天壇生物(600161.SH):“注射用重組人凝血因子Ⅷ-Fc融合蛋白”完成Ⅰ期臨牀試驗並取得臨牀試驗總結報告
格隆匯8月11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(簡稱“成都蓉生”)研製的“注射用重組人凝血因子Ⅷ-Fc融合蛋白”完成了Ⅰ期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-Fc融合蛋白”在成人及青少年(≥12歲)重型血友病A患者I期臨牀研究結果顯示:藥代動力學方面,與對照藥(任捷)相比,本品半衰期比對照藥延長約1.5~1.7倍;藥效學方面,使用本品後顯著縮短活化部分凝血活酶時間(APTT),有利於臨牀止血;安全性方面,本品不良反應發生率低,常見不良反應類型符合國外同類產品說明書已發佈不良反應類型。
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