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廣生堂(300436.SZ):乙肝治療創新藥GST-HG131獲得II期臨牀研究總結報告

格隆匯5月14日丨廣生堂(300436.SZ)公佈,公司乙肝治療創新藥GST-HG131已完成慢性乙型肝炎II期臨牀試驗,並於近日獲得II期臨牀試驗的研究總結報告。研究結果顯示,GST-HG131片對慢性乙型肝炎患者的乙肝表面抗原HBsAg有明顯抑制效果,且安全性良好。

乙肝HBsAg對維持HBV持續感染起到重要作用,患者長期暴露在高水平的HBsAg下產生的特異性T細胞凋亡和免疫耗竭狀態是HBV難以清除的重要原因,降低HBsAg對於乙肝臨牀治癒具有重要意義,因此HBsAg的持續清除被作爲目前乙肝臨牀治癒的主要終點之一。GST-HG131是一種口服小分子HBsAg抑制劑,能夠顯著抑制乙肝HBsAg的表達,從而發揮抗病毒作用,其作用機制是通過抑制HBVRNA的poly(A)尾部聚合,降低HBVRNA的穩定性而加速其降解。臨牀前研究表明GST-HG131片具有良好的藥理學特性,對靶點具有高親和力和特異性,且在動物模型中顯著降低血清中HBsAg水平。迄今爲止,全球範圍內尚無同類產品上市。

GST-HG131明顯降低慢性乙型肝炎患者HBsAg水平,爲公司未來聯合核衣殼抑制劑GST-HG141(2024年12月被納入突破性治療品種)推動實現乙肝臨牀治癒提供新的策略和可能。

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