萊美藥業(300006.SZ):艾司奧美拉唑鎂腸溶膠囊獲得藥品註冊證書
格隆匯8月16日丨萊美藥業(300006.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的20mg和40mg兩種規格的艾司奧美拉唑鎂腸溶膠囊《藥品註冊證書》。
艾司奧美拉唑鎂腸溶膠囊最早由阿斯利康研製,2001年在美國獲得FDA批准上市,2004年10月獲國家藥品監督管理局批准上市。目前國內艾司奧美拉唑鎂已上市制劑的主要劑型為片劑和膠囊劑。
艾司奧美拉唑是奧美拉唑的S-異構體,屬於質子泵抑制劑,能有效抑制胃酸分泌,臨牀上常用於:1、胃食管反流病(GERD)的治療: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NSAID治療的患者:與使用(非甾體抗炎藥)NSAID治療相關的胃潰瘍治療。
截止目前,除公司外,已有3家國產企業取得艾司奧美拉唑鎂腸溶膠囊藥品註冊證書。根據米內網數據顯示,艾司奧美拉唑口服制劑2019-2021年在中國城市公立醫院終端市場銷售額分別為16.26億元、15.33億元、11.80億元,在中國城市實體藥店終端市場銷售額分別為4.44億元、4.40億元、5.30億元。
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