SHANGHAI, China, Sept. 19 (Korea Bizwire) — 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 (FDA) has expanded the emergency use authorization (EUA) for etesevimab (JS016/LY-CoV016) 1,400 mg and bamlanivimab (LY-CoV555) 700 mg administered together (the “Therapy”) to include post-exposure prophylaxis in certain individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in institutional settings, including nursing homes and prisons, according to the company’s global partner Eli Lilly and Company (“Lilly”). In February 2021, the FDA granted the Therapy an EUA for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The expanded EUA is based on data from BLAZE-2 (NCT04497987), a study conducted in partnership with the National Institute of Allergy and Infectious Diseases, which is a part of the National Institutes of Health, and the COVID-19 Prevention Network. The study enrolled residents and staff at long-term care facilities in the US.
The pseudovirus and authentic virus studies demonstrated that the Therapy retains neutralization activity against the Alpha and Delta variants.
Lilly to Supply 388,000 Doses of Etesevimab to US Government
The US Government has made an additional purchase for the Therapy. As part of the agreement between Lilly and the US government. Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the US government, with approximately 200,000 doses expected to be shipped in the third quarter of 2021 and the remaining to be shipped in the fourth quarter of 2021. In February 2021, the US government agreed to purchase a minimum of 100,000 doses of the Therapy from Lilly.
Etesevimab is a recombinant fully human neutralizing monoclonal 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 Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology of the Chinese Academy of Sciences. Junshi Biosciences leads development in Greater China (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. The Therapy has been granted EUAs in more than 12 countries and regions worldwide, and Junshi Biosciences has completed a Phase Ib/II international multi-center clinical study (NCT04780321) of etesevimab for patients with mild to moderate COVID-19 in China.
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 44 drug candidates, 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 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 Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab received an 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 EUA was expanded to include post-exposure prophylaxis for COVID-19 in September 2021. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 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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Source: Junshi Biosciences via GLOBE NEWSWIRE