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恆瑞醫藥(600276.SH):甲磺酸阿帕替尼片註冊申請獲受理
格隆匯 02-14 16:28

格隆匯2月14日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司已於近期完成甲磺酸阿帕替尼片針對既往接受過至少一線系統性治療後失敗或不可耐受的晚期肝細胞癌患者的III期臨牀試驗,該藥品註冊申請已獲國家藥品監督管理局受理。

甲磺酸阿帕替尼是公司創新研發的小分子靶向藥物,2014年獲批上市用於治療既往至少接受過2種系統化療後進展或復發的晚期胃腺癌或胃-食管結合部腺癌患者。經查詢,甲磺酸阿帕替尼目前國內外有Solafeinib、Sunitinib等同類產品已獲批上市。Solafeinib由拜耳公司開發,最早於2005年在美國獲批上市;Sunitinib由輝瑞公司開發,最早於2006年在美國獲批上市。2018年甲磺酸阿帕替尼銷售額約為17億元人民幣。

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