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廣生堂(300436.SZ):乙肝治療全球創新藥GST-HG141臨牀試驗首例受試者成功入組
格隆匯 05-28 11:46

格隆匯5月28日丨廣生堂(300436.SZ)宣佈,公司乙肝治療全球創新藥GST-HG141臨牀試驗首例受試者於2020年5月28日成功入組給藥。

乙肝核心蛋白抑制劑GST-HG141系全新靶點的抗乙肝病毒1類新藥,可以抑制HBV(乙肝病毒)衣殼的脱殼與組裝,動物體內藥效試驗展現了優異的病毒抑制作用,是公司乙肝臨牀治癒“登峯計劃”重要組成藥物之一。目前,乙肝核心蛋白抑制劑是唯一能夠觸及HBV cccDNA的小分子藥物類型,對於乙肝臨牀治癒至關重要,是全球研究的熱點。

GST-HG141項目I期臨牀試驗在吉林大學第一醫院開展,由病毒性肝炎治療領域著名專家、吉林省肝病研究所所長、吉林大學第一醫院肝病科主任牛俊奇教授擔任I期臨牀試驗負責人(PI)。

I期臨牀旨在評價GST-HG141在健康受試者中單中心、隨機、雙盲、安慰劑對照多劑量、單次給藥、多次給藥的耐受性及藥代動力學,為Ⅱ期臨牀研究提供方案決策的科學數據。未來公司將啟動與乙肝表面抗原抑制劑GST-HG131或GST-HG121以及核苷(酸)類似物藥物聯合臨牀治癒乙肝的藥物組合研究。

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