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廣生堂(300436.SZ):乙肝治療全球創新藥GST-HG141獲臨牀試驗倫理委員會批件
格隆匯 04-23 18:17

格隆匯4月23日丨廣生堂(300436.SZ)公佈,公司於近日獲得吉林大學第一醫院倫理委員會出具的關於乙肝治療全球創新藥GST-HG141的臨牀試驗與研究審批件,標誌着I期臨牀試驗方案已經通過審核確定,試驗已經獲准進入實質性開展期。

GST-HG141項目I期臨牀試驗由上海方達生物技術有限公司承接,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)。

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,是公司乙肝臨牀治癒“登峯計劃”最重要的組成藥物之一,未來公司將啟動與乙肝表面抗原抑制劑GST-HG131(First-in-Class)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。

公司將嚴格按照國家藥品監督管理局藥物臨牀試驗相關規定儘快開展GST-HG141項目人體臨牀試驗,進一步證實其安全性和有效性。該項目尚需開展I期、II期、III期臨牀研究並經國家藥品審評部門審批通過後方可上市。

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