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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...
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Based on the positive global Phase III MANEUVER study, the NMPA has granted the world's first regulatory approval for pimicotinib.
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DUBLIN and OXFORD, United Kingdom and PHILADELPHIA, Aug. 05, 2025 (GLOBE NEWSWIRE) -- SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing emactuzumab for...
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DUBLIN, Ireland and OXFORD, United Kingdom, April 14, 2025 (GLOBE NEWSWIRE) -- SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing of emactuzumab for...
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Newly Appointed Board Chair, Philip Astley-Sparke, Brings Transatlantic Late-Stage Development, Regulatory and Commercial Expertise Strengthened Leadership and Expanded U.S. Presence Positions SynOx...
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Additions of Elyse Seltzer, M.D., as CMO and Robert Francomano as CCO Strengthen Company’s Presence in the U.S. Seasoned Team to Drive Forward Pivotal Phase 3 Trial of Emactuzumab in Patients...
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Gilde Healthcare Leads Series B Extension, Joining Premier Syndicate of Leading Life Science Investors Funding Supports Registrational Phase 3 TANGENT Trial of Emactuzumab, a Best-in-Class CSF-1...