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奧賽康(002755.SZ):艾司奧美拉唑鎂腸溶幹混懸劑獲批上市

格隆匯4月16日丨奧賽康(002755.SZ)公佈,公司全資子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)核准簽發的艾司奧美拉唑鎂腸溶幹混懸劑《藥品註冊證書》。

艾司奧美拉唑是首個手性質子泵抑制劑(PPI),系奧美拉唑的S-異構體,是通過特異性地抑制胃壁細胞H+-K+ATP酶而阻斷胃酸分泌的最後步驟。2007年,艾司奧美拉唑鎂腸溶幹混懸劑首次在瑞典批准上市(商品名:Nexium® ),規格為10mg,隨後在美國、歐洲各國及日本上市,主要適應症為(1)胃食管反流病(GERD):反流性食管炎的治療,已經治癒的食管炎患者預防復發的長期治療,GERD的症狀控制;(2)與適當的抗菌療法聯合用藥根除幽門螺桿菌,並且:癒合與幽門螺桿菌相關的十二指腸潰瘍,預防與幽門螺桿菌相關的消化性潰瘍復發;(3)需要持續非甾體抗炎藥(NSAID)治療的患者:與使用NSAID治療相關的胃潰瘍治療。美國FDA批准艾司奧美拉唑的口服混懸劑適用於12至17歲兒童和1至11歲兒童的胃食管反流病短期治療,是唯一獲准用於兒科臨牀患者的PPI製劑產品。

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