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]

君实生物(688180.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的《受理通知书》，特 瑞普利单抗(商品名：拓益，产品代号：JS001)联合荣昌生物制药(烟台)股份有限公司自主研发的抗体偶 联药物维迪西妥单抗用于HER2表达的(HER2表达定义为HER2免疫组织化学检查结果为1+、2+或3+)局 部晚期或转移性尿路上皮癌患者的新适应症上市申请获得受理。 本次新适应症的上市申请主要基于RC48-C016研究(NCT05302284)，该研究是一项多中心、随机、开 放、阳性药对照的Ⅲ期临床研究，旨在比较特瑞普利单抗联合维迪西妥单抗对比吉西他滨联合顺铂/卡 铂在既往未接受系统抗肿瘤治疗的HER2(人表体生长因子受体-2)表达的局部晚期或转移性尿路上皮癌患 者中的有效性和安全性。该研究由北京大学肿瘤医院郭军教授和中国医学科学院肿瘤医院周爱萍教授担 任主要研究者，在全国74家临床中心开展。 ...