Junshi Biosciences Announces the Acceptance of the sNDA for Toripalimab as the 1st-line Treatment of HER2-expressing Urothelial Carcinoma

CAR-T Digest - August 2020

Weekly Digest - August 2025

11 August 2025: Junshi Biosciences Announces the Acceptance of the sNDA for Toripalimab as the 1st-line Treatment of HER2-expressing Urothelial Carcinoma

Junshi Bioscience’s supplemental new drug application (sNDA) for toripalimab combined with disitamab vedotin as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (UC) has been accepted by China’s National Medical Products Administration
Urothelial carcinoma is among the ten most prevalent cancers globally, with rising incidence and mortality in China, highlighting a significant unmet medical need
Toripalimab was previously approved in 2021 in China for second-line and later treatment of advanced UC, and new therapies like PD-(L)1 inhibitors and ADCs are reshaping the UC treatment landscape with better outcomes than traditional chemotherapy
The sNDA is supported by data from the RC48-C016 phase 3 clinical trial, which showed that toripalimab plus disitamab vedotin significantly improved PFS and OS compared to standard chemotherapy in HER2-expressing UC patients
The safety profile of the toripalimab combination remained consistent with previous findings, with no new safety concerns, and more detailed results will be shared at major international medical conferences