【恒瑞医药:子公司收到药物临床试验批准通知书】金十数据4月21日讯,恒瑞医药公告称,子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监局核准签发关于SHR-8068注射液、阿得贝利单抗注射液的《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。根据相关法律法规,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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