从我国2016—2020年新药批准情况看新药研发及审批趋势  

Trends of new drug R&D and approval in China:an analysis of the data of new drug applications from 2016 to 2020 by NMPA

作　　者：王文文 黄曼丽 陈垂雄 李晨 王陵 WANG Wen-wen;HUANG Man-li;CHEN Chui-xiong;LI Chen;WANG Ling(Department of Health Statistics,Department of Military Prevention,Air Force Military Medical University,Xi'an 714600,China)

机构地区：[1]空军军医大学军事预防医学系卫生统计学教研室,西安714600

出　　处：《中国新药杂志》2023年第4期386-395,共10页Chinese Journal of New Drugs

基　　金：国家自然科学基金面上项目(82273729);国家自然科学基金面上项目(82273728)。

摘　　要：系统分析2016—2020年国家药品监督管理局(NMPA)新药审批情况,对比美国FDA同期获批新药,解析我国近5年的药物研发趋势,总结我国2016—2020年新药研发和审批趋势,并结合我国药品行政监督管理法规,分析我国在全球药物研发中的地位作用。研究发现,2016—2020年NMPA共批准新药申请(NDA)956个,其中化学药471个,中药235个,生物制药250个,5年间NMPA批准上市新药数量持续增加。与美国FDA申报审批情况相比,我国药品申报数量多,但通过比例较低,一类创新药申报数量较少,批准上市药物的适应证以抗肿瘤、消化系统和抗感染类为主,罕见病和孤儿药研发不足。中国新药批准数量逐年增加,但本土原研新药占比较小,基础研究及转化研究薄弱,新型靶点分子药物研发不够。The situation of new drug approval by the State Drug Administration(NMPA)from 2016 to 2020 was systematically analyzed and compared with that by the Food and Drug Admin-istration(FDA)of the United States in the same period,the trend of drug R&D in China in the past five years was analyzed,and the trend of new drug R&D and approval in China from 2016 to 2020 were summarized.Combined with China’s drug administrative supervision and management regulations,the status and role of China in global drug R&D were analyzed.It was found that a total of 956 new drug applications(NDA)were approved by NMPA from 2016 to 2020,including 471 for chemicals,235 for traditional Chinese medicine,and 250 for biopharmaceuticals.The number of new drugs approved by NMPA continued to increase in the 5 years.Compared with the application and approval of FDA,the number of drugs de-clared in China was larger,but the proportion of approval was smaller,the number of first-class innovative drugs was smaller,the main indications for approved listed drugs were anti-tumor,digestive system and anti-infection,and the R&D of drugs for rare diseases and orphans were insufficient.The number of approved new drugs in China was increasing year by year,but the proportion of local original research and new drugs was relatively small,basic research and transformation research was weak,and the R&D of new target molecular drugs was not enough.

关 键 词：药物研发 新药审批 新药申请 

分 类 号：R95[医药卫生—药学]