Toripalimab approved for urothelial carcinoma
Analysis based on 6 articles · First reported May 21, 2026 · Last updated May 21, 2026
The approval of toripalimab's 13th indication for urothelial carcinoma in China>>> is a positive development for Shanghai Junshi Biosciences>>> and RemeGen>>>, potentially boosting their stock prices due to increased market access and revenue streams. This also signals advancements in the biopharmaceutical industry, particularly in cancer treatment, which could attract further investment in the sector.
The China — National Medical Products Administration (NMPA) has approved the new drug application (NDA) for toripalimab, developed by Shanghai Junshi Biosciences>>>, in combination with disitamab vedotin, developed by RemeGen>>>, for the first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC) in the Chinese Mainland. This marks the 13th approved indication for toripalimab in China>>>. The approval is based on positive results from the RC48-C016 study, a multi-center, randomized, open-label, and controlled phase 3 clinical trial. The study demonstrated that the combination therapy significantly improved progression-free survival (PFS) and overall survival (OS) compared to traditional chemotherapy, with a median PFS of 13.1 months versus 6.5 months and a median OS of 31.5 months versus 16.9 months. Dr. Jianjun Zou, CEO of Shanghai Junshi Biosciences>>>, emphasized the importance of this milestone and the company's collaborative R&D strategy.
Set up alerts, explore entity relationships, search across thousands of events, and build custom intelligence feeds.
Open Dashboard