天士力(600535.SH):子公司苯扎貝特緩釋片獲批上市
格隆匯10月21日丨天士力(600535.SH)公佈,近日,公司全資子公司江蘇天士力帝益藥業有限公司(“帝益藥業”)收到國家藥品監督管理局核准簽發的苯扎貝特緩釋片《藥品註冊證書》。
苯扎貝特緩釋片於2019年10月完成BE試驗,2019年11月申報CDE技術評審(受理號:CYHS1900855),於近日獲得國家藥監局核准簽發的《藥品註冊證書》(證書編號:2021S01071)。截至目前,帝益藥業對該項目累計研發投入為908.27萬元人民幣。
苯扎貝特為降血脂藥物,能顯著降低血液中的甘油三酯,升高高密度脂蛋白水平。原研藥苯扎貝特緩釋片(0.4g)商品名為Bezalip®SR,於1994年12月在加拿大上市,持證商為Actavis Specialty Pharmaceuticals Co.。公司苯扎貝特緩釋片與Bezalip®SR質量和療效一致。
貝特類藥物在臨牀應用中對降甘油三酯有着明顯的優勢,為降甘油三酯首選藥物之一。苯扎貝特緩釋片作為常用的貝特類藥物,口服吸收迅速、患者依從性高。根據國家心血管病中心發佈的《中國心血管健康與疾病報吿》(2019年版),我國成人血脂異常患病率從2002年的18.6%持續上升至2012年的40.4%,血脂異常總體患病率隨年齡增長而升高。血脂異常通常指血漿中膽固醇和(或)甘油三酯升高,俗稱高脂血症。米內網化學藥醫療終端數據顯示國內城市公立、縣級公立苯扎貝特2020年銷售額為4075萬。目前國內尚無苯扎貝特緩釋片相關進口或批准信息。
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