廣生堂(300436.SZ):乙肝治療全球創新藥HBsAg抑制劑GST-HG131獲臨牀試驗倫理委員會審查批件
格隆匯8月3日丨廣生堂(300436.SZ)宣佈,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HBsAg抑制劑GST-HG131的臨牀試驗與研究的審查意見,標誌着Ia期臨牀試驗方案已經通過審核確定,已獲准進入實質性開展期,公司乙肝臨牀治癒“登峯計劃”全面啟航進入臨牀階段。
公司擁有全球知識產權的乙肝治療全球創新藥GST-HG131已研究開發五年,是公司乙肝臨牀治癒“登峯計劃”組合方案的重要組件。GST-HG131屬First-in-Class全球領先項目,有望成為全球首個上市的乙肝HBsAg小分子抑制劑創新藥。臨牀前體外及體內藥效學研究顯示,GST-HG131能夠誘導HBsAg mRNA降解,快速大幅降低HBsAg水平超過1Log10,且具有良好的安全性。
GST-HG131系列化合物已申請PCT國際專利,進入中國、美國、日本、歐洲等10多個國家和地區,其中國、澳門專利已獲得授權;並已佈局晶型PCT國際專利。
GST-HG131項目Ia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以及吉林大學第一醫院I期藥物臨牀試驗病房主任丁豔華教授共同擔任GST-HG131片Ia期臨牀試驗負責人(PI)。
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