恒瑞医药:获得四项药物临床试验批准通知书

格隆汇
17 Jul

恒瑞医药(600276.SH)公告称,公司及子公司收到国家药监局核准签发关于SHR-8068注射液、阿得贝利单抗注射液、贝伐珠单抗注射液、甲磺酸阿帕替尼片的《药物临床试验批准通知书》,将于近期开展临床试验。SHR-8068注射液是全人源抗CTLA-4单克隆抗体,阿得贝利单抗注射液是自主研发的人源化抗PD-L1单克隆抗体,贝伐珠单抗注射液是一种人源化抗VEGF单克隆抗体,甲磺酸阿帕替尼片是创新研发的小分子靶向药物。这些药物的研发投入分别为SHR-8068注射液约2.14亿元,阿得贝利单抗注射液约8.87亿元,贝伐珠单抗注射液约3.45亿元,甲磺酸阿帕替尼片约5.87亿元。根据相关法律法规要求,药物在获得药物临床试验批准通知书后,尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。

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