智通财经APP讯，先声药业(02096)发布公告，于2025年1月2日，集团自主研发的抗肿瘤候选药物CDH6抗体偶联药物(ADC)SIM0505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，拟开展晚期实体瘤的临床试验。于2024年12月28日，SIM0505新药临床试验申请(IND)已获美国食品药品监督管理局(FDA)批准。
CDH6是一种II型经典钙黏蛋白，在多种肿瘤中高表达，而在正常组织中表达极低。SIM0505是集团研发的一款靶向CDH6的ADC分子，将特异结合肿瘤细胞的CDH6单克隆抗体通过连接子与具有自主知识产权的喜树硷衍生物类毒素相连。SIM0505结合了抗体分子的肿瘤特异靶向性和毒素分子的高杀伤性优势，与传统的化疗药物相比，不仅能精准地靶向肿瘤细胞，还能降低毒副作用。该款ADC拟开发用于治疗卵巢癌、肾癌等恶性肿瘤。
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