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廣生堂(300436.SZ):乙肝治療First in class創新藥GST-HG141獲Ⅱ期臨牀試驗倫理委員會批件
格隆匯 02-25 11:48

格隆匯2月25日丨廣生堂(300436.SZ)公佈,公司於近日獲得吉林大學第一醫院倫理委員會出具的關於同意開展“一項評價GST-HG141聯合富馬酸丙酚替諾福韋片(TAF)在慢性乙型肝炎(CHB)患者中的有效性與安全性的多中心、隨機、雙盲、安慰劑對照的II期臨牀研究”的審查意見,標誌着公司乙肝治療創新藥GST-HG141的II期臨牀試驗方案已經通過PI臨牀單位審核確定。

公司正積極推進中國人類遺傳資源國際合作科學研究審批工作和國家藥品監督管理局藥品審評中心(CDE)審批工作,在取得前述行政許可後將盡快啟動GST-HG141的II期臨牀試驗。GST-HG141 II期臨牀試驗將由病毒性肝炎治療領域著名專家、吉林省肝病研究所所長、吉林大學第一醫院肝膽胰內科主任牛俊奇教授繼續擔任臨牀試驗負責人(PI)。

公司在研一類新藥乙肝核心蛋白抑制劑GST-HG141是全球First in class的MOA II型乙肝核心蛋白抑制劑,是公司乙肝臨牀治癒“登峯計劃”組合方案的重要組件,其Ia期臨牀試驗顯示GST-HG141片各研究劑量組在中國健康受試者中均可耐受,安全性良好,血藥濃度達到預期目標。目前已完成Ib期多中心臨牀試驗所有受試者的給藥和耐受性、藥效學和藥代動力學研究,待出具臨牀Ib期總結報吿,並將在2022年第31屆亞太肝臟研究協會年會APASL 2022 SEOUL發佈相關部分研究數據。

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