Shang Hai Zheng Quan Bao·2025-08-08 20:19Core Viewpoint - Shanghai Junshi Biosciences has received acceptance for a new indication application for Toripalimab in treating HER2-expressing urothelial carcinoma, highlighting the company's ongoing innovation in cancer treatment [1][2]. Group 1: Drug Information - Toripalimab (brand name: Tuoyi) is a PD-1 monoclonal antibody that has been approved for multiple indications in China, including advanced urothelial carcinoma [4]. - The new indication application is based on the RC48-C016 study, a Phase III clinical trial comparing Toripalimab combined with the antibody-drug conjugate Vadimezumab against traditional chemotherapy in patients with HER2-expressing locally advanced or metastatic urothelial carcinoma [2][3]. - The study's primary endpoints, progression-free survival (PFS) and overall survival (OS), met the pre-defined efficacy boundaries, indicating significant benefits over traditional chemotherapy [3]. Group 2: Market Context - Urothelial carcinoma is one of the top ten most common malignant tumors globally, with increasing incidence and mortality rates in China, posing a significant unmet clinical need [2]. - The introduction of new therapies, including PD-(L)1 inhibitors and novel antibody-drug conjugates, is reshaping the treatment landscape for advanced urothelial carcinoma, offering more diverse and precise treatment options compared to traditional chemotherapy [2]. Group 3: Regulatory and Approval Status - The application for the new indication has been officially accepted by the National Medical Products Administration, with the registration numbers CXSS2500079 and CXSS2500080 [1]. - Toripalimab has been involved in over 40 clinical studies across more than 15 indications globally, demonstrating its extensive research and development efforts [4].