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廣生堂(300436.SZ):乙肝治療全球創新藥HBsAg抑制劑GST-HG131獲批臨試
格隆匯 03-05 17:09

格隆匯3月5日丨廣生堂(300436.SZ)公佈,公司於2020年3月5日獲得國家藥品監督管理局下發的關於乙肝治療全球創新藥乙肝表面抗原抑制劑GST-HG131的《臨牀試驗通知書》,GST-HG131成為中國首個獲批臨牀的乙肝表面抗原(HBsAg)抑制劑!

廣生堂於2015年提出乙肝臨牀治癒路線圖,聯合戰略合作伙伴上海藥明康德新藥開發有限公司,開啟乙肝臨牀治癒“登峯計劃”研究,其開發構思與2016年9月美國肝病研究學會(AASLD)和歐洲肝臟研究學會(EASL)關於乙肝臨牀治癒的共識聲明完全吻合,且更早提出並實施。

廣生堂乙肝核心蛋白抑制劑GST-HG141、乙肝表面抗原抑制劑GST-HG131相繼獲批臨牀,讓乙肝臨牀治癒組合研究成為可能。2020年,廣生堂將開啟GST-HG131的I期臨牀試驗,並在成功之後發起單藥和聯合用藥的二期國際、多中心臨牀試驗。

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