Drug trials for in mainland China from 2013 to 2023 were mostly domestic, chemical-drug, and rather than late-stage innovative trials.
Evidence
This registry landscape analysis included 50 DKD drug trials from the National Medical Products Administration platform, with 48% bioequivalence trials, 10% phase III trials, and 12% international multicenter trials.
Caveat
The study maps registered trial activity rather than testing drug efficacy, and the abstract notes uneven geography and limited innovative development.
Simplified
With the increasing prevalence of diabetes, the incidence rate of (DKD) has risen yearly in China. While traditional therapies like renin-angiotensin system blockers remain foundational, the treatment paradigm is rapidly evolving with the emergence of novel agents, including SGLT2 inhibitors, mineralocorticoid antagonists, endothelin receptor antagonists, and GLP-1 receptor agonists. This study aims to provide an overview of the changing landscape of drug clinical trials on DKD in mainland China from 2013 to 2023. Detailed information of drug trials for DKD registered on the National Medical Products Administration Registration and Information Disclosure Platform for Drug Clinical Studies was collected. A total of 50 trials for DKD were included. Bioequivalence trials accounted for the most significant proportion (48%), followed by phase II (22%), phase I (20%), and phase III (10%). Chemical drugs accounted for the largest proportion (92%), followed by traditional Chinese medicine/natural medicine (8%). There were 18 different drugs involved in the 50 trials with Irbesartan ( = 24, 48%) ranked first in the number of trials. The parallel-group design was primarily used (48%), followed by crossover design (46%). Randomization was used by almost all trials (92%). Of all trials, 44 (88%) were launched domestically, whereas only 6 (12%) were international multi-center trials. Drug trials showed an uneven geographical distribution. Despite the progress in DKD drug clinical trials in mainland China during recent years, innovative drug research and development still has a long way to go. These findings provide an evidence base for optimizing global-regional alignment in DKD innovation policy. n
Key numbers
24 of 50
Bioequivalence Trials Proportion
Trials focused on among drug trials.
9
Novel Mechanism Drugs in Trials
Number of first-in-class drugs advancing to Phase II/III trials.
44 of 50
Domestic Trials Percentage
Trials launched domestically among total trials.
Full Text
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