天壇生物(600161.SH):成都蓉生研製的“注射用重組人凝血因子Ⅷ”完成了Ⅲ期臨牀試驗並取得臨牀試驗總結報吿
格隆匯12月17日丨天壇生物(600161.SH)公佈,近日,北京天壇生物製品股份有限公司所屬成都蓉生藥業有限責任公司(“成都蓉生”)研製的“注射用重組人凝血因子Ⅷ”完成了Ⅲ期臨牀試驗並取得臨牀試驗總結報吿。
成都蓉生生產的注射用重組人凝血因子Ⅷ在成人及青少年(≥12歲)人羣的Ⅲ期臨牀試驗結果顯示,輸注後能顯著提升該人羣血友病A患者的凝血因子Ⅷ水平、改善凝血功能。按需使用該品,能有效改善該人羣血友病A患者的出血症狀和體徵,具有良好的療效。預防使用該品能有效降低該人羣血友病A患者的年化出血率,同時能改善患者關節健康評分和生活質量評分。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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