【恒瑞医药:子公司收到HRS9531注射液临床试验批准通知书】金十数据5月30日讯,恒瑞医药公告称,子公司福建盛迪医药有限公司收到国家药监局核准签发关于HRS9531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。目前全球范围内,仅有礼来的同靶点药物替尔泊肽注射液于2022年在美国获批上市,用于治疗2型糖尿病。HRS9531相关项目累计研发投入约3.45亿元。根据我国药品注册相关的法律法规要求,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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