海思科(002653.SZ)HSK3486乳狀注射液擬納入優先審評
格隆匯8月21日丨海思科(002653.SZ)公佈,公司於2019年08月21日獲悉,公司全資子公司遼寧海思科製藥有限公司的HSK3486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2019年08月28日。
藥品名稱為HSK3486乳狀注射液;劑型為注射劑;規格為20ml:50mg;申報階段為生產;註冊分類為化學藥品1類。
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。
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。2019年08月02日,國家藥品監督管理局藥品審評中心承辦公司遞交的藥品註冊申請。
此次HSK3486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。由於醫藥產品具有高科技、高風險、高附加值的特點,藥品研發容易受到技術、審批、政策等多方面因素的影響,審評政策及未來產品市場競爭形勢等存在諸多不確定性風險,上述產品存在優先審評程序藥品註冊申請公示期被提出異議的風險,且能否成功上市及上市時間具有不確定性。
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