SHANGHAI and INDIANAPOLIS, May 4, 2020 /PRNewswire/ -- Junshi Biosciences (HKEX: 1877) and Eli Lilly and Company (NYSE: LLY) announced today they have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus.
At the beginning of the COVID-19 outbreak, Junshi Biosciences—a China-based biopharmaceutical company specializing in discovery, development and commercialization of novel therapies—launched one of the industry's first R&D efforts aimed at discovering therapies to combat COVID-19. Multiple neutralizing antibodies have been engineered, with the lead asset poised to enter clinical testing in the second quarter.
"Since the outbreak of COVID-19, we have been working diligently to join the fight against the pandemic. Entering into this agreement with Lilly empowers us to accelerate the clinical development of Junshi SARS-CoV-2 antibodies globally," said Ning Li, M.D., Ph.D., Junshi Biosciences' chief executive officer. "At the same time, by leveraging Lilly's global presence and capabilities, we have the potential to reach broader COVID-19 patient populations in a wider range of countries and regions."
"As the number of global cases continues to grow, there is an urgent need to study multiple complementary approaches to address this disease," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "The data generated by Junshi Biosciences suggest the lead antibody may have appropriate properties to support testing its therapeutic use in patients as well as exploring its potential for preventing infection in at-risk individuals. We look forward to partnering with Junshi Biosciences to quickly begin testing this potential new therapy in clinical trials."
Lilly will receive an exclusive license to conduct clinical development, manufacturing and distribution of products outside of Greater China. Junshi Biosciences will maintain all rights in Greater China.
About Junshi SARS-CoV-2 Antibodies
JS016 is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain and can effectively block the binding of viruses to host cell surface receptor ACE2. The project is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science.
At the beginning of the COVID-19 outbreak, Junshi Biosciences rapidly launched the research and development program of neutralizing antibodies to combat COVID-19. Within two months, the company has completed IND enabling pre-clinical studies, the process development and production for GLP toxicity study and GMP production of clinical material by leveraging the company's platform technology. Junshi Biosciences and Lilly aim to submit an IND application and initiate clinical studies in the United States in the second quarter of the year. Meanwhile, the company is communicating actively with the Center for Drug Evaluation of the National Medical Products Administration to initiate the IND application submission in China as soon as possible.
About Junshi Biosciences
Established in 2012, Junshi Biosciences is committed to developing first-in-class and best-in-class drugs through original innovation and becoming a pioneer in the area of translational medicine to provide patients with effective and affordable treatment options. On December 24, 2018, Junshi Biosciences was listed on the Main Board of the Stock Exchange of Hong Kong with the stock code: 1877.HK. The Company has established a diversified R&D pipeline comprising 21 drug candidates with therapeutic areas covering cancer, metabolic diseases, autoimmune diseases, neurologic diseases, and infectious disease. Product types include monoclonal antibodies, fusion proteins, antibody-drug conjugates, and small molecule drugs. With a combined 33,000L fermentation capacity in two GMP-facilities at Shanghai and Suzhou, Junshi has established the manufacturing infrastructure to support commercialization and provide our partners and patients with high-quality products through a global supply chain network. For more information, please visit: http://junshipharma.com/en/Index.html
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. C-LLY
Lilly Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of an agreement between Lilly and Junshi Biosciences and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the collaboration, or that the collaboration will yield commercially successful products. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
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SOURCE Eli Lilly and Company