✅ NMPA Peptide Drug Approvals (2020–2025)
This chapter catalogs therapeutic peptide (including peptidomimetic / chemically synthesized peptide) new drugs and generics approved by China's NMPA from 2020 through H1 2025. By reviewing recent approval data, we analyze CDE review trends and industry direction, with comparisons across US, EU, and Chinese review practices.
1. NMPA-Approved Peptide Drug List (2020–2025)
| Drug Name |
Company |
Indication |
Approval Date |
Registration Class |
Notes |
| Semaglutide Injection (Ozempic) |
Novo Nordisk |
Type 2 Diabetes |
2021.04 |
Class 5.1 (Imported) |
Once-weekly GLP-1 RA |
| Liraglutide Injection |
Novo Nordisk |
Obesity/Overweight |
2023.06 |
Class 5.1 (Imported, new indication) |
Saxenda |
| Tirzepatide Injection (Mounjaro) |
Eli Lilly |
Type 2 Diabetes |
2024.05 |
Class 5.1 (Imported) |
GIP/GLP-1 dual-target |
| Semaglutide Tablets (Rybelsus) |
Novo Nordisk |
Type 2 Diabetes |
2024.01 |
Class 5.1 (Imported) |
First oral GLP-1 |
| Tirzepatide Injection (Zepbound) |
Eli Lilly |
Obesity |
2024.07 |
Class 5.1 (Imported, new indication) |
Weight-loss indication |
| Thymalfasin for Injection |
Multiple (Shuangcheng, Sailong, etc.) |
Infection/Immunity |
2023 |
Class 4 (Generic) |
Consistency evaluation |
| Octreotide Acetate Microspheres |
Multiple |
Acromegaly / Neuroendocrine Tumors |
2022–2024 |
Class 4 (Generic) |
Microsphere formulation generic |
| Liraglutide Injection |
Sinopeptide / Shenggene |
Type 2 Diabetes |
2024.09 |
Class 4 (Generic) |
First Liraglutide generic |
| Terlipressin for Injection |
Hybio |
Esophageal Variceal Bleeding |
— |
Existing product |
API + formulation |
| Carbetocin Injection |
Aurisco |
Postpartum Hemostasis |
2023.12 |
Class 3 (Generic) |
Domestic substitution |
| Dulaglutide Injection (Trulicity) |
Eli Lilly |
Type 2 Diabetes |
2022.02 |
Class 5.1 (Imported) |
Fusion protein/peptide weekly preparation |
| Exenatide Microspheres for Injection |
3SBio |
Type 2 Diabetes |
2021.08 |
Class 4 (Generic) |
Bydureon generic |
| Goserelin Acetate Sustained-Release Implant |
Multiple |
Prostate Cancer / Breast Cancer |
2022–2024 |
Class 4 (Generic) |
LHRH agonist |
| Triptorelin Acetate Injection |
Multiple |
Precocious Puberty / Endometriosis |
2023 |
Class 4 (Generic) |
GnRH agonist |
| Carfilzomib Injection |
Multiple |
Multiple Myeloma |
2024 |
Class 4 (Generic) |
Tetrapeptide antitumor drug |
| Linaclotide Capsules |
AstraZeneca |
IBS-C |
2021.10 |
Class 5.1 (Imported) |
14-aa guanylate cyclase-C agonist |
| Teriparatide Injection |
Eli Lilly / Joinwat |
Osteoporosis |
2023 |
Class 5.1 / Class 4 |
PTH analog |
| Cetrorelix Injection |
Merck |
Assisted Reproduction |
2022 |
Class 5.1 (Imported) |
GnRH antagonist |
| Teduglutide |
Takeda |
Short Bowel Syndrome |
2024 (pending) |
Class 5.1 (Imported) |
GLP-2 analog |
| Pasireotide for Injection |
Novartis |
Cushing's Disease |
2022 |
Class 5.1 (Imported) |
Somatostatin analog |
Approval Trend Observations
NMPA peptide drug approvals from 2020–2025 show three notable trends:
1. GLP-1 Dominance: Over 40% of new approvals involve GLP-1 class peptide drugs (originator imports + generics)
2. Generic Acceleration: Post-2022, the number of peptide generic approvals has increased significantly, particularly for Liraglutide and Octreotide
3. Dual-Target Innovation: Tirzepatide's (GIP/GLP-1 dual-target) approval marks simultaneous China-global market launch
4. High Import Share: Class 5.1 imported drugs account for over 50% of approvals; domestic innovation remains modest
2. Import Drug Approval Trends (2020–2025)
| Year |
Import Peptide New Drug Approvals |
Companies Involved |
Key Therapeutic Areas |
| 2020 |
2 |
Novartis, Merck |
Neuroendocrine tumors, assisted reproduction |
| 2021 |
3 |
Novo Nordisk, AstraZeneca |
Diabetes, IBS-C |
| 2022 |
3 |
Eli Lilly, Novartis |
Diabetes, Cushing's Disease |
| 2023 |
2 |
Novo Nordisk, Eli Lilly |
Obesity, Osteoporosis |
| 2024 |
4 |
Eli Lilly, Novo Nordisk |
Diabetes, Obesity, Short Bowel Syndrome |
| 2025H1 |
2 |
TBD |
GLP-1 class |
Import vs. Domestic Drug Approval Comparison
| Year |
Import Products |
Domestic Products |
Import Share |
Notes |
| 2020 |
2 |
2 |
50% |
— |
| 2021 |
3 |
2 |
60% |
Semaglutide launch driving |
| 2022 |
3 |
2 |
60% |
— |
| 2023 |
2 |
6 |
25% |
Concentrated domestic generic approvals |
| 2024 |
4 |
6 |
40% |
Dual-target and new dosage forms: imports + generics |
| 2025H1 |
2 |
4 |
33% |
Growing influence of domestic generics |
3. Key Peptide Drugs Under CDE Review (as of June 2025)
| Drug Name |
Company |
Type |
Current Status |
Estimated Review Completion |
| Semaglutide Injection (Generic) |
Sinopeptide |
Class 4 Generic |
Under CDE Review |
Q4 2025 – Q1 2026 |
| Semaglutide Injection (Generic) |
Shenggene |
Class 4 Generic |
Under CDE Review |
Q4 2025 – Q1 2026 |
| Semaglutide Injection (Generic) |
Hybio |
Class 4 Generic |
Supplementary Data |
H1 2026 |
| Tirzepatide (Generic) |
Sinopeptide |
Class 4 Generic |
Preclinical → IND Preparation |
2027+ |
| Liraglutide New Indication (NASH) |
Multiple |
Generic New Indication |
Phase II Clinical |
TBD |
| Novel GLP-1 (Ecnoglutide) |
Sciwind Biosciences |
Class 1 Innovative |
Pre-NDA |
H2 2025 – 2026 |
| Oral Semaglutide (Generic) |
Multiple |
Class 4 Generic |
R&D Stage |
2027+ |
4. Peptide Generic Consistency Evaluation Progress
| Product |
Companies Passed Evaluation |
Companies Under Review |
Reference Product |
Technical Challenges |
| Thymalfasin for Injection |
8 |
3 |
SciClone (Zadaxin) |
Purity and impurity profile consistency |
| Octreotide Acetate Injection |
5 |
4 |
Novartis (Sandostatin) |
Microsphere formulation complexity |
| Octreotide Acetate Microspheres |
2 |
3 |
Novartis (Sandostatin LAR) |
High release curve consistency requirements |
| Liraglutide Injection |
2 |
5 |
Novo Nordisk |
Purity/impurity profile + bioequivalence |
| Terlipressin for Injection |
3 |
2 |
Ferring Pharmaceuticals |
Stability and formulation process |
| Carbetocin Injection |
4 |
2 |
Ferring Pharmaceuticals |
Synthesis process and purity control |
| Somatostatin (for Injection) |
6 |
3 |
— |
Short-cycle stability |
| Exenatide Microspheres for Injection |
1 |
2 |
AstraZeneca (Byetta) |
Microsphere manufacturing barriers |
Consistency Evaluation Acceleration
As of June 2025, over 30 peptide generic products in China have initiated or completed consistency evaluation. Thymalfasin and Somatostatin are the most thoroughly evaluated products (6–8 companies passed), while Liraglutide and Octreotide microspheres remain limited in pass-through due to higher technical barriers. Following Semaglutide's 2026 patent expiry, a peak wave of consistency evaluation filings is expected.
5. NMPA vs. FDA/EMA Review Comparison
| Comparison Dimension |
NMPA (CDE) |
FDA |
EMA |
| Dedicated Peptide Guidance |
✅ Yes (released 2024) |
✅ Yes (updated 2017) |
✅ Yes (updated 2022) |
| Impurity Control Requirements |
EPC ≤0.5%, DPA ≤1.0% |
ICH Q6A + Peptide Supplement |
ICH Q6A + Peptide Appendix |
| Generic Submission Pathway |
Class 4 (requires consistency evaluation) |
505(j) ANDA |
Hybrid/Simplified |
| Bioequivalence Requirements |
Short peptides: BE; Long peptides: clinical equivalence |
BE in principle |
BE in principle |
| Priority Review Channels |
Breakthrough/Priority Review |
Fast Track/Breakthrough/Priority |
PRIME/Accelerated Assessment |
| Average Review Cycle (peptides) |
9–14 months |
8–12 months |
10–14 months |
| Applicant Communication |
Pre-IND/Pre-NDA (60–90 days) |
Pre-IND/End-of-Phase-2/Pre-NDA |
Scientific Advice/Qualification |
| Foreign Data Acceptance |
Gradually opening (ICH guidelines) |
Fully accepted |
Fully accepted |
6. CDE Review Trend Analysis (2020–2025)
| Metric |
2020 |
2021 |
2022 |
2023 |
2024 |
2025H1 |
| Peptide New Drug IND Filings |
8 |
12 |
15 |
18 |
22 |
14 |
| Peptide NDA Filings |
3 |
4 |
5 |
7 |
8 |
5 |
| Generic ANDA Filings |
6 |
8 |
12 |
18 |
22 |
15 |
| Approvals Granted |
4 |
5 |
5 |
8 |
10 |
6 |
| Average Review Duration (months) |
18 |
16 |
14 |
12 |
10 |
9 |
CDE Technical Guidance Publication History
| Release Date |
Guidance Title |
Milestone Significance |
| 2018.07 |
"Technical Guidelines for Chemical Peptide Drug Pharmaceutical Research" |
First peptide pharmaceutical guidance |
| 2019.08 |
"Technical Guidelines for Synthetic Peptide Drug Pharmaceutical Research and Evaluation" |
Refined synthesis process and quality control requirements |
| 2020.06 |
"Technical Guidelines for Drug Genotoxic Impurity Research" |
Standardized EPC/DPA impurity control |
| 2022.03 |
"Technical Guidelines for Drug Impurity Research (Revised)" |
Supplemented special peptide impurity requirements |
| 2023.05 |
"Technical Guidelines for Peptide Drug Biosimilar Development and Evaluation" |
First recombinant peptide biosimilar guideline |
| 2024.05 |
"Technical Guidelines for Peptide Drug Quality Control (Trial)" |
Comprehensive quality control baseline finalized |
| 2025E |
"Technical Guidelines for Synthetic Peptide Continuous Flow Manufacturing Process" (Proposed) |
Continuous flow process review standardization |
Review Acceleration Trend
CDE review efficiency for peptide drugs has improved year-over-year, from an average of 18 months in 2020 to 9 months in 2025. Accelerating factors include:
1. CDE establishing a dedicated peptide drug review expert panel
2. Pre-review communication mechanism implemented by the Drug Evaluation Center
3. Accelerated channels for priority review/breakthrough therapy products
4. Increased acceptance of overseas clinical trial data (ICH E5/E17 implementation)
7. Registration Pathway Selection Guide
| Product Positioning |
Recommended Pathway |
Advantages |
Risks/Challenges |
| Novel Structure Peptide |
Class 1 Innovative Drug |
Long market exclusivity, pricing advantage |
Long clinical development cycle, high risk |
| Optimized Known Target |
Class 2.2 Improved New Drug |
Partial clinical trial exemptions |
Must demonstrate clinical advantage |
| Marketed Peptide Generic |
Class 4 Generic |
Low investment, clear pathway |
Requires consistency evaluation |
| Overseas Marketed, Not in China |
Class 5.1 Import |
Leverages foreign data |
Requires bridging study |
| Overseas Marketed, Not in China (API) |
Class 5.2 Import |
Direct filing pathway |
Must be linked with formulation |
Data Sources: CDE drug review reports, NMPA drug database, Insight database, Yaozhi.com. The approval list above includes representative products. For a complete NMPA peptide drug approval list (including APIs, intermediates, and formulations), CDE review historical data, and China-US-EU review comparison analysis — visit the drug regulatory database for full regulatory database services and drug registration strategy consulting.