東陽光藥(01558.HK)向藥監局遞交自主研發抗丙型肝炎新藥上市申請
東陽光藥(01558.HK)公布,公司自主研究及開發的抗丙型肝炎新藥磷酸依米他韋,已向國家藥品監督管理局遞交新藥上市申請,預計將於今年第三季度內獲得受理。該新藥已於內地完成II期及III期臨床試驗,為公司首個遞交上市申請的國家1類新藥,亦是將在中國實現商業化的首批國產自研DAA藥物。
據諮詢公司弗若斯特沙利文及中國疾控中心數據顯示,2017年中國丙肝患病率約1.82%,即存量患者數量約2,520萬人,且每年新發病患約20萬人。另根據艾美仕數據顯示,去年內地DAA藥物銷售金額為413.45萬美元,按年增長7.24倍,其中去年內地DAA藥物銷售金額佔抗丙肝類藥物銷售金額的份額僅為0.44%,具有可觀的增長潛力。
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