QIDP-美国如何从顶层设计推动抗耐药菌新药的研发  

QIDP–how the US administration prompts the development of new drugs against resistant bacteria through top-down design

作　　者：卢亮 王星海 袁征宇 

机构地区：[1]盟科医药技术(上海)有限公司,上海201203

出　　处：《中国抗生素杂志》2017年第3期176-182,共7页Chinese Journal of Antibiotics

摘　　要："限抗令"的逐渐升级导致国内药业对抗菌新药研发的动力严重不足,加剧了对耐药菌"无药可用"的困境。如何从顶层制定合适的政策来引导企业和风险投资,将更多的资源投入到新型抗菌药物的研发已成为迫在眉睫的问题。美国政府近几年执行的QIDP政策及其成功事例可以给我们很大的启示。本文整理了FDA已批准的60个QIDP药物的基本信息,并对这些信息进行简要讨论,为制定我国抗菌新药研发激励政策提供参考。With the stricter and stricter enforcing of ＂limited-use of antibiotics＂ policy, domestic pharmaceutical companies had inadequate aspiration to develop new drugs against resistant bacteria, which led to the dilemma of ＂no effective drug＂ in clinical treatments. It becomes an urgent issue to develop a top-down design that is suitable for attracting pharmaceutical companies and venture investments to put more resources into the development of new drugs against drug-resistant bacteria. To this account, the QIDP policy recently enacted by the US administration could serve as a good study case. This paper summarizes 60 FDA approved QIDP drugs and made brief discussions based on these data, which would provide valuable suggestions for the Chinese government to make suitable incentive policies for the development of new drugs against resistant bacteria.

关 键 词：限抗令 抗菌药物 耐药菌 QIDP 

分 类 号：R978.1[医药卫生—药品]