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批準
格隆匯4月24日丨廣生堂(300436.SZ)公佈,2025年4月24日,福建廣生堂藥業股份有限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”)收到國家藥品監督管理局下發的《藥物臨牀試驗批準通知書》,同意GST-HG131聯合GSTHG141用於慢性乙型肝炎的治療的臨牀試驗。前述聯合方案於今年3月被納入“優化創新藥臨牀試驗審評審批試點項目”和此次臨牀試驗申請獲得高效批準,均體現了國家對重大創新藥物研發的高度重視和政策支持。公司將積極推動三聯全口服治療乙肝用藥方案,針對核苷(酸)類似物經治乙肝患者,挑戰臨牀治癒乙肝。
GST-HG131和GST-HG141均是公司擁有自主知識產權的一類創新藥。基於GST-HG131和GST-HG141的臨牀前研究和已披露的臨牀研究結果,GST-HG131片對HBsAg具有明顯抑制作用,GST-HG141片對HBVDNA有顯著的抑制效應且明顯降低pgRNA,間接體現了對HBVcccDNA的潛在有效抑制和耗竭作用,兩者在抗病毒機制上預計協同互補。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,以期爲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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