Editor's Notes: New drugs in this article refer to any of the following drugs:
Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;
Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;
First generic drugs in China: the first generic chemical drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization. The term “first generic drug” is commonly used in the Chinese pharma industry but not specified in Chinese regulations.
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In January 2025, China NMPA approved 32 new drugs, among which 20 are chemical drugs and 12 are biological products. The details are shown as follows:
1. Prusogliptin Tablets
Generic name | Prusogliptin Tablets |
Brand | Shan Ze Ping (善泽平) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Cspc Ouyi Pharmaceutical Co., Ltd. |
Approved | 2025/01/08 |
Time from application acceptance to approval | 623 days |
Priority review | No |
Target(s) | DPP4 |
Indication(s) | Indicated for the improvement of blood glucose control in adult patients with type 2 diabetes mellitus. |
2. Senaparib Capsules
Generic name | Senaparib Capsules |
Brand | Pai Shu Ning (派舒宁) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | IMPACT Therapeutics |
Approved | 2025/01/14 |
Time from application acceptance to approval | 507 days |
Priority review | No |
Target(s) | PARP-1; PARP2 |
Indication(s) | Indicated for the maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response after first-line platinum-based chemotherapy. |
3. Limertinib Tablets
Generic name | Limertinib Tablets |
Brand | Ao Yi Xin (奥壹新) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Aosaikang Pharmaceutical Co., Ltd. |
Approved | 2025/01/14 |
Time from application acceptance to approval | 1155 days |
Priority review | No |
Target(s) | EGFR T790M |
Indication(s) | Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during or after prior therapy with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and have confirmed EGFR T790M mutation positivity. |
4. Levetiracetam Sustained-release Granules
Generic name | Levetiracetam Sustained-release Granules |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Anbison |
Approved | 2025/01/24 |
Time from application acceptance to approval | 713 days |
Priority review | No |
Target(s) | SV2A |
Indication(s) | Indicated as adjunctive therapy for partial-onset seizures in patients aged 12 years and older with epilepsy. |
5. Mercaptopurine Tablets（II）
Generic name | Mercaptopurine Tablets（II） |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | China Resources Double-crane Pharmaceutical Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 483 days |
Priority review | Yes (pediatric drug) |
Target(s) | HPRT |
Indication(s) | Indicated for the treatment of choriocarcinoma, malignant hydatidiform mole, acute lymphoblastic leukemia (ALL), acute non-lymphoblastic leukemia (ANLL), and the blast phase of chronic myeloid leukemia (CML) in adult and pediatric patients. |
6. Savolitinib Tablets
Generic name | Savolitinib Tablets |
Brand | ORPATHYS (沃瑞沙) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Hutchmed (China) Limited |
Approved | 2025/01/08 |
Time from application acceptance to approval | 287 days |
Priority review | No |
Target(s) | MET |
Indication(s) | Indicated for first-line and second-line treatment of non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping mutations. |
7. Ibrutinib Tablets
Generic name | Ibrutinib Tablets |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Qilu pharmaceutical co., Ltd. |
Approved | 2025/01/02 |
Time from application acceptance to approval | 563 days |
Priority review | No |
Target(s) | BTK; ITK |
Indication(s) | Indicated for the treatment of various B-cell related hematologic malignancies and immune system disorders. |
Notes | First generic in China |
8. Dexmethylphenidate Hydrochloride Sustained-release Capsules
Generic name | Dexmethylphenidate Hydrochloride Sustained-release Capsules |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Zhongshuai Pharmaceutical Sci&Tech Co., Ltd. |
Approved | 2025/01/08 |
Time from application acceptance to approval | 378 days |
Priority review | Yes (pediatric drug) |
Target(s) | SLC6A3; SLC6A2 |
Indication(s) | Indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). |
Notes | First generic in China |
9. Sitafloxacin Granules
Generic name | Sitafloxacin Granules |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Hubei Jumpcan Pharmaceutical Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 710 days |
Priority review | No |
Target(s) | Bacterial Topo II |
Indication(s) | Indicated for the treatment of severe, drug-resistant bacterial infections caused by resistant pathogens, including pharyngitis, laryngitis, tonsillitis, acute bronchitis, infectious pneumonia, and secondary infections in chronic respiratory diseases. |
Notes | First generic in China |
10. Compound Amino Acid (16AA), Glucose (12.6%) and Electrolyte Injection
Generic name | Compound Amino Acid (16AA), Glucose (12.6%) and Electrolyte Injection |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Fujian Shengdi Pharmaceutical Co., Ltd. |
Approved | 2025/01/14 |
Time from application acceptance to approval | 635 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for adult patients requiring parenteral nutrition when enteral nutrition is not feasible, insufficient, or contraindicated, providing essential amino acids, electrolytes, and glucose. |
Notes | First generic in China |
11. Imipenem and Cilastatin Sodium for Injection and Sodium Chloride Injection
Generic name | Imipenem and Cilastatin Sodium for Injection and Sodium Chloride Injection |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Hunan Kelun Pharmaceutical Co Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 474 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of infections caused by multiple pathogens, including mixed aerobic and anaerobic bacterial infections, and for early treatment prior to identification of the causative pathogen. |
Notes | First generic in China |
12. Ezetimibe and Atorvastatin Calcium Tablets（Ⅱ）
Generic name | Ezetimibe and Atorvastatin Calcium Tablets（Ⅱ） |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Sinopep-Allsino Biopharmaceutical Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 490 days |
Priority review | No |
Target(s) | HMGCR |
Indication(s) | Indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). |
Notes | First generic in China |
13. Ezetimibe and Atorvastatin Calcium Tablets（Ⅰ）
Generic name | Ezetimibe and Atorvastatin Calcium Tablets（Ⅰ） |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Sinopep-Allsino Biopharmaceutical Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 490 days |
Priority review | No |
Target(s) | HMGCR |
Indication(s) | Indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). |
Notes | First generic in China |
14. Tulobuterol Patches
Generic name | Tulobuterol Patches |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Beijing Tide Pharmaceutical Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 549 days |
Priority review | No |
Target(s) | ADRB2 |
Indication(s) | Indicated for the relief of symptoms of dyspnea associated with bronchial asthma, bronchitis, and other related respiratory conditions. |
Notes | First generic in China |
15. Menatetrenone Soft Capsules
Generic name | Menatetrenone Soft Capsules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Henan Taifeng Bio-Technology Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 471 days |
Priority review | No |
Target(s) | Menatetrenone |
Indication(s) | Indicated for the treatment of osteoporosis. |
Notes | First generic in China |
16. Lusutrombopag Tablets
Generic name | Lusutrombopag Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Sichuan Kelun Pharmaceutical Co., Ltd. |
Approved | 2025/01/02 |
Time from application acceptance to approval | 504 days |
Priority review | No |
Target(s) | TPO-R |
Indication(s) | Indicated for the management of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo surgical or diagnostic procedures. |
Notes | First generic in China |
17. Lxazomib Citrate Capsules
Generic name | Lxazomib Citrate Capsules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Qilu Pharmaceutical Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 465 days |
Priority review | No |
Target(s) | Proteasome |
Indication(s) | Indicated for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy. |
Notes | First generic in China |
18. Hemofiltration Replacement Fluid of Sodium Citrate
Generic name | Hemofiltration Replacement Fluid of Sodium Citrate |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Shanghai Maple Biological Technology Co., Ltd. |
Approved | 2025/01/02 |
Time from application acceptance to approval | 601 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for anticoagulation in the process of continuous renal replacement therapy (CRRT). |
Notes | First generic in China |
19. Ciprofloxacin Hydrochloride and Fluocinolone Acetonide Ear Drops
Generic name | Ciprofloxacin Hydrochloride and Fluocinolone Acetonide Ear Drops |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | LABORATORIOS SALVAT, S.A. |
Approved | 2025/01/02 |
Time from application acceptance to approval | 693 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of acute otitis externa. |
20. Erdafitinib Tablets
Generic name | Erdafitinib Tablets |
Brand | BALVERSA (博珂) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Janssen Biotech, Inc. |
Approved | 2025/01/08 |
Time from application acceptance to approval | 693 days |
Priority review | No |
Target(s) | RET; VEGFR-3; PDGFRB; FGFR2; FGFR3; KIT; CSF1R; FGFR4; FGFR1; PDGFRA; VEGFR-2 |
Indication(s) | Indicated for the treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) who harbor susceptible FGFR3 gene mutations and have experienced disease progression during or following at least one line of PD-1 or PD-L1 inhibitor therapy. |
21. Amimestrocel Injection
Generic name | Amimestrocel Injection |
Brand | Rui Bo Sheng (睿铂生) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Platinum Biotech Excellence (Beijing) Co., Ltd. |
Approved | 2025/01/02 |
Time from application acceptance to approval | 191 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | / |
Indication(s) | Indicated for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD). |
22. Tagitanlimab Injection
Generic name | Tagitanlimab Injection |
Brand | Ke Tai Lai (科泰莱) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
Approved | 2025/01/14 |
Time from application acceptance to approval | 247 days |
Priority review | No |
Target(s) | PD-L1 |
Indication(s) | Indicated for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma in combination with gemcitabine and cisplatin. |
23. Stapokibart Injection
Generic name | Stapokibart Injection |
Brand | Kang Yue Da (康悦达) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Chengdu Kangnuoxing Biopharma, Inc. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 270 days |
Priority review | No |
Target(s) | IL4RA |
Indication(s) | Indicated for the treatment of seasonal allergic rhinitis. |
24. Xeligekimab Injection
Generic name | Xeligekimab Injection |
Brand | Jin Li Xi (金立希) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Chongqing Genrix Biopharmaceutical Co., Ltd. |
Approved | 2025/01/14 |
Time from application acceptance to approval | 376 days |
Priority review | No |
Target(s) | IL17A |
Indication(s) | Indicated for the treatment of radiologically confirmed axial spondyloarthritis. |
25. Efsubaglutide Alfa Injection
Generic name | Efsubaglutide Alfa Injection |
Brand | Yi Nuo Qing (怡诺轻) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 485 days |
Priority review | No |
Target(s) | GLP-1R; GLP-1 |
Indication(s) | Indicated for the management of blood glucose in adult patients with type 2 diabetes. |
26. Recaticimab for Injection
Generic name | Recaticimab for Injection |
Brand | Ai Xin An (艾心安) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Guangdong Hengrui Pharmaceutical Co., Ltd. |
Approved | 2025/01/08 |
Time from application acceptance to approval | 567 days |
Priority review | No |
Target(s) | PCSK9 |
Indication(s) | Indicated as an adjunct to a cholesterol-lowering diet, either in combination with statins alone or with statins and other lipid-lowering therapies, for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who have not achieved their low-density lipoprotein cholesterol (LDL-C) target with moderate to high-dose statin therapy. Alternatively, it may be used as monotherapy in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and apolipoprotein B (ApoB) levels. |
27. Isatuximab Injection
Generic name | Isatuximab Injection |
Brand | SARCLISA (赛可益) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Sanofi Winthrop Industrie |
Approved | 2025/01/08 |
Time from application acceptance to approval | 247 days |
Priority review | No |
Target(s) | CD38 |
Indication(s) | Indicated for first-line treatment of multiple myeloma (MM) patients who are not eligible for stem cell transplantation. |
28. Pembrolizumab Injection
Generic name | Pembrolizumab Injection |
Brand | Keytruda (可瑞达) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Merck Sharp & Dohme LLC |
Approved | 2025/01/08 |
Time from application acceptance to approval | 279 days |
Priority review | No |
Target(s) | PD-1 |
Indication(s) | Indicated as monotherapy for first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in patients whose tumors express PD-L1, as assessed by a validated test with a combined positive score (CPS) of ≥1. |
29. Enfortumab Vedotin for Injection
Generic name | Enfortumab Vedotin for Injection |
Brand | PADCEV (备思复) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Astellas Pharma Europe B.V. |
Approved | 2025/01/02 |
Time from application acceptance to approval | 280 days |
Priority review | No |
Target(s) | NECTIN4 |
Indication(s) | Indicated for first-line treatment of locally advanced or metastatic urothelial carcinoma (la/mUC) in combination with the PD-1 inhibitor Keytruda. |
30. Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine
Generic name | Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine |
Brand | GARDASIL (佳达修) |
Classification | Class 3.1 preventive biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Merck Sharp & Dohme LLC |
Approved | 2025/01/02 |
Time from application acceptance to approval | 492 days |
Priority review | No |
Target(s) | HPV |
Indication(s) | Indicated for vaccination in males aged 9 to 26 years. |
31. Cetuximab N01 Injection
Generic name | Cetuximab N01 Injection |
Brand | / |
Classification | Class 3.3 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
Approved | 2025/01/24 |
Time from application acceptance to approval | 503 days |
Priority review | No |
Target(s) | EGFR |
Indication(s) | Indicated for first-line treatment of RAS wild-type metastatic colorectal cancer in combination with the FOLFOX or FOLFIRI chemotherapy regimens. |
32. Recombinant Human Tumor Necrosis Factor-α Receptor II: IgG Fc Fusion Protein Injection
Generic name | Recombinant Human Tumor Necrosis Factor-α Receptor II: IgG Fc Fusion Protein Injection |
Brand | / |
Classification | Class 3.4 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | BioRay Pharmaceutical Co., Ltd. |
Approved | 2025/01/08 |
Time from application acceptance to approval | 536 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of rheumatoid arthritis and ankylosing spondylitis. |
Note | First biosimilar in China |
Contact BaiPharm if you need more details of drug approvals in China.
