Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma

Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced that the United States Food and Drug Administration (“FDA”) has recently granted Breakthrough Therapy Designation (“BTD”) for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1^st line treatment of recurrent or metastatic nasopharyngeal carcinoma (“NPC”). The FDA had earlier granted BTD for toripalimab monotherapy for patients with recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

BTD is intended to expedite the development and regulatory review of drugs where preliminary clinical evidence demonstrates substantial improvement over existing therapies for a severe or life-threating disease. Drugs with BTD will be granted closer FDA guidance – including that from senior FDA officials – and various forms of support to avail patients with new therapy as soon as possible.

Junshi Biosciences expects to complete the biologics license application (“BLA”) submission for toripalimab plus chemotherapy for 1st line NPC and for toripalimab monotherapy for 2nd or 3rd line NPC later this quarter.

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