Shanghai Junshi Biosciences Co., Ltd. (01877) said its subsidiary TopAlliance Biosciences, Inc. has initiated the rolling submission of its Biologics License Application (BLA) for toripalimab (product code: TAB001/JS001) with the US Food and Drug Administration (the FDA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma.
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States.
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