廣生堂(300436.SZ):乙肝治療一類創新藥奈瑞可韋GST-HG141的III期臨牀試驗首例受試者成功入組
格隆匯7月25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的在研乙肝治療一類創新藥奈瑞可韋GST-HG141的III期臨牀試驗,已於2025年7月25日在樹蘭(杭州)醫院完成首例受試者成功入組給藥。公司將繼續加快創新藥臨牀研究進展,爭取早日為廣大乙肝患者提供更好的科學解決方案。
本次入組開展的GST-HG141的III期臨牀是“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”,已獲得組長單位樹蘭(杭州)醫院、北京大學第一醫院的倫理委員會同意,並已開始入組患者。
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,專利保護有效期20年(自授權日起算)。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HBV DNA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,因此可能成為新的乙肝治療基石藥物,重構乙肝防線。
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