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

1st line nasopharyngeal indication and 2nd/3rd line indications to be concurrently submitted 3Q 2021 in the toripalimab BLA SHANGHAI, China and REDWOOD CITY, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) Shanghai ....

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Junshi Biosciences and Coherus Announce Toripalimab First-Line Nasopharyngeal Carcinoma Clinical Data to be Showcased in Plenary Session at 2021 ASCO Annual Meeting

- Toripalimab data will also be featured in ASCO's official press program -SHANGHAI, China, and REDWOOD CITY, Calif., April 29, 2021 (GLOBE NEWSWIRE) Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences" ....

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Junshi Biosciences and Coherus BioSciences Announce Initiation of Rolling Submission of BLA for Toripalimab to the U.S. FDA for the Treatment of Nasopharyngeal Carcinoma

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- 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 o ....

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