歌禮制藥-B(01672.HK)全口服丙肝治療方案獲批上市
格隆匯 7 月 31日丨歌禮制藥-B(01672.HK)發佈公告,全口服丙肝治療方案已獲國家藥品監督管理局批准上市。公司的全口服丙肝治療方案是由拉維達韋(新力萊®)聯合達諾瑞韋(戈諾衞®)組成(RDV/DNV治療方案)。
在中國已經完成的II/III期臨牀試驗結果顯示,經過12周治療,RDV/DNV治療方案在基因1型非肝硬化患者中治癒率(SVR12)達99%,且針對基線發生NS5A耐藥突變的患者,100%實現SVR12。
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