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海思科(002653.SZ):注射用艾司奧美拉唑鈉通過仿製藥一致性評價
格隆匯 01-28 17:04

格隆匯 1 月 28日丨海思科(002653.SZ)公佈,公司之全資子公司遼寧海思科製藥有限公司於近日收到國家藥品監督管理局下發的《藥品補充申請批准通知書》,注射用艾司奧美拉唑鈉通過仿製藥一致性評價。

公司開發的仿製產品注射用艾司奧美拉唑鈉,於2018年3月取得國家藥品監督管理局頒發的藥品註冊批件(批件號:2018S00571)。公司分別於2019年7月、2019年9月向國家藥品監督管理局提交一致性評價補充申請並獲受理。2021年1月,該產品正式獲批一致性評價。

艾司奧美拉唑鈉為新一代的質子泵抑制劑(PPI),是奧美拉唑的S-異構體,通過特異性的質子泵抑制作用減少胃酸分泌。艾司奧美拉唑鈉為弱鹼性藥物,在壁細胞泌酸微管的高酸環境中濃集並轉化為活性形式,從而抑制該部位的H+/K+-ATP酶(質子泵),對基礎胃酸分泌和刺激的胃酸分泌均產生抑制。

經查詢,注射用艾司奧美拉唑鈉的原研廠家為AstraZeneca AB,2003年首次在瑞典上市,規格為40mg(按艾司奧美拉唑計)。2007年進口中國。

據米內網數據,艾司奧美拉唑鈉2019年在城市公立及縣級公立醫院2019年銷售額為33億元,2020年上半年銷售額超過15億元。

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