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 July 2024, China NMPA approved 20 new drugs, among which 15 are chemical drugs and 5 are biological products. The details are shown as follows:
1. Tirzepatide Injection
Generic name | Tirzepatide Injection |
Brand | MOUNJARO |
Classification | Class 2.4 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Eli Lilly and Company |
Approved | 2024/7/16 |
Time from application acceptance to approval | 330 days |
Priority review | No |
Target(s) | GIPR; GLP-1R |
Indication(s) | Indicated for the long-term management of overweight in adults with at least one weight-related comorbidity, in conjunction with a reduced-calorie diet and physical activity increase. |
2. Chiglitazar Sodium Tablets
Generic name | Chiglitazar Sodium Tablets |
Brand | Bilessglu |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Chengdu Chipscreen Pharmaceutical Ltd. |
Approved | 2024/7/16 |
Time from application acceptance to approval | 392 days |
Priority review | No |
Target(s) | PPAR-alpha; PPAR-delta; PPAR-gamma |
Indication(s) | Indicated for improving blood glucose control in adults with type 2 diabetes. |
3. Irbesartan and Amlodipine Besilate Tablets（Ⅰ）
Generic name | Irbesartan and Amlodipine Besilate Tablets（Ⅰ） |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Jiangxi Shimei Pharmaceutical Co., Ltd. |
Approved | 2024/7/9 |
Time from application acceptance to approval | 635 days |
Priority review | No |
Target(s) | AGTR1; Calcium channel |
Indication(s) | Indicated for the treatment of hypertension and hypertensive nephropathy associated with type 2 diabetes. |
Notes | First generic in China |
4. Irbesartan and Amlodipine Besilate Tablets（Ⅲ）
Generic name | Irbesartan and Amlodipine Besilate Tablets（Ⅲ） |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Jiangxi Shimei Pharmaceutical Co., Ltd. |
Approved | 2024/7/9 |
Time from application acceptance to approval | 635 days |
Priority review | No |
Target(s) | AGTR1; Calcium channel |
Indication(s) | Indicated for the treatment of hypertension and hypertensive nephropathy associated with type 2 diabetes. |
Notes | First generic in China |
5. Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
Generic name | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Qilu Pharmaceutical Co., Ltd. |
Approved | 2024/7/9 |
Time from application acceptance to approval | 539 days |
Priority review | No |
Target(s) | RTase |
Indication(s) | Indicated for the treatment of HIV-1 infection. |
Notes | First generic in China |
6. Frovatriptan Tablet
Generic name | Frovatriptan Tablet |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | C.P Pharmaceutical (Qingdao) Co. Ltd. |
Approved | 2024/7/30 |
Time from application acceptance to approval | 617 days |
Priority review | No |
Target(s) | 5-HT1B; 5-HT1D |
Indication(s) | Indicated for the treatment of migraines. |
Notes | First generic in China |
7. Alfacalcidol Drops
Generic name | Alfacalcidol Drops |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Hubei Jinluo Silk Cloth Co., Ltd. |
Approved | 2024/7/30 |
Time from application acceptance to approval | 489 days |
Priority review | No |
Target(s) | Vitamin D3 |
Indication(s) | Indicated for the treatment of calcium metabolism disorders resulted from insufficient endogenous production of 1,25-dihydroxyvitamin D3. |
Notes | First generic in China |
8. Vancomycin Hydrochloride Capsules
Generic name | Vancomycin Hydrochloride Capsules |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Speed Safety Healthy (Hangzhou) Pharmaceutical Co., Ltd. |
Approved | 2024/7/9 |
Time from application acceptance to approval | 379 days |
Priority review | Yes (Pediatric drug) |
Target(s) | PGLYRP |
Indication(s) | Indicated for the treatment of diarrhea related to clostridium difficile infection as well as enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in both adults and children aged 18 years and younger. |
Notes | First generic in China |
9. Meropenem for Injection and Sodium Chloride Injection
Generic name | Meropenem 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 | 2024/7/30 |
Time from application acceptance to approval | 472 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of infections caused by multiple drug-resistant pathogens and severe infections. |
Notes | First generic in China |
10. Multi-Trace Elements Injection（Ⅲ）
Generic name | Multi-Trace Elements Injection（Ⅲ） |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Yangpu Jingtai Pharmaceutical Co., Ltd. |
Approved | 2024/7/9 |
Time from application acceptance to approval | 609 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for meeting the essential and intermediate trace element needs in patients receiving parenteral nutrition. |
Notes | First generic in China |
11. Entacapone Tablets (II)
Generic name | Entacapone Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | SJZ No.4 Pharmaceutical Co., Ltd. |
Approved | 2024/7/30 |
Time from application acceptance to approval | 587 days |
Priority review | No |
Target(s) | AADC; COMT; DA receptor |
Indication(s) | Indicated for adult patients with Parkinson's disease experiencing motor fluctuations at the end of treatment with levodopa and decarboxylase inhibitors. |
Notes | First generic in China |
12. Ganaxolone Oral Suspension
Generic name | Ganaxolone Oral Suspension |
Brand | 泽元安 (Ze Yuan An) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Marinus Pharmaceuticals, Inc. |
Approved | 2024/7/9 |
Time from application acceptance to approval | 299 days |
Priority review | Yes (Pediatric drug) |
Target(s) | GABAAR |
Indication(s) | Indicated for the treatment of seizures in patients aged 2 years and older with CDKL5 Deficiency Disorder (CDD). |
13. Methotrexate Injection
Generic name | Methotrexate Injection |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Medac Gesellschaft für klinische Spezialpräparate mbH |
Approved | 2024/7/30 |
Time from application acceptance to approval | 239 days |
Priority review | No |
Target(s) | DHFR |
Indication(s) | Indicated for the treatment of active rheumatoid arthritis in adults. |
14. Peficitinib Hydrobromide Tablets
Generic name | Peficitinib Hydrobromide Tablets |
Brand | SMYRAF |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Astellas Pharma Inc. |
Approved | 2024/7/30 |
Time from application acceptance to approval | 699 days |
Priority review | No |
Target(s) | JAK; JAK3 |
Indication(s) | Indicated for the treatment of rheumatoid arthritis. |
15. Ursodeoxycholic Acid Oral Suspension
Generic name | Ursodeoxycholic Acid Oral Suspension |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Dr. Falk Pharma GmbH |
Approved | 2024/7/16 |
Time from application acceptance to approval | 194 days |
Priority review | Yes (Pediatric drug) |
Target(s) | Bile acid |
Indication(s) | Indicated for: 1. Radiolucent Cholesterol gallstones in the gallbladder when patients have normal gallbladder contraction function. 2. Cholestatic liver disease (e.g., primary biliary cirrhosis). 3. Bile reflux gastritis |
16. Telitacicept for Injection
Generic name | Telitacicept for Injection |
Brand | 泰爱(Tai Ai) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | RemeGen Co., Ltd. |
Approved | 2024/7/16 |
Time from application acceptance to approval | 313 days |
Priority review | No |
Target(s) | TNFRSF13B |
Indication(s) | Indicated for the treatment of rheumatoid arthritis. |
17. Efgartigimod Alfa Injection (Subcutaneous Injection)
Generic name | Efgartigimod Alfa Injection (Subcutaneous Injection) |
Brand | VYVGART HYTRULO |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | argenx BV |
Approved | 2024/7/9 |
Time from application acceptance to approval | 367 days |
Priority review | No |
Target(s) | FCGR; FCGRT |
Indication(s) | Indicated for the treatment of generalized myasthenia gravis (gMG). |
18. Insulin Degludec and Insulin Aspart Injection
Generic name | Insulin Degludec and Insulin Aspart Injection |
Brand | 惠优加 (Hui You Jia) |
Classification | Class 3.3 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Huisheng Bio-pharmacutical Co., Ltd |
Approved | 2024/7/30 |
Time from application acceptance to approval | 450 days |
Priority review | No |
Target(s) | INS; InsR |
Indication(s) | Indicated for the treatment of type 2 diabetes in adults. |
Notes | First biosimilar in China |
19. Bimekizumab Injection
Generic name | Bimekizumab Injection |
Brand | BIMZELX |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | UCB Pharma S.A. |
Approved | 2024/7/16 |
Time from application acceptance to approval | 447 days |
Priority review | No |
Target(s) | IL-17; IL-17F; IL17A |
Indication(s) | Indicated for active ankylosing spondylitis in adults with an inadequate response to or intolerance of conventional therapies. |
20. Vonicog alfa for Injection
Generic name | Vonicog alfa for Injection |
Brand | VONVENDI |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Takeda Pharmaceuticals U.S.A., Inc. |
Approved | 2024/7/30 |
Time from application acceptance to approval | 570 days |
Priority review | Yes (Other priority review situation) |
Target(s) | vWF |
Indication(s) | Indicated for adults (18 years and older) diagnosed with von Willebrand disease (VWD) for on-demand treatment and control of bleeding episodes, as well as for perioperative bleeding management. |
Contact BaiPharm if you need more details of drug approvals in China.
