Core 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].

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]