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

Toronto Star

10 hours ago

SHANGHAI, Aug. 08, 2025 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application ('sNDA') for toripalimab (trade name: TUOYI®) in combination with disitamab vedotin, an antibody-drug conjugate ('ADC') 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 ('UC'), has been accepted by the National Medical Products Administration ('NMPA'). This is toripalimab's 13th application for marketing submitted in the Chinese mainland.
UC is one of the ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising annually. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths reached over 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs.