在10个亚洲国家获得新抗菌剂:亚洲对抗性病原体监测网络的研究
Young Ho Lee1, Helmi Bin Sulaiman2, Visanu Thamlikitkul3
1Division of Infectious Diseases, Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
在亚洲,获得新分子实体 (NME) 抗菌剂的机会有限,批准延迟很大. 需要采取协调一致的努力,以改善该地区这些关键抗菌剂的可用性.
科学领域:
- 药理学和传染病的研究
- 全球卫生与药物获取
- 抗微生物耐药性 抗微生物耐药性
背景情况:
- 新分子实体 (NME) 抗菌剂对于对抗多药耐药生物体至关重要.
- 这些新型药物的可用性仍然受到限制,即使在发达国家.
- 这项研究调查了亚洲国家对NME抗菌药物的可获得性.
研究的目的:
- 评估目前在亚洲的NME抗菌剂的可用性.
- 确定亚洲市场NME抗菌药物批准的模式和延迟情况.
- 了解影响该地区NME抗菌药物可用性的因素.
主要方法:
- 包括美国FDA在2010年至2024年间批准的NME抗菌剂.
- 截至2025年6月,在10个亚洲国家收集了批准状态.
- 分析了药物批准,撤销,定价和医疗保健系统的数据.
主要成果:
- 在22种含有NME的抗微生物药物中,有13种在被调查的亚洲国家获得批准.
- β-乳酸/β-乳酸酶抑制剂是最广泛批准的类别.
- 在美国FDA和亚洲国家批准之间观察到3-5年的显著延迟.
结论:
- 在亚洲,获得NME抗菌药物的机会非常有限.
- 实质性的批准延迟阻碍了关键抗生素的及时可用性.
- 加强区域努力至关重要,以改善在亚洲获得NME抗菌剂的机会.
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