血脂康片高含量规格即将在华开展临试 绿叶制药帮助心血管患者提升依从性
绿叶制药集团(02186.HK)宣布，其天然调脂药物血脂康片的高含量规格(LY02404)已获得国家药品监督管理局许可，即将在中国开展临床试验。LY02404为已上市血脂康片的生产工艺变更品种，通过改进生产工艺，可显著提高主要有效成分含量，提升患者的服药依从性。
血脂康为绿叶制药自主研发的专利药品，分为胶囊和片剂两种剂型，目前已在中国大陆、中国台湾、中国香港、新加坡、马来西亚等国家和地区上市，市场表现良好。此次获批开展临床试验的LY02404拥有自主知识产权，并已在中国大陆和中国香港地区获得专利授权。
“此次开发的血脂康片高含量规格是对于血脂康现有制剂的有益补充。结合不同的临床需求，我们也在持续开发多元化的产品，以期为医生和患者提供更好的调脂治疗方案。”绿叶制药集团管理层表示：“血脂康是我们的核心产品之一，得益于明确的调脂疗效和安全性，该产品在长期临床运用中已获得国内外医生和患者的广泛认可，持续焕发出强大的生命力。”
市场在售的血脂康片剂和胶囊剂型，是目前国内唯一有临床硬终点获益的天然调脂药物，并已在美国完成FDA II期临床研究。包括中国冠心病二级预防研究(CCSPS)等大型临床循证医学研究均证实：血脂康能够抑制胆固醇合成，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。
基于明确的临床价值和疗效，血脂康片剂和胶囊剂型均已被纳入2019年中国《国家基本医疗保险、工伤保险和生育保险药品目录》。此外，血脂康胶囊还被《中国成人血脂异常防治指南(2016年修订版)》推荐为一线血脂管理药物，列入《国家基本药物目录(2018年版)》。
为了深度开发调脂药市场，使这一高品质药物惠及更多患者，今年1月，绿叶制药已将血脂康胶囊在中国大陆地区的推广权授予阿斯利康，此举开创了大型跨国药企推广国内高品质天然药物的先河。其后，双方再次签署战略合作备忘录，就血脂康胶囊的全球商业化进行深入合作，特别是就进入新兴市场与美国市场的合作加强沟通。目前，阿斯利康还获权在新加坡独家推广血脂康胶囊，该药物的国际化进程进一步加速。
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