A Message from BeiGene Regarding Our COVID-19
April 8, 2021
During the worldwide COVID-19 health crisis, our primary focus has been on keeping BeiGene colleagues and their families safe, upholding our commitments to patients, and providing assistance and materials to doctors and hospitals on the frontline.
Beyond our BeiGene business, which adapted, we must acknowledge the immense difficulties faced by people around the world during the year. The lives lost during the global pandemic have had an immeasurable impact on so many of our friends, families, and colleagues.
During the pandemic, we have continued to work to support each other and our mission to create impactful medicines that will be affordable and accessible to patients around the world.
About the BGB-3111-219 Trial of Zanubrutinib for Patients with COVID-19
Early in the COVID-19 health crisis, based on a developing understanding the disease and sound scientific rationale we initiated a Phase 2 trial in the U.S. evaluating zanubrutinib for the treatment of patients with COVID-19-related pulmonary distress ().
The trial unfortunately did not meet its co-primary endpoints of increasing the proportion of patients who remained alive and free of respiratory failure or reduction in days on oxygen as compared to placebo, though it provides valuable information we hope to detail more fully in the future. Additionally, no new safety signals were identified.
BeiGene's Alliance to Collaborate on a Novel Antibody Treatment for COVID-19
On April 29, 2020, BeiGene, Atreca, Inc. and IGM Biosciences plans to develop a treatment for COVID-19. In the spirit of scientific collaboration and cooperation, we are hopeful that our combined technology and expertise might help the companies discover, develop, and manufacture novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19.
BeiGene's Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies
On August 27, 2020, BeiGene and Singlomics Biopharmaceuticals an exclusive license agreement for BeiGene to develop, manufacture, and commercialize Singlomics’s investigational anti-SARS-Cov-2 antibodies globally outside of Greater China.
Under the scientific leadership of the Singlomics’ co-founder and renowned biophysical chemist Sunney Xie, Ph.D., Singlomics was able to identify SARS-Cov-2 neutralizing antibody drug candidates, including DXP-593 and DXP-604, by utilizing high-throughput single-cell sequencing of convalescent blood samples from recovered patients with COVID-19. Both DXP-593 and DXP-604 have exhibited strong neutralization potency in preclinical testing.
A Phase 2 randomized, double-bind, and placebo-controlled clinical trial (NCT04551898) has completed enrollment of approximately 180 patients with mild- to moderate COVID-19.
The Impact of COVID-19 on Our Supply Chain
We are monitoring the COVID-19 pandemic closely and, based on current inventory levels, do not currently foresee a disruption in our ability to supply our commercial products including tislelizumab and BRUKINSA (zanubrutinib).
We are also coordinating with authorities, hospitals, logistics providers and other firms in our supply chain to ensure the uninterrupted supply of our investigational medicines to patients on our clinical trials globally.
The Impact of COVID-19 on Our Clinical Trials
We have built an integrated global development team of more than 1,600 people in China, the United States, Europe, and Australia. Currently, we are conducting over 60 clinical trials globally, with 25+ filed or potentially registration-enabling trials ongoing.
While we conduct clinical trials globally, we have a high concentration of clinical trial activity in China. Since the beginning of the pandemic, we have adopted a variety of methods to minimize the impact of COVID-19 on our studies in China. We have adapted these methods to other geographies as the pandemic has spread to Europe, the United States, and other regions where we conduct trials. Our experience in China has allowed us to identify aspects of clinical trials that can be optimized so that patients avoid missing treatments and assessments. We are cautiously optimistic about how these efforts are going.
The FDA and other international regulatory agencies have also issued guidance on clinical trial conduct during the COVID-19 outbreak. This guidance, along with our experience, has been helpful as we work with our investigational sites to implement alternate methods where needed. We currently believe that the quality of data coming from our clinical trials during the COVID-19 outbreak will be minimally affected.
The Impact of COVID-19 on Our Business
We expect that the worldwide health crisis of COVID-19 will continue to have a negative impact on our operations globally, including clinical trial recruitment and participation, regulatory interactions and inspections, and commercial revenue. While there remains uncertainty regarding the future impact of the pandemic globally, we are working to minimize delays and disruptions and continue to execute on our clinical development, regulatory and commercialization goals.
BeiGene’s Additional Activities in the Fight Against COVID-19
We launched a charitable initiative, called BeGenerous, coordinated by our COVID-19 task force, to procure and donate personal protective equipment (PPE) to hospitals around the world and provide other charitable support. Initially, our team in China, with the assistance of our global team, secured and delivered much-needed PPE and supplies to doctors and hospitals on the frontlines in Wuhan and Hubei Province. We were among the first companies to do this. With the impact of the COVID-19 pandemic being felt outside of China, we have also helped to secure PPE for distribution to hospitals in the United States, while our employees globally, including in Europe and Australia, are engaged in active donations of medical supplies and other support in their communities.
For the safety of our employees, we were early in closing our offices in China and then in the United States and Europe as the COVID-19 pandemic spread. We were also early in suspending domestic and international travel, changing all in-person meetings to virtual meetings, and temporarily suspending all in-person field activities. Our employees in China have returned to the office, following required and recommended precautions such as wearing masks, temperature screening and social distancing, and we are monitoring the situation closely in the United States and Europe as we make plans for our employees to return to the office when it is deemed safe.
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 5,400+ employees around the world are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market additional oncology products in China licensed from Amgen Inc.; Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company; and EUSA Pharma; and have entered a collaboration with Novartis Pharma AG for Novartis to develop, manufacture and commercialize tislelizumab in North America, Europe, and Japan. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
This message contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the conduct of our clinical trials of SARS-Cov-2 neutralizing antibody drug candidates licensed from Singlomics in patients with COVID-19 who have pulmonary distress and the potential for these drug candidates to help these patients; the impact of the COVID-19 pandemic on our supply chain, clinical trials and other aspects of our business; our plans to collaborate with Singlomics and with Atreca and IGM Biosciences on potential treatments for COVID-19; our ongoing efforts in response to the COVID-19 pandemic; the possibility that the in-licensed SARS-Cov-2 neutralizing antibody drug candidates would demonstrate favorable safety profile or be effective; the possibility that the in-licensed SARS-Cov-2 neutralizing antibody drug candidates to receive regulatory approval for the treatment of COVID-19; the possibility of unfavorable results from the clinical trials of the in-licensed SARS-Cov-2 neutralizing antibody drug candidates for COVID-19; the possibility that BeiGene may be unable to complete these trials in the currently anticipated timeline or at all; the ability of Atreca, BeiGene and IGM to discover, develop and manufacture novel IgM or IgA antibodies targeting SARS-CoV-2 for the treatment of COVID-19; the risk that Atreca, BeiGene or IGM decide not to pursue the collaboration or that the parties are unable to agree to further terms and arrangements for the collaboration in the future; the risk that the potential benefits of the collaborations with Singlomics and with Atreca and IGM do not materialize or do not outweigh the costs. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this message is as of the date of this message, and BeiGene undertakes no duty to update such information unless required by law.