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东阳光药(01558.HK):降压药物苯磺酸氨氯地平片通过一致性评价
格隆汇 11-04 21:34

格隆汇11月4日丨东阳光药(01558.HK)宣布,公司苯磺酸氨氯地平片(5mg)已获国家药品监督管理局批准通过仿制药质量和疗效一致性评价。

苯磺酸氨氯地平片适用于高血压的治疗。高血压是引起心血管疾病最常见的独立危险因素。根据2018年中国心血管报告,推算心血管病现有病患人数2.9亿,其中患有中脑卒中1300万人,冠心病1100万人,肺原性心脏病500万人,心力衰竭450万人,风湿性心脏病250万人,先天性心脏病200万人,高血压2.45亿人。心血管病死亡率居首位,高於肿瘤及其他疾病,心血管疾病占居民疾病死亡因素的40%以上,而高血压是总体疾病死亡因素的第一危险因素。

降压药分为五大类:钙离子拮抗剂(CCB)、β-受体阻滞剂、利尿剂、血管紧张素转换酶抑制剂(ACEI)及血管紧张素II受体拮抗剂(ARB),其中CCB类市场占有率最高。苯磺酸氨氯地平片属于CCB类降压药物,为中国市场应用最广泛的降血压药品。

《苯磺酸氨氯地平临床应用中国专家建议书》强调,苯磺酸氨氯地平片优先适用于老年人收缩期高血压,分别患有左心室肥厚,颈动脉或冠状动脉粥样硬化,稳定性心绞痛,脑卒中病史,外周血管病和代谢综合症的病人。美国2017ACC/AHA高血压指南,欧洲2018ESH/ESC高血压指南,中国2018高血压防治指南,均推荐苯磺酸氨氯地平为降血压的一綫用药,可以与其他4类降压药同时联合使用。

公司苯磺酸氨氯地平片成功通过一致性评价,是对公司研发能力、生产和药品质量及药品疗效的权威性认可,也使该药品在未来的市场拓展、医保支付等层面获得优势。通过仿制药一致性评价工作,集团能为提升医药行业发展质量、进一步推动中国医药产业国际化和药品生产领域的结构性改革、实现原研药的国产替代贡献一份力量。本集团将继续推动其他仿制药一致性评价进程,为广大患者提供质价双优的用药选择。

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