Core Viewpoint - Sanofi (SNY.US) announced the approval of Aficamten (Chinese trade name: 星舒平), a second-generation cardiac myosin inhibitor, by the National Medical Products Administration for the treatment of adults with obstructive hypertrophic cardiomyopathy (HCM) classified as NYHA functional class II-III, aimed at improving exercise capacity and symptoms [1] Group 1 - Aficamten is a small molecule cardiac myosin inhibitor developed by Cytokinetics, designed to improve the therapeutic index and pharmacokinetic characteristics through comprehensive chemical optimization [1] - The drug reduces the number of active myosin cross-bridges per heartbeat, thereby inhibiting excessive myocardial contraction associated with hypertrophic cardiomyopathy [1] - Aficamten has a short half-life of only 3-4 days and can reach optimal dosing within 8 weeks [1] Group 2 - In 2020, Cytokinetics granted an exclusive license to Jiseng Pharmaceutical for the development and commercialization of Aficamten in the Greater China region [1] - In 2024, Sanofi will acquire the exclusive development and commercialization rights for Aficamten in Greater China from Jiseng Pharmaceutical [1] - Aficamten is considered a potential "best-in-class" treatment in the field of hypertrophic cardiomyopathy, and its approval marks the "global first launch" of this innovative drug in China, ahead of approvals in the US and EU [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 *僅供識別 1 自願性及業務進展公告 創新藥心肌肌球蛋白抑制劑CMS-D003獲藥物臨床試驗批准通知書 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，本集團自主研發的創新藥CMS-D003膠囊（「CMS-D003」）於二零二五年 三月十一日獲得中國國家藥品監督管理局（「NMPA」）簽發的藥物臨床試驗批准通知 書，於三月十二日收到藥物臨床試驗批准通知書。NMPA同意本集團在中國健康以及症 狀性梗阻性肥厚型心肌病（oHCM）成人受試者中開展評價CMS-D003安全性、耐受性 及藥代動力學和藥效學特徵的臨床試驗。 CMS-D003 CMS-D003是一種小分子心肌肌球蛋白抑制劑，是靶向治療肥厚型心肌病的藥物。通過 靶向抑制心肌肌球蛋白三磷酸腺苷（ATP）酶，抑制肌球蛋白-肌動蛋白相互作用，減少 肌絲滑動，抑制心肌的過度收縮，改善心 ...