Abstract

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

Application Overview

In 2020, CDE reviewed a total of 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, and 2,248 supplementary applications. Comparing to the previous year, the number of consistency evaluations has significantly increased 103.22% followed by CTAs (45.58%) and supplementary applications (23.72%). For an overview of the chemical drug applications reviewed in 2020, please see the diagram below (Fig. 1).

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Approval

Among the reviewed chemical drug applications, 907 INDs, 115 NDAs and 918 ANDAs were approved with an increase of 51.42%, 30.68% and 15.33% respectively comparing to the previous year. The table below (Table. 1) gives an overview of the chemical drug applications approved in 2020.

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IND Approval

Under the classification of IND application, 694 Class 1 Innovative New Drugs were approved with an increase of 40.77% comparing 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. For a comparison of IND and Class 1 drug IND approvals between the last five years, please see the diagram below (Fig. 2).

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Among the IND approvals of Class 1 drugs, anti-neoplastic, anti-infective, circulatory system, endocrine system, gastrointestinal, autoimmune disease, and immunosuppressant drugs shared a large proportion of 80.69%. The diagram below (Fig. 3) shows the number of Class 1 drug IND approvals for each therapeutic field in 2020.

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NDA Approval

CDE approved 115 chemical drug NDAs in 2020, among which Class 1 Innovative New Drugs covered 14 drug categories. For a comparison of NDA approvals between the last five years, please see the diagram below (Fig. 4).

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2. Biological Products

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.

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

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Approval

Among the reviewed BLAs, 500 INDs and 89 NDAs were approved with an increase of 60.26% and 20.27% respectively comparing to the previous year. The number of approvals for each application type is summarized in the table below (Table 3).

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

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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.

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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 in this year.

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3. Traditional Chinese Medicines

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.

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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).

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

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IND Approval

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

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Click here If you missed out on previous part 1 of the Drug Evaluation Report 2020.


* This article was prepared by Longxi Yi from Accestra Consulting providing China Regulatory Affairs Outsourcing for Drugs/Pharmaceutical 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.

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