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.