(1) - BLA submitted with FDA's breakthrough therapy designation - SHANGHAI, China and REDWOOD CITY, Calif., March 03, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. ("Coherus", Nasdaq: CHRS) announced today the initiation of the rolling submission of the Biologics License Application ("BLA") for toripalimab to the U.S. Food and Drug Administration ("FDA") for the treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC"). A rolling submission allows Junshi Biosciences to submit sections of the BLA to the FDA as they are completed. Toripalimab has been granted Breakthrough Therapy Designation by the FDA for the treatment of recurrent or metastatic nasopharyngeal carcinoma based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies. The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Toripalimab is the first anti-PD-1 monoclonal antibody developed in China with a BLA submission to the FDA in process.