SHANGHAI, China, Aug. 29, 2021 (Globalrelease Wire) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the United States Food and Drug Administration (the “FDA”), alongside the Office of the Assistant Secretary for Preparedness and Response, has resumed the shipment and distribution of etesevimab and bamlanivimab administered together (the “Therapy”), according to the company’s global partner Eli Lilly and Company (NYSE: LLY). Direct ordering will be available to authorized states in the U.S. effective immediately.
The decision to resume distribution aligns with the FDA’s issuance of an updated fact sheet (the “Fact Sheet”) and a revised letter of authorization for etesevimab and bamlanivimab together. These include a revised limitation of authorized use, only allowing use in the states, territories, and U.S. jurisdictions with a low prevalence of variants that are resistant to treatment with the antibodies.
The Delta variant (the “Delta”) currently accounts for nearly 96 percent of all identified COVID-19 cases in the U.S. As shown in revisions to the Fact Sheet, pseudovirus and authentic virus studies demonstrate that etesevimab and bamlanivimab together retained neutralization activity against the Alpha variant and the Delta.
Over the last several months, prevalence of variants varies by state, region and even country and can change rapidly. As variants continue to evolve and their patterns of transmission and prevalence shift, Eli Lilly and Company (“Lilly”), a partner of the Company, will continue to work with governments and regulators worldwide to ensure the Therapy is available to appropriate patients.
About Etesevimab (JS016/LY-CoV016)
Etesevimab 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 and can 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 the Company after it was jointly developed by the Company and the Institute of Microbiology of Chinese Academy of Science. The Company leads development in Greater China (including mainland China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region and the Taiwan region), while Lilly leads development in the rest of the world.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of the Chinese Academy of Sciences and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) from the US FDA in February 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at a high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.
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