2026年8月20日,江蘇恒瑞醫藥股份有限公司(01276)公告称,其子公司广东恒瑞医药有限公司已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》,同意对创新药物SHR-7012注射液开展临床试验。
公告显示,SHR-7012拟用于治疗皮肤型红斑狼疮(CLE),受理号为CXSL2600557。该申请于2026年5月21日获受理,并已通过审评,符合《中华人民共和国药品管理法》及相关规定。
SHR-7012为公司自主研发,目前国内外暂无同靶点药物获批上市。截至公告披露日,该项目累计研发投入约2,550万元(未经审计)。
恒瑞医药提示,药品从临床试验至最终上市尚需经过多环节审批,存在不确定性风险。公司表示将按照国家相关规定推进项目进展,并及时披露后续信息。
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