UM  > Faculty of Health Sciences  > DEPARTMENT OF PHARMACEUTICAL SCIENCES
Residential Collegefalse
Status已發表Published
Characteristics of clinical trials of new oncology drugs approved in China
Yang, Jing1; Yang, Ji2; Hu, Yuan Jia1,3,4
2024-03-01
Source PublicationCancer
ISSN0008-543X
Volume130Issue:5Pages:671-682
Abstract

Background: Since reforms were introduced to incentivize drug innovation in 2015, the Chinese pharmaceutical market has experienced unprecedented prosperity, with more new drugs than ever before, especially anticancer treatments. In 2021, Chinese regulatory agencies issued the new guideline for clinical research and development of antitumor drugs, triggering a series of responses on the drug market. Limited research has outlined the nature of the original new drugs in China to understand the dynamic response of the market. Methods: The objective of this article was to map the clinical development of approved new oncology drugs in China from 2015 to 2021 and differed from previous studies by focusing on original new drugs, using the United States as a benchmark, and elaborating the endogenous features of clinical trials. Results: Clinical trials conducted in China have risen to a level similar to that of the United States in many aspects of trial design, but there is still distance between the implementation and operational details of clinical trials. In the meantime, China has made significant breakthroughs in drug approval. Greater than 60% of novel anticancer drugs in China received accelerated approved for their first listing. Approximately 90% of the pivotal clinical trials supporting initial drug approval used surrogate measures as end points, and one half were nonrandomized or did not have a control group. However, duplicate development without evidence of a clinical advantage compared with current therapies was widely observed. Conclusions: By presenting a multidimensional landscape of clinical trials and approvals in the real world, this review allows interested researchers, developers, and even regulators to understand what has been done and what should be done next in anticancer drug development in China.

KeywordClinical Evidence Drug Lag Novel Anticancer Drugs Pivotal Clinical Trials Programmed Death-1 (Pd-1) Inhibitors Programmed Death-ligand 1 (Pd-l1) Inhibitors
DOI10.1002/cncr.35106
URLView the original
Indexed BySCIE
Language英語English
WOS Research AreaOncology
WOS SubjectOncology
WOS IDWOS:001104474400001
PublisherWILEY111 RIVER ST, HOBOKEN 07030-5774, NJ
Scopus ID2-s2.0-85177176470
Fulltext Access
Citation statistics
Document TypeJournal article
CollectionDEPARTMENT OF PHARMACEUTICAL SCIENCES
Institute of Chinese Medical Sciences
THE STATE KEY LABORATORY OF QUALITY RESEARCH IN CHINESE MEDICINE (UNIVERSITY OF MACAU)
Corresponding AuthorHu, Yuan Jia
Affiliation1.State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao
2.School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, China
3.DPM, Faculty of Health Sciences, University of Macau, Macao
4.Centre for Pharmaceutical Regulatory Sciences, University of Macau, Macao
First Author AffilicationInstitute of Chinese Medical Sciences
Corresponding Author AffilicationInstitute of Chinese Medical Sciences;  Faculty of Health Sciences;  University of Macau
Recommended Citation
GB/T 7714
Yang, Jing,Yang, Ji,Hu, Yuan Jia. Characteristics of clinical trials of new oncology drugs approved in China[J]. Cancer, 2024, 130(5), 671-682.
APA Yang, Jing., Yang, Ji., & Hu, Yuan Jia (2024). Characteristics of clinical trials of new oncology drugs approved in China. Cancer, 130(5), 671-682.
MLA Yang, Jing,et al."Characteristics of clinical trials of new oncology drugs approved in China".Cancer 130.5(2024):671-682.
Files in This Item:
There are no files associated with this item.
Related Services
Recommend this item
Bookmark
Usage statistics
Export to Endnote
Google Scholar
Similar articles in Google Scholar
[Yang, Jing]'s Articles
[Yang, Ji]'s Articles
[Hu, Yuan Jia]'s Articles
Baidu academic
Similar articles in Baidu academic
[Yang, Jing]'s Articles
[Yang, Ji]'s Articles
[Hu, Yuan Jia]'s Articles
Bing Scholar
Similar articles in Bing Scholar
[Yang, Jing]'s Articles
[Yang, Ji]'s Articles
[Hu, Yuan Jia]'s Articles
Terms of Use
No data!
Social Bookmark/Share
All comments (0)
No comment.
 

Items in the repository are protected by copyright, with all rights reserved, unless otherwise indicated.