JUNSHI BIO (688180.SH): The new indication for the first-line treatment of HER2-expressing urothelial carcinoma with Trastuzumab has been accepted for market application.

JUNSHI BIO (688180.SH) announced that the company has recently received a "Notice of Acceptance" issued by the National Medical Products Administration for the new indication application of Vediruximab monoclonal antibody, developed independently by REMEGEN Pharmaceutical (Yantai) Co., Ltd., in combination with Trastuzumab monoclonal antibody (trade name: Tuoyi, product code: JS001), for the treatment of locally advanced or metastatic urothelial carcinoma with HER2 expression (defined as HER2 immunohistochemistry results of 1+, 2+, or 3+). The new indication application is primarily based on the RC48-C016 study (NCT05302284), a multicenter, randomized, open-label, positive drug-controlled phase III clinical study, which aims to compare the efficacy and safety of Trastuzumab in combination with Vediruximab monoclonal antibody with Gemcitabine combined with cisplatin/carboplatin in patients with HER2-positive locally advanced or metastatic urothelial carcinoma who have not previously received systemic anti-tumor therapy. The study is led by Professor Guo Jun from Peking University Cancer Hospital and Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences, and is being conducted in 74 clinical centers nationwide.