 Home > Active Ingredient News > Drugs Articles > In-depth inventory: In 2021, CDE will accept 1,439 applications for the registration of domestically produced Class 1 innovative drugs, and the number of traditional Chinese medicine applications reaches a new high!

In-depth inventory: In 2021, CDE will accept 1,439 applications for the registration of domestically produced Class 1 innovative drugs, and the number of traditional Chinese medicine applications reaches a new high!

 Last Update: 2022-01-24
 Source: Internet
 Author: User

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In this year full of hardships and hardships, domestic drug registration is still in a state of vigorous development.
In the past six years, the number of CDE acceptance numbers has increased significantly; as of December 31, 2021, CDE review The evaluation center has accepted a total of 11,569 acceptance numbers (data statistics as of December 31, 2021, the same below), and the number of clinical applications and production applications has increased significantly compared with 2020.
Among them, there are 2,452 acceptance numbers for clinical applications and production applications.
There are 2157 acceptance numbers
.

The following is a detailed analysis of the acceptance situation in 2021:

/ 01 / General situation of drug registration application acceptance in 2021

1.
Application of each drug type

In terms of the total number of acceptance numbers, from 3,779 applications (in terms of acceptance numbers) in 2016 to 11,569 in 2021, the number has been increasing year by year; among them, 8,174 applications for chemical drugs will be accepted in 2021, which is not much different from 7,907 in 2020.
, 2022 biological drugs, only 154 different from 1868 in 2020, and there is no big difference, but the number of Chinese medicine applications in 2021 is significantly higher than 472 in 2020, reaching 1371, reaching the peak of the number of Chinese medicine applications in the past 6 years
.

Figure 1 Details of the application in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Figure 2 Comparison of application acceptance in 2021 and 2020

Data source: Yaozhi Data, Yaozhi Consulting

2.
Monthly declaration

The number of applications accepted from January to May 2021 is basically the same as that of 2020.
The number of applications in the second half of 2021 is significantly higher than or basically the same as the same period in 2020, but the number of applications in 2020 and 2021 is significantly higher than in 2019
.

See Figure 3 for the comparison of monthly acceptance in the past three years

Figure 3 Comparison of monthly acceptance in the past 3 years

Data source: Yaozhi Data, Yaozhi Consulting

3.
General situation of various types of declarations

The proportion of application types in the whole year of 2021 is basically the same as that in the first half of 2021.
It is still dominated by supplementary applications, accounting for 6,089 of the entire application types.
There are 2,452 acceptance numbers for clinical applications and production.
There are 2157 acceptance numbers and 377 applications for re-registration
.

Compared with 2020, the proportion of supplementary applications dropped from 65.

Figure 4 Classification of application acceptance in 2020

Data source: Yaozhi Data, Yaozhi Consulting

Figure 5 Classification of application acceptance in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: Statistical rules: S, L, B, Z are the 4th letter of the acceptance number respectively

4.
Acceptance of domestic innovative drugs

In 2021, CDE will accept 1,439 domestic Class 1 innovative drug registration applications, including 1,383 clinical applications and 52 marketing applications
.

According to the statistics of drug types, there are 896 chemical drugs, 489 biological products (including 481 biological products for treatment), and 54 traditional Chinese medicines

Figure 6 Application of domestic class 1 innovative drugs

Data source: Yaozhi Data, Yaozhi Consulting

5.
Acceptance of imported innovative drugs and original research drugs

In 2021, CDE will accept 169 applications for the registration of imported brand-name drugs of Category 5.
1 chemical drugs, 264 applications for the registration of Category 1 imported innovative drugs, 133 biological products for treatment of Category 1 and 1 biological product for prevention of Category 1.
1
.

6.
Application and completion of review in 2021

According to the latest statistics of Yaozhi's registration and acceptance database, the number of acceptance numbers that have completed the review in 2021 (Note: CDE's undertaking date is from January 1, 2021 to December 31, 2021) (referring to the review conclusions included in Yaozhi.
com) (excluding the acceptance number for which the review has ended but the review conclusion has not been announced), a total of 5,414, including 4,414 chemical drugs, 206 traditional Chinese medicines, and 792 biological products
.

Please refer to Figure 7 for details of the hosting and approval in 2021

Figure 7 The 2021 CDE Undertaking and Approval Status

Data source: Yaozhi Data, Yaozhi Consulting

7.
Completion of the review in 2021

According to the latest statistics of the Yaozhi registration and acceptance database, in 2021 (Note: the status start time (Yaozhi) will be from January 1, 2021 to December 31, 2021) the number of acceptance numbers that have been reviewed and completed will be 11,210, which will be included in Yaozhi.
The number of conclusions reached is 11,021 acceptance numbers, including 7,874 for chemical drugs, 1,316 for traditional Chinese medicine, and 1,832 for biological products
.

The detailed statistics of the conclusion of the CDE review in 2021 are shown in Figure 8

Figure 8 Details of CDE's review conclusion in 2021

Data source: Yaozhi Data, Yaozhi Consulting

8.
Application area

In terms of drug declarations in various provinces and cities, the annual declarations in 2021 are the same as in the first half of 2021.
Jiangsu is far ahead with 1750, followed by Shanghai with 1307, followed by Beijing, Guangdong and Zhejiang
.

Figure 9 shows the application status of each province and city in 2021

Figure 9 Distribution of declarations by province in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Let us analyze in detail the registration acceptance and review of chemical drugs, traditional Chinese medicines, biological products, priority review and breakthrough therapy
.

/ 02 / Chemical Medicine

1.
Application of chemical drugs in 2021

In 2021, CDE will undertake a total of 8,174 new chemical drug registration applications in terms of acceptance numbers
.

See Figure 10 for monthly CDE chemical drug acceptance in 2021

Figure 10 Acceptance of chemical drug applications in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Chemical drug registration applications are classified by task type, with 1485 IND applications accepted, 199 NDA applications accepted, and 1794 ANDA applications accepted; the classification of chemical drug task types in 2021 is shown in Figure 11
.

Figure 11 Classification of chemical drug task types in 2021

Data source: Yaozhi Data, Yaozhi Consulting

From the perspective of chemical drug application types, supplementary applications still account for the majority.
In 2021, 3958 chemical drug supplementary application registration applications will be accepted, accounting for 48.
42% of the total chemical drug applications
.

Please refer to Figure 12 for the acceptance of each application type of CDE chemical drugs in 2021
.

Figure 12 Types of chemical drug applications in 2021

Data source: Yaozhi Data, Yaozhi Consulting

The number of applications for the consistency evaluation of chemical drugs was 888, and the number of applications deemed to have passed the consistency evaluation was 2,076
.

1.
1 Application of Class 1 New Drugs of Chemical Drugs

According to the current chemical drug registration classification, chemical drug class 1 is defined as: innovative drugs that have not been marketed at home and abroad, including new drugs with clear structures and pharmacological effects, and drugs with clinical value
.

In 2021, there will be a total of 1,457 application acceptance numbers for Category 1 new drugs of chemical drugs, including 297 supplementary applications, 896 applications for domestic Category 1 new drug registration, and 264 applications for imported Category 1 registration.
See Figure 13 for details
.

Figure 13 Distribution of Category 1 New Drug Applications in 2021

Data source: Yaozhi Data, Yaozhi Consulting

1.
2 Chemical Drug Category 1 New Drugs (Domestic) and Import Declaration

Among the 1,457 Class 1 chemical drug innovative drug registration applications, domestic chemical innovative drugs are the main ones.
There are 896 domestic chemical drug innovative drug registration applications in terms of acceptance numbers, including 866 IND applications and 27 NDA applications; imported chemical drug innovative drugs There are 264 registration applications in terms of acceptance numbers, including 257 IND applications and 7 NDA applications; there are 297 supplementary applications for chemical drug innovation drug registration applications, including 196 domestic chemical drug innovation drug registration supplementary applications and imported ones.
There were 101 supplementary applications for the registration of innovative chemical drugs
.
See Figure 14 for the acceptance of chemical class 1 new drugs and import registration applications in 2021, and see Figure 15 for the classification of monthly review tasks for domestic class 1 new drugs
.

Figure 14 Acceptance of new drugs and import registration applications for chemical drugs in Category 1 in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Figure 15 Classification of domestic class 1 new drug review tasks in 2021

Data source: Yaozhi Data, Yaozhi Consulting

1.
3 Acceptance of Consistency Evaluation

As the consistency evaluation continues, in 2021 and the same period in 2020, the number of supplementary acceptances for consistency evaluation by CDE will be the same, 890 in 2021 and 898 in 2020, which are basically the same, and the overall consistency evaluation applications accepted in 2021 remain the same.
Steady state, not as volatile as 2020
.
Figure 16 shows the acceptance of consistency evaluation in 2021 and the comparison in 2020
.

Figure 16 Acceptance of consistency evaluation in 2020 and 2021

Data source: Yaozhi Data, Yaozhi Consulting

2.
Completion of chemical drug review in 2021

2021 (Note: The processing date (Yaozhi) is from January 1, 2021 to December 31, 2021) CDE will complete the review (refers to the number of review conclusions included in the Yaozhi website, excluding the end of the review, There are 7875 chemical drug registration applications, including 3939 supplementary applications, 1008 new drugs, and 813 imported ones
.
Please refer to Figure 17 for the review status of each application type of chemical drugs in 2021
.

Figure 17 Completion of review for each application type of chemical drugs in 2021

Data source: Yaozhi Data, Yaozhi Consulting

The review conclusions in 2021 are still mainly based on approval and supplementation.
For specific conclusions, please check the drug registration and acceptance database of Yaozhi.
com
.
See Figure 18 for the results of chemical drug review in 2021
.

Figure 18 The conclusion of chemical drug review in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: The statistical time is January 11, 2022.
Statistics at different time points will cause differences in the number of completed review and review conclusions
.

/ 03 / Traditional Chinese Medicine

1.
Application of traditional Chinese medicine

In 2021, CDE will undertake a total of 1,371 new Chinese medicine registration applications in terms of acceptance numbers
.
Affected by the characteristics of its own medicines, the application of traditional Chinese medicines has always been in a relatively sluggish state, but the number of applications for traditional Chinese medicines in 2021 has increased significantly, nearly three times the number of applications in 2020
.
In 2021, there will be 62 new drug applications, including 52 IND applications and 10 NDA applications; supplementary applications still occupy the majority of the acceptance of traditional Chinese medicine, with 1,297 accepted.
Please refer to Figure 19 for the acceptance of each application type of CDE traditional Chinese medicine in 2021
.

Figure 19 Distribution of acceptance of traditional Chinese medicine in 2021

Data source: Yaozhi Data, Yaozhi Consulting

2.
Completion of the review of traditional Chinese medicine registration applications

2021 (Note: the status date (Yaozhi) is from January 1, 2021 to December 31, 2021) CDE completes the review (referring to the number of review conclusions included in the Yaozhi website, excluding the end of the review, But there are 1,316 TCM registration applications for which the acceptance number of the review conclusion has not been published), of which 1,106 are approved for supplementation, 44 are clinically approved (34 new drug IND applications, 10 are supplemented by application), 43 are approved for transfer, and 86 are not approved
.
Figure 20 shows the completion of Chinese medicine application review in 2021
.

Figure 20 Completion of Chinese medicine application review in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: The statistical time is January 11, 2022.
Statistics at different time points will cause differences in the number of completed review and review conclusions
.

/ 04 / Biological Products

1.
Declaration of biological products

In 2021, CDE will undertake a total of 2022 new biological product registration applications in terms of acceptance numbers
.
Compared with the gradual increase in the number of acceptances every month in 2020, the number of undertakings per month in 2021 will basically remain stable
.
See Figure 21 for monthly CDE biological product acceptances in 2021 and the same period in 2020
.

Figure 21 Comparison of the number of monthly declarations of biological products in 2020 and 2021

Data source: Yaozhi Data, Yaozhi Consulting

In 2021, CDE will accept 2,022 applications for the registration of biological products (mainly for therapeutic biological products), of which 822 clinical trials of biological products (27 for preventive biological products and 795 for therapeutic biological products) are accepted, and supplementary biological products are accepted.
896 applications (128 for preventive biological products, 768 for therapeutic biological products), and 162 marketing applications for biological products (8 for preventive biological products, 154 for therapeutic biological products) were accepted
.
See Figure 22 for the acceptance of various registration applications for biological products in 2021
.

Figure 22 Acceptance of applications by category for each review task of biological products in 2021

Data source: Yaozhi Data, Yaozhi Consulting

2.
1 Acceptance of innovative drugs for biological products

CDE accepted 744 applications for the registration of innovative drugs for Class 1 biological products, a significant increase from the 336 applications in the whole of last year, including 10 biological products for prevention and 734 biological products for treatment
.
See Figure 23 for details of the number of declarations
.

Figure 23 Classification and application of Class 1 biological products by review type in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Among the applications for the registration of innovative drugs for Class 1 biological products, there are 606 clinical trial applications (9 for preventive biological products) and 16 marketing applications (for therapeutic biological products)
.
See Figure 24 for details
.

Figure 24 Classification of review tasks for Category 1 biological products in 2021

Data source: Yaozhi Data, Yaozhi Consulting

3.
Completion of the review of biological product registration applications

2021 (Note: the status date (Yaozhi) is from January 1, 2021 to December 31, 2021) CDE completes the review (referring to the number of review conclusions included in the Yaozhi website, excluding the end of the review, There are a total of 1,832 biological product registration applications for which the acceptance number of the review conclusion has not been published), of which 930 have completed clinical applications (36 for preventive biological products, 894 for therapeutic biological products), and 556 supplementary applications (for preventive 106 biological products and 444 therapeutic biological products)
.
See Figure 25 for the completion of the review of biological products in 2021.

Figure 25 Completion of Biologics Review in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: The statistical time is January 11, 2022.
Statistics at different time points will cause differences in the number of completed review and review conclusions
.

/ 05 / Inclusion of Priority Review Varieties

In 2021, CDE will include 97 registration applications with acceptance numbers into the priority review process, including 57 chemical drugs, 38 biological products, and 2 traditional Chinese medicines; the reasons for inclusion include 35 qualified drugs, 26 children's drugs, and other priority.
17 cases have been reviewed and approved, and 11 have been included in the breakthrough therapy drug program; the indications include idiopathic short stature, psoriasis, cancer and other fields
.
See Table 1 for details
.

Table 1 Status of acceptance numbers accepted and included in the priority review sequence in 2021

/ 06 / Inclusion of Breakthrough Therapy Varieties

The conditions for applying for the breakthrough therapy drug program: during the clinical trial of the drug, it is used for the prevention and treatment of diseases that are seriously life-threatening or seriously affecting the quality of life, and there is no effective prevention and treatment method or there is sufficient evidence to show that it has obvious clinical advantages compared with the existing treatment methods.
innovative drugs or improved new drugs
.

In 2021, CDE will include 4 acceptance numbers accepted after 2021-01-01 into the breakthrough therapy program; see Table 2 for details
.
For details, please refer to Yaozhi.
com's drug registration and acceptance database
.

Table 2 Accepted and included in the breakthrough therapy program in 2021

Data source: Yaozhi Drug Registration and Acceptance Database

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