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安科生物(300009.SZ):富馬酸丙酚替諾福韋片生產註冊申請獲受理
格隆匯 03-23 12:36

格隆匯3月23日丨安科生物(300009.SZ)公佈,2020年3月21日,公司全資子公司安科恆益收到國家藥品監督管理局下發的富馬酸丙酚替諾福韋片生產註冊申請《受理通知書》。

富馬酸丙酚替諾福韋片適用於治療成人和青少年(年齡12歲及以上,體重至少為35kg)慢性乙型肝炎。由美國製藥公司吉利德(Gilead)研製,於2016年11月被FDA批准上市,商品名為Vemlidy®,2018年11月被NMPA批准上市,商品名為韋立得。

安科恆益已完成富馬酸丙酚替諾福韋片與原研製劑的體外質量與體內療效一致性評價,即與原研藥體外藥學質量一致且人體生物等效。本品生產所用的富馬酸丙酚替諾福韋原料由安科恆益自行生產,且已在國家藥品監督管理局藥品審評中心登記,登記號Y20200000***。

公司表示,富馬酸丙酚替諾福韋片若成功獲批上市,將為中國乙肝患者提供更多的用藥選擇,造福廣大乙肝患者,同時將進一步完善公司抗乙肝病毒藥物產品線,為乙肝功能性治癒提供更多的組合方案,有力提升公司市場競爭力。

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