海思科(002653.SZ):環泊酚乳狀注射液擬納入優先審評
格隆匯2月20日丨海思科(002653.SZ)公佈,公司於2020年02月20日獲悉,公司全資子公司四川海思科製藥有限公司的環泊酚乳狀注射液被國家藥品監督管理局藥品審評中心納入《擬優先審評品種公示》名單,公示截止日期2020年02月27日。
藥品名稱:環泊酚乳狀注射液;劑型:注射劑;規格:5ml:50mg;申請階段:生產;註冊分類:化學藥品1類;申請人:四川海思科製藥有限公司;受理號:CXHS2000001;擬優先審評理由:經審核,本申請符合《總局關於鼓勵藥品創新實行優先審評審批的意見》(食藥監藥化管[2017]126號)規定的優先審評審批範圍,同意按優先審評範圍(一)3款具有明顯治療優勢創新藥納入優先審評程序。
環泊酚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。
國家藥品監督管理局於2019年07月29日受理“消化道內鏡診斷和治療鎮靜和/或麻醉”適應症的新藥申請(特殊審批程序),並於2019年08月02日承辦公司遞交的藥品註冊申請。
國家藥品監督管理局於2020年01月19日受理“全身麻醉誘導”適應症新藥申請(特殊審批程序),並於2020年01月22日承辦公司遞交的藥品註冊申請。
此次環泊酚乳狀注射液被納入優先審評程序不會對公司當期生產經營產生重大影響。
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