2020 China Drug Evaluation Report - Part 2

Part 2. Chemical Drugs, Biological Products and Traditional Chinese Medicines

1. Chemical Drugs.
1.1. Application Overview.
1.2. Approval.
2. Biological Products.
2.1. Application Overview.
1.2. Approval.
3. Traditional Chinese Medicine.
3.1. Application Overview.
3.2. Approval.

Despite severe challenges from the COVID-19 pandemic, the Center for Drug Evaluation (CDE) of China reviewed 8,606 drug applications in 2020 and approved many new drugs to help patients suffering from different diseases.

As a follow-up on part 1 of the Drug Evaluation Report 2020, part 2 gives an overview of drug applications and approvals respectively for chemical drugs, biological products, and traditional Chinese medicines.

1. Chemical Drugs

1.1 Application Overview

In 2020, CDE reviewed 6,778 chemical drug applications, including:

1,086 Clinical Trial Applications (CTAs) for Investigational New Drugs (INDs) and confirmatory trials,
163 New Drug Applications (NDAs),
1,697 Abbreviated New Drug Applications (ANDA),
1,136 consistency evaluations,
2,248 supplementary applications.

Comparing to the previous year, the number of consistency evaluations has increased 103.22%

This is followed by CTAs (45.58%) and supplementary applications (23.72%).

View an overview of the chemical drug applications reviewed in 2020 below (Fig. 1).

Fig. 1 Number of Chemical Drug Applications Reviewed in 2020

1.2. Approval

907 INDs, 115 NDAs, and 918 ANDAs were approved with an increase of 51.42%, 30.68%, and 15.33% respectively compared to the previous year.

The table below (Table. 1) gives an overview of the chemical drug applications approved in 2020.

Table 1. Overview of Chemical Drug Application Approvals in 2020

APPLICATION TYPE	NUMBER OF APPLICATIONS
	APPROVAL (INCL. AFTER MATERIAL SUPPLEMENT)	NO APPROVAL SUGGESTED/NOT APPROVED	OTHERS*	TOTAL NUMBER
IND	907	39	14	960
Confirmatory Clinical Trial	108	11	7	126
NDA	115	3	45	163
ANDA	918	32	747	1,697
Supplementary Application	1,732	126	390	2,248
License Renewal of Imported Drugs	380	17	25	422
Consistency Evaluation	577	12	547	1,136
Re-Review	N/A			26
Total	4,737	240	1,775	6,778

Others*: herein refers to the applications which were withdrawn by the applicants or pending for material supplement after technical review, similarly hereinafter.

1.2.1. IND Approval

Under the classification of IND application, the approval rate of 694 Class 1 Innovative New Drugs increased by 40.77% compared to 2019.

Based on the Active Pharmaceutical Ingredients (APIs) of these drugs, 298 categories were approved for Class 1 Drugs with an increase of 57.67% comparing to the previous year.

View the following diagram for a comparison of IND and Class 1 drug IND approvals between the last five years (Fig. 2).

Fig. 2 Number of IND and Class 1 Innovative New Drug IND Approvals from 2016 to 2020

Among the IND approvals of Class 1 drugs, the following shared a large proportion of 80.69%:

Anti-neoplastic,
anti-infective,
circulatory system,
endocrine system,
gastrointestinal,
autoimmune disease,
immunosuppressant drugs.

The diagram below (Fig. 3) shows the number of Class 1 drug IND approvals for each therapeutic field in 2020.

Fig. 3 Number of Class 1 Innovative New Drug IND Approvals for Each Therapeutic Field in 2020

1.2.2. NDA Approval

CDE approved 115 chemical drug NDAs in 2020, among which Class 1 Innovative New Drugs covered 14 drug categories.

View a comparison of NDA approvals between the last five years below (Fig. 4).

Fig. 4 Number of NDA Approvals from 2016 to 2020

2. Biological Products

2.1 Application Overview

CDE reviewed a total of 1,410 Biologics License Applications (BLA) in 2020.

The number of reviewed IND applications and NDAs is given in the below table (Table 2) respectively for preventive and therapeutic biological products and in vitro diagnostics.

Table 2. Number of INDs and NDAs Reviewed for Biological Products in 2020

CLASSIFICATION	NUMBER OF INDs	NUMBER OF NDAs
Preventive Biological Product	27	9
Therapeutic Biological Product	537	108
In-vitro Diagnostics	0	1

The diagram below (Fig. 5) shows the number of BLAs reviewed for every application type.

Fig. 5 Number of BLAs Reviewed in 2020

2.2 Approval

Among the reviewed BLAs, 500 INDs and 89 NDAs were approved with an increase of 60.26% and 20.27% respectively compared to the previous year.

The number of approvals for each application type is summarized in the table below (Table 3).

Table 3. Overview of BLA Approvals in 2020

APPLICATION TYPE	NUMBER OF APPLICATIONS
	APPROVAL (INCL. AFTER MATERIAL SUPPLEMENT)	NO APPROVAL SUGGESTED/NOT APPROVED	OTHERS*	TOTAL NUMBER
Preventive IND	19	4	4	27
Therapeutic IND	481	45	11	537
Preventive NDA	7	0	2	9
Therapeutic NDA	81	1	26	108
In vitro Diagnostic NDA	1	0	0	1
Supplementary Application	551	22	102	675
License Renewal of Imported Drugs	45	0	4	49
Re-Review	N/A	N/A	N/A	4
In Total	1,185	72	149	1,410

For a comparison of biologics IND and NDA approvals between the last five years, please see the diagram below (Fig. 6).

Fig. 6 Number of Biologics IND and NDA Approvals from 2016 to 2020

2.2.1. IND Approval

Under the classification of biologics IND application, 294 cancer drugs were approved in 2020 which covered 58.8% of the total amount. The diagram below (Fig. 7) shows the number of IND approvals for each therapeutic field of biological products in this year.

Fig. 7 Number of Biologics IND Approvals for Each Therapeutic Field in 2020

2.2.2. NDA Approval

Under the classification of biologics NDA, cancer, endocrine, and cardiovascular drugs shared a large proportion of 65.17% of the total amount approved in 2020. The diagram below (Fig. 8) shows the number of NDA approvals for each therapeutic field of biological products this year.

Fig. 8 Number of Biologics NDA Approvals for Each Therapeutic Field in 2020

3. Traditional Chinese Medicines

3.1 Application Overview

CDE reviewed a total of 418 Traditional Chinese Medicine (TCM) applications in 2020, including 37 IND applications, 8 NDAs and 3 ANDAs. The diagram below (Fig. 9) shows the number of TCMs reviewed for each application type.

Fig. 9 Number of TCM Applications Reviewed in 2020

3.2 Approval

Among the reviewed TCM applications, 28 INDs and 4 NDAs were approved by CDE. The number of approvals for each application type is summarized in the table below (Table 4).

Table 4. Overview of TCM Approvals in 2020

APPLICATION TYPE	NUMBER OF APPLICATIONS
	Approval (incl. approval after material supplement)	No Approval Suggested / Not Approved	Others*	Total Number
IND	28	5	4	37
NDA	4	0	4	8
ANDA	0	2	1	3
Supplementary Application	220	42	65	327
License Renewal of Imported Drugs	17	6	4	27
Re-Review	N/A			16
In Total	269	55	78	418

For a comparison of TCM IND and NDA approvals between the last five years, please see the diagram below (Fig. 10).

Fig. 10 Number of TCM IND and NDA Approvals from 2016 to 2020

3.2.1. IND Approval

Under the classification of IND applications, 28 TCMs of 10 therapeutic fields were approved in 2020.

Respiratory, orthopedic, and gastrointestinal drugs shared a large proportion of 53.57%.

The diagram below (Fig. 11) shows the number of IND approvals for each therapeutic field of TCMs this year.

Fig. 11 Number of TCM IND Approvals for Each Therapeutic Field in 2020

Accestra Consulting Provides China Regulatory Affairs Outsourcing for:

Drugs/Pharmaceutical,
Food and Feed products for China NMPA (Formerly CFDA).
Regulatory approval including product registration for China Investigational New Drug (IND),
China New Drug Application (NDA),
China Drug Master File (DMF) for APIs,
Excipients and Packaging Materials,
ANDA,
eCTD submission and others.

Read part 1 of the 2020 Drug Evaluation Report.

Contact Accestra Consulting Group

Part 2. Chemical Drugs, Biological Products and Traditional Chinese Medicines

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