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羅欣藥業(002793.SZ):注射用艾司奧美拉唑鈉獲批上市
格隆匯 02-08 17:19

格隆匯2月8日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司山東裕欣藥業有限公司(“山東裕欣”)於近日收到國家藥品監督管理局核准簽發的注射用艾司奧美拉唑鈉《藥品註冊證書》。

注射用艾司奧美拉唑鈉是一種應用於臨牀的光學異構體質子泵抑制劑(PPI)。可作為當口服療法不適用時,胃食管反流病的替代療法,用於口服療法不適用的急性胃或十二指腸潰瘍出血的低危患者(胃鏡下Forrest分級IIc-III),用於降低成人胃和十二指腸潰瘍出血內鏡治療後再出血風險,預防重症患者應激性潰瘍出血。

注射用艾司奧美拉唑鈉是由阿斯利康製藥公司(AstraZeneca AB)研製開發的第一個應用於臨牀的光學異構體質子泵抑制劑(PPI),2003年率先在瑞典上市,商品名為NEXIUM®

I.V,2005年3月31日在FDA批准上市,2007年在中國批准上市。

山東裕欣於2019年6月向國家藥品監督管理局藥品審評中心按照化學藥品新註冊分類4類進行申報並獲得受理。

根據IQVIA數據,注射用艾司奧美拉唑鈉2019年度在全球的銷售金額為3.9億美元(以出廠價計算),在我國境內銷售金額為31億元人民幣(以招標價計算)。

注射用艾司奧美拉唑鈉是公司具有傳統優勢的消化領域的產品,公司在消化領域一直具備較強的市場競爭力,注射用艾司奧美拉唑鈉獲得藥品註冊批件,視同通過一致性評價,將進一步提升公司的市場競爭力,擴大市場份額,對公司產生積極影響。

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