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廣生堂(300436.SZ):乙肝治療創新藥奈瑞可韋GST-HG141獲得III期臨牀試驗倫理審查批件
格隆匯 06-15 16:23

格隆匯6月15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”)於近日獲得樹蘭(杭州)醫院臨牀試驗倫理委員會出具的同意“GST-HG141 用於慢性乙型肝炎(CHB)抗病毒藥物應答不佳患者聯合治療(add-on)的隨機、雙盲、安慰劑對照、多中心 III期臨牀試驗”的倫理審查批件,標誌着 GST-HG141 的 III 期臨牀試驗方案已經通過組長單位審核確定,將由樹蘭(杭州)醫院李蘭娟院士擔任主要研究者(PI)。公司將繼續積極推進另一組長單位北京大學第一醫院(王貴強教授擔任 PI)及其他研究中心的倫理委員會審評,並組織開展臨牀研究。

奈瑞可韋 GST-HG141 是新型乙肝核心蛋白/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。迄今為止,全球範圍內尚無同類產品上市。Ib 期和 II 期臨牀試驗研究結果顯示,GST-HG141 片具有顯著藥效和良好的安全性,並且起效快,在核苷類藥物治療基礎上對 HBVDNA 具有進一步顯著優勢的抑制效果,且明顯降低 HBV pgRNA,間接體現了對 HBV cccDNA 的潛在有效抑制和耗竭作用,因此可能成為新基石藥物,重構乙肝防線。2024 年 11 月,GST-HG141 的 II 期臨牀研究成果被全球肝病研究領域的權威專業學術機構美國肝病研究協會(AASLD)作為最新突破摘要(Late-breaking Abstract)形式接受並展示。2024 年 12 月,GST-HG141 被國家藥品監督管理局藥品審評中心納入突破性治療品種名單。

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