智通财经APP讯,恒瑞医药(600276.SH)发布公告,近日,公司子公司上海盛迪医药有限公司、苏州盛迪亚生物医药有限公司、上海恒瑞医药有限公司收到国家药品监督管理局核准签发关于注射用SHR-4602、注射用SHR-A2102、阿得贝利单抗注射液的《药物临床试验批准通知书》,同意SHR-4602联合SHR-A2102加或不加阿得贝利单抗在晚期实体瘤患者中开展临床试验。
注射用SHR-4602拟用于治疗HER2表达或突变的实体瘤,可诱导肿瘤细胞周期阻滞和细胞凋亡。注射用SHR-A2102为公司自主研发且具有知识产权的靶向Nectin-4的抗体药物偶联物(ADC),其有效载荷是拓扑异构酶抑制剂(TOPi)。阿得贝利单抗注射液是公司自主研发的人源化抗PD-L1单克隆抗体,能通过特异性结合PD-L1分子从而阻断导致肿瘤免疫耐受的PD-1/PD-L1通路,重新激活免疫系统的抗肿瘤活性,从而达到治疗肿瘤的目的。
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