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2022 CDE drug review report: 7911 varieties accepted, Hengrui, Chia Tai Tianqing, Shiyao ...

 Last Update: 2023-02-01
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As of December 31, 2022, the Center for Drug Evaluation of the State Medical Products Administration (hereinafter referred to as CDE) has accepted a total of 7,911 varieties (acceptance number 12,244) (according to the statistics of the PharmacoIntelligence Registration and Acceptance Database, the data statistics as of December 31, 2022, including the two statistical dimensions of acceptance number and variety (drug + enterprise), the same below), compared with 2021, the number of clinical and production declared this year has decreased
to a certain extent.

7911 acceptance number 12244

The following is a detailed analysis
of the 2022 drug registration review.

1.
Acceptance and review of drug applications in 2022

1.
Overall situation of the declaration in 2022

1.
1 Annual Acceptance

In 2022, CDE accepted 12,244 registration application acceptance numbers (7,911 varieties), a year-on-year increase of 5.
8%; Among them, there were 8,790 chemical drug application acceptance numbers (5,483 varieties), a year-on-year increase of 7.
5%, accounting for 71.
7% of the total number of applications accepted throughout the year; The number of applications received for registration from 2018 to 2022 is detailed in Figure 1
.

Figure 1 Number of applications received for registration, 2018-2022

Figure 1

1.
2 Declaration of each type of registration application throughout the year

In 2022, CDE accepted applications by registration application category, and accepted 1226 varieties (IND) of new drug clinical trial applications (hereinafter referred to as IND) (2197 acceptance numbers), a year-on-year decrease of 4.
9%; There are 208 varieties (328 acceptance numbers) in the application for new drug marketing authorization (hereinafter referred to as NDA), which is basically the same as last year; There were 1,722 varieties (2,317 acceptance numbers) of the same name, such as prescription drugs, generic drugs and biosimilars (hereinafter referred to as ANDA), a year-on-year increase of 29.
7%; 575 varieties (835 acceptance numbers) of generic drug quality and efficacy consistency evaluation registration application (hereinafter referred to as consistency evaluation application category); At present, the percentage of NDA declarations to IND declarations is about
20% per year.
The number of applications received for registration by application category from 2018 to 2022 is detailed in Figure 2
.

Figure 2 Number of applications received for registration by application category from 2018 to 2022

Figure 2

1.
3 Acceptance of applications for registration of innovative drugs

In 2022, 946 varieties (acceptance number 1727) of Class 1 innovative drugs were applied, of which 452 varieties (acceptance number 1036) were applied for chemical drugs, a year-on-year decrease of 12.
0%, including 436 varieties of IND applications and 16 varieties of NDA applications; 42 varieties of traditional Chinese medicine applications (48 acceptance numbers), a year-on-year decrease of 19.
2%, including 33 varieties of IND applications and 9 varieties of NDA applications; 452 varieties of biological products were applied for (643 acceptance numbers), a year-on-year increase of 8.
3%, including 441 varieties applied for IND and 13 varieties applied for NDA; The application acceptance status of Class 1 innovative drugs in 2021 and 2022 is detailed in Figure 3
.

Figure 3 Application acceptance status of Class 1 innovative drugs from 2021 to 2022

Figure 3

1.
4 Declared area

In terms of drug declaration in various provinces and cities in China (according to the statistics of the location of the enterprise, excluding import declaration data), Jiangsu declared in 2022 with 1304 acceptance numbers, followed by Shandong ranked second with 842 acceptance numbers, followed by Zhejiang, Guangdong and Shanghai; The declaration status of domestic provinces and cities in 2022 is shown in Figure 4
.

Figure 4 Declaration status of domestic provinces and cities in 2022

Figure 4

2.
Complete the overall review in 2022

2.
1 Review completed throughout the year

According to the latest statistics of the PharmaSmart Registration and Acceptance Database, 7416 varieties (acceptance number 11286) were reviewed in 2022 (Note: the status start time (PharmacoIntelligence) is from January 1, 2022 to December 31, 2022); The number of conclusions included in PharmaSmart was 10830 acceptance numbers, and the acceptance numbers with conclusions were analyzed and counted, including 4822 varieties of chemical drugs (7565 acceptance numbers), 1363 varieties of traditional Chinese medicines (acceptance number 1443), and 952 varieties of biological products (acceptance number 1797).

The detailed statistics of the conclusion of the review of registration applications in 2022 are shown in Figure 5
.

Figure 5 Statistics on the conclusion of the review of registration applications in 2022

Figure 5

According to the statistics of drug types, 4981 varieties of chemical drugs were reviewed in 2022 (acceptance number 7822); 1393 varieties of traditional Chinese medicines were reviewed (1478 acceptance numbers); 1025 varieties of biological products were reviewed (acceptance number 1906); The completion of the review of registration applications by drug type from 2018 to 2022 is shown in Figure 6
.

Figure 6 Review of registration applications by drug type from 2018 to 2022

Figure 6

2.
2 Review of each category of registration application completed throughout the year

According to the statistics of registration application categories, among the acceptance numbers of CDE review completed in 2022, there were 1305 varieties of IND (2260 acceptance numbers), accounting for 17.
6% of the total, 202 varieties of NDA (319 acceptance numbers), accounting for 2.
7% of the total, 1035 varieties (1383 acceptance numbers) of ANDA, accounting for 13.
9% of the total, and 679 varieties (acceptance numbers 927) of the consistency evaluation; Details of the completion of the review by category of review task for 2018-2022 are shown in Figure 7
.

Figure 7 Completion of review by category of review task, 2018-2022

Figure 7

2.
3 Review of innovative drugs in 2022

In 2022, 994 varieties (acceptance number 1760) of Class 1 innovative drugs will be reviewed, of which 488 varieties (acceptance number 1019) will be completed for chemical drugs, of which 476 varieties will be applied for IND and 14 varieties will be applied for NDA; A total of 46 varieties of traditional Chinese medicine were reviewed, 39 varieties were applied for IND and 7 varieties were applied for NDA.
460 varieties (571 acceptance numbers) of biological products were reviewed, a year-on-year increase of 17.
9%, including 452 varieties applied for IND and 8 varieties for NDA;

In 2022, a total of 21 varieties of Class 1 innovative drugs will be approved for marketing, with indications including anti-tumor field, cardiovascular system, digestive tract and metabolism; The distribution of ATC of Class 1 innovative drugs approved in 2022 is detailed in Figure 8
.

Figure 8 Distribution of ATC of Class 1 innovative drugs approved in 2022

Figure 8

Image source: PharmaSmart Data Enterprise Edition

2.
Application and review of chemical drugs in 2022

1.
Chemical drug declaration in 2022

1.
1 Overall acceptance of chemical drugs

In 2022, CDE accepted a total of 5,483 chemical drug registration applications (8,790 acceptance numbers), and 493 varieties (acceptance numbers 1,029) were applied for new drugs by application type, a year-on-year decrease of 7.
5%; 293 varieties of import applications (582 acceptance numbers); 1,722 varieties (acceptance number 2,303) were applied for imitation, 168 varieties were re-registered for import (350 acceptance numbers), and 2,741 varieties were supplemented (acceptance number 4,285);

According to the statistics of review task categories, IND applied for 622 varieties (1315), a year-on-year decrease of 12.
0%; ANDA applied for 1,722 varieties (2,317 acceptance numbers), a year-on-year increase of 29.
8%; NDA applied for 106 varieties (186 varieties) and 575 varieties (acceptance number 835); The acceptance of applications for each review task category of chemical drugs in 2022 is detailed in Figure 9
.

Figure 9 Application acceptance status of each category of chemical drug review task in 2022

Figure 9

1.
2 Declaration of Class 1 innovative drugs for chemical drugs

In 2022, 452 varieties (acceptance number 1036) of Class 1 innovative drugs of chemical drugs will be accepted, and 802 of them will be accepted in China, involving 343 varieties; There are 234 import acceptance numbers, involving 109 varieties; According to the statistics of review task categories, 436 varieties (acceptance number 1007) were applied for IND, a year-on-year decrease of 11.
5%, and NDA applications were 16 varieties (29 acceptance numbers), a year-on-year decrease of 23.
8%; The acceptance status of applications for the registration of Class 1 innovative drugs of chemical drugs from 2018 to 2022 is detailed in Figure 10
.

Figure 10 Acceptance of applications for the registration of Class 1 innovative drugs of chemical drugs from 2018 to 2022

Figure 10

As can be seen from Figure 10, from 2018 to 2022, the percentage of NDA declarations to IND declarations is 12.
7%, 6.
2%, 6.
3%, 4.
3% and 3.
7% respectively.
At present, the annual NDA declaration volume as a percentage of IND declaration is about 6%;

1.
3 Application status of improved new drugs for chemical drugs

In 2022, CDE will accept 197 varieties of improved new drugs of Class 2 (acceptance number) of chemical drugs, including 168 varieties applied for IND and 34 varieties for NDA; Compared with the number of Class 1 innovative drug registration applications, there is still a big gap in the number of improved innovative drugs, and there is still more room for development as a whole; The acceptance status of applications for the registration of Class 2 improved new drugs of chemical drugs from 2019 to 2022 is detailed in Figure 11
.

Figure 11 Application acceptance of applications for the registration of improved new drugs of Class 2 from 2019 to 2022

Figure 11

As can be seen from Figure 11, from 2019 to 2022, the percentage of annual NDA declarations in IND declarations is 25.
6%, 27.
9%, 16.
4% and 20.
2, respectively; at present, the annual NDA declaration as a percentage of IND declaration is about
22.
5%.

2.
Completion of chemical drug review in 2022

2.
1 Overall situation of the completion of the review of chemical drugs

In 2022, CDE completed the review of a total of 4,981 varieties of chemical drugs (7,822 acceptance numbers, including acceptance numbers that did not require technical review); In terms of application type, 541 varieties of new drugs were applied for (acceptance number 1072); 296 varieties of import applications (578 acceptance numbers); 1,041 varieties (acceptance number 1,380) for imitation, 186 varieties for import re-registration (370 acceptance number), and 2,865 varieties for supplementary applications (acceptance number 4,190);

According to the statistics of review task categories, IND applications were 674 varieties (1370 acceptance numbers), a year-on-year increase of 2.
2%; ANDA applied for 1,031 varieties (1,379 acceptance numbers), a year-on-year decrease of 38.
4%; NDA applications were 115 varieties (182 acceptance numbers), a year-on-year decrease of 9.
4%; 679 varieties (acceptance number: 927); The completion of the review of each review task category of chemical drugs in 2022 is detailed in Figure 12
.

Figure 12 Completion of review of chemical drug review task categories in 2022

Figure 12

2.
2 Completion of the review of innovative chemical drugs

In 2022, a total of 488 varieties (acceptance number 1077) of chemical drugs Class 1 innovative drugs will be reviewed, and 374 varieties (824 acceptance numbers) will be produced in China; 114 varieties imported (253 acceptance numbers); According to the statistics of review task categories, IND applications were 476 varieties (1056 acceptance numbers), a year-on-year increase of 2.
8%, and NDA applications were 14 varieties (acceptance numbers 21), a year-on-year decrease of 51.
7%; The completion of the review of the application for the registration of Class 1 innovative drugs for chemical drugs from 2018 to 2022 is detailed in Figure 13
.

Figure 13 Review of applications for the registration of Class 1 innovative drugs for chemical drugs from 2018 to 2022

Figure 13

In 2022, 24 varieties of chemical drugs will be approved for marketing as Class 1 innovative drugs, involving cardiovascular, neurological and blood system fields; Details of the approved innovative chemical drugs in 2022 are shown in Table 1
.

Table 1 Class 1 innovative drugs of chemical drugs approved in 2022

Table 1

2.
3 Review of improved new chemical drugs

In 2022, a total of 199 varieties (acceptance number 328) of CDE for Class 2 improved new drugs of chemical drugs were reviewed, and the completion volume was basically the same as last year, including 170 varieties (274 acceptance numbers) and 39 NDA applications (61 acceptance numbers); The completion of the review of the application for the registration of Class 2 improved new drugs for chemical drugs from 2019 to 2022 is detailed in Figure 14
.

Figure 14 Review of applications for the registration of Class 2 improved new drugs for chemical drugs from 2019 to 2022

Figure 14

In 2022, 30 varieties of chemical drugs will be approved for marketing in Class 2 improved new drugs, involving anti-tumor, neurological and blood system fields; The details of the improved new drugs approved in 2022 are shown in Table 2
.

Table 2 Class 2 improved new drugs approved in 2022

Table 2

3.
Application and review of traditional Chinese medicines in 2022

1.
The declaration of traditional Chinese medicines in 2022

In 2022, CDE undertook a total of 1,550 new applications for registration of traditional Chinese medicines with acceptance numbers (1,420 varieties, including acceptance numbers without technical review); According to the statistics of review task categories, IND applied for 49 varieties (55 acceptance numbers), including 38 innovative drug acceptance numbers (involving 33 varieties) and 14 improved new drug acceptance numbers (involving 13 varieties); NDA applied for 11 varieties (13 acceptance numbers), including 9 innovative drugs and 2 classic prescription varieties; The acceptance of applications for each review task category of Chinese medicines in 2022 is detailed in Figure 15
.

Figure 15 Application acceptance status of various review task categories of traditional Chinese medicines in 2022

Figure 15

2.
Review of traditional Chinese medicines in 2022

2.
1 Overall situation of the completion of the review of traditional Chinese medicines

In 2022, the CDE review completed the registration application of 1393 varieties of traditional Chinese medicines (acceptance number 1478, including the acceptance number without technical review); According to the statistics of review task categories, IND applied for 52 varieties, including 39 varieties of innovative drugs and 11 varieties of improved new drugs; NDA applied for 11 varieties; The completion of the review of each review task category of Chinese medicines in 2022 is detailed in Figure 16
.

Figure 16 Application completion of each review task category of traditional Chinese medicines in 2022

Figure 16

2.
2 Approval of innovative drugs in traditional Chinese medicine

In 2022, 4 varieties of innovative Chinese medicine drugs were approved for marketing, namely Prince Shenyue Capsules, Guangqian Cao Total Flavonoid Capsules, Hemostatic Menstrual Regulation Granules and Acoladine Soft Capsules; Details of the approved innovative drugs of traditional Chinese medicine in 2022 are shown in Table 3
.

Table 3 Innovative drugs for traditional Chinese medicine approved in 2022

Table 3

2.
3 Approval of classical Chinese medicines

In 2022, there are 2 varieties of traditional Chinese medicine classics approved for marketing, which are Sanhanhua wet granules and Lingguishugan granules, both of which are products of Jiangsu Kangyuan; Details of the 2022 Classic Names approved are shown in Table 4
.

Table 4 Approved classical prescriptions of traditional Chinese medicines in 2022

Table 4

4.
Declaration and review of biological products in 2022

1.
Declaration of biological products in 2022

1.
1 Acceptance of biological products

In 2022, CDE accepted 998 varieties (acceptance number 1882) for biological product registration, of which 555 varieties (acceptance number 827) accepted biological product IND applications, a year-on-year increase of 4.
5%; 91 varieties (129 acceptance numbers) were accepted for biological product NDA applications, a year-on-year increase of 8.
3%; The acceptance status of applications for registration of biological products from 2018 to 2022 is detailed in Figure 17
.

Figure 17 Acceptance of applications for registration of biological products from 2018 to 2022

Figure 17

1.
2 Application status of innovative drugs for biological products

In 2022, 452 varieties of biological products Class 1 innovative drugs will be accepted (643 acceptance numbers), and 372 varieties (acceptance numbers 516, including 8 biological products for prevention and 508 biological products for treatment) will be accepted in China; 80 varieties were imported (127 acceptance numbers, including 2 biological products for prevention and 125 biological products for treatment); According to the statistics of review task categories, 441 varieties (623 acceptance numbers) and 13 NDA applications (20 acceptance numbers) were applied for NDA.
The acceptance status of applications for the registration of Class 1 innovative drugs in 2022 is detailed in Figure 18
.

Figure 18 Acceptance of applications for the registration of Class 1 innovative drugs for biological products in 2022

Figure 18

2.
Review of biological products in 2022

2.
1 Overall situation of the completion of the review of biological products

In 2022, CDE completed the evaluation of a total of 1025 varieties of biological products (acceptance number 1960); According to the statistics of review task categories, 578 varieties (836 acceptance numbers) were applied for IND, a year-on-year increase of 15.
3%, including 29 biological products for prevention and 549 biological products for treatment; NDA applications were 76 varieties (123 acceptance numbers), a year-on-year decrease of 21.
6%, including 6 biological products for prevention and 70 biological products for treatment; The completion of each category of biologics review task in 2022 is detailed in Figure 19
.

Figure 19 Completion of each category of review task for biological products in 2022

Figure 19

2.
2 Approval of innovative drugs for biological products

In 2022, there will be 6 varieties of innovative biological drugs approved for marketing (except new crown drugs), with indications including solid tumors and cervical cancer; Details of the approval of innovative biologics in 2022 are shown in Table 5
.

Table 5 Approved innovative drugs for biological products in 2022

Table 5

5.
Review of accelerated marketing registration procedures for drugs

1.
Priority review and approval

In 2022, CDE included 49 varieties (72 acceptance numbers) registration applications into the priority review process, including 33 varieties of chemical drugs (54 acceptance numbers) and 16 varieties of biological products (18 acceptance numbers); Reasons for inclusion include compliance with conditional approval, pediatric use, and inclusion in breakthrough therapy procedures; Indications include psoriasis, hyperammonemia and cancer; Details of the varieties included in the priority review and approval process in 2022 are shown in Table 6
.

Table 6 Varieties included in the priority review and approval procedure in 2022

Table 6

2.
Review of breakthrough therapy

Application for breakthrough therapy drug procedure conditions: during the clinical trial of the drug, it is used to prevent and treat diseases that seriously threaten life or seriously affect the quality of life, and there are no effective prevention and treatment methods, or there is sufficient evidence of obvious clinical advantages compared with existing treatment methods of innovative drugs or improved new drugs.

In 2022, CDE included 39 varieties (52 acceptance numbers) registration applications into the breakthrough therapy drug program, covering indications such as non-small cell lung cancer, spinal muscular atrophy and gastric cancer; The varieties of breakthrough therapies included in 2022 are shown in Table 7
.

Table 7 Breakthrough therapy varieties included in 2022

Table 7

Source: PharmacoIntelligence Registration and Acceptance Database

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