我国化学药改良型新药临床试验最新进展研究  

Progress in Clinical Trials of Chemical Modified New Drugs in China

作　　者：杨丽香 林琳[1] 田丽娟[1] Yang Lixiang;Lin Lin;Tian Lijuan(College of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;Livzon Pharmaceutical Group Co.,Ltd,Zhuhai 519090,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]丽珠医药集团股份有限公司,珠海519090

出　　处：《中国药事》2024年第8期860-868,共9页Chinese Pharmaceutical Affairs

摘　　要：目的:总结已公开的化学药改良型新药临床试验开展情况,以期为后续化学药改良型新药临床试验的顺利开展提供参考。方法:通过国家药品监督管理局药品审评中心药物临床试验登记与信息公示平台并结合药智、丁香园等第三方数据库,检索2020年1月1日至2023年12月31日期间的化学药改良型新药临床试验信息,并采用Excel等方法进行统计分析,研究其临床试验开展情况。结果:自2020年1月1日至2023年12月31日,化学药改良型新药临床试验公示的数量逐年上升,3年时间总计公示了548次。其中,2.2类改良型新药占比最高,超过50%,2.1类改良型新药占比最少。开展的临床试验分期主要以Ⅰ期临床研究为主。结论:化学药改良型新药可借鉴已上市产品的临床开发数据,减免部分临床研究,缩短研发周期,这些是目前新药研发的热点。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 1s,2020 to December 31",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.

关 键 词：化学药 改良型新药 临床试验 临床优势 已知活性成分 

分 类 号：R95[医药卫生—药学]