Junshi Biosciences (HK: 1877) out-licensed ex-China rights for a therapeutic antibody aimed at prevention and treatment of COVID-19 to Eli Lilly (NYSE: LLY). JS016 is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain and blocks the binding of viruses to host cell surface receptor ACE2. The antibody research was developed jointly by Junshi and the Institute of Microbiology, Chinese Academy of Science. Lilly plans to file an IND and start trials in the US in Q2 of 2020. Junshi retains all China rights to the candidate.

Lilly will have an exclusive license to conduct clinical development, manufacturing and distribution of JS016 outside of Greater China. Terms were not disclosed. Lilly formed a $1 billion partnership with China's Innovent Bio in 2015, but hasn't been previously associated with Junshi. In 2018, Junshi won China drug development bragging rights by earning the first China approval for a PD-1 drug, just after it completed an IPO on the Hong Kong exchange.

At the beginning of the COVID-19 outbreak, Junshi launched an R&D program to discover neutralizing antibodies to COVID-19. Within two months, the company used its platform technology to complete IND enabling pre-clinical studies, process development and production for GLP toxicity study and GMP production of clinical material.

“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, MD, PhD, Junshi Biosciences’ CEO. “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, MD, PhD, 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.”

Established in 2012, Junshi Bio aims to develop first-in-class and best-in-class drugs through original innovation and translational medicine to provide patients with effective and affordable treatment options. Its R&D pipeline comprises 21 drug candidates for cancer, metabolic diseases, autoimmune diseases, neurologic diseases, and infectious disease. With a combined 33,000L fermentation capacity in two GMP-facilities at Shanghai and Suzhou, Junshi has established the manufacturing infrastructure to support commercialization.

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Disclosure: none.