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In-depth inventory: Jiangsu leads the country in the total amount of drug declarations!

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

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Highlights:

The total number of applications accepted in Jiangsu Province in 2021 is 1762 (excluding re-examination)

In 2021, 9 innovative Class 1 chemical drugs in Jiangsu Province will apply for listing, and 11 innovative Class 1 chemical drugs will be approved for marketing

Yinqiao Qingre Tablets, an innovative traditional Chinese medicine drug of Jiangsu Kangyuan Pharmaceutical, was approved for marketing

With the promulgation of the new "Administrative Measures for Drug Registration" in 2020 and the modernization of the drug review system and review capabilities, the national drug application in 2021 will still show an upward trend.

Figure 1 Drug acceptance in Jiangsu Province from 2017 to 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: Data as of January 13, 2022

Figure 2 Acceptance of CDE Drug Application Types in Jiangsu Province in 2021

Data source: Yaozhi Data, Yaozhi Consulting

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

Figure 3 Acceptance of domestic innovative drugs in Jiangsu Province in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Figure 4 The review and approval of various drug types in CDE in Jiangsu Province in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: Data as of January 13, 2022
.

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

2.
Chemical drugs

1.
Application of chemical drugs in 2021

In 2021, a total of 1,361 chemical drug applications (calculated by acceptance number) were accepted, including 406 chemical drug IND applications, an increase of 96% compared with 2020; 49 chemical drug NDA applications were accepted, an increase of 28.
9% compared with 2020; accepted generic drugs There were 315 listing applications (ANDAs), an increase of 17.
5% over 2020; 119 supplementary applications for consistency evaluation were accepted
.
See Figure 5 for the acceptance of various registration applications for chemical drugs in Jiangsu Province in 2021
.
Figure 6 shows the acceptance of chemical drug IND applications, NDAs, ANDAs and conformity evaluation registration applications in Jiangsu Province from 2019 to 2021
.

Figure 5 Acceptance of various registration applications for chemical drugs in Jiangsu Province in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Figure 6 The acceptance of chemical drug IND applications, NDAs, ANDAs and conformity evaluation registration applications in Jiangsu Province from 2019 to 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: Data as of January 13, 2022
.

1.
1 Application of Class 1 Innovative 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
.
Refers to drugs containing new compounds with clear structures and pharmacological effects and with clinical value
.

In 2021, there will be 441 Class 1 applications (in terms of acceptance numbers) for Jiangsu chemical drugs, of which 317 are IND applications, including 281 domestic applications and 36 import applications; Nanjing Ai has the most single-variety applications in domestic IND applications.
Meifei Bio's IPG1094 is intended to be used for the treatment of solid tumors, psoriasis, systemic lupus erythematosus, and multiple sclerosis, and has been approved for clinical use; in 2021, Jiangsu Province's domestic chemical drug category 1 IND single species application TOP5 details See Table 1
.

Table 1 TOP5 of Jiangsu Province's domestic chemical drug category 1 IND single-variety declaration in 2021

Note: Data as of January 13, 2022
.

In addition, 14 NDA applications have been accepted in Category 1 application of chemical drugs, with a total of 9 varieties, involving 11 enterprises; the application and acceptance of Category 1 NDA applications for chemical drugs in Jiangsu Province in 2021 is shown in Table 2:

Table 2 Acceptance of NDA applications for Class 1 chemical drugs in Jiangsu Province in 2021

Note: Data as of January 13, 2022
.

2.
Completion of chemical drug review in 2021

In 2021, Jiangsu Province will complete 1,420 reviews (counted by acceptance number), of which 382 are IND applications, all of which are approved for clinical use by default; 368 ANDA applications are approved for production, and 246 are approved for production; 54 are NDA applications, of which category 1 is approved There are 16 innovative drugs and 11 imported original research drugs
.
(If you want to know the specific situation, please pay attention to the Yaozhi registration acceptance database)
.
See Table 3 for the approval and marketing of Class 1 new chemical drugs approved by Jiangsu Province in 2021
.

Table 3 Approval and marketing of Class 1 new chemical drugs in Jiangsu Province in 2021

Note: Data as of January 13, 2022
.

3.
Consistency Evaluation Application Review Status

At present, the consistency evaluation of generic drugs has entered the normal state.
In 2021, Jiangsu Province will declare 119 acceptance numbers for consistency evaluation (counted by acceptance number), involving 84 varieties and 50 enterprises, accounting for the total acceptance of consistency evaluation nationwide in 2021.
(If you want to know the specific situation, please pay attention to the Yaozhi registration acceptance database)
.
See Figure 7 for the TOP 5 number of acceptances for enterprise consistency evaluation in Jiangsu Province in 2021
.

Figure 7 TOP 5 of Jiangsu Province's TOP 5 Enterprise Consistency Evaluation Acceptance in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: Data as of January 13, 2022
.

In 2021, Jiangsu Province has completed 175 acceptance numbers, involving a total of 93 varieties and 51 enterprises, of which 168 have been approved.
With 17 acceptance numbers, Osaikang and Hengrui Medicine ranked second with 17 acceptance numbers; the top 5 enterprises in Jiangsu Province that passed the consistency evaluation in 2021 are shown in Figure 8:

Figure 8 The number of enterprises in Jiangsu Province passing the consistency evaluation in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: Data as of January 13, 2022
.

3.
Traditional Chinese Medicine

1.
The application of traditional Chinese medicine in 2021

In 2021, there are 61 registration applications of traditional Chinese medicines in Jiangsu Province undertaken by CDE in terms of acceptance numbers, including 7 new drug applications, all of which are IND applications, and 54 supplementary applications.
For details on the acceptance of new drug applications of traditional Chinese medicines in Jiangsu Province in 2021, see Table 4:

Table 4 Acceptance of new drug applications of traditional Chinese medicine in Jiangsu Province in 2021

Note: Data as of January 13, 2022
.

2.
Completion of Chinese medicine review in 2021

In 2021, Jiangsu Province will review and complete 65 Chinese medicine applications (according to the acceptance number), of which 5 are IND applications, all of which are approved for clinical use by default; 58 supplementary application applications; 1 NDA application, which is Yinqiao Qingre Tablets of Jiangsu Kangyuan Pharmaceutical Co.
, Ltd.
Approved for listing
.
(If you want to know the specific situation, please pay attention to the Yaozhi registration acceptance database)

Yinqiao Heat-clearing Tablets

Yinqiao Qingre Tablets is an innovative traditional Chinese medicine drug developed by Kangyuan Pharmaceutical on the basis of clinical experience.
The results of clinical trials show that it can be used for the treatment of common cold of exogenous wind-heat type.
treatment options
.

4.
Biological products

1.
The application of biological products in 2021

In 2021, a total of 335 acceptance numbers in Jiangsu Province will be accepted by CDE, including 9 for preventive biological products, including: 6 new drug clinical trial applications, 3 supplementary applications; 313 therapeutic biological products, including: 186 clinical trial applications, There were 35 listing applications, 81 supplementary applications and 11 re-registration applications
.
See Figure 9 for the acceptance of biological product declarations in Jiangsu Province in 2021:

Figure 9 Acceptance of biological product declarations in Jiangsu Province in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: Data as of January 13, 2022
.

2.
Completion of the review of biological products in 2021

In 2021, Jiangsu Province has completed the review of 281 (acceptance numbers, the same below) biological product acceptance numbers, including 185 new drug applications, 13 import applications, 65 supplementary applications, 11 import re-registration applications, and 7 one-time import applications.
; Among the new drug applications, there are a total of 25 marketing applications; 22 of them have been approved for marketing, most of which are PD-1 target therapy drugs
.
(If you want to know the specific situation, please pay attention to the Yaozhi registration acceptance database)
.
See Figure 10 for the completion of the review of biological products in Jiangsu Province in 2021
.
See Table 5 for the approval and marketing of new biological products in Jiangsu Province in 2021:

Figure 10 Completion of the review of biological products in Jiangsu Province in 2021

Data source: Yaozhi Data, Yaozhi Consulting

Note: Data as of January 13, 2022
.

Table 5 Approval and marketing of new biological products in Jiangsu Province in 2021

Note: Data as of January 13, 2022
.

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