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廣生堂(300436.SZ):非酒精性脂肪性肝炎及肝纖維化治療新藥GST-HG151的Ⅰ期臨牀試驗首例受試者成功入組
格隆匯 03-11 11:46

格隆匯3月11日丨廣生堂(300436.SZ)公佈,公司的創新藥控股子公司福建廣生中霖生物科技有限公司非酒精性脂肪性肝炎及肝纖維化治療新藥GST-HG151的Ⅰ期臨牀試驗首例受試者於2022年3月11日成功入組給藥,標誌着GST-HG151項目臨牀試驗已進入實質性開展期。

非酒精性脂肪性肝炎(NASH)會引起肝臟炎症,進而發展為肝纖維化和肝硬化,最終引發肝衰竭、肝癌和死亡,目前針對該疾病還沒有有效的治療藥物,是全球藥物開發的難點,市場前景廣闊。GST-HG151屬於First in class候選藥物,已入選“十三五”國家重大新藥創制科技重大專項。GST-HG151能夠起到降低炎性細胞因子的生成,調低與纖維化相關的基因表達,抑制過度細胞凋亡的作用。

GST-HG151片的I期臨牀試驗在福建醫科大學孟超肝膽醫院開展,由I期臨牀試驗研究室主任鄭玲擔任臨牀試驗負責人(PI)。該試驗旨在評價GST-HG151在健康成人受試者中單次和多次給藥的安全性、耐受性、藥代動力學及食物影響,為後續臨牀研究提供方案決策的科學數據。

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