智通财经APP讯，荣昌生物(688331.SH)发布公告，公司自主研发的抗体偶联药物(ADC)维迪西妥单抗(代号：RC48，商品名：爱地希®)联合特瑞普利单抗对比化疗治疗HER2表达的一线局部晚期或转移性尿路上皮癌的Ⅲ期临床研究(RC48-C016)达到无进展生存期(PFS)和总生存期(OS)两项主要研究终点。
维迪西妥单抗联合特瑞普利单抗对比化疗治疗HER2表达的一线局部晚期或转移性尿路上皮癌的Ⅲ期临床研究(RC48-C016)，在预先设定的独立数据监察委员会(IDMC)中期分析中显示强阳性结果，达到PFS和OS的两项主要研究终点，研究结果具有统计学显著差异和重大临床获益。在主要亚组分析中，不论患者是否接受过顺铂治疗以及不论HER2表达状态，维迪西妥单抗联合特瑞普利单抗相比化疗均显著改善PFS和OS，且安全性良好，不良反应可控。公司将择机向国家药品监督管理局药品审评中心(CDE)递交该适应症的新药上市申请。
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