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海思科(002653.SZ):一類新藥HSK21542注射液獲准臨牀試驗
格隆匯 12-24 17:10

格隆匯12月24日丨海思科(002653.SZ)公佈,公司20191223日查詢到1類新藥HSK21542注射液在國家食品藥品監督管理局藥品審評中心網站公示的《臨牀試驗默示許可》當中,表明公司已獲得該品種的臨牀試驗許可

HSK21542注射液(“HSK21542”)是公司開發的全新的具有自主知識產權的鎮痛藥物,擬用於急慢性疼痛的治療。按我國新化學藥品註冊分類規定,其藥品註冊分類為化藥1類。臨牀前研究表明,HSK21542為外周kappa 阿片受體的選擇性激動劑,具有強效且長效的鎮痛作用,本品不易透過血腦屏障,在發揮外周鎮痛的同時,能避免中樞阿片類藥物相關副作用,如致幻、成癮、呼吸抑制等。這些特點表明HSK21542具有藥效顯著、安全性良好等明顯臨牀優勢,可為眾多的急慢性疼痛患者提供更優的用藥選擇。

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