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海思科(002653.SZ):創新藥HSK3486乳狀注射液獲得受理通知書及藥物臨牀試驗批准通知書
格隆匯 10-11 20:22

格隆匯10月11日丨海思科(002653.SZ)宣佈,公司的全資子公司四川海思科於近日收到國家藥品監督管理局下發的《受理通知書》、《藥物臨牀試驗批准通知書》。

《受理通知書》顯示,藥品名稱為HSK3486乳狀注射液;規格為20ml:200mg;申請事項為境內生產藥品註冊根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。

《藥物臨牀試驗批准通知書》顯示,藥品名稱為HSK3486乳狀注射液;規格為20ml:50mg。根據《中華人民共和國藥品管理法》及有關規定,經審查,2020年8月受理的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“全麻維持”的Ⅲ期臨牀試驗。

HSK3486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。

國家藥品監督管理局此次受理HSK3486乳狀注射液的“重症監護期間的鎮靜”適應症境內生產藥品註冊及批准開展“全麻維持”的Ⅲ期臨牀試驗申請,標誌該產品可申請開展新的適應症“重症監護期間的鎮靜”Ⅲ期臨牀試驗,同時可以開展適應症“全麻維持”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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