君实生物：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

Core Viewpoint - Junshi Biosciences (688180.SH) has received the Acceptance Notification from the National Medical Products Administration for the new indication application of Trastuzumab combined with Rongchang Biopharmaceutical's independently developed antibody-drug conjugate, Vidisizumab, for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [1] Group 1 - The application is primarily based on the RC48-C016 study, which is a multicenter, randomized, open-label, positive-controlled Phase III clinical trial [1] - The main study endpoints, Progression-Free Survival (PFS) and Overall Survival (OS), have both met the pre-defined superiority boundaries set in the study protocol [1]