海思科(002653.SZ):創新藥環泊酚乳狀注射液獲受理通知書
格隆匯1月19日丨海思科(002653.SZ)公告,海思科醫藥集團股份有限公司(以下簡稱“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2020年01月19日收到國家藥品監督管理局下發的《受理通知書》,基本情況如下:
環泊酚乳狀注射液(以下簡稱“環泊酚”)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。
環泊酚於2016年1月獲得國家食品藥品監督管理局下發的《藥物臨牀試驗批件》,啟動“消化道內鏡診斷和治療鎮靜和/或麻醉”和“全身麻醉誘導”適應症的臨牀試驗。“消化道內鏡診斷和治療鎮靜和/或麻醉”適應症新藥申請(特殊審批程序)於2019年07月29日獲得國家藥品監督管理局受理(受理號:CXHS1900019國、CXHS1900020國),“全身麻醉誘導”適應症新藥申請(特殊審批程序)於2020年1月19日獲得國家藥品監督管理局受理。
基於未來開拓環泊酚國際市場的考慮,公司擬在美國開展臨牀試驗,公司已於2019年7月31日與美國FDA召開了Pre-IND會議,計劃2020年底啟動美國全麻誘導III期臨牀試驗。
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