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IND applications are one of the important markers of China's chemical innovation drug research and development capabilities.
The number of first-time applications for varieties reflects the overall research and development progress of domestic pharmaceutical companies in the past year
.
According to statistics, for the whole year of 2021, the number of domestic chemical drug category 1 IND applications for the first time is> 243.
On the basis of 2019, the number of new varieties has doubled
In 2021, the IND's first application for varieties reached a new high
In 2021, the IND's first application for varieties reached a new high The author of this article screened the category 1 chemical drug IND varieties that were accepted in 2021 (as of 2021.
12.
19, the full text is counted at this time) and found that a total of 243 varieties have achieved the first registration application for data
.
As shown in the figure below, compared with the past 3 years, the data in 2019 was >110.
In 2020, a breakthrough of about 50% of the growth rate was achieved on the basis of 2019, and the growth rate of ≈44% on the basis of 2020 in 2021.
Figure 1 Statistics of the first application of category 1 IND of chemical drugs for three consecutive years from 2019 to 2021
Separately, in the 1-12 natural months of 2021, there are more than 20 varieties in half of the months, and the overall number is 16-27 varieties per month; for this data in 2019, the highest number of natural monthly varieties is only 16
.
In 2021, compared with the previous two years, both the number of declarations and the number of acceptances have achieved substantial growth
.
Figure 2 Statistics of the first IND application for category 1 chemical drugs from January to December 2021
Hengrui, Chia Tai Tianqing, and Hausen IND lead the way
Hengrui, Chia Tai Tianqing, and Hausen IND lead the way In terms of enterprises, the leading companies are still the established first-line innovative pharmaceutical companies.
For example, Hengrui (including Jiangsu Hengrui, Shanghai Hengrui, Shandong Shengdi, Fujian Shengdi, and Beijing Shengdi) has 16 varieties of IND accepted for the first time; companies with the same gradient Zhengda Tianqing Pharmaceutical Group has 11 varieties, and Jiangsu Haosen Pharmaceutical Group Co.
, Ltd.
has 9 varieties
.
CSPC, BeiGene, Betta Pharmaceuticals, Suzhou Junjing, and Sichuan Kelunbotai all have 4 varieties of first application IND accepted; Nuocheng Jianhua, Guangzhou Lupeng Pharmaceutical, Shanghai Jiyu Pharmaceutical, Chinese Medicine The Institute of Materia Medica of the Academy of Sciences and the China Medical Research and Development Center applied for the first class 1 chemical drug IND for the first time in 3 varieties
.
Figure 3 Distribution of companies with a large number of domestic Class 1 chemical drug new drug IND applications in 2021
Geographical Distribution of IND Companies
Geographical Distribution of IND Companies The research and development of new drugs has certain geographical distribution characteristics.
Relatively speaking, the more developed the economy, the stronger the ability to attract talents, the faster the implementation of projects, the stronger and more concentrated innovation capabilities, and the representative ones are the Yangtze River Delta, Beijing-Tianjin-Hebei, and Pearl River Delta.
Triangle
.
The Yangtze River Delta region, with Shanghai and Jiangsu, can be said to be the main concentration of China's pharmaceutical industry, especially the chemical medicine field.
Shanghai has more innovative start-up companies, while Jiangsu has more established first-line innovative pharmaceutical companies.
Assembling other surrounding cities in the Yangtze River Delta region, in 2021, the number of first IND applications for chemical category 1 innovative drugs will reach 141, accounting for 58% of the national total.
It is an absolute concentration of domestic innovative drug research and development
.
The Beijing-Tianjin-Hebei region is centered on the capital Beijing and radiates to the surrounding areas, which naturally forms a concentration of innovation in the industry; especially in recent years, some start-up companies have been established, except for the Yangtze River Delta region, but also the Beijing region
.
In 2021, the number of IND applications for Category 1 innovative drugs for the first time is 34 varieties.
Although it is far less than the number of the Yangtze River Delta, it is also relatively high in the country
The Pearl River Delta, mainly centered on Guangzhou and Shenzhen, gathers surrounding cities, and has also formed a research and development center for innovative drugs.
In 2021, the number of IND applications for chemical category 1 innovative drugs will be 21 varieties
.
Figure 4 The geographical distribution of the first IND application for category 1 chemical drugs in 2021
Conclusion
Conclusion Through the comparison of the number of domestic chemical drugs Class 1 new drug INDs for the first time for three consecutive years, it can be seen that domestic Class 1 new drug INDs have become the norm, with a high growth rate, and are gradually becoming a concentrated area for registration review
.
The first-tier innovative drug R&D companies are still leading in volume, and it is difficult to be surpassed; the overall innovative drug R&D area is dominated by the Yangtze River Delta region, which has concentrated domestic first-class new drug R&D capabilities; some companies have reached annual output of 2~4 An IND, R&D management is worth learning
.
