Lilly, Junshi Biosciences to Develop COVID-19 Antibody Therapies

May 07, 2020 - Eli Lilly Company and Junshi Biosciences recently entered into an agreement to co-develop COVID-19 antibody therapies for the prevention and treatment of the novel coronavirus.

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Junshi Biosciences, a China-based pharmaceutical company, specializes in drug discovery, as well as the development and commercialization of novel therapies. 

At the start of the COVID-19 pandemic, Junshi launched one of the industry’s first research and development (R&D) efforts to discover therapies to tackle coronavirus. The company has already engineered various neutralizing antibodies, with the lead candidate expected to enter clinical trials in the second quarter of 2020.

Lilly plans to leverage the company’s work to address the rapidly spreading novel coronavirus. The pharmaceutical leader will receive a license to conduct clinical development, manufacturing and distribution of products outside of China. Junshi Biosciences will maintain all rights in Greater China.

"As the number of global cases continues to grow, there is an urgent need to study multiple complementary approaches to address this disease," Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories said in the press release.

"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."

Junshi’s SARS-CoV-2 antibodies, JS016, is a fully human monoclonal neutralizing antibody that is specific to this strain of coronavirus surface spike protein receptor-binding domain, Lilly noted. The antibodies can effectively block the binding of viruses to host cell surface receptor ACE2.

The biopharmaceutical companies intend to submit an investigational new drug (IND) application and initiate clinical studies in the US in the second quarter of the year. Junshi said it will keep contact with the Center for Drug Evaluation of the National Medical Products Administration to initiate the IND application submission in China as soon as possible.

With the help of Lilly, the company’s CEO Ning Li, MD, PhD, anticipates a faster track to clinical development.

"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,” Lilly stated.

The news of Lilly and Junshi’s partnership comes on the heels of an announcement from another pharmaceutical heavy-hitter.

Roche recently announced that the FDA issued an emergency use authorization (EUA) for its new COVID-19 antibody test.

The new antibody test, Elecsys, will help uncover if a patient has been exposed to COVID-19 and if they have developed antibodies against the virus. Roche has begun shipping the new antibody tests to leading laboratories globally. 

The company will increase production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark as well as the US, the announcement stated. 

“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” Severin Schwan, CEO of Roche Group said in the announcement.

”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”

Roche noted that its antibody test has a specificity greater than 99.8 percent and 100 percent sensitivity, which can help assess immune response to the virus. As experts continue to uncover more about immunity to COVID-19, the test may help to assess who has built up immunity to the virus.

“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” said Thomas Schinecker, CEO of Roche Diagnostics. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”