我国化学药改良型新药申报审批情况分析与思考  

Analysis and thinking on the application and approval of improved new chemical drugs in China

作　　者：吕奕 张怡萌 茅宁莹[1] LÜYi;ZHANG Yi-meng;MAO Ning-ying(School of International Medicine Business,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学国际医药商学院,南京211198

出　　处：《中国新药杂志》2023年第15期1523-1530,共8页Chinese Journal of New Drugs

摘　　要：通过分析2016—2021年化学药改良型新药的申报审批情况,从化学药改良型新药的治疗领域分布、改良的剂型统计、优先审评审批数据等角度分别比较分析,以期为化学药改良型新药的研究开发提供思路和参考。结果表明在研发分类选择方面,选择2.2和2.4类改良型新药治疗往往会获得较高的注册成功率,其研发风险和技术难度相对较低,可以作为未来研究与开发的重点;在治疗领域方面,抗肿瘤药和免疫机能调节药、神经系统用药等是改良型新药的研发热门,符合我国政策导向;在剂型选择方面,高端制剂技术可作为2.2类改良型新药的研发切入口;在审评审批通过率方面,避免如注射用紫杉醇聚合物胶束等品种的“扎堆”申报。By analyzing the application and approval of new chemical drugs from 2016 to 2021,this paper compares and analyzes the distribution of treatment fields,statistics of improved dosage forms,and priority review and approval data of new chemical drugs,so as to provide ideas and reference for the research and development of new chemical drugs.The results shows that in the aspect of R&D classification,choosing classes 2.2 and 2.4 improved new drugs for the treatment often leads to higher registration success rate,and its R&D risk and technical difficulty are relatively low,which can be the focus of future research and development.In the field of treatment,anti⁃tumor drugs,immune function regulating drugs,nervous system drugs,etc.,are hot spots of R&D for improved new drugs,which are in line with China's policy orientation.In the aspect of dosage form selection,high⁃end preparation technology can be used as the entry point for the research and development of class 2.2 improved new drugs.In terms of examination and approval rate,“piling up”declaration of varieties should be avoided such as paclitaxel polymer micelles for injection.

关 键 词：改良型新药 新药开发 优先审评审批 化学药 

分 类 号：R95[医药卫生—药学]