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Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

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  • China’s NMPA has accepted sNDA of toripalimab + disitamab vedotin for the treatment of HER2+ locally advanced or metastatic urothelial carcinoma (LA/M UC)
  • sNDA was backed by P-III (RC48-C016) trial assessing toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin across 74 centres in systemic-treatment-naïve Chinese pts with HER2+ LA/M UC
  • Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-1/PD-L1 pathway to reduce immune suppression & enhance anti-tumor immune responses, while disitamab vedotin is an ADC designed to target the HER2 receptor

Ref: Junshi Biosciences| Image: Junshi Biosciences| Press Release

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