恒瑞医药(600276.SH)子公司多款药品获药物临床试验批准通知书

智通财经网
14 Apr

恒瑞医药(600276.SH)公告,近日,公司子公司山东盛迪医药有限公司、苏州盛迪亚生物医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局(简称“国家药监局”)核准签发关于HRS-7058胶囊/片、阿得贝利单抗注射液、贝伐珠单抗注射液和注射用SHR-1826的《药物临床试验批准通知书》,将于近期开展临床试验。

HRS-7058是一种新型、高效、选择性的小分子共价抑制剂,拟用于治疗KRASG12C突变的晚期实体肿瘤。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。贝伐珠单抗是一种人源化抗VEGF单克隆抗体,由中外制药和罗氏的子公司基因泰克合作开发,2004年由美国食品药品监督管理局批准上市,商品名为Avastin(安维汀),目前已在中国和全球多个国家上市销售。注射用SHR-1826是一款以c-MET为靶点的抗体偶联药物,通过与肿瘤细胞表面的靶抗原特异性结合,被内吞进入肿瘤细胞后杀伤肿瘤细胞。

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