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廣生堂(300436.SZ):乙肝治療一類創新藥GST-HG131聯合GST-HG141針對乙肝經治患者的的臨牀試驗申請獲得受理
格隆匯 03-17 20:12

格隆匯3月17日丨廣生堂(300436.SZ)公佈,公司創新藥控股子公司福建廣生中霖生物科技有限公司(簡稱“廣生中霖”)於近日收到國家藥品監督管理局下發的關於乙肝治療創新藥GST-HG131聯合GST-HG141的臨牀試驗申請《受理通知書》,擬針對核苷(酸)類似物NUC經治乙肝患者,挑戰臨牀治癒乙肝。前述II期臨牀研究已於日前被納入優化創新藥臨牀試驗審評審批試點項目,將有效縮短本次臨牀試驗申請的審評審批週期。

基於GST-HG131和GST-HG141的臨牀前研究和臨牀研究結果,GST-HG131片對HBsAg具有顯著抑制作用,GST-HG141片對HBVDNA和pgRNA具有顯著抑制和耗竭作用,兩者在抗病毒機制上預計存在協同互補。GST-HG131聯合GST-HG141的II期臨牀研究旨在探索基於核苷(酸)類似物基礎治療上,GST-HG131片聯合GST-HG141片在慢性乙型肝炎患者中的安全性、耐受性、有效性,以期為乙肝患者提供更有效的治療選擇,致力於實現公司乙肝登峯計劃,三聯全口服用藥挑戰乙肝臨牀治癒。

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