2015年至2023年我国审评上市药品分析  

Analysis of the Evaluated and Marketed Drugs in China from 2015 to 2023

作　　者：党子悦 张钰 谈维 郭冬梅[1] DANG Ziyue;ZHANG Yu;Tan Wei;GUO Dongmei(School of Management,Beijing University of Chinese Medicine,Beijing,China 100029;College of Clinical Medicine,Yangzhou University·Jiangsu Subei People's Hospital,Yangzhou,Jiangsu,China 225001)

机构地区：[1]北京中医药大学管理学院,北京100029 [2]扬州大学临床医学院·江苏省苏北人民医院,江苏扬州225001

出　　处：《中国药业》2024年第23期6-11,共6页China Pharmaceuticals

基　　金：国家社会科学基金“十四五”规划教育学青年课题[CLA210281];江苏省苏北人民医院管理课题[YYGL202023]。

摘　　要：目的了解我国审评上市药品的整体情况。方法检索2015年至2023年国家药品监督管理局药品审评中心(CDE)公开的审评上市药品的相关信息,从药品数量、创新程度、治疗领域3个方面分析我国上市药品的发展趋势,从政策和产业角度为我国未来的药品研发创新提出合理建议。结果从药品数量分析,2015年至2023年我国审评上市药品共1138件,包括1类新药168件、改良型新药315件、其他类型新药655件,平均增幅约为28.22%,中药(24件)的新药数量较化学药品(680件)和生物制品(434件)少。从创新程度分析,化学药品在1类、改良型、其他类型新药的占比分别为60.71%,39.05%,69.47%,生物制品分别为30.95%,58.73%,30.08%,中药分别为8.33%,2.22%,0.46%;中药、化学药品、生物制品1类新药在自身药品中的占比分别为58.33%,15.00%,11.98%。从治疗领域分析,抗肿瘤药物数量最多(391件,占34.36%),同质化竞争明显。结论建议国家药品监督管理部门加大对中药品种审评的关注力度,不断提升中药新药、原创新药的研发能力;药品生产企业应注重原创基础研究,提升供给能力和新药开发能力。Objective To understand the overall situation of evaluated and marketed drugs in China.Methods The relevant information on drugs evaluated and marketed by the Center for Drug Evaluation(CDE)of the National Medical Products Administration(NMPA)from 2015 to 2023 was searched,the development trend of drugs marketed in China from three aspects:number of marketed drugs,innovation level,and treatment field were analyzed,and reasonable suggestions for future drug research and development innovation in China were provided from policy and industry perspectives.Results In terms of the number of marketed drugs,1138 drugs were evaluated and marketed in China from 2015 to 2023,including 168 Class 1 new drugs,315 improved new drugs,and 655 other types of new drugs,with an average increase of about 28.22%.The number of new drugs for traditional Chinese medicine(24)was fewer than that for chemical drugs(680)and biological products(434).In terms of innovation levels,the proportions of chemical drugs in Class 1,improved,and other types of new drugs were 60.71%,39.05%,and 69.47%,respectively;the proportions of biological products were 30.95%,58.73%,and 30.08%,respectively;the proportions of traditional Chinese medicine were 8.33%,2.22%,and 0.46%,respectively;the proportions of Class 1 new drugs for traditional Chinese medicine,chemical drugs,and biological products in their own kinds of drugs were 58.33%,15.00%,and 11.98%,respectively.In terms of the treatment field,the number of anti-tumor drugs(391,accounting for 34.36%)was the highest,and the homogenization competition was obvious.Conclusion It is recommended that the national drug administration departments should pay more attention to the varieties of traditional Chinese medicine,increase the support of drug innovation policies,and constantly improve the research and development ability of new drugs and original new drugs of traditional Chinese medicine.Pharmaceutical manufacturers should focus on the original basic research,and improve the supply capacity and the development

关 键 词：审评上市药品 药品创新 新药研发 医药产业 

分 类 号：R95[医药卫生—药学]