廣生堂(300436.SZ):乙肝治療全球創新藥GST-HG141召開臨牀啟動會
格隆匯1月16日丨廣生堂(300436.SZ)公佈,公司於2019年11月5日獲得國家藥品監督管理局下發的關於乙肝治療全球創新藥乙肝核心蛋白抑制劑GST-HG141的《臨牀試驗通知書》。
GST-HG141是全新靶點的新型抗乙肝病毒1類新藥。近日,公司已在吉林大學第一醫院召開了GST-HG141片I期臨牀的啟動會。將由病毒性肝炎治療領域著名專家、中華傳染病學會等多家組織及雜誌的委員、領事,原吉林大學第一醫院副院長、肝膽胰內科主任牛俊奇教授擔任GST-HG141片I期臨牀試驗負責人(PI)。
公司GST-HG141項目I期臨牀試驗將由方達生物承接,承擔受試者招募和篩選、臨牀試驗項目管理和監查、臨牀生物樣品分析、總結等事項。方達生物是全方位一體化的醫藥研發合同研究組織(CRO),在藥物發現到開發過程中能夠提供綜合的、立足科學的分析研究和開發服務,致力於為製藥公司提供高品質的服務。
隨着乙肝表面抗原抑制劑GST-HG131、GST-HG121項目在中國的IND(臨牀註冊)申請和推進,公司將於2020年在全球範圍內陸續啟動針對乙肝治療新靶點的臨牀試驗和藥物組合方案研究。
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