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普利製藥(300630.SZ):注射用艾司奧美拉唑鈉獲中國藥品註冊批件
格隆匯 10-10 18:15

格隆匯10月10日丨普利製藥(300630.SZ)公佈,公司於近日收到國家藥品監督管理局簽發的注射用艾司奧美拉唑鈉的藥品註冊批件。

艾司奧美拉唑,又名埃索美拉唑,是奧美拉唑的單一左旋異構體,兩者均屬於質子泵抑制劑,能有效抑制胃酸分泌,臨牀上用於治療胃食管反流性疾病、糜爛性反流性食管炎等。該藥是最成功的異構體開發範例之一,較第一代的奧美拉唑而言,其抑制胃酸的效果更強,不良反應也更小。該藥最早由阿斯利康研發,2000年其口服制劑在瑞典上市,商品名為Nexium,其注射劑於2003年推出,於2005年03月獲美國食品藥品監督管理局(FDA)批准上市。

普利製藥的注射用艾司奧美拉唑鈉成功研發後,分別遞交美國、歐洲和中國的仿製藥註冊申請。2022年2月獲得美國食品藥品監督管理局(FDA)批准上市,2022年3月獲得荷蘭的上市許可。近日,公司收到國家藥品監督管理局簽發的新註冊分類4類的藥品註冊批件,這標誌着普利製藥的注射用艾司奧美拉唑鈉具備了在中國上市銷售的資格,對公司拓展國內市場帶來積極影響。

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