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奧賽康(002755.SZ):艾司奧美拉唑鎂腸溶幹混懸劑上市申請獲受理
格隆匯 12-01 20:28

格隆匯12月1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”)近日收到國家藥品監督管理局(“藥監局”)下發艾司奧美拉唑鎂腸溶幹混懸劑上市申請受理通知書》

艾司奧美拉唑是首個手性質子泵抑制劑(PPI)奧美拉唑的S-異構體,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:使與幽門螺桿菌感染相關的十二指腸潰瘍癒合,防止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療相關的胃潰瘍的治療美國FDA批准艾司奧美拉唑的口服混懸劑適用於1217歲兒童和111歲兒童的胃食管反流病短期治療是唯一獲准用於兒科患者PPI製劑產品

艾司奧美拉唑對酸不穩定,製劑採用腸溶微丸包衣,製劑難度大國內尚無該品種上市20175月,國家衞生健康委公佈了第二批鼓勵研發申報兒童藥品清單埃索美拉唑顆粒劑(10mg)在列;本品被列入 “重大新藥創制”科技重大專項2018度實施計劃第一批立項課題(課題編號:2018ZX09736007)項目之一。公司研製的艾司奧美拉唑鎂腸溶幹混懸劑獲批上市後,可進一步豐富臨牀用藥產品供應,增加患者用藥選擇性,為胃食管反流病、與適當的抗菌療法聯合用藥根除幽門螺桿菌、需要持續非甾體抗炎藥治療的患者帶來更多獲益。2020年艾司奧美拉唑口服制劑PDB數據庫顯示中國樣本醫院總銷售額達到4.24億元,銷售市場前景廣闊。

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