廣生堂(300436.SZ)：乙肝治療創新藥GST-HG131聯合GST-HG141的II期臨牀研究獲得優化審評審批試點項目確認書
格隆匯3月10日丨廣生堂(300436.SZ)公佈，2024年7月，國家藥品監督管理局下發《國家藥監局關於印發優化創新藥臨牀試驗審評審批試點工作方案的通知》(國藥監藥注〔2024〕21號)，持續深化藥品審評審批制度改革，提升藥品審評審批效能，支持創新藥研發，並在之後批覆同意北京作爲開展優化創新藥臨牀試驗審評審批試點的兩個試點城市之一。2025年3月10日，福建廣生堂藥業股份有限公司(簡稱“公司”)創新藥控股子公司福建廣生中霖生物科技有限公司收到北京市藥品監督管理局下發的《優化創新藥臨牀試驗審評審批試點項目確認書》，同意GST-HG131聯合GST-HG141的II期臨牀研究納入試點項目，將有效縮短臨牀審評審批週期。
GST-HG131是乙肝口服表面抗原抑制劑，能使HBVmRNA去穩定和發生降解，從而阻斷HBVmRNA的表達，有效抑制乙肝表面抗原(HBsAg)合成。目前全球範圍內尚無同類產品上市，GST-HG131爲目前針對該作用機制和靶點的唯一進入臨牀II期的口服表面抗原抑制劑，公司擁有其全球自主知識產權。2025年1月，GST-HG131已按照II期臨牀方案要求完成了計劃例數全部的患者入組。GST-HG131片II期臨牀試驗第一組研究結果顯示，GST-HG131在第一組(30mg，每日口服給藥兩次)28天研究中顯著降低慢性乙型肝炎患者血清表面抗原(HBsAg)水平，最大下降值達到1.07log10IU/ml，同時安全性和耐受性良好。
奈瑞可韋GST-HG141是新型乙肝核心蛋白或核衣殼調節劑，屬於全新機制的在研抗乙肝病毒的一類新藥，公司擁有其全球自主知識產權。迄今爲止，全球範圍內尚無同類產品上市。
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NUC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。
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