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科倫藥業(002422.SZ):氨基酸(15)腹膜透析液獲批上市
格隆匯 06-21 11:49

格隆匯6月21日丨科倫藥業(002422.SZ)宣佈,公司的化學藥品“氨基酸(15)腹膜透析液”於近日獲得國家藥品監督管理局的藥品註冊批准。

氨基酸(15)腹膜透析液為百特開發,目前已在英國、意大利、西班牙等多個歐洲國家獲批上市,主要用於腎衰竭患者的腹膜透析治療,尤其適用於營養不良(血清白蛋白低於35g/L)的慢性腎功能衰竭患者。

國內臨牀常用的腹膜透析液採用葡萄糖作為滲透劑,存在生物不相容、高糖以及葡萄糖降解產物引起腹膜纖維化導致腹膜功能改變和超濾失敗的缺點。此外,營養不良為終末期腎衰竭患者的常見併發症,也是引起腹膜透析預後不良的重要因素。氨基酸(15)腹膜透析液為全球唯一含營養成分(多種氨基酸)的腹膜透析液,以氨基酸替代葡萄糖作為滲透劑,可減少對腹膜的損害、糾正鈣磷代謝紊亂、改善患者的營養狀態,有望為營養不良和糖尿病慢性腎衰竭患者提供更具臨牀優勢的解決方案。2020年中國腹膜透析液銷售42億元。

公司已有系列腹膜透析液及其他血液淨化製品批准上市,為血液淨化領域的專業服務商,此次公司的氨基酸(15)腹膜透析液獲批,將進一步豐富公司在血液淨化領域的產品管線,併為臨牀提供新的用藥選擇。

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