Core Viewpoint - Junshi Biosciences announced the acceptance of a supplemental new drug application for toripalimab in combination with disitamab vedotin for treating HER2-expressing locally advanced or metastatic urothelial carcinoma, marking toripalimab's 13th marketing application in mainland China [1] Group 1: Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diversified R&D pipeline of over 50 drug candidates [11] - The company has five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases, and has received approvals for five products in China and international markets [11] - Toripalimab is China's first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in 40 countries and regions, including China, the US, and Europe [11][10] Group 2: Industry Context - Urothelial carcinoma (UC) is one of the ten most prevalent malignant tumors globally, with rising incidence and mortality rates in China; in 2022, there were 92,900 new cases and over 40,000 deaths [2] - The treatment landscape for advanced UC has been reshaped by the emergence of PD-(L)1 monoclonal antibodies and novel antibody-drug conjugates (ADCs), offering significant improvements in survival benefits and tolerability compared to conventional chemotherapy [3] - The RC48-C016 study demonstrated that toripalimab combined with disitamab vedotin significantly improved progression-free survival (PFS) and overall survival (OS) compared to traditional chemotherapy regimens [5][4]