Core Viewpoint - Shanghai Junshi Biosciences has received acceptance for a new indication application for Toripalimab in treating HER2-expressing urothelial carcinoma, highlighting the company's ongoing innovation in cancer treatment [1][2]. Group 1: Drug Information - Toripalimab (brand name: Tuoyi) is a PD-1 monoclonal antibody that has been approved for multiple indications in China, including advanced urothelial carcinoma [4]. - The new indication application is based on the RC48-C016 study, a Phase III clinical trial comparing Toripalimab combined with the antibody-drug conjugate Vadimezumab against traditional chemotherapy in patients with HER2-expressing locally advanced or metastatic urothelial carcinoma [2][3]. - The study's primary endpoints, progression-free survival (PFS) and overall survival (OS), met the pre-defined efficacy boundaries, indicating significant benefits over traditional chemotherapy [3]. Group 2: Market Context - Urothelial carcinoma is one of the top ten most common malignant tumors globally, with increasing incidence and mortality rates in China, posing a significant unmet clinical need [2]. - The introduction of new therapies, including PD-(L)1 inhibitors and novel antibody-drug conjugates, is reshaping the treatment landscape for advanced urothelial carcinoma, offering more diverse and precise treatment options compared to traditional chemotherapy [2]. Group 3: Regulatory and Approval Status - The application for the new indication has been officially accepted by the National Medical Products Administration, with the registration numbers CXSS2500079 and CXSS2500080 [1]. - Toripalimab has been involved in over 40 clinical studies across more than 15 indications globally, demonstrating its extensive research and development efforts [4].

2025年5月，RC48-C016研究的主要研究终点无进展生存期(PFS，基于独立影像评估)和总生存期(OS)均 达到方案预设的优效边界。研究结果表明，相较于吉西他滨联合顺铂╱卡铂，特瑞普利单抗联合维迪西 妥单抗一线治疗HER2表达的局部晚期或转移性尿路上皮癌可显著延长患者的PFS和OS。特瑞普利单抗 安全性数据与既往研究相似，未发现新的安全性信号。本研究的详细数据将在重要国际学术会议上公 布。 特瑞普利单抗注射液是中国首个批准上市的以PD-1为靶点的国产单抗药物，曾荣膺国家专利领域最高 奖项"中国专利金奖"，至今已在全球(包括中国、美国、欧洲及东南亚等地)开展了覆盖超过15个适应症 的40多项由公司发起的临床研究。正在进行或已完成的关键注册临床研究在多个瘤种范围内评估特瑞普 利单抗的安全性及疗效。截至本公告日期，特瑞普利单抗的12项适应症已于中国内地获批。2020年12 月，特瑞普利单抗注射液首次通过国家医保谈判，目前已有10项获批适应症纳入国家医保目录，是国家 医保目录中唯一用于黑色素瘤、非小细胞肺癌围手术期、肾癌和三阴性乳腺癌治疗的抗PD-1单抗。 2024年10月，特瑞普利单抗用于复发╱转移性鼻咽癌治 ...