Etesevimab (JS016) Administered with Bamlanivimab Receives FDA Emergency Use Authorization for COVID-19

• Etesevimab and bamlanivimab administered together is authorized for treatment of recently diagnosed, mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19
• More than 250,000 doses manufactured throughout Q1 2021; up to 1 million doses by mid-2021
• FDA authorizes shortened infusion time for this neutralizing antibody therapy authorized for emergency use
  

SHANGHAI, China, Feb. 10, 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 U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for investigational etesevimab (JS016 or LY-CoV016) 1400 mg and bamlanivimab (LY-CoV555) 700 mg together, according to the company’s global partner Eli Lilly and Company (NYSE: LLY). This therapy is authorized 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. 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.

In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes. This change has been made in response to feedback received from front-line nurses and doctors administering these infusions and is aimed at reducing the burden on the healthcare system.

The EUA is based on Phase 3 data from the BLAZE-1 trial, announced on January 26, 2021, which demonstrated that etesevimab and bamlanivimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent. These data replicate 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 more often reported for patients receiving etesevimab and bamlanivimab together versus placebo was nausea on the day of infusion.