Latest News and Press Releases

Want to stay updated on the latest news?

Sign into Reader Account Create Reader Account

December 22, 2025 06:29 ET | Source: 上海和誉生物医药科技有限公司

和誉医药CSF-1R抑制剂贝捷迈®获NMPA批准，填补中国腱鞘巨细胞瘤系统性治疗空白

基于全球III期MANEUVER研究的积极数据，中国国家药品监督管理局（NMPA）批准了贝捷迈®（盐酸匹米替尼胶囊）的全球首个新药上市申请，也是中国首个自主研发的腱鞘巨细胞瘤（TGCT）系统性治疗药物。默克作为我们的合作伙伴，拥有贝捷迈®在全球的商业化权益。贝捷迈®是和誉医药自主研发的1类新药，上市申请（NDA）获受理后仅6个多月即实现零发补批准。期间顺利通过国家药监局核查中心（CFDI）首次赴海...
December 22, 2025 06:29 ET | Source: Abbisko Therapeutics Co., Ltd.

Abbisko Therapeutics’ CSF-1R Inhibitor Pimicotinib Approved by the China NMPA, Addressing the Treatment Gap for Tenosynovial Giant Cell Tumor

Based on the positive global Phase III MANEUVER study, the NMPA has granted the world's first regulatory approval for pimicotinib.