Progress in Clinical Trials of Chemical Modified New Drugs in China
Objective:To summarize the clinical trials of chemical modified new drugs that have been published,in order to provide a reference for the subsequent clinical trials of chemical modified new drugs.Methods:Based on drug clinical trial registration and information publicity platform of the Center for Drug Evaluation of National Medical Products Administration and combined with third-party databases such as Yaozhi and Insight,the clinical trial in for mation of chemically modified new drugs during the period from January 1st,2020 to December 31th,2023 was retrieved,and statistical analysis was conducted using excel and other method to study the development of clinical trials.Results:From January 1st,2020 to December 31th,2023,the number of clinical trials announcements of chemical modified new drugs had increased year by year,and a total of 548 announcements had been made in three years.Clinical trials for 2.2 types of chemical modified new drugs accounted for more than 50％,which was the highest,and clinical trials for 2.1 types of chemical modified new drugs accounted for the least.The stages of clinical trials were mainly phase Ⅰ clinical trials.Conclusion:The chemical modified new drugs can draw on the clinical development data of the marketed products,reduce part of the clinical trial research,and shorten the research and development cycle,which is the hot spot of new drug research and development.
chemical drugsmodified new drugsclinical trialclinical advantageactive pharmaceutical ingredient
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