NMPA accepts supplementary NDA for Toripalimab in 1L HER2-expressing Urothelial Carcinoma
sNDA for toripalimab (trade name: TUOYI®) in combination with disitamab vedotin, an antibody-drug conjugate developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is defined as a HER2 immunohistochemistry test result of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma, has been accepted by the National Medical Products Administration. This is toripalimab’s 13th application for marketing submitted in the Chinese mainland.
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