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 February 2024, China NMPA approved 13 new drugs, among which 8 are chemical drugs and 5 are biological products.
1. Zhaoke Ophthalmology’s Adapalene and Clindamycin Hydrochloride Gel
2. Pfizer’s Abrocitinib Tablets
3. Nobelpharma’s Zinc Acetate Tablets
4. Roche’s Entrectinib Capsules
5. Kelun Pharma’s ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acid (16)/Glucose (16%) Injection (first generic in China)
6. Brilliant Pharma’s Furosemide Oral Solution (first generic in China)
7. Timehome Pharma’s Anagrelide Hydrochloride Capsules (first generic in China)
8. Hepoer Pharma’s Isosulfan Blue Injection (first generic in China)
9. Kaixing Life Science’s Zevorcabtagene Autoleucel Injection (innovative biologic)
10. Roche’s Crovalimab Injection (innovative biologic)
11. Takeda’s Teduglutide for Injection
12. Takeda’s Susoctocog Alfa for Injection
13. Merz Pharma’s Botulinum Toxin Type A for Injection
1. Adapalene and Clindamycin Hydrochloride Gel
Generic name | Adapalene and Clindamycin Hydrochloride Gel |
Brand | / |
Classification | Class 2.3 chemical drug |
Application type | New drug application (NDA), domestic |
Marketing authorization holder (MAH) | |
Approved | 20/02/2024 |
Time from application acceptance to approval | 1,112 days |
Priority review | No |
Target(s) | Retinoic acid receptor (RAR) |
Indication(s) | Indicated for the treatment of moderate acne vulgaris. |
2. Abrocitinib Tablets
Generic name | Abrocitinib Tablets |
Brand | 希必可 (CIBINQO) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 23/02/2024 |
Time from acceptance to approval | 221 days |
Priority review | Yes (pediatric drug) |
Target(s) | Tyrosine-protein kinase JAK1 |
Indication(s) | Previously approved: 1. Indicated for adult patients with refractory, moderate to severe atopic dermatitis who have had inadequate response to other systemic treatments (such as hormones or biological agents) or who are not suitable for the above treatments. Newly approved: 2. For the treatment of adolescents (12 to<18 years old) with refractory, moderate to severe atopic dermatitis who have had inadequate response to other systemic therapies or who are not suitable for the above treatments. |
3. Zinc Acetate Tablets
Generic name | Zinc Acetate Tablets |
Brand | Nobelzin |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 06/02/2024 |
Time from acceptance to approval | 360 days |
Priority review | Yes (pediatric drug) |
Target(s) | Zinc |
Indication(s) | Indicated for the treatment of hepatolenticular degeneration. |
4. Entrectinib Capsules
Generic name | Entrectinib Capsules |
Brand | 罗圣全 (Rozlytrek) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 06/02/2024 |
Time from acceptance to approval | 260 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | ALK tyrosine kinase receptor; Proto-oncogene tyrosine-protein kinase ROS1; Tropomyosin-related kinase (Trk). |
Indication(s) | Previously approved: 1. Indicated for the treatment of patients no younger than 12 years old with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. 2. Indicated for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). Newly approved: 3. Indicated for the treatment of pediatric older than 1 month of age with solid tumors that have a NTRK gene fusion. |
5. ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acid (16)/Glucose (16%) Injection
Generic name | ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acid (16)/Glucose (16%) Injection |
Brand | / |
Classification | Class 3 chemical drug |
Application type | Abbreviated new drug application (ANDA), domestic |
MAH | |
Approved | 23/02/2024 |
Time from acceptance to approval | 499 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for parenteral nutrition of adult patients who have moderate-to-severe catabolism conditions and cannot take nutrition orally or enterally. |
Notes | First generic in China |
6. Furosemide Oral Solution
Generic name | Furosemide Oral Solution |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 06/02/2024 |
Time from acceptance to approval | 593 days |
Priority review | No |
Target(s) | Solute carrier family 12 member 1 (SLC12A1) |
Indication(s) | Not revealed |
7. Anagrelide Hydrochloride Capsules
Generic name | Anagrelide Hydrochloride Capsules |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 23/02/2024 |
Time from acceptance to approval | 603 days |
Priority review | No |
Target(s) | Phosphodiesterase 3 (PDE3) |
Indication(s) | Indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. |
Notes | First generic in China |
8. Isosulfan Blue Injection
Generic name | Isosulfan Blue Injection |
Brand | 博林兰 (Bo Lin Lan) |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 20/02/2024 |
Time from acceptance to approval | 718 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated as an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities. |
Notes | First generic in China |
9. Zevorcabtagene Autoleucel Injection
Generic name | Zevorcabtagene Autoleucel Injection |
Brand | 赛恺泽 (Sai Kai Ze) |
Classification | Class 1 therapeutic biological product |
Application type | Biologics License Application (BLA), domestic |
MAH | Kaixing Life Science (Shanghai) Co., Ltd. |
Approved | 23/02/2024 |
Time from acceptance to approval | 493 days |
Priority review | Yes (with breakthrough therapy designation) |
Target(s) | Tumor necrosis factor receptor superfamily member 17 (TNFRSF17) |
Indication(s) | Indicated for adult patients with relapsed or refractory multiple myeloma who have failed previous treatment with at least one immunomodulator and proteasome inhibitor. |
10. Crovalimab Injection
Generic name | Crovalimab Injection |
Brand | 派圣凯 (Piasky) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 06/02/2024 |
Time from acceptance to approval | 545 days |
Priority review | Yes (urgently needed in clinical settings; with breakthrough therapy designation; eligible for conditional approval) |
Target(s) | Complement C5 |
Indication(s) | Indicated for the treatment of adults and adolescents (≥12 years old) with paroxysmal nocturnal hemoglobinuria who have not received complement inhibitor therapy. |
11. Teduglutide for Injection
Generic name | Teduglutide for Injection |
Brand | 瑞唯抒 (Revestive) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 20/02/2024 |
Time from acceptance to approval | 607 days |
Priority review | No |
Target(s) | Glucagon-like peptide 2 (GLP-2) |
Indication(s) | Indicated for the treatment of adults and pediatric patients aged year and above with short bowel syndrome. |
12. Susoctocog Alfa for Injection
Generic name | Susoctocog Alfa for Injection |
Brand | 助因止(OBIZUR) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 20/02/2024 |
Time from acceptance to approval | 614 days |
Priority review | Yes (other conditions eligible for priority review) |
Target(s) | Coagulation factor VIII |
Indication(s) | Indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A. |
13. Botulinum Toxin Type A for Injection
Generic name | Botulinum Toxin Type A for Injection |
Brand | Xeomin |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 23/02/2024 |
Time from acceptance to approval | 1,141 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for The treatment of blepharospasm, hemifacial spasm, and related focal dystonia in patients 12 years of age and older. Temporarily improving moderate to severe frown lines caused by corrugator supercilia or procerus muscle activity in adults 65 years of age and younger. Temporarily improving moderate to severe canthus wrinkles (crow’s feet) in adults. |
Contact BaiPharm if you need more details of drug approvals in China.
