奧賽康(002755.SZ):注射用艾司奧美拉唑鈉通過一致性評價
格隆匯1月13日丨奧賽康(002755.SZ)宣佈,公司全資子公司江蘇奧賽康藥業有限公司於近日收到國家藥監局核准簽發的注射用艾司奧美拉唑鈉(40mg;20mg)《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價。
注射用艾司奧美拉唑鈉的適應症為:1、作為當口服療法不適用時,胃食管反流病的替代療法。2、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)。3、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。4、預防重症患者應激性潰瘍出血。
艾司奧美拉唑為奧美拉唑的手性異構體,作為新一代的質子泵抑制劑(PPI),通過抑制胃壁細胞H+-K+-ATP酶的活性而抑制胃酸分泌。艾司奧美拉唑由阿斯利康研發,口服制劑於2000年和2001年分別在歐盟和美國上市;注射劑於2003年首次在瑞典上市,隨後於2005年和2007年分別在美國和中國上市。公司研製的注射用艾司奧美拉唑鈉於2016年在國內首家上市,規格有40mg、20mg,艾司奧美拉唑鈉及注射劑的研發及產業化被列入“重大新藥創制”國家科技重大專項課題。
根據中國藥學會CPA2019年數據顯示,注射用艾司奧美拉唑鈉在整個質子泵抑制劑中市場份額佔比23%,銷售額達16.98億元,臨牀應用廣泛,獲得臨牀高度認可。
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