Thank you, Mike. And good afternoon, everyone, and welcome to our first quarter 2020 earnings call.
Given the challenges presented by the COVID-19 pandemic, I would like to take a moment on behalf of FibroGen to reassure patients, healthcare providers, investigators, and stakeholders of our continued commitment to bring to patients a potential, first-in-class medicine for the treatment of chronic and life-threatening conditions.
Governments, businesses, and society in general, have taken unprecedented measures to mitigate the spread of the COVID-19 outbreak. Like many businesses, FibroGen has taken a number of actions to support both our workforce and communities in these challenging times. In the U.S., our employees are working remotely when possible.
While in China, they are now back working in our offices, manufacturing plants, and the field.
We have implemented protocols globally to minimize the risk of illness for our employees who need to work on-site at any of our facilities.
Despite the difficult circumstances, we remain committed to ensuring the regulatory and commercial success of roxadustat, a potentially transformational oral medicine in anemia therapy, first demonstrated in patients with chronic kidney disease.
With Pamrevlumab, we are implementing a comprehensive plan to accelerate development across the three indications of idiopathic pulmonary fibrosis or IPF, locally advanced unresectable pancreatic cancer or LAPC, and Duchenne Muscular Dystrophy or DMD, once the situation with COVID-19 improves.
Finally, we continue to advance the innovation of our hypoxia-inducible factor or HIF and connective tissue growth factor or CTGF platforms.
Our business continuity plans are in effect and we are seeing an impact to our operations resulting from COVID-19, we remain confident that FibroGen has the resources and capabilities to navigate through these uncertain times and achieve our stated goals.
As China comes back online, we are continuing our manufacturing operations and launch efforts there.
We have ample drug supply to support both the roxadustat launches and clinical trials in additional indications, as well as the Pamrevlumab clinical trials.
We will continue to monitor the situation closely. To our employees and patients and to the thought leaders, clinicians, regulators, and countless others who interact with FibroGen, please know our thoughts are with you and your families.
Now let me begin with Roxadustat.
During the first quarter, our roxadustat NDA submission was accepted by the FDA and interaction with the FDA on the file continues.
We expect action by the PDUFA date of December 20, 2020.
In Europe, the Marketing Authorization Application filing for roxadustat for the treatment of anemia in both dialysis and non-dialysis-dependent patients with CKD is expected in the second quarter of 2020. We and our partners are working diligently in preparation to make this novel, first-in-class medicine available to as many patients worldwide as quickly as possible.
Turning to China.
As you know, roxadustat was first approved in China and was included in the National Drug Reimbursement List or NRDL, which went into effect at the beginning of the year. A key focus has been and continues to be, expanding hospital listing so that roxadustat can be widely prescribed.
We saw positive momentum in hospital listings in January before the start of the COVID-19 restrictions, which caused a slowdown in new listings from late January to late March.
As we stand here today, we have seen a steady return to a new normal in China and we continue to be encouraged by the roxadustat opportunity there.
The COVID-19 pandemic, however, is still causing disruption in clinical trials across the globe and the FDA, EMA and other regulatory agencies have issued guidance for the conducts of clinical trials during the pandemic.
We are incorporating these regulatory recommendations as appropriate or closed our clinical trials.
Our first priority at FibroGen is ensuring the safety and well-being of the patients participating in our studies.
While we do not intend to provide specific details on the COVID – on the impact of COVID-19 for each one of our trials, we can say that we have seen an impact across all of our trials to varying degrees.
Our most effective trial is pamrevlumab's ZEPHYRUS IPF trial, where we decided to pause near-term enrollment for the safety of patients. And are currently focused on providing continual care for the patients who had already been enrolled. The rest of our trials continue enrollment, albeit, at a slower rate.
In 2020, we are committed to accelerating and expanding the development of pamrevlumab. To that end, we have developed a comprehensive plan, which includes clinical site activations, geographic expansion and protocol amendment, such that once things return to a new normal, we can be in the best position to accelerate enrollments.
Our locally-advanced unresectable pancreatic cancer study continues to enroll.
We continue preparations for ZEPHYRUS 2, our second IPF Phase III study and our Phase III program in Duchenne Muscular Dystrophy is slated to begin in the second half of the year.
In summary, despite COVID-19, we continue to be focused on getting roxadustat approved in the U.S., advancing pamrevlumab development and finally, leveraging our expertise in both hypoxia-inducible factor and connective tissue growth factor biology to expand our pipeline of novel drug candidates.
Now, I will turn it over to Peony, who will provide you with a more in-depth discussion of roxadustat.