阿斯利康(AZN.US)哮喘三联疗法“布地格福吸入气雾剂”在华申报上市

智通财经
Sep 17, 2025

智通财经APP获悉,9月17日,CDE网站显示,阿斯利康(AZN.US)的布地格福吸入气雾剂(英文商品名:Breztri®,中文商品名:倍泽瑞®令畅®)在华申报新适应症。根据临床试验进展,推测此次申报的适应症为哮喘。

布地格福吸入气雾剂是阿斯利康开发的一款固定剂量三联疗法,包含布地奈德(吸入糖皮质激素)、格隆溴铵(长效毒蕈碱型乙酰胆碱受体拮抗剂)、福莫特罗(长效β2肾上腺素受体激动剂)三种药物活性成分。

今年5月,阿斯利康宣布布地格福吸入气雾剂治疗哮喘的两项III期研究(KALOS和LOGOS)达到主要终点。这两项研究共纳入4461例控制不佳的哮喘成人和青少年患者,评估了布地格福吸入气雾剂对比二联疗法Symbicort®(布地奈德+福莫特罗)作为维持治疗的疗效和安全性。

结果显示,相较于Symbicort组,布地格福吸入气雾剂组患者的1秒内用力呼气量(FEV1)显著改善,并且重度哮喘恶化发生率显著降低。详细数据尚未公布。

哮喘是一种常见的慢性呼吸道疾病,其特征是气道炎症和肌肉紧缩(支气管收缩),可能导致呼吸困难。全球有多达2.62亿人受哮喘影响,估计近一半接受二联疗法的患者仍控制不佳,这会显著限制肺功能并降低生活质量。

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