海思科(002653.SZ)獲得創新藥HSK21542注射液新藥申請受理通知書
格隆匯10月20日丨海思科(002653.SZ)公佈,公司及公司全資子公司四川海思科製藥有限公司、遼寧海思科製藥有限公司於近日收到國家藥品監督管理局下發的《受理通知書》,藥品名稱為HSK21542注射液。
HSK21542注射液(以下簡稱“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。該項目尚未開展臨牀研究,公司將積極推進該項工作儘快啟動。
據臨牀前研究,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,如成癮、致幻、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。
截至目前,公司在HSK21542注射液的研發投入約2,000萬元。
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