C21 · Pharmaceuticals · CN

New drug approvals in China

China: 11 (first-in-class drug approvals, 2025), −77.1% on 2024.

  • 11 Latest · 2025
  • −77.1% vs 2024
  • 70Records · 40 measures

Annual · 5 publishers · Next period 2026

First-in-class drug approvals in China

Fig 1 · C21 · China Annual

First-in-class drug approvals

China, 2022 to 2025

4 observations · 2022 to 2025
First-in-class drug approvalsFirst-in-class drug approvals. 4 observations from 2022 to 2025, ranging from 11 to 48. Latest value 11 (2025). 0 10 20 30 40 50 2022 2023 2024 2025 21 11
First-in-class drug approvalsFirst-in-class drug approvals. 4 observations from 2022 to 2025, ranging from 11 to 48. Latest value 11 (2025). 0 20 40 60 2022 2023 2024 2025 21 11
First-in-class drug approvalsFirst-in-class drug approvals. 4 observations from 2022 to 2025, ranging from 11 to 48. Latest value 11 (2025). 0 20 40 60 2022 2023 2024 2025 21 11
View the underlying data
First-in-class drug approvals
Period Type Value
2022 Actual 21
2023 Actual 40
2024 Actual 48
2025 Actual 11
Source: NMPA, NHSA · CC BY 4.0 · statorigin.org

Every record

70 records across 40 measures, newest first within each. Each period opens its record and quote.

Measure Period Value Source
Antibody-drug conjugate approvals 2025 3 DIA
Approved Class 1 innovative drugs 2025 76 NHSA
Approved Class 1 innovative drugs (half year) January–June 2026 38 NHSA
Approved innovative drugs designated as breakthrough therapies 2024 13 State Council
Approved innovative drugs designated as breakthrough therapies 2024 13 NMPA
Approved innovative drugs growth rate 2025 58.3% MOFCOM
Approved innovative drugs with new targets or mechanisms 2025 11 NHSA
Approved innovative drugs with new targets or mechanisms (half year) January–June 2026 11 NHSA
Approved novel drugs in breakthrough therapy programs 2024 13 NMPA
Bispecific antibody approvals 2025 4 DIA
Breast cancer drug approvals 2025 9 DIA
Cell therapy approvals 2025 3 DIA
Domestic developer drug approvals 2025 63 DIA
Domestic developer share of drug approvals 2025 52% DIA
Domestic first-in-class drug approvals 2025 4 NHSA
Domestic first-in-class drug approvals 2025 4 MOFCOM
Domestic innovative biological product approvals 2025 21 NHSA
Domestic innovative biological product approvals 2025 21 MOFCOM
Domestic innovative chemical drug approvals 2025 38 NHSA
Domestic innovative chemical drug approvals 2025 38 MOFCOM
Domestic innovative drug approvals (half year) January–June 2026 31 State Council
Domestic innovative drug approvals (half year) January–June 2026 31 MOFCOM
Domestic share of approved innovative biological products 2025 91.3% NHSA
Domestic share of approved innovative biological products 2025 91.3% MOFCOM
Domestic share of approved innovative chemical drugs 2025 80.8% NHSA
Domestic share of approved innovative chemical drugs 2025 80.8% MOFCOM
First global drug approvals 2025 61 DIA
First-in-class drug approvals 2025 11 NHSA
First-in-class drug approvals 2025 11 MOFCOM
First-in-class drug approvals 2024 48 NMPA
First-in-class drug approvals 2024 48 State Council
First-in-class drug approvals 2024 48 NMPA
First-in-class drug approvals 2023 40 State Council
First-in-class drug approvals 2023 40 NMPA
First-in-class drug approvals 2022 21 State Council
First-in-class drug approvals 2022 21 NMPA
Fusion protein approvals 2025 3 DIA
Imported drug share of approvals 2025 48% DIA
Imported innovative biological product approvals 2025 2 NHSA
Imported innovative biological product approvals 2025 2 MOFCOM
Imported innovative chemical drug approvals 2025 9 NHSA
Imported innovative chemical drug approvals 2025 9 MOFCOM
Innovative biological product approvals 2025 23 NHSA
Innovative biological product approvals 2025 23 MOFCOM
Innovative biological product approvals (half year) January–June 2026 17 NHSA
Innovative drug approvals 2025 76 NHSA
Innovative drug approvals 2025 76 MOFCOM
Innovative drug approvals 2024 48 NHSA
Innovative drug approvals 2024 48 MOFCOM
Innovative drug approvals 2024 48 State Council
Innovative drug approvals (half year) January–June 2026 38 State Council
Innovative drug approvals (half year) January–June 2026 38 MOFCOM
Innovative drug approvals (year to date) 1 Jan 2026 to 15 Apr 2026 14 NHSA
Innovative drugs approved via priority review pathway 2024 17 State Council
Innovative drugs approved via priority review pathway 2024 17 NMPA
Innovative drugs granted conditional market approval 2024 11 State Council
Innovative drugs granted conditional market approval 2024 11 NMPA
Innovative traditional medicine approvals 2025 6 NHSA
Innovative traditional medicine approvals 2025 6 MOFCOM
Innovative traditional medicine approvals (half year) January–June 2026 1 NHSA
New drugs approved for marketing after clinical trials (China registration category) 2025 248 NHSA
Novel drug approvals via priority review pathway 2024 17 NMPA
Novel drugs granted conditional market approval 2024 11 NMPA
Pediatric medicine approvals 2024 106 NMPA
Pediatric medicine approvals 2024 106 State Council
Pediatric medicine approvals 2024 106 NMPA
Rare disease drug varieties approved 2024 39 State Council
Rare disease medicine approvals 2024 55 NMPA
Rare disease medicine approvals 2024 55 State Council
Rare disease medicine approvals 2024 55 NMPA

Frequently asked questions

What is the latest new drug approvals figure for China?

China: 11 first-in-class drug approvals in 2025, −77.1% on 2024.

Where does the China data come from?

70 records from 12 documents by DIA, NHSA, State Council, NMPA, MOFCOM. Each figure links to its record and the sentence it was read from.

Cite this page

Free to reuse under CC BY 4.0 with attribution to StatOrigin and the original publisher.

StatOrigin. (2026). New drug approvals in China [Data set]. Retrieved September 29, 2026, from https://statorigin.org/statistics/new-drug-approvals/china

"New drug approvals in China." StatOrigin, 2026, https://statorigin.org/statistics/new-drug-approvals/china. Accessed 29 Sep. 2026.

StatOrigin. "New drug approvals in China." Data set, 2026. Accessed September 29, 2026. https://statorigin.org/statistics/new-drug-approvals/china.

@misc{statorigin_new_drug_approvals_china_2026, title = {New drug approvals in China}, author = {{StatOrigin}}, year = {2026}, url = {https://statorigin.org/statistics/new-drug-approvals/china}, note = {Data set. Accessed 2026-09-29} }