廣生堂(300436.SZ):一類廣譜抗新冠口服小分子創新藥GST-HG171關鍵性註冊臨牀試驗首例受試者入組
格隆匯12月21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片的II/III期無縫設計的關鍵性註冊臨牀試驗經中國人類遺傳資源管理辦公室特殊審批批准,現首例受試者已於2022年12月21日成功入組給藥。公司正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。
GST-HG171片是具有全球自主知識產權的強效、廣譜、安全性優異的抗新冠病毒3CL蛋白酶抑制劑,其II/III期關鍵性註冊臨牀試驗由廣州醫科大學附屬第一醫院和深圳市第三人民醫院擔任組長單位開展研究,旨在評估GST-HG171片聯合Ritonavir片在輕型/普通型新型冠狀病毒肺炎(COVID-19)患者中的國際多中心、隨機、雙盲、安慰劑對照的有效性和安全性。項目委託杭州泰格醫藥科技股份有限公司作為主要臨牀CRO公司,將快速在廣東、北京、上海、武漢、福建等超過20個主要醫療機構開展相關注冊臨牀研究。
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