海思科(002653.SZ)：創新藥HSK3486乳狀注射液獲得受理通知書
格隆匯 8 月 17日丨海思科(002653.SZ)公佈，公司之全資子公司四川海思科製藥有限公司(“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》。
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。
HSK3486於2019年07月獲得國家藥品監督管理局受理“消化道內鏡診斷和治療鎮靜和/或麻醉”適應症及原料藥的新藥申請(特殊審批程序)(受理號：CXHS1900019/CXHS1900020)，並於2019年08月被納入優先評審；該適應症於2020年3月收到CDE下發的《補充資料通知》(藥審補字[2020]第0539號、藥審補字[2020]第0540號)，並於2020年07月遞交了書面發補資料。
HSK3486於2020年01月獲得國家藥品監督管理局受理“全身麻醉誘導”適應症新藥申請(特殊審批程序)(受理號：CXHS2000001)，並於2020年02月被納入優先評審；該適應症於2020年6月收到CDE下發的《補充資料通知》(藥審補字[2020]第1641號)，目前公司正在積極推進補充資料的相關工作，根據《補充資料通知》的要求儘快向CDE遞交相關資料。
HSK3486於2016年1月獲得國家食品藥品監督管理總局的《藥物臨牀試驗批件》；2016年5月至2016年8月在四川大學華西醫院開展了Ⅰ期臨牀試驗；2016年12月至2018年6月在四川大學華西醫院等多家中心開展了Ⅱ期(Ⅱa和Ⅱb)臨牀試驗；2018年7月至今在四川大學華西醫院等多家中心開展了HSK3486用於消化內鏡、全麻誘導、纖支鏡適應症的三項Ⅲ期臨牀試驗。
HSK3486於2020年08月國家藥品監督管理局受理“全麻維持”適應症境內生產藥品註冊(受理號：CXHL2000357國)。
國家藥品監督管理局此次受理HSK3486乳狀注射液的申請，標誌該產品可申請開展新的適應症“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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