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恆瑞醫藥(600276.SH):撤回沙美特羅替卡松粉吸入劑藥品註冊申請
格隆匯 04-09 16:57

格隆匯4月9日丨恆瑞醫藥(600276.SH)宣佈,近日,公司根據國家藥監局關於藥品審評審批的最新政策,並結合公司實際情況,向國家藥監局提交了撤回沙美特羅替卡松粉吸入劑藥品註冊申請。截至目前,該產品累計已投入研發費用約為3353萬元。

沙美特羅替卡松粉吸入劑以聯合用藥形式(支氣管擴張劑和吸入糖皮質激素),擬用於可逆性氣道阻塞性氣道疾病的規律治療,包括成人和兒童哮喘。沙美特羅替卡松粉吸入劑含有沙美特羅與丙酸氟替卡松,兩者有不同的作用方式,沙美特羅起控制症狀的作用,而丙酸氟替卡松能改善肺功能並預防病情惡化,二者結合能為同時使用β-受體激動劑和吸入型皮質激素治療的患者提供更方便的方案。

沙美特羅替卡松粉吸入劑由Glaxo Wellcome公司開發,最早於1999年3月在英國上市,商品名為Seretide,2000年8月獲美國FDA批准,商品名為Advair Diskus,現已在全球廣泛上市。國內目前已批准進口Glaxo Wellcome UK Limited的沙美特羅替卡松粉吸入劑,商品名為舒利迭。經查詢,除公司外,國內已有天津信諾、努泰克、潤生藥業等廠家申報生產,目前未見獲批上市信息。

經查詢Evaluate Pharma數據庫,沙美特羅替卡松粉吸入劑2020年全球銷售額為28.07億美元。

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