樂普醫療(300003.SZ):氯沙坦鉀氫氯噻嗪片通過藥品一致性評價
格隆匯 12 月 2日丨樂普醫療(300003.SZ)公佈,公司全資子公司樂普藥業科技有限公司於近日收到國家藥品監督管理局核准簽發的關於“氯沙坦鉀氫氯噻嗪片”的《藥品補充申請批件》,該藥品通過了仿製藥質量和療效一致性評價。
氯沙坦鉀氫氯噻嗪片原研製劑為默沙東製藥生產的“海捷亞”,適用於聯合用藥治療高血壓的患者。根據《中國高血壓防治指南2018》指出,複方製劑與隨機組方的降壓聯合治療相比,複方製劑使用方便,改善治療的依從性,更有利於保障二藥聯合用藥的療效,是聯合治療的新趨勢。氯沙坦鉀與氫氯噻嗪具有協同的降壓作用,有利於增強降壓效果,且氯沙坦鉀能拮抗氫氯噻嗪長期應用可能導致的低血鉀、高血糖和高尿酸等不良反應,提高安全性和依從性,是中外高血壓指南優先推薦的聯合用藥處方。
公司生產的氯沙坦鉀氫氯噻嗪片每片含有100mg氯沙坦鉀和25mg氫氯噻嗪,是國內獨家規格通過藥品一致性評價的藥品品種。公司將藉助在心血管領域的品牌優勢,發揮樂普營銷網絡的協同效應,實現該藥品的快速放量。
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