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海思科(002653.SZ)獲得創新藥HSK16149膠囊新適應症藥物臨牀試驗批准通知書
格隆匯 04-17 16:39

格隆匯4月17日丨海思科(002653.SZ)公佈,公司於近日收到國家藥品監督管理局下發的《藥物臨牀試驗批准通知書》。經審查,2024年1月受理的HSK16149膠囊臨牀試驗申請符合藥品註冊的有關要求,同意本品開展臨牀試驗。

公司開發的HSK16149是一個全新的具有獨立知識產權的口服γ-氨基丁酸(γ-aminobutyric acid,GABA)類似物,HSK16149可與中樞神經系統中電壓敏感型鈣離子通道α2δ受體結合,減少中樞神經系統電壓依賴性鈣通道的鈣離子內流,從而減少穀氨酸鹽、去甲腎上腺素(Noradrenaline,NE)和P物質等興奮性神經遞質的釋放,具有鎮痛、抗癲癇和抗焦慮的活性。目前,與HSK16149同機製藥普瑞巴林為美國食品藥品管理局(FDA)推薦的FM一線治療藥物,其在國內也已經獲批准治療FM。而相比於普瑞巴林,HSK16149與α2δ亞受體結合力更強,預期止痛療效更好,有望為纖維肌痛的治療提供安全有效的新選擇。

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