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 April 2024, China NMPA approved 27 new drugs, among which 18 are chemical drugs and 9 are biological products. The details are shown as follows:
1. Iptacopan Hydrochloride Capsules
Generic name | Iptacopan Hydrochloride Capsules |
Brand | 飞赫达 (FABHALTA) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | |
Approved | 2024/4/24 |
Time from application acceptance to approval | 315 days |
Priority review | Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases; granted breakthrough therapy designation) |
Target(s) | Complement factor B |
Indication(s) | Indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) |
2. Entinostat Tablets
Generic name | Entinostat Tablets |
Brand | 景助达 (Jing Zhu Da) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | |
Approved | 2024/4/24 |
Time from application acceptance to approval | 476 days |
Priority review | No |
Target(s) | |
Indication(s) | Indicated for the treatment of locally advanced or metastatic breast cancer patients with hormone receptor (HR)-positive and human epidermal growth factor receptor-2 (HER-2)-negative disease who have experienced recurrence or progression following endocrine therapy |
3. Vebreltinib Enteric Capsules
Generic name | Vebreltinib Enteric Capsules |
Brand | 万比锐 (Wan Bi Rui) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | |
Approved | 2024/4/17 |
Time from application acceptance to approval | 176 days |
Priority review | Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases) |
Target(s) | Hepatocyte growth factor receptor |
Indication(s) | Indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with a MET exon 14 skipping (METex14) alteration |
4. Unecritinib Fumarate Capsules
Generic name | Unecritinib Fumarate Capsules |
Brand | 安柏尼 (An Bo Ni) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | |
Approved | 2024/4/24 |
Time from application acceptance to approval | 671 days |
Priority review | No |
Target(s) | ALK tyrosine kinase receptor Hepatocyte growth factor receptor Proto-oncogene tyrosine-protein kinase ROS1 |
Indication(s) | Indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) |
5. Dexmedetomidine Hydrochloride Nasal Spray
Generic name | Dexmedetomidine Hydrochloride Nasal Spray |
Brand | 特美定 (Te Mei Ding) |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
MAH | |
Approved | 2024/4/24 |
Time from acceptance to approval | 630 days |
Priority review | No |
Target(s) | Alpha-2 adrenergic receptor |
Indication(s) | Indicated for reoperative sedation/anxiolysis for adults Indicated for adjunctive sedation during adult regional anesthesia |
6. Chidamide Tablets
Generic name | Chidamide Tablets |
Brand | 爱谱沙 (Epidaza) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
MAH | |
Approved | 2024/4/24 |
Time from acceptance to approval | 280 days |
Priority review | Yes ( (eligible for conditional approval) |
Target(s) | Histone deacetylase |
Indication(s) | Indicated for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received at least one prior systemic chemotherapy regimen |
7. Baricitinib Tablets
Generic name | Baricitinib Tablets |
Brand | 艾乐明 (OLUMIANT) |
Classification | Class 2.4 chemical drug |
Application type | NDA, imported |
MAH | |
Approved | 2024/4/29 |
Time from acceptance to approval | 460 days |
Priority review | No |
Target(s) | Tyrosine-protein kinase JAK1 Tyrosine-protein kinase JAK2 |
Indication(s) | Indicated for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs) |
8. Isavuconazonium Sulfate for Injection
Generic name | Isavuconazonium Sulfate for Injection |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 2024/4/30 |
Time from acceptance to approval | 669 days |
Priority review | No |
Target(s) | Lanosterol 14-alpha demethylase |
Indication(s) | Indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adult patients |
Notes | First generic in China |
9. Linezolid for Oral Suspension
Generic name | Linezolid for Oral Suspension |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 2024/4/17 |
Time from acceptance to approval | 545 days |
Priority review | No |
Target(s) | 50S ribosomal subunit |
Indication(s) | Indicated for the treatment of hospital-acquired pneumonia, community-acquired pneumonia, skin and soft tissue infections caused by specific susceptible strains of microorganisms, and vancomycin-resistant Enterococcus infections |
Notes | First generic in China |
10. Letermovir Tablets
Generic name | Letermovir Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 2024/4/7 |
Time from acceptance to approval | 530 days |
Priority review | No |
Target(s) | Terminase |
Indication(s) | Indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult recipients who are seropositive for cytomegalovirus (CMV) and are undergoing allogeneic hematopoietic stem cell transplantation (HSCT) |
Notes | First generic in China |
11. Metformin Hydrochloride and Empagliflozin Tablets（Ⅲ）
Generic name | Metformin Hydrochloride and Empagliflozin Tablets（Ⅲ） |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 2024/4/17 |
Time from acceptance to approval | 457 days |
Priority review | No |
Target(s) | 5'-AMP-activated protein kinase sodium/glucose cotransporter 2 |
Indication(s) | Indicated for improving blood sugar control in patients with Type 2 diabetes |
Notes | First generic in China |
12. Bisoprolol Fumarate and Amlodipine Besilate Tablets
Generic name | Bisoprolol Fumarate and Amlodipine Besilate Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 2024/4/7 |
Time from acceptance to approval | 452 days |
Priority review | No |
Target(s) | β-adrenoceptors |
Indication(s) | Indicated as an alternative therapy for the treatment of hypertension in patients who are currently well-controlled on a single medication at the same dosage as the combination formulation |
Notes | First generic in China |
13. Oxcarbazepine Oral Suspension
Generic name | Oxcarbazepine Oral Suspension |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 2024/4/24 |
Time from acceptance to approval | 520 days |
Priority review | No |
Target(s) | Sodium channel |
Indication(s) | Indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 2 years and older, with or without secondary generalized seizures |
Notes | First generic in China |
14. Nicorandil for Injection
Generic name | Nicorandil for Injection |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | |
Approved | 2024/4/24 |
Time from acceptance to approval | 847 days |
Priority review | No |
Target(s) | Nitric oxide |
Indication(s) | Indicated for the treatment of unstable angina |
15. Cabotegravir Injection
Generic name | Cabotegravir Injection |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | ViiV Healthcare BV |
Approved | 2024/4/30 |
Time from acceptance to approval | 549 days |
Priority review | No |
Target(s) | Integrase |
Indication(s) | Indicated for the treatment of HIV infection |
16. Cabotegravir Sodium Tablets
Generic name | Cabotegravir Sodium Tablets |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | ViiV Healthcare BV |
Approved | 2024/4/30 |
Time from acceptance to approval | 549 days |
Priority review | No |
Target(s) | Integrase |
Indication(s) | Indicated for the treatment of HIV infection |
17. Perampanel Tablets
Generic name | Perampanel Tablets |
Brand | 卫克泰 (Fycompa) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | |
Approved | 2024/4/30 |
Time from acceptance to approval | 403 days |
Priority review | No |
Target(s) | Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor |
Indication(s) | Indicated for the treatment of generalized tonic-clonic seizures in patients with epilepsy |
18. Mavacamten Capsules
Generic name | Mavacamten Capsules |
Brand | 迈凡妥 (CAMZYOS) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | |
Approved | 2024/4/24 |
Time from acceptance to approval | 368 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | Myosin |
Indication(s) | Indicated for the treatment of symptomatic adults with class II-III obstructive hypertrophic cardiomyopathy (HCM) classified by New York Heart Association (NYHA), to improve functional capacity and symptoms |
19. Benmelstobart Injection (TQB2450)
Generic name | Benmelstobart Injection (TQB2450) |
Brand | 安得卫 (An De Wei) |
Classification | Class 1 therapeutic biological product |
Application type | Biologics license application (BLA), domestic |
MAH | |
Approved | 2024/4/30 |
Time from acceptance to approval | 473 days |
Priority review | No |
Target(s) | Programmed cell death 1 ligand 1 |
Indication(s) | Indicated for combination therapy with Anlotinib hydrochloride capsules, Carboplatin, and Etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer |
20. Penpulimab Injection
Generic name | Penpulimab Injection |
Brand | 安尼可 (An Ni Ke) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
MAH | |
Approved | 2024/4/24 |
Time from acceptance to approval | 993 days |
Priority review | No |
Target(s) | Programmed cell death protein 1 |
Indication(s) | Indicated for the treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed second-line or subsequent systemic therapies |
21. Tislelizumab Injection
Generic name | Tislelizumab Injection |
Brand | 百泽安 (Bai Ze An) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
MAH | |
Approved | 2024/4/24 |
Time from acceptance to approval | 238 days |
Priority review | No |
Target(s) | Programmed cell death protein 1 |
Indication(s) | Indicated for the first-line treatment for locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ), combining with fluoropyrimidine and platinum-based chemotherapy |
22. Toripalimab Injection
Generic name | Toripalimab Injection |
Brand | 拓益 (Tuo Yi) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
MAH | |
Approved | 2024/4/2 |
Time from acceptance to approval | 266 days |
Priority review | No |
Target(s) | Programmed cell death protein 1 |
Indication(s) | Indicated for the first-line treatment of locally advanced unresectable or metastatic renal cell carcinoma (RCC) in patients at intermediate to high risk, combining with axitinib |
23. Faricimab Injection
Generic name | Faricimab Injection |
Brand | 罗视佳 (VABYSMO) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, imported |
MAH | |
Approved | 2024/4/24 |
Time from acceptance to approval | 379 days |
Priority review | No |
Target(s) | Angiopoietin-2 Vascular endothelial growth factor A |
Indication(s) | Indicated for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO) |
24. Recombinant Human Thrombopoietin Injection
Generic name | Recombinant Human Thrombopoietin Injection |
Brand | 特比澳 (Te Bi Ao) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
MAH | |
Approved | 2024/4/2 |
Time from acceptance to approval | 517 days |
Priority review | No |
Indication(s) | Indicated for the treatment of persistent or chronic primary immune thrombocytopenia (ITP) in children and adolescents |
25. Rituximab Injection (Subcutaneous Injection)
Generic name | Rituximab Injection (Subcutaneous Injection) |
Brand | / |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
MAH | |
Approved | 2024/4/2 |
Time from acceptance to approval | 440 days |
Priority review | No |
Target(s) | Vascular endothelial growth factor receptor |
Indication(s) | Indicated for the treatment of diffuse large B-cell lymphoma (DLBCL) |
26. Human Follitropin delta Injection
Generic name | Human Follitropin delta Injection |
Brand | 贺可唯 (Rekovelle) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
MAH | |
Approved | 2024/4/30 |
Time from acceptance to approval | 1,177 days |
Priority review | No |
Indication(s) | Indicated for controlled ovarian stimulation (COS) for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) cycle |
27. Human Thyrotropin Injection
Generic name | Human Thyrotropin Injection |
Brand | / |
Classification | Class 3.2 therapeutic biological product |
Application type | BLA, domestic |
MAH | |
Approved | 2024/4/2 |
Time from acceptance to approval | 620 days |
Priority review | No |
Indication(s) | Indicated for patients with differentiated thyroid cancer without distant metastasis after total thyroidectomy or near-total thyroidectomy, to facilitate the clearance of residual thyroid tissue through the use iodine-131 |
Contact BaiPharm if you need more details of drug approvals in China.
