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海思科(002653.SZ):創新藥HSK21542注射液新適應症IND申請獲受理
格隆匯 05-24 15:56

格隆匯5月24日丨海思科(002653.SZ)公佈,公司全資子公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(“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、瘙癢等適應症的治療。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。

該品種“急慢性疼痛”適應症201910月獲得國家藥品監督管理局下發的《受理通知書》,受理號為CXHL1900316/CXHL1900317,於201912月獲許進入臨牀III期臨牀試驗方案20213獲得CDE同意“瘙癢症”適應症20202月獲得國家藥品監督管理局下發的《受理通知書》,受理號為CXHL2000068/CXHL200006920205獲許進入臨牀此次獲得受理的適應症為“肝病瘙癢”

HSK21542注射液201910-202010月在澳洲開展了I期臨牀試驗20201-20209月在中國開展了I期臨牀試驗20206-20212月在中國開展了用於腹部腔鏡手術術後鎮痛的II期臨牀試驗,目前正在進行該適應症的III期臨牀試驗

除上述適應症和臨牀試驗外,HSK21542目前還在開展在血液透析受試者中的II期臨牀試驗。

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