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Junshi/Lilly Dual Antibody Treatment Approved in US to Treat COVID-19
Junshi Biosciences (HK: 1877; SHA: 688180) and Eli Lilly (NYSE: LLY) announced their dual mAb treatment was approved in the
Junshi's etesevimab (JS016 or LY-CoV016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity. It is designed to block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi after it was jointly developed by Junshi and the
The US approval said etesevimab and bamlanivimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The FDA also allowed infusion times for bamlanivimab alone and the bamlanivimab/etesevimab combination to be as short as 16 or 21 minutes, respectively, down from the previously authorized time of 60 minutes.
The EUA is based on Phase III data from the BLAZE-1 trial, announced on January 26, 2021, which replicated earlier results, published in The Journal of the American Medical Association (IF=45.54), in a much larger group of patients. The most common adverse event most often reported for patients in the active arm was nausea on the day of infusion.
Although Phase II and III trials evaluated a range of doses of bamlanivimab alone and etesevimab/bamlanivimab in combination, data showed consistent and similar clinical effects among all doses studied. In addition, initial results from an ongoing Phase II study produced viral load and pharmacodynamic/pharmacokinetic data that demonstrated etesevimab 1400 mg and bamlanivimab 700 mg together produced similar effects to the results from the Phase III trial with etesevimab 2800 and bamlanivimab 2800 together. Together, these data provide confidence in the reduced dose, which expands available supply to help more patients without sacrificing potential efficacy.
Lilly's bamlanivimab alone is authorized in numerous countries, while bamlanivimab and etesevimab together is currently authorized in the
Lilly said it has 100,000 doses ready immediately and another 150,000 doses will be available during the first quarter.
Dr. Ning Li, CEO of Junshi Biosciences said: “Since the outbreak of the pandemic, Junshi Biosciences and the IMCAS have been dedicated to the co-development of neutralizing antibodies. Now, with Lilly, our global partner’s participation, the innovative therapy is authorized for use in the
Lilly has successfully completed a Phase 1 study (NCT04441931) of etesevimab in healthy
Lilly's bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies that prevent and treat COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.
Founded in December 2012, Junshi has established a diversified R&D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first
In early 2020, Junshi joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016,
See our other articles on Junshi and Lilly.
Disclosure: none.
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