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On November 10, the Center for Drug Evaluation of the National Food and Drug Administration issued the "Annual Report on the Current Status of Clinical Trials for New Drug Registration in China (2020)" (hereinafter referred to as the "Report").
Based on the registration information of the drug clinical trial registration and information disclosure platform, it was the first time to report to China.
A comprehensive analysis of the current status of clinical trials for new drug registration
.
According to the "Report", a total of 2,602 clinical trials were registered in 2020, an overall increase of 9.
1% over 2019
.
According to the analysis of the "Report", the number of clinical trials of new drugs and the number of drug varieties in China have increased significantly compared with the past.
Number of clinical trials Number of drug varieties Class 1 new drug Drug target Indication field
2602 items
2602 items Year 2020 registered a total of clinical trials 2602
.
According to new drugs (ie non-bioequivalence clinical trial varieties) and generic drugs category (including generic drug quality and efficacy consistency evaluation), the number of clinical trial registrations is calculated, and the proportion of new drugs is 57% (1473 items)
2602 new drugs accounted for 57% (1473)
1473 items
1473 items According to different drug types, a statistical analysis of the number of varieties involved in 1473 non-bioequivalence/consistency evaluation clinical trials found that 91% of TCM varieties only carried out one clinical trial; the top 10 varieties in chemical drug clinical trials were basically As an anti-tumor drug , the top 3 are apatinib mesylate tablets (15 items), mitoxantrone hydrochloride liposome injection (10 items), fluzoparil capsules (10 items); biological products development The top 10 varieties in clinical trials are mainly therapeutic biological products, and the top 3 are recombinant humanized anti-PD-1 monoclonal antibody injection (17 items), atilizumab injection (11 items), Bolizumab injection (11 items)
.
More than 60 items
More than 60 items Analyze the target points.
The top 10 targets of the drugs registered in clinical trials are PD-1, CYP51A1, VEGFR, PD-L1, etc.
, and 9 of the top 10 targets have drug indications that are concentrated in the same field Indications area
.
The top 10 targets with the largest number of clinical trials are also concentrated in PD-1, VEGFR, etc.
The drug indication field with 9 targets in the top 10 targets is concentrated in the same indication field and more than 60 items
61.
2%
2%
From the perspective of indications, the clinical trials of new Chinese medicines mainly focus on the three indications of breathing, cardiovascular and digestion , accounting for about 61.
2% of the total clinical trials of Chinese medicines
.
Chemical drug indications are mainly anti-tumor drugs , accounting for 42.
Respiratory, cardiovascular and digestive 61.
91.
91.
643 items
Analyzing the phases of new drug clinical trials in 2020, phase I clinical trials accounted for the highest proportion of 43.
7% ( 643 items ), followed by phase III and phase II, accounting for 24.
4% (359 items) and 19.
9% (293 items) respectively
.
Four of the 39 Phase IV clinical trials are real-world studies
The highest proportion of phase I clinical trials is 643
The "Report" pointed out that China's new drug clinical trials have obvious homogeneity problems, and there are also challenges such as low implementation efficiency after approval of clinical trials, low proportion of pediatric clinical trials, and uneven regional distribution of clinical trials
