廣生堂(300436.SZ):一類廣譜抗新冠口服小分子創新藥GST-HG171獲得關鍵性註冊臨牀試驗組長單位倫理審查批件
格隆匯12月15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(簡稱“廣生中霖”)的口服小分子廣譜抗新型冠狀病毒3CL蛋白酶抑制劑一類創新藥物GST-HG171於近日獲得組長單位廣州醫科大學附屬第一醫院和深圳市第三人民醫院關於啟動II/III期臨牀試驗的倫理委員會審查批件,標誌着公司GST-HG171項目的II/III期無縫設計的關鍵性註冊臨牀研究已全面實質啟動。同時由研究者發起的在輕型/普通型新冠患者中評價初步藥效和安全性的臨牀研究(IIT研究)已順利完成全部患者入組和給藥,尚待總結報吿。公司將全力高效推進關鍵性註冊臨牀研究,爭取早日為抗疫貢獻企業力量和承擔社會責任。
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