Toripalimab filed with FDA in rolling submission for nasopharyngeal carcinoma.- Junshi Biosciences and Coherus Biosciences

Junshi Biosciences and Coherus Biosciences announced the initiation of the rolling submission of the Biologics License Application for toripalimab to the FDA for the treatment of recurrent or metastatic nasopharyngeal carcinoma. 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. Following potential approval of toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma, and assuming successful closing of their collaboration agreement, Coherus and Junshi Biosciences plan to file additional toripalimab BLA supplements with the FDA over the next three years for multiple rare cancers as well as highly prevalent cancers, including non-small cell lung cancer.