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歌禮第三個丙肝創新藥ASC21臨床試驗申請獲受理

歌禮第三個丙肝創新藥ASC21臨床試驗申請獲受理

Market Information PR Newswire
By PR Newswire on 03 Jan 2019
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杭州和紹興2019年1月3日電 /美通社/ -- 歌禮製藥有限公司(歌禮製藥 1672.HK),一家致力於解決抗病毒、癌症及脂肪肝病三大領域中尚未被滿足醫療需求的生物科技公司,今日宣佈,公司第三個丙肝創新藥ASC21的臨床試驗申請已獲國家藥品監督管理局受理。

ASC21是一種與NS5B聚合酶結合的核甘酸抑制劑,通過抑制NS5B聚合酶的活性從而阻止慢性丙肝病毒感染。臨床前研究表明,ASC21是一種有效的泛基因型藥物,耐藥基因屏障高。歌禮計劃將其與拉維達韋聯用,用於治療難治型、肝硬化及HCV/HIV共感染的患者。

2018年6月,歌禮首個丙肝創新藥戈諾衛®(達諾瑞韋,ASC08)正式獲得批准上市銷售;2018年7月,歌禮提交第二個丙肝創新藥拉維達韋(ASC16)的新藥上市申請並於同年10月被納入優先審評;此次ASC21臨床試驗申請獲得受理,意味著歌禮將有望為中國丙肝患者提供更多的治療選擇。

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