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海思科(002653.SZ):國家藥監局批准HSK3486開展“ICU期間鎮靜”Ⅲ期臨試申請
格隆匯 12-16 17:58

格隆匯12月16日丨海思科(002653.SZ)宣佈,公司之全資子公司四川海思科於近日收到國家藥監局核准簽發的關於HSK3486乳狀注射液的《藥物臨牀試驗批准通知書》。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2020年9月29日受理的HSK3486乳狀注射液符合藥品註冊的有關要求,同意該藥品開展用於重症監護(ICU)期間鎮靜的Ⅲ期臨牀試驗。

HSK3486乳狀注射液是公司開發的全新的具有自主知識產權的靜脈麻醉藥物,擬用於手術全麻誘導、內鏡診療的鎮靜/麻醉、ICU鎮靜等適應症。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。

HSK3486於2020年9月獲得藥監局受理“重症監護期間的鎮靜”適應症境內生產藥品註冊(受理號:CXHL2000515國);近日藥監局同意該品種開展用於重症監護(ICU)期間鎮靜的Ⅲ期臨牀試驗。

公司表示,國家藥監局此次批准HSK3486開展“重症監護(ICU)期間鎮靜”Ⅲ期臨牀試驗申請,標誌該產品可以開展適應症“重症監護(ICU)期間鎮靜”Ⅲ期臨牀試驗,如相關臨牀試驗成功將有望進一步拓寬其適應症,增強市場競爭力。

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