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江蘇吳中(600200.SH):注射用艾司奧美拉唑鈉獲藥品註冊證書
格隆匯 09-23 15:43

格隆匯 9 月 23日丨江蘇吳中(600200.SH)公佈,近日,公司全資子公司江蘇吳中醫藥集團有限公司下屬分支機構江蘇吳中醫藥集團有限公司蘇州製藥廠(“蘇州製藥廠”)收到了國家藥品監督管理局(“國家藥監局”)準簽發的注射用艾司奧美拉唑鈉《藥品註冊證書》。

質子泵抑制劑(PPI)是治療消化性潰瘍、胃食管反流病等酸相關疾病的首選藥物。目前臨牀上常用的PPI有奧美拉唑、蘭索拉唑、雷貝拉唑、泮托拉唑和艾司奧美拉唑5種。艾司奧美拉唑的作用機制與奧美拉唑相同,即在酸性條件下質子化,艾司奧美拉唑轉變為具有抑制H+/K+ -ATP酶活性的化合物次磺酰胺,迅速與H+/K+ -ATP酶上半胱氨酸的巰基結合形成二硫鍵,從而使酶失活,特異性抑制胃壁細胞內的H+/K+ -ATP酶活性從而抑制胃酸分泌。

蘇州製藥廠於20127月提交注射用艾司奧美拉唑鈉的註冊生產申請。2020831日,該研發項目共計已投入約579.71萬元人民幣。根據我國藥品註冊相關的法律法規要求,蘇州製藥廠在收到上述證書後,將着手啟動生產和銷售相關工作。

根據國家藥品監督管理局網站數據查詢:目前有1家國外企業(進口)AstraZeneca AB獲得該產品生產批文,國內有江蘇正大豐海製藥有限公司、博瑞製藥(蘇州)有限公司、遼寧海思科製藥有限公司等31家企業獲得該產品生產批文。

根據PDB藥物綜合數據庫的重點城市醫院典型醫院用藥數據顯示,注射用艾司奧美拉唑鈉2019年度銷售金額約10.74億元人民幣。

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