美国国立卫生研究院药物新治疗应用计划及对我国新药研发的启示

National Institute of Health new therapeutic uses program and its enlightenment to new drug research and development in China

相对于传统新药研发模式,药物新治疗应用(NTU)投资少、周期短、风险小;但出于研发成本回收和收益的考量,制药企业进行药物再开发的意愿不高。美国国立卫生研究院自2012年实施NTU计划以来,取得良好成效。本文介绍NTU计划项目的资助遴选程序、对新药研发的促进作用和实施成效,分析该计划对药物再开发产生引导作用的机制,总结成功经验,提出有益于促进我国药物再开发行动的对策。

New therapeutic uses（NTU） program is an activity which requires less investment,shorter cycle and less risk,compared with traditional model of new drug research and development（RD）.However,due to consideration of RD costs and benefits,the willingness of pharmaceutical companies to redevelop drugs is not positive.National Institutes of Health（NIH） has achieved good results since the implementation of NTU program from 2012.This paper introduced the funding and selection process,and promotion and implementation effect on new drug RD of NTU program,analyzed guiding mechanism of NTU for drug redevelopment,summarized successful experience,and put forward the countermeasures to promote drug redevelopment activities in China.