Progress on clinical trials of cancer drugs in China, 2019
10.3760/cma.j.issn.0253-3766.2020.02.008
- VernacularTitle: 2019年中国肿瘤药物临床试验进展
- Author:
Huiyao HUANG
1
;
Dawei WU
1
;
Haixue WANG
2
;
Jun WANG
2
;
Qi FAN
1
;
Shuhang WANG
1
;
Ying BAI
1
;
Yue YU
1
;
Yuan FANG
1
;
Chao SUN
1
;
Hong FANG
1
;
Hua BAI
3
;
Xin WANG
4
;
Zeyuan LIU
5
;
Min JIANG
6
;
Zhe LIU
7
;
Xinghe WANG
8
;
Haiyan LI
9
;
Ning LI
1
;
Cai CAO
10
;
Binghe XU
1
;
Yan SUN
1
;
Jie HE
11
Author Information
1. 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
2. National Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
3. Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing 100032, China
4. Beijing Institute of Geriatrics/Clinical Trial Center, Beijing Hospital, Beijing 100730, China
5. Clinical Pharmacology Research Center, the Fifth Medical Center, Chinese PLA General Hospital, Beijing 100071, China
6. National Drug Clinical Trials Institutions, Peking University Cancer Hospital and Institute, Beijing 100142, China
7. Oncology Medicine Department, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China
8. Phase Ⅰ Drug Clinical Trial Laboratory, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China
9. Cardiology Department & Drug Clinical Trial Institution, Peking University Third Hospital, Beijing 100191, China
10. ZhongGuanCun JiuTai Good Clinical Practice Union, Beijing 100027, China
11. 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
- Publication Type:Clinical Trail
- Keywords:
Neoplasm;
Drug;
Clinical trial;
China
- From:
Chinese Journal of Oncology
2020;42(2):127-132
- CountryChina
- Language:Chinese
-
Abstract:
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 large number of innovative agents represented by targeted drugs and immune drugs under clinical development or putting into clinical practice. Those local enterprises are playing more and more critical roles. Strengthening clinical research and development on Chinese unique cancer types is the key direction of future work.
