Core Viewpoint - Junshi Biosciences (688180.SH) has received the acceptance notice 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 Vidutolimab for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [1] Group 1 - The new indication application is based on the RC48-C016 study (NCT05302284), which is a multicenter, randomized, open-label, positive-controlled Phase III clinical trial [1] - The study aims to compare the efficacy and safety of Toripalimab combined with Vidutolimab versus Gemcitabine combined with Cisplatin/Carboplatin in patients with locally advanced or metastatic urothelial carcinoma expressing HER2 who have not previously received systemic antitumor therapy [1] - The study is led by Professor Guo Jun from Peking University Cancer Hospital and Professor Zhou Aiping from the Chinese Academy of Medical Sciences Cancer Hospital, conducted across 74 clinical centers nationwide [1]
君实生物(688180.SH):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