OBJECTIVE To discuss the characteristics of research and development on the new drugs of renal disease and technical considerations envolved.METHODS By investigating the advance of the regulatory agencies home and abroad and the related literature,the nephrotic drugs of the last decade in the market and in research were summerized domestically and overseas,the characteristics of research and key technical points were analyzed and relevant suggestions were put forward.RESULTS and CONCLUSIONS Ten new drugs have been approved by China,European Union and United States since 2013.The applications of the new drugs on this field has continued to increase in the recent 5 years,mainly on the chronic kidney disease and IgA nephropathy.To better promote the drug innovation development in this field,the following aspects should be paid attention to:The first is to further strengthen the basic scientific research about the pathogenesis of diseases,and screen the potential new drugs with new target and mechanism,so that make it possible to delay and even reverse the progression of the disease.The second is to better evaluate the patients beneifts by developing scientific and rational clinical outcome assessment tools with the basis of the patients'needs.The third is to choose the representative population by the combination of epidemiology,natural history,the feature of drugs and the aim of clinical trials since the pathology of renal diseases is complicated.The fourth,early management of renal disease is crucial.So it's of great significance to explore,develop and validate the surrogate endpoints since the disease progresses slowly and the investigation often requires both long study cycle of several years or even longer and a larger sample size.The surrogate indicators should be selected pru-dently.The sponsors are suggested to communicate with the regulatory agency when necessary.The fifth,a sufficent safety study can be very supportive to the general evaluation of benefit-risk balance.
nephrotic drugresearch and developmentmechanism of actionconsideration
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