Skip to main content

Junshi Biosciences Announces FDA Expanded Emergency Use Authorization For Etesevimab And Bamlanivimab Administered Together To Include Individuals Under The Age Of 12

First and only neutralizing antibody therapy for this age group

SHANGHAI, China, Dec. 06, 2021 (GLOBE NEWSWIRE) -- 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") has expanded the emergency use authorization ("EUA") for etesevimab (JS016/LY-CoV016) and bamlanivimab (LY-CoV555) administered together (the "Therapy") to include certain high-risk pediatric patients from birth to under 12 years old for the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis, according to Eli Lilly and Company ("Lilly"), the company's global partner. The Therapy has been the first and only authorized neutralizing antibody therapy for emergency use in COVID-19 individuals under the age of 12 and offers treatment and prevention options to high-risk individuals of any age.

In February 2021, the Therapy was granted 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 by the FDA. In September 2021, the Therapy was granted EUA for post-exposure prophylaxis in high-risk 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 an institutional setting, including a nursing home or prison.

The expanded EUA is based on safety and efficacy data of pediatric and infant patients in BLAZE-1 (NCT04427501), a phase II/III clinical trial studying the Therapy for the treatment of mild to moderate COVID-19 and who are at high risk for severe disease progression. The median time to complete symptom resolution as recorded in a trial-specific daily symptom diary was 7 days for subjects treated with etesevimab (1,400 mg) and bamlanivimab (700 mg) and 5 days for subjects treated with weight-based dosing of etesevimab and bamlanivimab. No pediatric subject died or required hospitalization due to COVID-19.

Pseudovirus and authentic virus studies demonstrate that the Therapy retains neutralization activity against the Delta (B.1.617.2/AY.3) variant, the currently predominant variant of concern worldwide.

According to the statistics from Lilly, over 700,000 patients have been treated with the Therapy or bamlanivimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst of the pandemic.

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, 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. The Therapy has obtained EUA in more than 15 countries and regions worldwide. The Company has completed a Phase Ib/II international multi-center clinical study (NCT04780321) of etesevimab for patients with mild to moderate COVID-19. Results from a Phase 2/3 study sponsored by Lilly in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1,  NCT04427501) were published in the  New England Journal of Medicine .

About Junshi BiosciencesFounded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) 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 45 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 Chinese Academy of Science 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 been granted Emergency Use Authorizations (EUA) in 15 countries and regions worldwide. 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.

Junshi Biosciences Contact InformationIR Team:Junshi Biosciences info@junshipharma.com + 86 021-2250 0300

Solebury TroutBob Ai bai@soleburytrout.com+ 1 646-389-6658

PR Team:Junshi BiosciencesZhi Li zhi_li@junshipharma.com+ 86 021-6105 8800