2026年8月20日，恒瑞医药(01276)公告称，其子公司北京盛迪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》，同意在晚期实体瘤患者中开展SHR-8203注射液的单药临床试验。批准对应受理号为CXSL2600576。
SHR-8203注射液为公司自主研发的创新型抗肿瘤药物，拟用于治疗晚期实体瘤。截至目前，该项目累计研发投入约2,040万元（未经审计）。经公司查询，国内外尚无同类药物上市。
公司提示，药物上市仍需完成临床试验并通过国家药监局后续审评审批，研发及上市周期存在不确定性。公司将按相关法规推进项目进展，并及时披露后续信息。
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