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中國生物製藥(01177.HK):泌尿系統藥物“米拉貝隆緩釋片”獲藥品註冊證書
格隆匯 03-17 06:48

格隆匯3月17日丨中國生物製藥(01177.HK)發佈公吿,集團開發的泌尿系統藥物“米拉貝隆緩釋片”(商標名:固正)獲得中國國家藥品監督管理局頒發藥品註冊證書。該產品按化學藥品4類申報,視同通過仿製藥質量和療效一致性評價,同品種國內仿製藥第二家獲批。

根據披露,米拉貝隆是一款選擇性β-腎上腺受體激動劑,用於成年膀胱過度活動症(OAB)患者尿急、尿頻和╱ 或急迫性尿失禁的對症治療。米拉貝隆通過作用於β腎上腺素受體,選擇性鬆弛膀胱逼尿肌、促進尿液儲存,從而增加膀胱容量和延長排尿間隔,且不影響膀胱排空。米拉貝隆在中國已被列入國家藥品監督管理局藥品審評中心(CDE)發佈的《第二批鼓勵仿製藥品目錄》,2020年進入國家醫保。集團米拉貝隆緩釋片的獲批,為國內膀胱過度活動症患者提供了新的用藥選擇。

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