和誉医药首个自研CSF-1R抑制剂NDA获受理,治疗腱鞘巨细胞瘤

药事纵横
Jun 16, 2025

6月10日,国家药品监督管理局(NMPA)官网显示正式受理了和誉医药自主研发的CSF-1R抑制剂匹米替尼的新药上市申请(NDA),用于治疗成人腱鞘巨细胞瘤(TGCT)患者。对于成立仅9年的和誉医药(02256.HK),这是其首个进入NDA审批流程的自主研发项目,标志着公司发展进入全新阶段,董事长兼CEO徐耀昌博士称之为“和誉医药发展历程中的重大里程碑时刻”。腱鞘巨细胞瘤(TGCT)是一种局部浸润性...

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