先声药业(02096):SIM0610(EGFR/cMET双特异性抗体偶联药物)获国家药监局签发药物临床试验批准通知书

智通财经
Dec 23, 2025

智通财经APP讯,先声药业(02096)发布公告,集团自主研发的双特异性抗体偶联药物(BsADC)候选新药SIM0610已获得中国国家药品监督管理局签发的药物临床试验批准通知书,拟开展针对局部晚期╱转移性实体瘤患者的临床试验。

SIM0610是一款同时靶向表皮生长因子受体(EGFR)和间质表皮转化因子(cMET)的BsADC,通过内化释放拓扑异构酶I抑制剂(TOP1i)诱导肿瘤细胞凋亡。EGFR与cMET在非小细胞肺癌等多种实体瘤中异常激活,其中cMET激活是表皮生长因子受体络氨酸激酶抑制剂(EGFR-TKI)产生耐药性的重要机制之一。 SIM0610通过双靶点协同作用,有望增强抗肿瘤活性并克服耐药。临床前研究显示,SIM0610在多种肿瘤模型中表现出显著的抗肿瘤活性。

该公司是一家创新与研发驱动的制药公司,建设有“神经与肿瘤药物研发全国重点实验室”。该公司聚焦神经科学、抗肿瘤、自身免疫及抗感染领域,同时积极前瞻性布局未来有重大临床需求的疾病领域,履行“为患者而生”的企业使命。公司以自主研发及协同创新双轮驱动,与多家创新企业、科研院校建立战略合作伙伴关系。

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