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Since the opening of clinical registration on the CTR platform, there have been a total of 5,537 new drug-related clinical trials, of which Phase I accounted for about 47%, Phase I/II and Phase II accounted for 24%, and Phase II/III and Phase III accounted for 29% , The reason for the high proportion of Phase II/III and Phase III is that the imported drugs directly conduct Phase III clinical trials in China, and do not do early clinical trials to a certain extent
.
From the overall trend, the number of clinical registrations has grown rapidly after 2016, especially in 2021, the number of clinical registrations will reach 1,490, a year-on-year increase of nearly 50%.
The main source of growth is the substantial increase in the number of new drug registrations in Phase I clinical trials
From the indication distribution of nearly 1,500 clinical trials filed in 2021, it can be seen that the indications for newly registered clinical trials in China are still mainly solid tumors.
Phase III clinical trials of immunotherapy are carried out, which are mainly related to PD-1, and a large number of PD-1 products targeting gastrointestinal tumors are approaching the approval stage
.
In addition, a large number of clinical trials for atopic dermatitis, asthma and other diseases are also being carried out.
With the rapid advancement of type 2 inflammation-related targets, especially the rapid advancement of IL-4, IL-5, IL-13 and other targets, Drive the explosive growth of related products in China
In order to more accurately analyze the most important and core clinical applications of various companies around the world, we define the registration clinical trials carried out by the original research companies and some high-quality research initiated by researchers as core clinical trials
.
It can be seen from the figure below that the global core clinical practice has increased year by year since 2016.
During this period, the number of core clinical trials carried out in the United States has stabilized at more than 200 per year, while the core clinical development of Chinese companies has increased rapidly since 2017.
Among the top Chinese and foreign companies carrying out core clinical trials in 2021, Novartis has carried out 35 core clinical trials, ranking first in the world
.
Hengrui has carried out 34 core clinical trials, ranking second in the world in number and far ahead of other domestic companies
.
In 2021, the core clinical trials carried out by Chinese companies will focus on diseases in the field of oncology, and the therapies will be mainly PD1/PDL1-based dual antibodies or combination therapy with small molecule targeted drugs.
The proportion of cancer is relatively low, and PD1-related core clinics have shown a downward trend
.
There are also obvious differences in the core clinical therapies of Chinese and foreign companies.
From the perspective of the PCSK9 target of hypercholesterolemia: the core clinical trials currently being conducted in China are mainly monoclonal antibodies against PCSK9, and the products under development in foreign core clinical trials are except monoclonal antibodies.
The overall trend of PD1/PDL1-related core clinics began to show an upward trend in 2014, reached a peak in 2019-2020, and then showed a significant downward trend
.
The number of core clinical trials of PD1/PDL1 in Chinese companies accounts for nearly half of the world's total, but the overall development speed lags behind the global R&D time by 3-4 years
.
