天壇生物(600161.SH):“注射用重組人凝血因子Ⅷ”完成相關臨牀試驗並取得臨牀試驗總結報告
格隆匯8月5日丨天壇生物(600161.SH)公佈,公司下屬成都蓉生藥業有限責任公司已上市產品“注射用重組人凝血因子Ⅷ”完成了<12 歲適應症人羣的臨牀試驗並取得臨牀試驗總結報告。成都蓉生生產的“注射用重組人凝血因子Ⅷ”在<12歲人羣的Ⅲ期臨牀試驗結果顯示,使用本品進行常規預防治療能顯著降低患兒的出血頻率,患者的關節健康評分(HJHS評分)、靶關節數和生活質量評分(CHO-KLAT評分)均能獲得改善。對於預防期間的突破性出血,使用本品也能有效控制。安全性分析結果顯示,該藥物在臨牀應用過程中對該人羣血友病A患者具有良好的安全性。
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