智通财经APP讯，康哲药业(00867)公布，于2026年1月30日，集团自主研发的创新药CMS-D017胶囊获得中国国家药品监督管理局(NMPA)签发的药物临床试验批准通知书。NMPA同意集团在中国健康参与者中开展评价CMS-D017安全性、耐受性、药代动力学和药效动力学特征的临床试验。
CMS-D017是一种新型选择性补体因子B小分子抑制剂。补体系统是先天免疫系统的重要组成部分，可通过经典途径、凝集素途径和旁路途径被激活从而发挥生物学功能。补体因子B是一种主要由肝脏合成的特异性丝氨酸蛋白酶，是补体旁路途径中的“核心开关”和“效应放大器”，其活性直接影响补体反应的强度。CMS-D017通过靶向抑制补体因子B，阻止补体旁路途径的异常活化，减低膜攻击复合物对靶组织和器官的损伤，缓解补体失调相关疾病的进展。CMS-D017在临床前研究中表现出优异的有效性和安全性，临床拟用于治疗阵发性睡眠性血红蛋白尿症。CMS-D017未来还拟开发用于治疗补体参与介导的肾脏疾病、年龄相关性黄斑变性和重症肌无力等疾病。
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