億帆醫藥(002019.SZ):控股子公司在研產品F-627中國III期臨牀試驗結果達到預設評價結果
格隆匯1月5日丨億帆醫藥(002019.SZ)公佈,公司控股子公司健能隆醫藥技術(上海)有限公司(以下簡稱"上海健能隆")於2020年1月5日收到在研品種重組人粒細胞集落刺激因子-Fc融合蛋白(以下簡稱"F-627")中國III期臨牀試驗的《統計數據圖表合集》(Table,Listingand Figures),根據臨牀試驗數據統計結果表明,F-627中國III期臨牀試驗的有效性結果已全面達到臨牀試驗預設評價標準,療效與對照藥物(原研進口藥物重組人粒細胞集落刺激因子)相當。
另外,F-627的整體安全性良好,較對照藥物,不良事件發生率及嚴重程度等方面均無明顯差異,與F-627相關的不良反應多為輕中度,表明F-627具有良好的安全性和耐受性。同時,此次臨牀試驗有關免疫原性的篩選、確證及中和抗體檢測方法按美國食品藥品監督管理局(以下簡稱"FDA")最新指導原則方法開發和驗證,此次免疫原性中和抗體檢測最終結果均為陰性。此次F-627中國III期臨牀試驗結果標誌着上海健能隆自主研發的F-627在國內III期臨牀試驗有效性與安全性均達到預設評價標準,取得了圓滿成功。
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