2019年中国肿瘤药物临床试验进展  

Progress on clinical trials of cancer drugs in China, 2019

作　　者：黄慧瑶 吴大维 王海学 王骏 樊琦 王书航 白颖 俞悦 方元 孙超 房虹 白桦[3] 王欣[4] 刘泽源 江旻 刘喆[7] 王兴河 李海燕[9] 李宁 曹彩 徐兵河 孙燕 赫捷 Huang Huiyao;Wu Dawei;Wang Haixue;Wang Jun;Fan Qi;Wang Shuhang;Bai Ying;Yu Yue;Fang Yuan;Sun Chao;Fang Hong;Bai Hua;Wang Xin;Liu Zeyuan;Jiang Min;Liu Zhe;Wang Xinghe;Li Haiyan;Li Ning;Cao Cai;Xu Binghe;Sun Yan;He Jie(Department of Clinical Trials Center,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;National Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Clinical Pharmacology Research Center,Peking Union Medical College Hospital,Beijing 100032,China;Beijing Institute of Geriatrics/Clinical Trial Center,Beijing Hospital,Beijing 100730,China;Clinical Pharmacology Research Center,the Fifth Medical Center,Chinese PLA General Hospital,Beijing 100071,China;National Drug Clinical Trials Institutions,Peking University Cancer Hospital and Institute,Beijing 100142,China;Oncology Medicine Department,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China;PhaseⅠDrug Clinical Trial Laboratory,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China;Cardiology Department&Drug Clinical Trial Institution,Peking University Third Hospital,Beijing 100191,China;ZhongGuanCun JiuTai Good Clinical Practice Union,Beijing 100027,China;Department of Thoracic Surgery,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China)

机构地区：[1]国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,100021 [2]国家药品监督管理总局药品审评中心,北京100022 [3]北京协和医院临床药理研究中心,100032 [4]北京医院国家老年医学中心临床试验研究中心,100730 [5]解放军总医院第五医学中心临床药理室,北京100071 [6]北京肿瘤医院国家药物临床试验机构,100142 [7]首都医科大学附属北京胸科医院肿瘤内科,101149 [8]首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室,100038 [9]北京大学第三医院心血管内科和药物临床试验机构,100191 [10]北京中关村玖泰药物临床试验技术创新联盟,100027 [11]国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院北京协和医学院肿瘤医院胸外科,100021

出　　处：《中华肿瘤杂志》2020年第2期127-132,共6页Chinese Journal of Oncology

基　　金：北京国际医药临床研发平台项目。

摘　　要：目的宏观了解2019年中国肿瘤药物临床试验开展及抗肿瘤药物上市情况。方法自中国国家食品药品监督管理总局药物临床试验登记与信息公示平台登记数据库提取2019年登记的肿瘤药物临床试验和相关试验药品信息,从中国国家药品监督管理局国产药品及进口药品数据查询系统收集2019年抗肿瘤药物的上市信息,汇总分析肿瘤药物临床试验的数量、试验分期、试验范围、适应证、药物类型、作用机制等以及上市肿瘤药物情况。结果2019年中国共登记了474项肿瘤药物临床试验,占同期全部药物临床试验的21.8%,其中由国内制药企业发起397项(83.8%),国际多中心试验62项(13.1%),Ⅰ期临床试验所占比例(47.3%)最高。国内制药企业发起的国际多中心试验所占比例为4.8%,低于全球制药企业(55.8%,P<0.001),Ⅰ期临床试验和等效性试验所占比例(51.9%和19.4%)高于全球制药企业(23.4%和1.3%,P<0.001)。肿瘤药物临床试验共涉及27种肿瘤,肺癌、实体瘤、乳腺癌为最常见的适应证,分别有103、95和49项相关药物临床试验。我国三大特色肿瘤——胃癌、肝癌和食管癌的相关药物临床试验共计47项。临床试验共涉及335种肿瘤试验药物,其中288种(86.0%)由国内制药企业开发,47种(14.0%)由全球制药企业开发。药物类型以原研药为主,原研药占72.2%(242/335);药物作用以治疗为主,肿瘤治疗药占89.6%(300/335);作用机制以靶向治疗和免疫治疗为主,分别占74.6%(250/335)和20.3%(68/335)。国内制药企业开发的药物中,原研药占68.4%,低于全球制药企业的95.7%,差异有统计学意义(P<0.001)。2019年,有针对11种肿瘤的17种抗肿瘤药物在中国获批上市。结论中国肿瘤药物临床试验已进入蓬勃发展时期,以靶向药和免疫药为代表的大量创新药物进入试验及临床,本土制药企业已成为肿瘤药物研发的重要力量。针对中国高发肿瘤加强药物研发�Objective To deliver macro understanding of the latest research progress on clinical trials and approved products of cancer drugs in China in 2019.Methods The number of clinical trials and related investigational products by domestic and foreign enterprises in 2019 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies,while listed drugs were obtained in the China Food and Drug Administration Query System for Domestic and Imported Drug.Characteristics on stage,scope,indication of those trials,classification and mechanism of involved products,as well as listed anticancer drugs were summarized and depicted.Results There were 474 cancer drug trials registered in China in 2019,accounting for 21.8%of the total,and 397(83.8%)were initiated by domestic pharmaceutical enterprises.Overall,international multicenter trials accounted for 13.1%,and phase I trials accounted for 47.3%.Compared with global enterprises,the proportion of international multi-center trials initiated by domestic companies is lower(4.8%vs.55.8%,P<0.001),and the proportion of phase I clinical trials and bioequivalence trials is higher(51.9%vs.23.4%,19.4%vs.1.3%,P<0.001).An accumulative of 27 cancer types were involved for all the cancer drug trials,and lung cancer,solid tumor,and breast cancer were the most common cancer types,with 103,95 and 49 trials,respectively.For the three cancer types unique to Chinese population,gastric,liver and esophageal cancer,the total number of initiated trials was 47.For all those trials,there were 335 cancer drug varieties,with 86.0%developed by domestic pharmaceutical enterprises,including 300 therapeutic drugs,30 adjunctive drugs and 5 preventive drugs.In terms of mechanism,targeted drugs and immune drugs were the most popular,accounting for 74.6%and 20.3%,respectively.In addition,17 anticancer drugs targeting on 11 cancer types were approved in China in 2019.Conclusions Clinical trials on cancer drugs in China have ushered a booming era,with

关 键 词：恶性肿瘤 药物 临床试验 中国 

分 类 号：R9[医药卫生—药学]