绿叶制药旗下调脂药物血脂康正式获准在港注册上市

2017-12-05 佚名 MedSci原创

上海2017年12月4日电 /美通社/ -- 绿叶制药集团(02186.HK)宣布其心血管治疗领域产品血脂康胶囊已正式在香港获准注册上市。血脂康是绿叶制药自主研发的天然他汀类调脂药物,是目前国内首个拥有大型循证证据并已完成美国FDA二期临床研究的国际公认的国产调脂药品牌。

作为绿叶制药旗下的核心产品之一,血脂康胶囊由特制红曲发酵精制而成,是包含多种有效成分的纯天然药物。血脂康的降脂疗效经由中国冠心病二级预防研究(CCSPS)及其他临床研究证实:能降低胆固醇,并显著降低冠心病患者总死亡率、冠心病死亡率以及心血管事件发生率,不良反应少。自2016年起,血脂康胶囊作为一线用药,和其他他汀类调脂药物一起被列入《中国成人血脂异常防治指南》(2016年修订版),作为调脂治疗首选。此外,从2009年及2012年起,该药物还分别被列入中国《国家医疗保险目录》及《国家基本药物目录》。

绿叶制药集团管理层表示:“我们很高兴地看到血脂康在香港正式获批注册上市。血脂康是绿叶制药自主研发的创新药物,其降脂疗效已在长期临床运用中获得医生和患者的广泛认可。我们希望能将这一优质药物引入更多国家和地区,服务全球患者。”

除了中国大陆、台湾和香港地区以外,目前血脂康胶囊还在新加坡、马来西亚等国家取得当地药品注册证。此外,该药物已在美国完成二期临床试验,未来有望满足更多国际主流市场的患者需求。

作为最早在国际主流市场进行临床试验并取得突破性进展的中国制药企业之一,绿叶制药旗下30多个产品涵盖规模最大及增长速度最快的治疗领域,覆盖包括中国、美国、欧洲、澳洲、日本和韩国市场,心血管治疗领域是其聚焦的四大核心治疗领域之一。

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    2017-12-07 zhyy93
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    2017-12-07 gostraight

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