億帆醫藥(002019.SZ):在研產品F-627第二個國際III期關鍵性臨牀試驗結果達到預設臨牀終點
格隆匯 6 月 29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(“上海健能隆”)自主研發的在研品種重組人粒細胞集落刺激因子-Fc融合蛋白(“F-627”)在美國食品藥品監督管理局(“美國FDA”)同意下開展的第二個國際III期臨牀試驗(研究編號:GC-627-05,“05試驗”),在完成數據清理、盲態數據審核、數據庫鎖定等流程後,於近日收到05試驗的《統計數據圖表合集》(Tables, Listing and Figures),根據05試驗臨牀數據統計結果,F-627在美國及歐洲開展的第二個國際III期臨牀試驗成功達到預設主要療效終點(Primary end point)和次要療效終點(secondary endpoint),藥物療效與對照藥品(原研品種Neulasta®)相當。另外,F-627的整體安全性良好,較原研對照藥品,不良事件發生率及嚴重程度等方面均無明顯差異,與F-627相關的不良事件多為輕中度,表明F-627具有良好的安全性和耐受性。
本次F-627第二個國際III期臨牀試驗結果標誌着上海健能隆自主研發的F-627在國際III期臨牀試驗的有效性與安全性均達到預設評價標準,標誌着上海健能隆自主研發的生物創新藥F-627的05試驗這一關鍵臨牀試驗的成功,也標志着F-627在中國、美國同時開展的所有臨牀試驗的成功,是在研項目F-627新藥開發的關鍵里程碑事件。
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