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中國生物製藥(01177.HK):治療胃酸相關性疾病藥物“艾司奧美拉唑鎂腸溶膠囊”獲藥品註冊證書
格隆匯 02-08 16:59

格隆匯 2 月 8日丨中國生物製藥(01177.HK)發佈公吿,集團開發的治療胃酸相關性疾病藥物“艾司奧美拉唑鎂腸溶膠囊”(規格:20mg及40mg)已獲中國國家藥品監督管理局頒發藥品註冊證書。該產品按照化學藥品註冊分類新3類申報並獲批上市,且視同通過仿製藥質量和療效一致性評價。

根據披露,艾司奧美拉唑通過其特異性的質子泵抑制作用,可減少胃酸分泌,進而達到治療胃酸相關性疾病的目的。此外,艾司奧美拉唑對根除幽門螺桿菌有效。此次獲批上市的艾司奧美拉唑產品劑型為腸溶微丸充填膠囊,易於吞嚥,可大幅提高患者的順應性,而且給藥方式更為靈活(可採用與蘋果醬同服或鼻胃管方式給藥),便利兒童、老年人、精神病患者、吞嚥困難患者服用,具有明顯的臨牀使用優勢。

公司表示,胃酸相關性疾病的發病率在國內有逐漸上升的趨勢,其複發率亦較高,且治療費用高昂,給患者帶來了沉重的經濟壓力。目前國內僅有片劑的原研藥進口,膠囊劑和片劑的仿製產品為數不多,因此集團開發的艾司奧美拉唑鎂腸溶膠囊的市場容量大、發展空間可觀。

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