Junshi Biosciences and Eli Lilly 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, chief executive officer, Junshi Biosciences. “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.”
 
Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said, “As the number of global cases continues to grow, there is an urgent need to study multiple complementary approaches to address this disease. 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.
 
Junshi’s 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 U.S. 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.