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Junshi Biosciences: Tislelizumab approved for the 13th indication, for HER2-expressing urothelial carcinoma

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Junshi Biosciences announced that it has received the “Drug Registration Certificate” approved and issued by the National Medical Products Administration. The application for approval of a new indication for Toripalimab (brand name: Tuoyi) in combination with disitamab vedotin for patients with locally advanced or metastatic urothelial carcinoma with HER2 expression has been approved. This is the 13th approved indication for Toripalimab injection in Mainland China. The approval is based on a Phase III clinical study, and the results showed that compared with traditional chemotherapy, the combination therapy doubled the median progression-free survival (13.1 months vs. 6.5 months) and significantly extended overall survival (31.5 months vs. 16.9 months).
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