華仁藥業(300110.SZ):低鈣腹膜透析液(乳酸鹽-G1.76%)及低鈣腹膜透析液(乳酸鹽-G2.55%)獲批上市
格隆匯1月6日丨華仁藥業(300110.SZ)公佈,近日,華仁藥業股份有限公司(以下簡稱“公司”)收到國家藥品監督管理局核准簽發的“低鈣腹膜透析液(乳酸鹽-G1.76%)”與“低鈣腹膜透析液(乳酸鹽-G2.55%)”的《藥品註冊證書》。
公司該次獲得註冊證書的低鈣腹膜透析液(乳酸鹽)適用於需要進行腹膜透析治療的慢性腎功能衰竭患者,屬於國家醫保甲類產品,國家基藥品種。公司該次獲得註冊證書的低鈣腹膜透析液(乳酸鹽)同時含有乳酸鹽及少量的碳酸氫鹽,是採用有弱焊隔層的雙室軟袋包裝的中性pH腹膜透析液,使用前混合,混合後藥液呈生理性pH值,根據國內外已有相關研究,相較於傳統腹膜透析液,具有保留殘餘腎功能、保護腹膜功能、改善灌入痛等優勢,將為腹膜透析患者帶來新的治療選擇。
低鈣腹膜透析液產品由美國Baxter公司研發,於1992年在美國批准上市。目前國內共有7家企業取得了低鈣腹膜透析液的註冊證書,其中已獲得與公司該次獲批藥品同類規格腹膜透析液(即採用雙室袋包裝的中性pH腹膜透析液)註冊證書的企業僅有威高泰爾茂(威海)醫療製品有限公司1家。(數據來源:國家藥品監督管理局網站)
根據米內網數據統計,2021年低鈣腹膜透析液(乳酸鹽)在中國城市公立醫院銷售額約為2.45億元。
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