东阳光药(01558.HK)向药监局递交自主研发抗丙型肝炎新药上市申请
东阳光药(01558.HK)公布,公司自主研究及开发的抗丙型肝炎新药磷酸依米他韦,已向国家药品监督管理局递交新药上市申请,预计将於今年第三季度内获得受理。该新药已於内地完成II期及III期临床试验,为公司首个递交上市申请的国家1类新药,亦是将在中国实现商业化的首批国产自研DAA药物。
据谘询公司弗若斯特沙利文及中国疾控中心数据显示,2017年中国丙肝患病率约1.82%,即存量患者数量约2,520万人,且每年新发病患约20万人。另根据艾美仕数据显示,去年内地DAA药物销售金额为413.45万美元,按年增长7.24倍,其中去年内地DAA药物销售金额占抗丙肝类药物销售金额的份额仅为0.44%,具有可观的增长潜力。
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