment company, within the meaning of Section 1297 of the Internal Revenue Code of 1986, as amended, or PFIC, for 2016. Given that the transactions with Celgene closed during the third quarter of 2017, we do not ~~expect to be~~ a PFIC for ~~2017. However, as~~the taxable year ended December 31, 2022. Nevertheless, because our PFIC status must be determined annually with respect to each taxable year and will depend on the composition and character of our assets and income, including our use of proceeds from any equity offerings, and the value of our assets (which may be determined, in part, by reference to the market value of our ADSs and ordinary shares, which may be volatile) over the course of such taxable year, we may be a PFIC in any taxable year. The determination of whether we will be or become a PFIC may also depend, in part, on how, and how quickly, we use our liquid assets and the cash raised in equity offerings. If we determine not to deploy significant amounts of cash for active purposes, our risk of being a PFIC may substantially increase. Because there are uncertainties in the application of the relevant rules and PFIC status is a factual determination made annually after the close of each taxable year, there can be no assurance that we will not be a PFIC for the current taxable year or any future taxable year. In addition, it is possible that the Internal Revenue Service may challenge our classification of certain income and assets as non-passive, which may result in our being or becoming a PFIC in the current or subsequent years.

If we are a PFIC for any taxable year during a U.S. shareholder’s holding period of the ~~ADSs or~~ ordinary shares or ADSs, then ~~regardless of whether we cease to meet the threshold requirements for PFIC status,~~ such U.S. shareholder ~~generally will be required to treat any~~may incur significantly increased United States income tax on gain ~~realized upon a~~recognized on the sale or other disposition of the ~~ADSs or~~ ordinary shares or ~~any~~ADSs and on the receipt of distributions on the ordinary shares or ADSs to the extent such distribution is treated as an “excess distribution” ~~received on~~under the ~~ADSs or ordinary shares, as ordinary~~United States federal income earned over the U.S. shareholder’s holding period for the ADSs or ordinary shares, and to pay the applicable taxes on such ordinary income along with an interest charge at the rate applicable to underpayments of tax on a portion of the resulting tax liability, unless the shareholder makes a timely and effective “qualified electing fund” election, or QEF election, or “mark-to-market” election with respect to the ADSs or ordinary shares.rules. In addition, ~~the U.S. shareholder would~~such holders may be subject to ~~the same adverse~~burdensome reporting requirements.

Further, if we are classified as a PFIC for any year during which a U.S. ~~federal income tax consequences on (i) certain distributions by any of~~shareholder holds our ~~subsidiaries~~ordinary shares or ADSs, we generally will continue to be treated as ~~PFICs (“lower-tier PFICs”), and (ii)~~ a ~~disposition of sharers of a lower-tier~~ PFIC ~~in each case as if the~~for all succeeding years during which such U.S. shareholder owned the shares of the relevant lower-tier PFIC directly, even though the U.S. shareholder has not received the proceeds of those distributions or dispositions. A U.S. shareholder who makes an effective QEF election generally must report on a current basis its share of our net capital gain and ordinary earnings for any taxable year in which we are a PFIC, whether or not we distribute any amounts to our shareholders. If a QEF election is not in effect for the first taxable year in your holding period in which we are a PFIC, a QEF election can only be made if you elect to recognize gain as if you had sold the ADSs orholds such ordinary shares for their fair market value on the first day of your taxable year in which the PFIC becomes a QEF pursuant to the QEF election. The gain recognized on this deemed sale would be subject to the general tax treatment of PFICs discussed above. We have posted on our website the information necessary for U.S. investors to make a QEF election for 2016. We intend to determine our PFIC status at the end of each taxable year and to satisfy any

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~~Table of Contents~~

~~applicable record keeping and reporting requirements that apply to a QEF, and will endeavor to provide to you, for each taxable year that we determine we are~~ or may be a PFIC, the information that is necessary for you to make a QEF election with respect to us (and any of our subsidiaries which are lower-tier PFICs). We may elect to provide such information on our website. However, there can be no assurances that we will make the necessary information available to you. You are urged to consult your own tax advisors regarding the availability and advisability of, and procedure for making, a QEF election. A U.S. shareholder who makes an effective mark-to-market election generally must include as ordinary income any gain recognized in a year that we are a PFIC in an amount equal to the excess of the fair market value of the ADSs over the shareholder’s adjusted tax basis therein.ADSs. Each U.S. shareholder should consult its ~~own~~ tax ~~advisors~~advisor regarding the PFIC rules and the U.S. federal income tax consequences of the acquisition, ownership and disposition of the ~~ADSs or~~ ordinary ~~shares.~~

shares and ADSs.

If you are a “Ten Percent Shareholder,” you may be subject to adverse U.S. federal income tax consequences if we are classified as a Controlled Foreign Corporation.

Each “Ten Percent Shareholder” (as defined below) in a non-U.S. corporation that is classified as a “controlled foreign ~~corporation,” or a CFC,~~corporation” (“CFC”), for U.S. federal income tax purposes is generally is required to include in income for U.S. federal tax purposes such Ten Percent Shareholder’s pro rata share of the ~~“CFC’s”~~CFC’s “Subpart F income” and investment of earnings in U.S. property, even if the CFC has made no distributions to its shareholders. Each Ten Percent Shareholder is also required to include in gross income its “global intangible low-taxed income,” which is determined by reference to the income of CFCs of which such Ten Percent Shareholder is a Ten Percent Shareholder. Ten Percent Shareholders that are corporations may be entitled to a deduction equal to the foreign portion of any dividend when a dividend is paid. A non-U.S. corporation will generally ~~will~~ be classified as a CFC for ~~U.S~~U.S. federal income tax purposes if Ten Percent Shareholders own in the aggregate, directly or indirectly, more than 50% of either the total combined voting power of all classes of stock of such corporation entitled to vote or of the total value of the stock of such corporation. A “Ten Percent Shareholder” is a U.S. person (as defined by the Internal Revenue Code of 1986, as amended), who owns or is considered to own 10% or more of the total combined voting power of all classes of stock entitled to vote of such corporation or 10% of the value of all classes of stock of such corporation. The determination of CFC status is complex and includes attribution rules, the application of which is not entirely certain. ~~We may currently be~~

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Although we believe we are not a CFC ~~and/or~~now, we may become one or own interests in one in the future. Holders are urged to consult their own tax advisors with respect to our potential CFC status and the consequences thereof.

~~We may be subject to adverse legislative or regulatory tax changes that could negatively affect our financial condition.~~

The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the IRS and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect our stockholders or us. In recent years, many changes have been made and changes are likely to continue to be made in the future. We cannot predict whether, when, in what form, or with what effective dates, tax laws, regulations and rulings may be enacted, promulgated or decided that could result in an increase in our, or our stockholders’, tax liability or require changes in the manner in which we operate in order to minimize increases in our tax liability.

*Failure to comply with NASDAQ Marketplace Rules could materially and adversely affect our business.

We currently have two members on our Audit Committee and one vacancy. In accordance with NASDAQ Marketplace Rule 505(c)(2)(A), we are required to maintain an audit committee composed of at least three members who meet certain eligibility criteria in order to remain listed on the NASDAQ Global Select Market. Under NASDAQ rules, we have a cure period which extends until the earlier of (1) our next annual general meeting of shareholders or (2) June 1, 2018 to regain compliance, or, if the next annual general meeting of shareholders is held no later than November 28, 2017, then we must regain compliance no later than November 28, 2017. We intend to appoint an additional independent director to the Audit Committee prior to the end of the cure period. In the event that we were delisted from the NASDAQ Global Select Market, our ADSs would become significantly less liquid, which would adversely affect their value. Although our ADSs would likely be traded over-the-counter or on pink sheets, these types of listings involve more risk and trade less frequently and in smaller volumes than securities traded on the NASDAQ Global Select Market.

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~~Table of Contents~~

Item 2. Unregistered Sales of Equity Securities, ~~and Use of Proceeds.~~

~~Recent Sales of Unregistered Securities~~

We did not sell any of our ordinary shares or ADSs, or grant any share options or other equity awards, during the three months ended September 30, 2017 that were not registered under the Securities Act of 1933, as amended, or the Securities Act, except as follows:

On August 31, 2017, we sold 32,746,416 ordinary shares to Celgene Switzerland LLC, or Celgene Switzerland, for an aggregate cash price of $150 million, or $4.58 per ordinary share, or $59.55 per ADS, pursuant to Share Subscription Agreement dated July 5, 2017 by and between BeiGene and Celgene Switzerland, or the Share Subscription Agreement. The offer and sale of the shares issued pursuant to the Share Subscription Agreement was made in a private placement in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act, for transactions by an issuer not involving a public offering, and/or Regulation D under the Securities Act. All certificates evidencing the shares will bear a standard restrictive legend under the Securities Act.

Use of Proceeds ~~from Sales~~and Issuer Purchases of ~~Registered Securities~~

On February 8, 2016, we closed the sale of 7,590,000 ADSs to the public at an initial public offering price of $24.00 per ADS, including the exercise in full by the underwriters of their option to purchase additional ADSs. The ordinary shares in the form of ADSs in our initial public offering were registered under the Securities Act pursuant to a registration statements on Form S‑1 (File No. 333‑207459), which was filed with the SEC on October 16, 2015 and amended subsequently and declared effective on February 2, 2016. Following the sale of the ADSs in connection with the closing of our initial public offering, the offering terminated. The offering did not terminate before all the securities registered in the registration statements were sold. The underwriters of the offering were Goldman, Sachs & Co., Morgan Stanley, and Cowen and Company acting as joint book-running managers for the offering and as representatives of the underwriters. Baird acted as co-manager for the offering.

We raised $166.2 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses of approximately $16.0 million. No offering expenses were paid directly or indirectly to any of our directors or officers (or their associates) or persons owning ten percent or more of any class of our equity securities or to any other affiliates.

As of September 30, 2017, we have used all of the net proceeds from our initial public offering to fund the costs of ongoing clinical development for our clinical drug candidates, BGB‑3111, BGB-A317, BGB‑290 and BGB‑283, and preclinical drug candidates, as well as for working capital, capital expenditures and general corporate purposes. Prior to their use, we invested a significant portion of the balance of the net proceeds from our initial public offering in short-term, interest-bearing investment-grade securities and government securities in accordance with our investment policy. Our use of the net offering proceeds was consistent with the use of proceeds described in our final prospectus filed with the SEC on February 3, 2016 pursuant to Rule 424(b) under the Securities Act, and there has been no material change in our planned use of the balance of the net proceeds from the offerings described in such prospectus.

Equity Securities.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

~~Not applicable.~~

~~120~~

(c)

There were no trading arrangements for the purchase or sale of our securities entered into, modified or terminated by our directors or officers during the quarterly period covered by this report.

~~Table of Contents~~

Item 6. Exhibits.

See the Exhibit Index ~~on the page immediately following the signature page to this Quarterly Report~~below for a list of the exhibits filed as part of, or incorporated by reference into, this Quarterly Report, which Exhibit Index is incorporated herein by reference.

~~121~~

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EXHIBIT INDEX

Exhibit

Incorporated by Reference

Filed
Number

Exhibit Description

Form

Date

Number

Herewith
3.1

Fourth Amended and Restated Memorandum and Articles of Incorporation of the Registrant, as currently in effect

8-K

02/11/2016

3.1

4.1

Deposit Agreement dated February 5, 2016 by and among the Registrant, the Depositary and holders of the American Depositary Receipts

8-K

02/11/2016

4.1

4.2

Amendment No. 1 to Deposit Agreement, dated April 11, 2016, by and among the Registrant, Citibank, N.A. and holders of the American Depositary Receipts

8-K

04/11/2016

4.1

4.3

Form of American Depositary Receipt (included in Exhibit 4.2)

8-K

04/11/2016

4.2

4.4

Specimen Certificate for Ordinary Shares

S-1

12/09/2015

4.3

4.5

Second Amended and Restated Investors’ Rights Agreement, dated as of April 21, 2015, by and among the Registrant and certain shareholders named therein

S-1

10/16/2015

4.4

4.6

Amendment No. 1 to Second Amended and Restated Investors’ Rights Agreement, dated January 26, 2016, by and among the Registrant and certain shareholders named therein

S-1

01/27/2016

10.21

4.7

Letter Agreement, dated as of July 11, 2016, between the Registrant and Citibank, N.A.

10-Q

08/10/2016

4.7

4.8

Registration Rights Agreement, dated as of November 16, 2016, by and among the Registrant and the investors name therein

8-K

08/10/2016

4.1

4.9

Form of Letter Agreement, between the Registrant and Citibank, N.A.

10-Q

05/10/2017

4.9

10.1

Share Subscription Agreement, dated July 5, 2017, by and between Celgene Switzerland LLC and the Registrant

8‑K

07/06/2017

10.1

10.2#

Amended and Restated Exclusive License and Collaboration Agreement, dated August 31, 2017, by and among the Registrant, Celgene Corporation and Celgene Switzerland LLC

X
10.3#

License and Supply Agreement, dated July 5, 2017, by and between the Registrant and Celgene Logistics Sàrl

X
10.4†

Amendment No. 1 to BeiGene, Ltd. 2016 Share Option and Incentive Plan

X
10.5†

Forms of Restricted Share Unit Award Agreement and Share Option Agreement under BeiGene, Ltd. 2016 Share Option and Incentive Plan

X

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~~Table of Contents~~

~~31.1~~

Exhibit No.

Exhibit Description

Filed/Furnished Herewith

Incorporated by Reference Herein from Form or Schedule

Filing Date

SEC File / Reg. Number

10.1#

Settlement and Termination Agreement, dated as of August 1, 2023, by and between the Registrant, BeiGene Switzerland GmbH, Bristol-Myers Squibb Company, Celgene Corporation, Celgene Switzerland LLC , Celgene Kappa Holdings LLC, Celgene Holdings East Corporation and Celgene Logistics Sàrl

10.2#

Mutual Termination and Release Agreement, dated September 17, 2023, by and between BeiGene Switzerland GmbH and Novartis Pharma AG

31.1

Certification of Principal Executive Officer Required Under Rule 13a‑14(a) and 15d‑14(a) of the Securities Exchange Act of 1934, as amended

31.2

Certification of Principal Financial Officer Required Under Rule 13a‑14(a) and 15d‑14(a) of the Securities Exchange Act of 1934, as amended

*32.1

32.1*

Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a‑14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350

~~101~~

101.INS

XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document

~~The following materials from Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, formatted~~

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

104

Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in eXtensible Business Reporting Language (XBRL) includes: (i) Condensed Consolidated Balance Sheets; (ii) Condensed Consolidated Statements of Operations; (iii) Condensed Consolidated Statements of Comprehensive Income (Loss); (iv) Condensed Consolidated Statements of Cash Flows; and (v) Notes to the Condensed Consolidated Financial Statements.

Exhibits 101.*)

~~†Indicates a management contract or any compensatory plan, contract or arrangement.~~

~~#Confidential treatment has been requested for~~

# Certain portions of ~~this exhibit. These portions~~the exhibit have been omitted ~~from this Quarterly Report on Form 10-Q~~by means of redacting a portion of the text and ~~filed separately~~replacing it with “[…***…]”, because they are both (i) not material and (ii) the ~~U.S. Securities and Exchange Commission.~~

type of information that the Registrant treats as private or confidential.

*Furnished herewith.

~~123~~

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Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	BEIGENE, LTD.

Date: November ~~13, 2017~~ 9, 2023	By:	/s/ John V. Oyler
	John V. Oyler
	Chief Executive Officer and Chairman
	(Principal Executive Officer)

Date: November ~~13, 2017~~ 9, 2023	By:	/s/ ~~Howard Liang~~ Julia Wang
	~~Howard Liang~~ Julia Wang
	Chief Financial Officer ~~and Chief Strategy Officer~~
	(Principal Financial and Accounting Officer)

~~124~~

105


☐
	~~For the quarterly period ended September 30, 2017~~

	OR

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

~~Cayman Islands~~	~~98-1209416~~
Cayman Islands		98-1209416
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)


c/o Mourant ~~Ozannes Corporate~~Governance Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman
Cayman Islands			KY1-1108
(Address of principal executive offices)			(Zip Code)


		As of
		September 30,	December 31,			As of
	Note	2017	2016			September 30,	December 31,
		$	$		Note	2023	2022
		(unaudited)	(audited)			$	$
						(unaudited)	(audited)
Assets				Assets
Current assets:				Current assets:
Cash and cash equivalents		208,510	87,514	Cash and cash equivalents		3,067,336	3,869,564
Short-term restricted cash				Short-term restricted cash	4	11,548	196
Short-term investments	5	548,925	280,660	Short-term investments	4	106,989	665,251
Accounts receivable		10,521	—
Unbilled receivable		170,950	—
Inventories	6	5,712	—
Accounts receivable, net				Accounts receivable, net		309,079	173,168
Inventories, net				Inventories, net	5	316,929	282,346
Prepaid expenses and other current assets		17,712	6,225	Prepaid expenses and other current assets	9	241,661	216,553
Total current assets		962,330	374,399	Total current assets		4,053,542	5,207,078
Property and equipment, net	7	55,322	25,977
Land use right, net	8	12,251	—

Property, plant and equipment, net				Property, plant and equipment, net	6	1,178,038	845,946
Operating lease right-of-use assets				Operating lease right-of-use assets		98,742	109,960
Intangible assets, net	9	7,437	—	Intangible assets, net	7	53,657	40,616
Goodwill	9	1,984	—
Deferred tax assets	10	7,684	768

Other non-current assets		2,051	4,669	Other non-current assets	9	140,900	175,690
Total non-current assets		86,729	31,414	Total non-current assets		1,471,337	1,172,212
Total assets		1,049,059	405,813	Total assets		5,524,879	6,379,290
Liabilities and shareholders’ equity
Liabilities and shareholders' equity				Liabilities and shareholders' equity
Current liabilities:				Current liabilities:
Accounts payable		35,168	11,957	Accounts payable		341,857	294,781
Accrued expenses and other payables	11	46,991	22,297	Accrued expenses and other payables	9	505,824	467,352
Deferred revenue, current portion		9,132	—	Deferred revenue, current portion	3	—	213,861
Tax payable	10	2,852	804	Tax payable	8	20,158	25,189
Current portion of long-term bank loan	14	9,018	—
Operating lease liabilities, current portion				Operating lease liabilities, current portion		23,246	24,041
Research and development cost share liability, current portion				Research and development cost share liability, current portion	3	63,652	114,335
Short-term debt				Short-term debt	10	328,560	328,969
Total current liabilities		103,161	35,058	Total current liabilities		1,283,297	1,468,528
Non-current liabilities:				Non-current liabilities:
Long-term bank loan	14	9,018	17,284
Shareholder loan	15	140,311	—
Long-term bank loans				Long-term bank loans	10	202,491	209,148
Deferred revenue, non-current portion		29,477		Deferred revenue, non-current portion	3	300	42,026
Operating lease liabilities, non-current portion				Operating lease liabilities, non-current portion		25,474	34,517
Deferred tax liabilities	10	1,859	—	Deferred tax liabilities	8	16,358	15,996
Research and development cost share liability, non-current portion				Research and development cost share liability, non-current portion	3	191,739	179,625
Other long-term liabilities		744	564	Other long-term liabilities	9	41,986	46,095
Total non-current liabilities		181,409	17,848	Total non-current liabilities		478,348	527,407
Total liabilities		284,570	52,906	Total liabilities		1,761,645	1,995,935
Commitments and contingencies	24			Commitments and contingencies	17
Equity:
Ordinary shares (par value of US$0.0001 per share; 9,500,000,000 shares authorized; 589,772,330 shares issued and outstanding as of September 30, 2017 (December 31, 2016: 9,500,000,000 shares authorized; 515,833,609 shares issued and outstanding))		59	52
Shareholders' equity:				Shareholders' equity:
Ordinary shares, US$0.0001 par value per share; 9,500,000,000 shares authorized; 1,352,997,624 and 1,356,140,180 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively				Ordinary shares, US$0.0001 par value per share; 9,500,000,000 shares authorized; 1,352,997,624 and 1,356,140,180 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively		135	135
Additional paid-in capital		981,237	591,213	Additional paid-in capital		11,502,527	11,540,979
Accumulated other comprehensive income /(loss)	20	38	(946)

Accumulated other comprehensive loss				Accumulated other comprehensive loss	14	(144,931)	(77,417)
Accumulated deficit		(231,194)	(237,412)	Accumulated deficit		(7,594,497)	(7,080,342)
Total BeiGene, Ltd. shareholders’ equity		750,140	352,907
Noncontrolling interest	21	14,349	—
Total equity	22	764,489	352,907
Total liabilities and equity		1,049,059	405,813
Total shareholders' equity				Total shareholders' equity		3,763,234	4,383,355
Total liabilities and shareholders' equity				Total liabilities and shareholders' equity		5,524,879	6,379,290


		Three Months Ended		Nine Months Ended
		September 30,		September 30,
	Note	2017	2016	2017	2016
		$	$	$	$
Revenue
Product revenue, net	17	8,822	—	8,822	—
Collaboration revenue	3	211,391	—	211,391	1,070
Total revenues		220,213	—	220,213	1,070
Expenses
Cost of sales - product		(1,944)	—	(1,944)	—
Research and development		(87,660)	(30,106)	(177,678)	(69,100)
Selling, general and administrative		(15,641)	(4,722)	(35,187)	(11,760)
Amortization of intangible assets		(63)	—	(63)	—
Total expenses		(105,308)	(34,828)	(214,872)	(80,860)
Income /(loss) from operations		114,905	(34,828)	5,341	(79,790)
Interest (expense)/income, net		(1,785)	(75)	(3,581)	336
Changes in fair value of financial instruments	12	—	—	—	(1,514)
(Loss)/gain on sale of available-for-sale securities		—	(137)	10	(1,077)
Other income/(expense), net		1,103	(327)	1,531	732
Income/(loss) before income tax expense		114,223	(35,367)	3,301	(81,313)
Income tax benefit /(expense)	10	3,061	(127)	2,680	(306)
Net income /(loss)		117,284	(35,494)	5,981	(81,619)
Less: Net loss attributable to noncontrolling interest		(102)	—	(237)	—
Net income /(loss) attributable to BeiGene, Ltd.		117,386	(35,494)	6,218	(81,619)
Net income/(loss) per share attributable to BeiGene, Ltd.	18
Basic (in dollars per share)		0.21	(0.08)	0.01	(0.21)
Diluted (in dollars per share)		0.20	(0.08)	0.01	(0.21)
Weighted-average shares used in net income/(loss) per share calculation	18
Basic (in shares)		547,546,656	428,137,509	527,329,985	383,472,372
Diluted (in shares)		600,612,680	428,137,509	561,237,818	383,472,372
Net income /(loss) per American Depositary Share (“ADS”)
Basic (in dollars per ADS)		2.79	(1.08)	0.15	(2.77)
Diluted (in dollars per ADS)		2.54	(1.08)	0.14	(2.77)

☒
☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

	~~Page~~
						Page

PART I.	FINANCIAL INFORMATION		3 3

	Item 1.	Financial Statements		3 3

	Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		29 29

	Item 3.	Quantitative and Qualitative Disclosures about Market Risk		42 47

	Item 4.	Controls and Procedures		43 48

	PART II.	OTHER INFORMATION		44 48

	Item 1.	Legal Proceedings		44 48

	Item 1A.	Risk Factors		44 49

	Item 2.	Unregistered Sales of Equity Securities, ~~and~~ Use of Proceeds and Issuer Purchases of Equity Securities		103 ~~120~~

	Item 3.	Defaults Upon Senior Securities		103 ~~120~~

	Item 4.	Mine Safety Disclosures		103 ~~120~~

	Item 5.	Other Information		103 ~~120~~

	Item 6.	Exhibits		103 ~~121~~

			SIGNATURES		105 ~~124~~


		Nine Months Ended September 30,
	Note	2023	2022
		$	$
Operating activities:
Net loss		(514,155)	(1,558,480)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense		63,856	48,262
Share-based compensation expenses	13	274,697	225,036

Unrealized losses on equity investments	4	12,273	16,413

Acquired in-process research and development		15,000	20,000
Amortization of research and development cost share liability	3	(38,569)	(70,389)

Deferred income tax benefits		735	380
Gain on BMS termination settlement	15	(362,917)	—
Other items, net		822	7,762
Changes in operating assets and liabilities:
Accounts receivable		(143,511)	284,717
Inventories		(52,371)	(75,632)
Other assets		(17,598)	30,325
Accounts payable		31,366	4,203
Accrued expenses and other payables		50,089	1,628

Deferred revenue		(255,587)	(112,820)
Other liabilities		55	167

Net cash used in operating activities		(935,815)	(1,178,428)
Investing activities:
Purchases of property, plant and equipment		(404,937)	(204,076)
Purchase of intangible asset		(9,413)	—

Purchases of investments		(15,581)	(14,735)
Proceeds from sale or maturity of investments		567,519	1,352,398
Purchase of in-process research and development		(15,000)	(95,000)

Net cash provided by investing activities		122,588	1,038,587
Financing activities:



Proceeds from long-term loan	10	22,502	37,372
Repayment of long-term loan	10	(8,462)	—
Proceeds from short-term loans	10	162,614	163,774
Repayment of short-term loans	10	(159,576)	(145,428)
Proceeds from option exercises and employee share purchase plan		52,352	35,677
Net cash provided by financing activities		69,430	91,395
Effect of foreign exchange rate changes, net		(50,348)	(133,929)
Net decrease in cash, cash equivalents, and restricted cash		(794,145)	(182,375)
Cash, cash equivalents, and restricted cash at beginning of period		3,875,037	4,382,887
Cash, cash equivalents, and restricted cash at end of period		3,080,892	4,200,512
Supplemental cash flow information:
Cash and cash equivalents		3,067,336	4,197,132
Short-term restricted cash		11,548	191
Long-term restricted cash		2,008	3,189
Income taxes paid		42,516	25,006
Interest expense paid		15,893	19,865
Supplemental non-cash information:
Capital expenditures included in accounts payable and accrued expenses		107,611	47,310
Acquired intangible asset included in accounts payable		9,384	—



	Ordinary Shares		Additional Paid-In Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit	Total
	Shares	Amount
		$		$	$	$	$
Balance at December 31, 2022	1,356,140,180	135		11,540,979	(77,417)	(7,080,342)	4,383,355

Use of shares reserved for share option exercises	(98,774)	—		—	—	—	—
Exercise of options, ESPP and release of RSUs	6,610,695	1		28,656	—	—	28,657
Share-based compensation	—	—		75,322	—	—	75,322
Other comprehensive income	—	—		—	18,403	—	18,403
Net loss	—	—		—	—	(348,431)	(348,431)
Balance at March 31, 2023	1,362,652,101	136		11,644,957	(59,014)	(7,428,773)	4,157,306
Use of shares reserved for share option exercises	220,116	—		—	—	—	—
Exercise of options, ESPP and release of RSUs	13,379,119	1		3,691	—	—	3,692
Share-based compensation	—	—		103,371	—	—	103,371
Other comprehensive loss	—	—		—	(84,673)	—	(84,673)
Net loss	—	—		—	—	(381,137)	(381,137)
Balance at June 30, 2023	1,376,251,336	137		11,752,019	(143,687)	(7,809,910)	3,798,559

Use of shares reserved for share option exercises	(4,689,438)	—		—	—	—	—
Exercise of options, ESPP and release of RSUs	4,708,834	—		17,419	—	—	17,419
Cancellation of ordinary shares	(23,273,108)	(2)		(362,915)	—	—	(362,917)
Share-based compensation	—	—		96,004	—	—	96,004
Other comprehensive loss	—	—		—	(1,244)	—	(1,244)
Net income	—	—		—	—	215,413	215,413
Balance at September 30, 2023	1,352,997,624	135		11,502,527	(144,931)	(7,594,497)	3,763,234

Balance at December 31, 2021	1,334,804,281	133		11,191,007	17,950	(5,076,527)	6,132,563
Cost from issuance of ordinary shares	—	—		(152)	—	—	(152)
Use of shares reserved for share option exercises	(2,850,328)	—		—	—	—	—
Exercise of options, ESPP and release of RSUs	2,851,316	—		11,880	—	—	11,880
Share-based compensation	—	—		65,555	—	—	65,555
Other comprehensive loss	—	—		—	(496)	—	(496)
Net loss	—	—		—	—	(435,198)	(435,198)
Balance at March 31, 2022	1,334,805,269	133		11,268,290	17,454	(5,511,725)	5,774,152
Use of shares reserved for share option exercises	5,016,518	—		—	—	—	—
Exercise of options, ESPP and release of RSUs	9,817,938	1		7,091	—	—	7,092
Share-based compensation	—	—		81,305	—	—	81,305
Other comprehensive loss	—	—		—	(99,904)	—	(99,904)
Net loss	—	—		—	—	(565,726)	(565,726)
Balance at June 30, 2022	1,349,639,725	134		11,356,686	(82,450)	(6,077,451)	5,196,919

Use of shares reserved for share option exercises	(3,971,942)	—		—	—	—	—
Exercise of options, ESPP and release of RSUs	3,972,397	1		16,704	—	—	16,705
Share-based compensation	—	—		78,176	—	—	78,176
Other comprehensive loss	—	—		—	(79,073)	—	(79,073)
Net loss	—	—		—	—	(557,556)	(557,556)
Balance at September 30, 2022	1,349,640,180	135		11,451,566	(161,523)	(6,635,007)	4,655,171


			~~Percentage of~~
		~~Date of~~	~~Ownership by~~
~~Name of Company~~	~~Place of Incorporation~~	~~Incorporation~~	~~the Company~~		~~Principal Activities~~
~~BeiGene (Hong Kong) Co., Limited.("BeiGene HK")~~	~~Hong Kong~~	~~November 22,~~ 2010,	~~100~~	%	~~Investment holding~~
~~BeiGene (Beijing) Co., Ltd. ("BeiGene (Beijing)")~~	~~The People’s Republic of China (“PRC” or “China”)~~	~~January 24, 2011~~	~~100~~	%	~~Medical and pharmaceutical research~~
~~BeiGene AUS Pty Ltd.~~	~~Australia~~	~~July 15, 2013~~	~~100~~	%	~~Clinical trial activities~~
~~BeiGene 101~~	~~Cayman Islands~~	~~August 30, 2012~~	~~100~~	%	~~Medical and pharmaceutical research~~
~~BeiGene (Suzhou) Co., Ltd. (“BeiGene (Suzhou)”)~~	~~PRC~~	~~April 9, 2015~~	~~100~~	%	~~Medical and pharmaceutical research~~
~~BeiGene USA, Inc.("BeiGene (USA)")~~	~~United States~~	~~July 8, 2015~~	~~100~~	%	~~Clinical trial activities~~
~~BeiGene (Shanghai) Co., Ltd. (“BeiGene (Shanghai)”)~~	~~PRC~~	~~September 11, 2015~~	~~100~~	%	~~Medical and pharmaceutical research~~
~~BeiGene Biologics Co., Ltd. ("BeiGene Biologics")~~	~~PRC~~	~~January 25, 2017~~	95	%	~~Biologics manufacturing~~
~~BeiGene Guangzhou Biologics Manufacturing Co., Ltd. ("BeiGene Guangzhou Factory")~~	~~PRC~~	~~March 3, 2017~~	95	%	~~Biologics manufacturing~~
~~BeiGene (Guangzhou) Co., Ltd.~~	~~PRC~~	~~July 11, 2017~~	~~100~~	%	~~Medical and pharmaceutical research~~
BeiGene Pharmaceutical (Shanghai) Co., Ltd. (BeiGene Pharmaceutical (Shanghai))*	~~PRC~~	~~December 15, 2009~~	~~100~~	%	~~Medical and pharmaceutical consulting, marketing and promotional services~~
~~BeiGene Switzerland GmbH~~	~~Switzerland~~	~~September 6, 2017~~	~~100~~	%	~~Clinical trial activities and commercial~~
~~BeiGene Ireland Limited~~	~~Republic of Ireland~~	~~August 11, 2017~~	~~100~~	%	~~Clinical trial activities~~


	Quoted Price in Active Market for Identical Assets	Significant Other Observable Inputs	Significant Unobservable Inputs
As of September 30, 2023	(Level 1)	(Level 2)	(Level 3)
	$	$	$
Cash equivalents
Money market funds	616,845	—	—
Time deposits	42,348	—	—
Short-term investments (Note 4):
U.S. Treasury securities	106,989	—	—
Prepaid expenses and other current assets:
Convertible debt instrument	—	—	4,668
Other non-current assets (Note 4):
Equity securities with readily determinable fair values	1,014	72	—
Convertible debt instrument	—	—	3,239
Total	767,196	72	7,907


	~~Quoted Price~~
	~~in Active~~	~~Significant~~
	~~Market for~~	~~Other~~	~~Significant~~
	~~Identical~~	~~Observable~~	~~Unobservable~~
	~~Assets~~	~~Inputs~~	~~Inputs~~
~~As of September 30, 2017~~	~~(Level 1)~~	~~(Level 2)~~	~~(Level 3)~~
	$	$	$
~~Short-term investment (note 5):~~
~~U.S. Treasury securities~~	~~498,864~~	—	—
~~Time deposits~~	~~50,061~~	—	—
~~Cash equivalents:~~
~~Money market funds~~	~~51,928~~	—	—
~~Total~~	~~600,853~~	—	—



	Purchase Price
Cash paid to acquire Celgene Shanghai	$	4,532
Discount on Share Subscription Agreement		23,606
Total purchase price	$	28,138


		Amount
Cash and cash equivalents	$	24,448
Other current assets		518
Property and equipment, net		204
Intangible assets		7,500
Deferred tax asset		1,069
Total identifiable assets		33,739
Current liabilities		(5,710)
Deferred tax liability		(1,875)
Total liabilities assumed		(7,585)
Goodwill		1,984
Total fair value of consideration transferred	$	28,138


Investing activities
Cash acquired	$	24,448
Cash paid to acquire Celgene Shanghai		(4,532)
Cash acquired in business combination, net of cash paid	$	19,916

Non-cash activities
Discount provided on sale of ordinary shares for business combination	$	(23,606)


		Three Months Ended		Nine Months Ended
		September 30,		September 30,
	Note	2023	2022	2023	2022
		$	$	$	$
Revenues
Product revenue, net	11	595,290	349,506	1,559,326	915,590
Collaboration revenue	3	186,018	38,122	265,044	120,236
Total revenues		781,308	387,628	1,824,370	1,035,826
Expenses
Cost of sales - product		96,309	76,543	274,088	212,953
Research and development		453,259	426,363	1,284,607	1,194,485
Selling, general and administrative		364,421	322,892	1,087,954	948,868
Amortization of intangible assets		1,287	187	1,662	563
Total expenses		915,276	825,985	2,648,311	2,356,869
Loss from operations		(133,968)	(438,357)	(823,941)	(1,321,043)
Interest income, net		26,649	12,759	57,735	34,261
Other income (expense), net		336,657	(125,640)	291,142	(243,290)
Income (loss) before income taxes		229,338	(551,238)	(475,064)	(1,530,072)
Income tax expense	8	13,925	6,318	39,091	28,408
Net income (loss)		215,413	(557,556)	(514,155)	(1,558,480)

Earnings (loss) per share
Basic	12	0.16	(0.41)	(0.38)	(1.16)
Diluted	12	0.15	(0.41)	(0.38)	(1.16)
Weighted-average shares outstanding—basic		1,360,716,279	1,345,303,747	1,358,392,470	1,337,976,853
Weighted-average shares outstanding—diluted		1,390,331,833	1,345,303,747	1,358,392,470	1,337,976,853

Earnings (loss) per American Depositary Share (“ADS”)
Basic	12	2.06	(5.39)	(4.92)	(15.14)
Diluted	12	2.01	(5.39)	(4.92)	(15.14)
Weighted-average ADSs outstanding—basic		104,670,483	103,484,904	104,491,728	102,921,296
Weighted-average ADSs outstanding—diluted		106,948,603	103,484,904	104,491,728	102,921,296


		Gross	Gross	Fair Value
	Amortized	Unrealized	Unrealized	(Net Carrying
	Cost	Gains	Losses	Amount)
	$	$	$	$
U.S. Treasury securities	498,905	—	41	498,864
Time deposits	50,061	—	—	50,061
Total	548,966	—	41	548,925


								As of
								September 30, 2023			December 31, 2022
	September 30, 2017			December 31, 2016				Gross			Gross
	Gross			Gross				carrying	Accumulated	Intangible	carrying	Accumulated	Intangible
	carrying	Accumulated	Intangible	carrying	Accumulated	Intangible		amount	amortization	assets, net	amount	amortization	assets, net
	amount	amortization	assets, net	amount	amortization	assets, net		$	$	$	$	$	$
Finite-lived intangible assets:							Finite-lived intangible assets:
Product distribution rights	7,500	(63)	7,437	—	—	—	Product distribution rights	7,500	(5,663)	1,837	7,500	(4,000)	3,500
Developed products							Developed products	58,396	(6,576)	51,820	41,235	(4,119)	37,116
Trading license							Trading license	816	(816)	—	816	(816)	—
Total finite-lived intangible assets	7,500	(63)	7,437	—	—	—	Total finite-lived intangible assets	66,712	(13,055)	53,657	49,551	(8,935)	40,616


Year Ending December 31,	Cost of Sales - Product	Operating Expenses	Total
	$	$	$
2023 (remainder of year)	1,561	1,837	3,398
2024	6,240	—	6,240
2025	6,240	—	6,240
2026	6,240	—	6,240
2027	6,240	—	6,240
2028 and thereafter	25,299	—	25,299
Total	51,820	1,837	53,657


		$
~~Balance as of December 31, 2016~~		—
~~Goodwill related to acquisition of the Celgene Shanghai business~~		~~1,984~~
~~Foreign currency translation adjustments~~		—
~~Balance as of September 30, 2017~~		~~1,984~~


Lender	Agreement Date	Line of Credit	Term	Maturity Date	Interest Rate	As of
						September 30, 2023		December 31, 2022
						$	RMB	$	RMB
China Construction Bank	April 4, 2018	RMB580,000	9-year	April 4, 2027	(1)	10,273	75,000	7,250	50,000
China Merchants Bank	January 22, 2020	(2)	9-year	January 20, 2029	(2)	6,800	49,643	1,450	10,000
China Merchants Bank	November 9, 2020	RMB378,000	9-year	November 8, 2029	(3)	5,479	40,000	5,437	37,500
China Minsheng Bank (the “Senior Loan”)	September 24, 2020	$200,000	(4)		4.3%	150,000	1,095,130	150,000	1,034,554
Shanghai Pudong Development Bank	February 25, 2022	$50,000	1-year	February 25, 2023	2.2%	—	—	50,000	344,851
China Merchants Bank	June 5, 2023	RMB 400,000	1-year	June 4, 2024	3.2%	54,788	400,000	—	—
HSBC Bank	May 4, 2023	RMB 340,000	1-year	May 3, 2024	4.7%	46,570	340,000	—	—
China Industrial Bank	May 30, 2023	RMB 200,000	1-year	May 29, 2024	2.8%	27,394	200,000	—	—
Other short-term debt (5)						27,257	199,000	114,832	792,000
Total short-term debt						328,560	2,398,773	328,969	2,268,905

China Construction Bank	April 4, 2018	RMB580,000	9-year	April 4, 2027	(1)	64,376	470,000	75,395	520,000
China Merchants Bank	January 22, 2020	(2)	9-year	January 20, 2029	(2)	38,743	282,857	47,847	330,000
China Merchants Bank	November 9, 2020	RMB378,000	9-year	November 8, 2029	(3)	42,529	310,500	49,369	340,500
China CITIC Bank	July 29, 2022	RMB480,000	10-year	July 28, 2032	(6)	56,842	415,000	36,537	252,000
Total long-term bank loans						202,491	1,478,357	209,148	1,442,500


		Market Price1				Purchase Price2
Issuance Date	Number of Ordinary Shares Issued	ADS		Ordinary		ADS		Ordinary		Proceeds
August 31, 2023	794,144	$	207.55	$	15.97	$	176.42	$	13.57	$	10,777
February 28, 2023	930,582	$	171.10	$	13.16	$	145.44	$	11.19	$	10,414
August 31, 2022	861,315	$	171.66	$	13.20	$	145.91	$	11.22	$	9,667
February 28, 2022	667,160	$	210.52	$	16.19	$	178.94	$	13.76	$	9,183


		Unrealized
	Foreign Currency	Losses on
	Translation	Available-for-Sale
	Adjustments	Securities	Total
	$	$	$
Balance as of December 31, 2016	(847)	(99)	(946)
Other comprehensive income before reclassifications	926	68	994
Amounts reclassified from accumulated other comprehensive income	—	(10)	(10)
Net-current period other comprehensive income	926	58	984
Balance as of September 30, 2017	79	(41)	38


		Unrealized
	Foreign Currency	Gains/(Losses) on	Pension
	Translation	Available-for-Sale	Liability
	Adjustments	Securities	Adjustments	Total
	$	$	$	$
Balance as of December 31, 2022	(62,523)	(9,011)	(5,883)	(77,417)
Other comprehensive (loss) income before reclassifications	(75,732)	8,218	—	(67,514)

Net-current period other comprehensive (loss) income	(75,732)	8,218	—	(67,514)
Balance as of September 30, 2023	(138,255)	(793)	(5,883)	(144,931)


	BeiGene, Ltd.	Non-controlling
	Shareholders’ Equity	Interest	Total Equity
	$	$	$
Balance as of January 1, 2017	352,907	—	352,907
Net income/(loss)	6,218	(237)	5,981
Issuance of ordinary shares in secondary follow-on offering, net of transaction costs	188,517	—	188,517
Equity purchase by Celgene, net of transaction costs	149,928	—	149,928
Discount on the sale of ordinary shares to Celgene	23,606	—	23,606
Contributions from shareholders	—	14,527	14,527
Share-based compensation	26,401	—	26,401
Exercise of options	1,579	—	1,579
Other comprehensive income, net of tax of nil:
Foreign currency translation adjustments	926	59	985
Unrealized holding gain, net	58	—	58
Other comprehensive income, net of tax of nil	984	59	1,043
Balance as of September 30, 2017	750,140	14,349	764,489


		$
~~Three months ending December 31, 2017~~		~~1,676~~
~~Year ending December 31, 2018~~		~~5,691~~
~~Year ending December 31, 2019~~		~~5,338~~
~~Year ending December 31, 2020~~		~~4,118~~
~~Year ending December 31, 2021~~		~~2,565~~
~~Year ending December 31, 2022 and thereafter~~		~~3,693~~
~~Total~~		~~23,081~~


		Three and Nine Months Ended September 30, 2017
		(in thousands)
Product revenue, net	$	8,822
License revenue		211,391
Total	$	220,213


	BGB-283		BGB-290		Total
	(in thousands)
2013	$	8,317	$	2,823	$	11,140
2014		5,906		7,048		12,954
2015		6,707		2,109		8,816
2016		1,070		—		1,070
Total	$	22,000	$	11,980	$	33,980


	Three Months Ended September 30,						Nine Months Ended September 30,
	2017		2016		Change		2017		2016		Change
	(in thousands)
Product revenue, net	$	8,822	$	—	$	8,822	$	8,822	$	—	$	8,822
Collaboration revenue		211,391		—		211,391		211,391		1,070		210,321
Total revenue		220,213		—		220,213		220,213		1,070		219,143
Expenses
Cost of sales - product		(1,944)		—		(1,944)		(1,944)		—		(1,944)
Research and development		(87,660)		(30,106)		(57,554)		(177,678)		(69,100)		(108,578)
Selling, general and administrative		(15,641)		(4,722)		(10,919)		(35,187)		(11,760)		(23,427)
Amortization of intangible assets		(63)		—		(63)		(63)		—		(63)
Total expenses		(105,308)		(34,828)		(70,480)		(214,872)		(80,860)		(134,012)
Income/(loss) from operations		114,905		(34,828)		149,733		5,341		(79,790)		85,131
Interest (expense)/income, net		(1,785)		(75)		(1,710)		(3,581)		336		(3,917)
Changes in fair value of financial instruments		—		—		—		—		(1,514)		1,514
(Loss)/gain on sale of available-for-sale securities		—		(137)		137		10		(1,077)		1,087
Other income/(expense), net		1,103		(327)		1,430		1,531		732		799
Income/(loss) before income tax expense		114,223		(35,367)		149,590		3,301		(81,313)		84,614
Income tax benefit /(expense)		3,061		(127)		3,188		2,680		(306)		2,986
Net income/(loss)		117,284		(35,494)		152,778		5,981		(81,619)		87,600
Less: Net loss attributable to noncontrolling interest		(102)		—		(102)		(237)		—		(237)
Net income/(loss) attributable to BeiGene, Ltd.	$	117,386	$	(35,494)	$	152,880	$	6,218	$	(81,619)	$	87,837


	Three Months Ended
	September 30,				Changes
	2023		2022		$		%
	(dollars in thousands)
Product revenue	$	595,290	$	349,506	$	245,784	70.3	%
Collaboration revenue:
Material rights revenue	71,980		—		71,980		NM
Research and development service revenue	59,052		9,834		49,218		500.5	%
Right to access intellectual property revenue	51,978		26,249		25,729		98.0	%
Other	3,008		2,039		969		47.5	%
Total collaboration revenue	186,018		38,122		147,896		388.0	%
Total Revenue	$	781,308	$	387,628	$	393,680	101.6	%

Exhibit		Incorporated by Reference			Filed
Number	Exhibit Description	Form	Date	Number	Herewith
3.1	Fourth Amended and Restated Memorandum and Articles of Incorporation of the Registrant, as currently in effect	8-K	02/11/2016	3.1
4.1	Deposit Agreement dated February 5, 2016 by and among the Registrant, the Depositary and holders of the American Depositary Receipts	8-K	02/11/2016	4.1
4.2	Amendment No. 1 to Deposit Agreement, dated April 11, 2016, by and among the Registrant, Citibank, N.A. and holders of the American Depositary Receipts	8-K	04/11/2016	4.1
4.3	Form of American Depositary Receipt (included in Exhibit 4.2)	8-K	04/11/2016	4.2
4.4	Specimen Certificate for Ordinary Shares	S-1	12/09/2015	4.3
4.5	Second Amended and Restated Investors’ Rights Agreement, dated as of April 21, 2015, by and among the Registrant and certain shareholders named therein	S-1	10/16/2015	4.4
4.6	Amendment No. 1 to Second Amended and Restated Investors’ Rights Agreement, dated January 26, 2016, by and among the Registrant and certain shareholders named therein	S-1	01/27/2016	10.21
4.7	Letter Agreement, dated as of July 11, 2016, between the Registrant and Citibank, N.A.	10-Q	08/10/2016	4.7
4.8	Registration Rights Agreement, dated as of November 16, 2016, by and among the Registrant and the investors name therein	8-K	08/10/2016	4.1
4.9	Form of Letter Agreement, between the Registrant and Citibank, N.A.	10-Q	05/10/2017	4.9
10.1	Share Subscription Agreement, dated July 5, 2017, by and between Celgene Switzerland LLC and the Registrant	8‑K	07/06/2017	10.1
10.2#	Amended and Restated Exclusive License and Collaboration Agreement, dated August 31, 2017, by and among the Registrant, Celgene Corporation and Celgene Switzerland LLC				X
10.3#	License and Supply Agreement, dated July 5, 2017, by and between the Registrant and Celgene Logistics Sàrl				X
10.4†	Amendment No. 1 to BeiGene, Ltd. 2016 Share Option and Incentive Plan				X
10.5†	Forms of Restricted Share Unit Award Agreement and Share Option Agreement under BeiGene, Ltd. 2016 Share Option and Incentive Plan				X