智通财经APP获悉,荣昌生物(09995)再涨超5%,截至发稿,涨3.7%,报40.65港元,成交额1.1亿港元。
消息面上,荣昌生物公告称,公司自主研发的抗体偶联药物(ADC)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期临床研究达到无进展生存期和总生存期两项主要研究终点。
公告称,研究结果显示强阳性结果,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。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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