Exhibit 4.7
THE SYMBOL [***] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) CUSTOMARILY AND ACTUALLY TREATED AS PRIVATE.
EXCLUSIVE RESEARCH COLLABORATION, OPTION AND LICENSE AGREEMENT
by and between
Silence Therapeutics PLC
and
HANSOH (Shanghai) Healthtech Co., Ltd. and Jiangsu Hansoh Pharmaceutical Group Company Limited
Dated as of October 14, 2021
THIS EXCLUSIVE RESEARCH COLLABORATION, OPTION AND LICENSE AGREEMENT is made and entered into effective as of October 14, 2021 (the “Effective Date”) by and between
(1) Silence Therapeutics PLC, a public limited company organized under the laws of England and Wales with a registered office at 27 Eastcastle Street, London, W1W 8DH (“Silence”), and
(2) HANSOH (Shanghai) Healthtech Co., Ltd., a corporation organized and existing under the laws of the People’s Republic of China having a principal place of business at Room 102, Block 1 No. 298 Xiangke Road, China (Shanghai) Pilot Free Trade Zone, China (“Hansoh Healthtech”) and Jiangsu Hansoh Pharmaceutical Group Company Limited, a corporation organized and existing under the laws of the People’s Republic of China having a place of business at No. 9 Dongjin Road, Huaguoshan Avenue, Lianyungang, Jiangsu, China (“Jiangsu Hansoh” and together with Hansoh Healthtech, “Hansoh”); and
Silence and Hansoh are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
Background
(A) Silence owns certain intellectual property rights with respect to the research and development of RNAi Molecules (as defined below).
(B) Hansoh has expertise in the development, manufacturing, and commercialization of drugs.
(C) The Parties have agreed to collaborate to perform drug discovery and research on certain Licensed Targets, which will be chosen in accordance with this Agreement. Hansoh wishes to obtain, and Silence wishes to grant to Hansoh, an option to obtain a license under Silence’s rights in such technology and related intellectual property rights to develop and
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commercialize Licensed Compounds and Licensed Products directed to those Licensed Targets.
NOW, THEREFORE, in consideration of the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
DEFINITIONS
As used in this Agreement and the Schedules to this Agreement the following capitalized terms, whether used in the singular or plural, shall have the meanings set out below:
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Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes, provided such transfer takes place for no consideration. Net Sales shall include the amount or fair market value of all other consideration received by Hansoh, its Affiliates, or Sublicensees in respect of the Licensed Product, whether such consideration is in cash, payment in kind, exchange, or other form. Net Sales shall not include sales between or among Hansoh, its Affiliates, or Sublicensees.
Where a Licensed Product is sold as part of a Combination Product, the Net Sales applicable to such transaction will be calculated by multiplying the total Net Sales of such combined product by the fraction A/(A+B), where A is the sale price of the Licensed Product portion of such Combination Product when sold separately and B is the sale price of the other active ingredient(s) in such Combination Product when sold separately; provided, however, that if the Licensed Product portion of such Combination Product or any of the other active ingredients in such Combination Product is not then sold separately, then Net Sales for purposes of determining royalty payments will be agreed upon by the Parties based on the relative value contributed by each component, such agreement not to be unreasonably withheld, conditioned or delayed.
If “A” or “B” cannot be determined by reference to non-Combination Product sales as described above, then Net Sales will be calculated as above, but the sale price in the above equation will be determined by mutual agreement reached in good faith by the Parties
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prior to the end of the accounting period in question based on an equitable method of determining the same that takes into account, in the applicable country, variations in dosage units and the relative fair market value of each therapeutically-active component in the Combination Product. If the Parties are unable to reach such an agreement prior to the end of the applicable accounting period, the Parties will refer such matter to a jointly selected Third Party with expertise in the pricing of pharmaceutical products in the Hansoh Territory or relevant part thereof that is not, and has not in the past five (5) years been, an employee, consultant, legal advisor, officer, director or stockholder of, and does not have any conflict of interest with respect to, either Party for resolution.
Subject to the above, Net Sales shall be calculated in accordance with [***], which must be in accordance with Accounting Standards and consistent with the audited net sales reported externally by Hansoh.
For the purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 10.2.
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COLLABORATION MANAGEMENT
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DEVELOPMENT AND REGULATORY
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EXCLUSIVITY
OPTION GRANTS
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LICENSE GRANTS
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DEVELOPMENT AND COMMERCIALIZATION
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MANUFACTURING & SUPPLY
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PAYMENTS AND RECORDS
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Milestone Event | Milestone Payment |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
Total | $37,000,000 |
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Milestone Event | Milestone Payment |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
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Total | $81,000,000 |
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Annual Gross Sales of Licensed Products directed to a Licensed Target | Sales Milestone Payments |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
[***] | $[***] |
Total | $367,500,000 |
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Net Sales of a Licensed Product | Royalty Rate |
For that portion of Net Sales of all Licensed Products directed to a particular Licensed Target in any Year which are less than $[***] | [***]% |
For that portion of Net Sales of all Licensed Products directed to a particular Licensed Target in any Year which are equal to or greater than $[***] but less than $[***] | [***]% |
For that portion of Net Sales of all Licensed Products directed to a particular Licensed Target in any Year which are equal to or greater than $[***] but less than $[***] | [***]% |
For that portion of Net Sales of all Licensed Products directed to a particular Licensed Target in any Year | [***]% |
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which are equal to or greater than $[***] but less than $[***] |
|
For that portion of Net Sales of all Licensed Products directed to a particular Licensed Target in any Year which are equal to or greater than $[***] but less than $[***] | [***]% |
For that portion of Net Sales of all Licensed Products directed to a particular Licensed Target in any Year which are equal to or greater than $[***] | [***]% |
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payment; records; audits
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INTELLECTUAL PROPERTY
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Confidentiality and Non-Disclosure
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Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
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REPRESENTATIONS AND Warranties
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Indemnity
except in each case to the extent of those Losses for which Silence, in whole or in part, has an obligation to indemnify Hansoh pursuant to Section 14.2.
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except to the extent of those Losses for which Hansoh, in whole or in part, has an obligation to indemnify Silence pursuant to Section 14.1.
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Term and Termination
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(collectively the “Returned Targets”),
then, in each case, as of the date that any Licensed Target first becomes a Returned Target: (a) following a written notice from Silence to Hansoh requesting the same, Hansoh shall, subject to the provisions of Section 15.6.7, transfer to Silence any Regulatory Approval held by Hansoh in respect of any Returned Target or the relevant Licensed Compounds or Products and to the extent that such Regulatory Approval is not transferable, hold the foregoing on trust for Silence and grant Silence a right of reference to such Regulatory
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Approval in order for Silence to obtain an equivalent Regulatory Approval in the relevant country; and (b) Hansoh hereby grants to Silence (without any further action required on the part of Hansoh) (i) an exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses, under any Joint Research Patents, Hansoh Research IP and Hansoh China Product Development IP, and (ii) a non-exclusive, royalty-free and fully paid-up, irrevocable and perpetual license, with the right to grant sublicenses, under any Hansoh Background IP, in each case (i) and (ii) solely to Exploit Licensed Compounds and Licensed Products directed to such Returned Target in the Field throughout the territories that were the subject of the relevant termination. In respect of each of the Joint Research Patents, Hansoh Research Patents and Hansoh China Product Development Patents licensed to Silence pursuant to this Section 15.6.1, Silence shall benefit from equivalent rights with respect to the maintenance, prosecution, enforcement and defense of such Patents as if such Patents were Joint Research Patents, and not Product Specific Patents, for the purposes of ARTICLE 11. For clarity, the license set out in this Section shall survive any expiration or termination of this Agreement.
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Miscellaneous
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The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties, and the name of a Party appearing herein will be deemed to include the name of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Section 16.3. Any assignment not in accordance with this Section 16.3 shall be null and void.
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In addition, in the event that any acquiring entity of Silence or a Holding Company of Silence, or any of its Affiliates, is conducting any research, development or commercialisation activities in respect of any Licensed Targets, or does so in the future (a “Competing Program”) then Silence will establish and implement appropriate firewall procedures to segregate all activities (and the personnel conducting such activities) in such Competing Program from the activities performed by or on behalf of Silence pursuant to this Agreement, including ensuring that personnel involved in working in such Competing Program shall not have access to any Confidential Information of either Party with respect to activities under this Agreement, provided that such firewall procedures and obligation to segregate shall not extend to any accounts, financial or administrative personnel and that the directors of the applicable acquiring entity may receive general updates on progress and all financial information with respect to both the Competing Program and the activities performed under this Agreement.
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Provided that Silence has complied with this obligation, Silence shall not be in breach of Section 4.1 by reason of such Acquisition or by reason of the acquiring entity or its Affiliates having, initiating or performing a Competing Program.
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If to Hansoh, to:
Hansoh Bio LLC
9900 Medical Center Dr, Ste 200
Rockville, MD 20850
Attention: [***]
Email: [***]; [***]
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If to Silence, to:
Silence Therapeutics Plc
72 Hammersmith Road
London W14 8TH
United Kingdom
Attention: [***]
With a copy to:
[***];
[***]; and
[***]
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{SIGNATURE PAGE FOLLOWS}
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THIS RESEARCH COLLABORATION, OPTION AND LICENSE AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.
SILENCE THERAPEUTICS PLC |
By: /s/ Mark Rothera
Name: Mark Rothera
Title: CEO |
HANSOH (SHANGHAI) HEALTHTECH CO., LTD. |
By: /s/ Yuan Sun
Name: Yuan Sun
Title: Authorized Representative |
JIANGSU HANSOH PHARMACEUTICAL GROUP COMPANY LIMITED |
By: /s/ Yuan Sun
Name: Yuan Sun
Title: Authorized Representative |
Schedule 1.68
Joint Development Plan Template
Phase | Study design | Countries | Start Month | Duration (months) | End Month | Responsibility |
[***] | [***] | [***] |
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[***] | [***] | [***] |
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Schedule 1.78
Licensed Targets
Section 1. China Licensed Targets
[***]
[***]
Section 2. Global Licensed Target
[***]
[***]
Schedule 1.95
Preliminary Targets
[***]
[***]
[***]
Schedule 1.105
Research Plan Template
Function | Activity | Start Month | Duration (months) | End Month | Direct Cost (USD 000's) | Total FTE Resource * |
[***] | [***] | [***] | [***] | [***] |
| [***] |
[***] | [***] | [***] | [***] | [***] |
| [***] |
[***] | [***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | [***] | [***] |
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Function | Activity | Start Month | Duration (months) | End Month | Direct Cost (USD 000's) | Total FTE Resource * |
[***] | [***] | [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] | [***] | [***] |
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Function | Activity | Start Month | Duration (months) | End Month | Direct Cost (USD 000's) | Total FTE Resource * |
[***] | [***] | [***] | [***] | [***] | [***] |
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Function | Activity | Start Month | Duration (months) | End Month | Direct Cost (USD 000's) | Total FTE Resource * |
[***] | [***] | [***] | [***] | [***] | [***] |
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Function | Activity | Start Month | Duration (months) | End Month | Direct Cost (USD 000's) | Total FTE Resource * |
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Function | Activity | Start Month | Duration (months) | End Month | Direct Cost (USD 000's) | Total FTE Resource * |
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* [***].
** [***].
Schedule 12.4
Form of Press Release.
1. SILENCE PRESS RELEASE
Silence Therapeutics and Hansoh Pharma Announce Collaboration to Develop Therapeutics Leveraging Silence’s mRNAi GOLD™ Platform
Hansoh will make a $16 million upfront cash payment and Silence has the potential to receive up to $1.3 billion in milestones
Silence gains exclusive rights to two targets in all territories except the China region; Hansoh has rights to those two targets in the China region and global rights to a third target
15 October 2021
LONDON and SHANGHAI, Silence Therapeutics plc (AIM: SLN and Nasdaq: SLN), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, and Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”, 3692.HK), one of the leading biopharmaceutical companies in China, today announced a collaboration to develop siRNAs for three undisclosed targets leveraging Silence’s proprietary mRNAi GOLD™ platform.
Under the terms of the agreement, Hansoh will have the exclusive option to license rights to the first two targets in Greater China, Hong Kong, Macau and Taiwan following the completion of phase 1 studies. Silence will retain exclusive rights for those two targets in all other territories. Silence will be responsible for all activities up to option exercise and will retain responsibility for development outside the China region post phase 1 studies.
Hansoh will also have the exclusive option to license global rights to a third target at the point of IND filing. Hansoh will be responsible for all development activities post option exercise for the third target.
Hansoh will make a $16 million upfront payment and Silence is eligible to receive up to $1.3 billion in additional development, regulatory and commercial milestones. Silence will also receive royalties tiered from low double-digit to mid-teens on Hansoh net product sales.
Mark Rothera, President and Chief Executive Officer of Silence Therapeutics, said: “We believe Hansoh’s extensive clinical development and commercialization experience in China make them an ideal partner. This collaboration is a good example of our hybrid model in action, balancing proprietary and partnered programs to maximize the substantial opportunity of our mRNAi GOLD™ platform for targeting disease associated genes in the liver. The Hansoh partnership enables us to move two new proprietary programs forward subsidized by non-dilutive capital while also gaining access to the second largest pharmaceutical market globally. We look forward to discussing this deal and our broader pipeline in more detail at our upcoming R&D Day on October 21st in New York City.”
Eliza Sun, Executive Director of the Board of Hansoh Pharma, said: “We are excited to partner with Silence, a pioneer in siRNA therapeutic development with decades of scientific and technical experience. As one of the largest biopharma in China, Hansoh strives to partner with innovative companies globally to build out and advance our robust pipeline spanning across multiple therapeutic areas. We see substantial opportunity in Silence’s mRNAi GOLD™ platform to develop and bring better precision-based medicines to patients across China and worldwide.”
Enquiries:
Silence Therapeutics plc Gem Hopkins, Head of IR and Corporate Communications ir@silence-therapeutics.com
| Tel: +1 (646) 637-3208 |
Investec Bank plc (Nominated Adviser and Broker) Daniel Adams/Gary Clarence
| Tel: +44 (0) 20 7597 5970 |
European PR Consilium Strategic Communications Mary-Jane Elliott/Chris Welsh/Angela Gray silencetherapeutics@consilium-comms.com
| Tel: +44 (0) 20 3709 5700 |
Hansoh Pharma Dr. Sophia Dong, Director of Investor Relations IR@hspharm.com
|
|
About Hansoh Pharma
Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in Asia, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 12,000 dedicated employees in China and the United States. Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions across a broad range of therapeutic areas, including oncology, central nervous system (CNS) disorders, infectious diseases, cardiovascular disease, diabetes, and autoimmune diseases. With the support of over 1,600 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including aumolertinib (阿 美乐®), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations, flumatinib (昕福®), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML), PEG-loxenatide (孚来 美®), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes, morinidazole (迈灵达®), a third-generation nitroimidazole antibiotic and tenofovir amibufenamide (恒 沐®), the first second-generation oral anti-HBV drug developed in China. For more information, please visit www.hspharm.com.
About Silence Therapeutics
Silence Therapeutics is developing a new generation of medicines by harnessing the body's natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet need. Silence's proprietary mRNAi GOLD™ platform can be used to create siRNAs (short interfering RNAs) that precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. Silence's wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of lipoprotein(a) and SLN124 designed to address iron-loading anemia conditions. Silence also maintains ongoing research and development collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals, and Takeda, among others. For more information, please visit https://www.silence-therapeutics.com/.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other securities laws, including with respect to the Company’s clinical and commercial prospects and the anticipated timing of data reports from the Company’s clinical trials. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are
subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including those risks identified in the Company’s most recent Admission Document and its amended Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 29, 2021. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
2. HANSOH PRESS RELEASE
Hansoh Pharma and Silence Therapeutics Announce Collaboration to Develop Therapeutics Leveraging Silence’s mRNAi GOLD™ Platform
Hansoh will make a $16 million upfront cash payment and Silence has the potential to receive up to $1.3 billion in milestones
Hansoh has rights to two targets in the China region and global rights to a third target;
Silence gains exclusive rights to those two targets in all territories except the China region
15 October 2021
SHANGHAI and LONDON, Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”, 3692.HK), one of the leading biopharmaceutical companies in China and Silence Therapeutics plc (AIM:SLN and Nasdaq: SLN), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, today announced a collaboration to develop siRNAs for three undisclosed targets leveraging Silence’s proprietary mRNAi GOLD™ platform.
Under the terms of the agreement, Hansoh will have the exclusive option to license rights to the first two targets in Greater China, Hong Kong, Macau and Taiwan following the completion of phase 1 studies. Silence will retain exclusive rights for those two targets in all other territories. Silence will be responsible for all activities up to option exercise and will retain responsibility for development outside the China region post phase 1 studies.
Hansoh will also have the exclusive option to license global rights to a third target at the point of IND filing. Hansoh will be responsible for all development activities post option exercise for the third target.
Hansoh will make a $16 million upfront payment and Silence is eligible to receive up to $1.3 billion in additional development, regulatory and commercial milestones. Silence will also receive royalties tiered from low double-digit to mid-teens on Hansoh net product sales.
Eliza Sun, Executive Director of the Board of Hansoh Pharma, said: “We are excited to partner with Silence, a pioneer in siRNA therapeutic development with decades of scientific and technical experience. As one of the largest biopharma in China, Hansoh strives to partner with innovative companies globally to build out and advance our robust pipeline spanning across multiple
therapeutic areas. We see substantial opportunity in Silence’s mRNAi GOLD™ platform to develop and bring better precision-based medicines to patients across China and worldwide.”
Mark Rothera, President and Chief Executive Officer of Silence Therapeutics, said: “We believe Hansoh’s extensive clinical development and commercialization experience in China make them an ideal partner. This collaboration is a good example of our hybrid model in action, balancing proprietary and partnered programs to maximize the substantial opportunity of our mRNAi GOLD™ platform for targeting disease associated genes in the liver. The Hansoh partnership enables us to move two new proprietary programs forward subsidized by non-dilutive capital while also gaining access to the second largest pharmaceutical market globally. We look forward to discussing this deal and our broader pipeline in more detail at our upcoming R&D Day on October 21st in New York City.”
Enquiries:
Silence Therapeutics plc Gem Hopkins, Head of IR and Corporate Communications ir@silence-therapeutics.com
| Tel: +1 (646) 637-3208 |
Investec Bank plc (Nominated Adviser and Broker) Daniel Adams/Gary Clarence
| Tel: +44 (0) 20 7597 5970 |
European PR Consilium Strategic Communications Mary-Jane Elliott/Chris Welsh/Angela Gray silencetherapeutics@consilium-comms.com
| Tel: +44 (0) 20 3709 5700 |
Hansoh Pharma Dr. Sophia Dong, Director of Investor Relations IR@hspharm.com
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About Hansoh Pharma
Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in Asia, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 12,000 dedicated employees in China and the United States. Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions across
a broad range of therapeutic areas, including oncology, central nervous system (CNS) disorders, infectious diseases, cardiovascular disease, diabetes, and autoimmune diseases. With the support of over 1,600 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including aumolertinib (阿 美乐®), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations, flumatinib (昕福®), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML), PEG-loxenatide (孚来 美®), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes, morinidazole (迈灵达®), a third-generation nitroimidazole antibiotic and tenofovir amibufenamide (恒 沐®), the first second-generation oral anti-HBV drug developed in China. For more information, please visit www.hspharm.com.
About Silence Therapeutics
Silence Therapeutics is developing a new generation of medicines by harnessing the body's natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet need. Silence's proprietary mRNAi GOLD™ platform can be used to create siRNAs (short interfering RNAs) that precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. Silence's wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of lipoprotein(a) and SLN124 designed to address iron-loading anemia conditions. Silence also maintains ongoing research and development collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals, and Takeda, among others. For more information, please visit https://www.silence-therapeutics.com/.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other securities laws, including with respect to the Company’s clinical and commercial prospects and the anticipated timing of data reports from the Company’s clinical trials. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including those risks identified in the Company’s most recent Admission Document and its amended Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 29, 2021. The
Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
翰森制药和Silence Therapeutics宣布利用Silence mRNAi GOLD™ 平台合作开发治疗药物
翰森制药将现金支付1,600万美元首付款,Silence有望收到最高超过13亿美元潜在里程碑付款
翰森制药在中国地区拥有这两个靶点的权利和第三个靶点的全球权利;
Silence在除中国地区以外的所有地区获得两个靶点的排他权益
10月 15 2021
上海及伦敦,翰森制药集团有限公司(翰森制药,3692.HK),中国顶尖的生物制药企业,Silence Therapeutics (AIM: SLN及Nasdaq: SLN), siRNA治疗领域的领先的创新企业,致力于发现、开发和提供新型短干扰核糖核酸(siRNA)疗法,用于治疗具有显著未满足医疗需求的疾病,今日宣布利用Silence独有的mRNAi GOLD™平台合作开发针对3个未披露靶点的siRNA药物。
根据协议条款,在完成1期临床研究后,翰森制药将拥有两个靶点在中国的独家许可权。Silence将保留这两个靶点在所有其他地区的权益。Silence将负责执行期权之前的所有开发活动,并将保留在1期临床研究结束后中国地区以外的开发责任。
翰森制药还将在第三个靶点提交IND时拥有全球独家权益,并将负责第三个靶点期权行使后的所有开发活动。
翰森制药将支付1,600万美元首付款,Silence有望收到包含研发、注册及商业化里程碑在内的最高超过13亿美元潜在里程碑付款。Silence还将获得基于产品净销售额的低双位数至中位百分之十几的销售提成。
翰森制药集团执行董事孙远女士表示: “我们很高兴与Silence合作,Silence 是siRNA治疗领域的研发先驱,拥有数十年的科学和技术经验。作为中国最大的制药企业之一,翰森制药努力与全球创新公司合作,以建立和推进我们跨越多个治疗领域的强大研发管线。我们认为Silence的mRNAi GOLD™ 平台中有非常大的潜力,可以为中国和全球患者开发和提供更好的精准治疗药物。”
Silence Therapeutics总裁兼首席执行官Mark Rothera表示: “翰森制药在中国有丰富的临床开发和商业化经验,我们相信会是我们理想的合作伙伴。此次合作是我们多元化合作模式的范例,可以很好地平衡独立研发和合作项目,最大限度地利用我们mRNAi GOLD™ 平台,针对肝脏疾病相关基因靶向开发药物。与翰森制药的合作使我们能够推进两个新的非稀释资本补贴的专有项目,同时还可以进入全球第二大医药市场。我们期待在即将于10月21日在纽约市举行的研发开放日更详细地讨论这笔交易和我们丰富的研发管线布局。”
联系方式:
Silence Therapeutics plc Gem Hopkins, 投资者关系及企业合作负责人 ir@silence-therapeutics.com
| Tel: +1 (646) 637-3208 |
Investec Bank plc (指定顾问和经纪人) Daniel Adams/Gary Clarence | Tel: +44 (0) 20 7597 5970 |
欧洲媒体联系 Consilium Strategic Communications Mary-Jane Elliott/Chris Welsh/Angela Gray silencetherapeutics@consilium-comms.com | Tel: +44 (0) 20 3709 5700 |
翰森制药 董穗穗博士,投资者关系总监 IR@hspharm.com
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关于翰森制药集团
翰森制药(3692.HK),中国及亚洲最大的制药公司之一, 致力于发现和开发提升生命质量的药物,以帮助患者克服严重的疾病和障碍。翰森制药目前在中国及美国拥有超过12,000名员工。翰森制药成立于1995年,翰森制药拥有药物研发、制造和商业化能力,在多个治疗领域中处于领先地位,包括抗肿瘤、中枢神经系统(CNS)、抗感染、心血管疾病、糖尿病及自身免疫疾病等。翰森制药拥有超过1,600名专业研发人员,已经在中国成功上市了5个自主研发的创新药,包括阿美乐®,用于EGFR突变的NSCLC治疗的三代EGFR抑制剂;昕福®,用于一线慢性粒细胞白血病(CML)治疗的二代BCR-ABL抑制剂;孚来美®,用于糖尿病治疗的首款获批上市的国产长效GLP-1周制剂;迈灵达®,三代硝基咪唑类抗生素;恒沐®,首个中国原研的二代口服抗乙肝病毒(HBV)药物。
更多信息详见:www.hspharm.com
关于Silence Therapeutics
Silence Therapeutics通过利用人体天然的RNA干扰或RNAi机制来抑制特定靶基因的表达,开发新一代药物。这些靶基因在多种疾病的病理学中发挥作用,具有显著未满足的临床需求。Silence专有的mRNAi GOLD™ 平台可用于创建siRNA(短干扰RNA),以精确靶向和沉默肝脏中的相关疾病基因,具有非常大的潜力。Silence的候选药物包括SLN360,旨在解决脂蛋白(a)高表达,降低出生时伴随脂蛋白(a)高表达人群的心血管病风险,具有广泛的未被满足的医疗需求;SLN124旨在解决铁负荷性贫血。Silence还拥有多项在研项目并与阿斯利康、Mallinckrodt Pharmaceuticals和武田等多家企业有研发合作。
更多信息详见:https://www.silence-therapeutics.com/.