华东医药(000963.SZ)公告称,公司全资子公司中美华东收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,注射用HDM2012临床试验申请获得批准。该药物是由中美华东自主研发的靶向人粘蛋白-17的新型抗体药物偶联物,属于全球首创的1类生物制品。临床前研究结果显示,HDM2012具有良好的成药性、安全性和有效性。本次临床试验获批是该产品研发进程中的重要进展,将进一步提升公司在肿瘤治疗领域的核心竞争力。但需注意,药物在获得临床试验批准通知书后,尚需完成后续临床试验并经国家药品监督管理局审评、审批通过后方可上市。
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