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君实生物(01877):特瑞普利单抗一线治疗HER2表达的尿路上皮癌的新适应症上市申请获得受理
智通财经网·2025-08-08 12:36

Core Viewpoint - Junshi Biosciences (01877) has received a notice of acceptance from the National Medical Products Administration for the new indication application of Toripalimab (brand name: Tuoyi®, product code: JS001) in combination with the antibody-drug conjugate Vidisirtan for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [1] Group 1: Clinical Research and Results - The new indication application is based on the RC48-C016 study, a Phase III clinical trial comparing the efficacy and safety of Toripalimab combined with Vidisirtan versus Gemcitabine combined with Cisplatin/Carboplatin in patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [1] - The primary endpoints of the RC48-C016 study, progression-free survival (PFS) and overall survival (OS), met the predefined superiority boundaries, indicating that the combination therapy significantly extends PFS and OS compared to the standard treatment [2] Group 2: Product and Market Position - Toripalimab is the first domestically approved PD-1 monoclonal antibody in China and has been involved in over 40 clinical studies covering more than 15 indications globally [3] - As of the announcement date, Toripalimab has received approval for 12 indications in mainland China and has been included in the national medical insurance directory for 10 indications, making it the only PD-1 monoclonal antibody listed for treating melanoma, non-small cell lung cancer perioperatively, renal cancer, and triple-negative breast cancer [3] - The product has also gained approval in various international markets, including the US, EU, India, UK, Jordan, Australia, and Singapore [3]