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 definition of “first generic drug” is commonly used in the Chinese pharma industry but not written in Chinese regulations.
Related Articles:
In Aug. 2023, China NMPA approved 17 new drugs, among which 14 are chemical drugs and 3 are biological products.
Dizal Pharma's Sunvozertinib Tablets (class 1 innovative drug)
AstraZeneca's Acalabrutinib Capsules (CALQUENCE)
Novartis' Inclisiran Sodium Injection
Anacor Pharma's Crisaborole Ointment (Staquis)
Kadmon Pharma's Belumosudil Mesylate Tablets
Hengrui Pharma's Dexmedetomidine Hydrochloride Nasal Spray
AstraZeneca's Dapagliflozin Tablets (FORXIGA)
Suzhou Chung-hwa Chemical & Pharmaceutical Industrial's Calcium Polycarbophil Granules (first generic)
Desano's Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets (I) (first generic)
Hefei Weilai Medicine's Fludrocortisone Acetate Tablets (first generic)
Nanjing Cawendi Bioengineering Technology's Eplerenone Tablets (first generic)
Xinjiang Tefeng Pharma's Haloperidol Oral Solution (first generic)
Sichuan Hongming Bosi Pharma's Dimethyl Fumarate Enteric Capsules (first generic)
Zhejiang Poly Pharma's Voriconazole for Oral Suspension (first generic)
Innovent Biologics' Tafolecimab Injection
Roche's Tocilizumab Injection (Subcutaneous Injection) (ACTEMRA)
MacroGenics' Margetuximab Injection (MARGENZA)
The approval details are as follows.
1. Sunvozertinib Tablets
1 | Generic name | Sunvozertinib Tablets |
2 | Brand | 舒沃哲 (Shuwozhe) |
3 | Classification | Class 1 chemical drug |
4 | Application type | New drug application (NDA), domestic |
5 | Marketing authorization holder (MAH) | |
6 | Approved | 22/08/2023 |
7 | Time from application acceptance to approval | 224 days |
8 | Priority review | Yes (breakthrough therapy; eligible for conditional approval) |
9 | Target(s) | Epidermal growth factor receptor exon 20 (EGFR exon 20); Receptor tyrosine-protein kinase erbB-2 exon 20 (HER2 exon 20) |
10 | Indication(s) | Indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after a prior platinum-containing chemotherapy, or who are intolerant to platinum-containing chemotherapy and have been tested positive for EGFR exon 20 insertion mutation. |
2. Acalabrutinib Capsules
1 | Generic name | Acalabrutinib Capsules |
2 | Brand | 康可期 (CALQUENCE) |
3 | Classification | Class 5.1 chemical drug |
4 | Application type | NDA, import |
5 | MAH | |
6 | Approved | 29/08/2023 |
7 | Acceptance to approval | 249 days |
8 | Priority review | No |
9 | Target(s) | Tyrosine-protein kinase BTK |
10 | Indication(s) | Previously approved: 1. Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Newly approved: 2. Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
3. Inclisiran Sodium Injection
1 | Generic name | Inclisiran Sodium Injection |
2 | Brand | 乐可为 (Lekewei) |
3 | Classification | Class 5.1 chemical drug |
4 | Application type | NDA, import |
5 | MAH | |
6 | Approved | 22/08/2023 |
7 | Acceptance to approval | 277 days |
8 | Priority review | No |
9 | Target(s) | Asialoglycoprotein receptor (ASGPR); Proprotein convertase subtilisin/kexin type 9 (PCSK9) |
10 | Indication(s) | Indicated as an adjunct to diet for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C). |
4. Crisaborole Ointment
1 | Generic name | Crisaborole Ointment |
2 | Brand | 舒坦明 (Staquis) |
3 | Classification | Class 5.1 chemical drug |
4 | Application type | NDA, import |
5 | MAH | |
6 | Approved | 01/08/2023 |
7 | Acceptance to approval | 308 days |
8 | Priority review | Yes |
9 | Target(s) | Phosphodiesterase 4 (PDE4) |
10 | Indication(s) | Indicated for the treatment of mild to moderate atopic dermatitis in adults and pediatric patients from 3 months of age. |
5. Belumosudil Mesylate Tablets
1 | Generic name | Belumosudil Mesylate Tablets |
2 | Brand | 乐舒克 (Leshuke) |
3 | Classification | Class 5.1 chemical drug |
4 | Application type | NDA, import |
5 | MAH | |
6 | Approved | 01/08/2023 |
7 | Acceptance to approval | 614 days |
8 | Priority review | No |
9 | Target(s) | Rho-associated protein kinase 2 (ROCK2) |
10 | Indication(s) | Indicated for the treatment of chronic graft-versus-host disease (cGVHD) in patients 12 years of age and older who have had an inadequate response to glucocorticoids or other systemic therapy. |
6. Dexmedetomidine Hydrochloride Nasal Spray
1 | Generic name | Dexmedetomidine Hydrochloride Nasal Spray |
2 | Brand | / |
3 | Classification | Class 2.2 & 2.4 chemical drug |
4 | Application type | NDA, domestic |
5 | MAH | Shanghai Hengrui Pharmaceutical Co., Ltd. |
6 | Approved | 22/08/2023 |
7 | Acceptance to approval | 318 days |
8 | Priority review | Yes (pediatric drug) |
9 | Target(s) | Alpha-2 adrenergic receptor (ADRA2) |
10 | Indication(s) | Indicated for preoperative sedation (e.g., general anesthesia) in children. |
7. Dapagliflozin Tablets
1 | Generic name | Dapagliflozin Tablets |
2 | Brand | 安达唐 (FORXIGA) |
3 | Classification | Class 2.4 chemical drug |
4 | Application type | NDA, import |
5 | MAH | AstraZeneca AB |
6 | Approved | 15/08/2023 |
7 | Acceptance to approval | 339 days |
8 | Priority review | No |
9 | Target(s) | Sodium/glucose cotransporter 2 (SLC5A2) |
10 | Indication(s) | Previously approved: 2. Indicated for the treatment of adult patients with heart failure with reduced ejection fraction. Newly approved: 3. Indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) at risk of progression, no matter whether the patients have type-2 diabetes mellitus. |
8. Calcium Polycarbophil Granules
1 | Generic name | Calcium Polycarbophil Granules |
2 | Brand | / |
3 | Classification | Class 3 chemical drug |
4 | Application type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | Suzhou Chung-hwa Chemical & Pharmaceutical Industrial Co., Ltd. |
6 | Approved | 01/08/2023 |
7 | Acceptance to approval | 530 days |
8 | Priority review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for relieving constipation symptoms in patients with irritable bowel syndrome (constipation type). |
11 | Notes | First generic drug in China |
9. Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets (I)
1 | Generic name | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets (I) |
2 | Brand | / |
3 | Classification | Class 3 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 01/08/2023 |
7 | Acceptance to approval | 557 days |
8 | Priority review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. |
11 | Notes | First generic drug in China |
10. Fludrocortisone Acetate Tablets
1 | Generic name | Fludrocortisone Acetate Tablets |
2 | Brand | / |
3 | Classification | Class 3 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 29/08/2023 |
7 | Acceptance to approval | 595 days |
8 | Priority review | Yes (other situations eligible for priority review) |
9 | Target(s) | Glucocorticoid receptor (GR); Mineralocorticoid receptor (NR3C2) |
10 | Indication(s) | Indicated for the treatment of salt-wasting congenital adrenal hyperplasia (CAH) and salt-wasting primary chronic adrenal insufficiency (Addison's disease). |
11 | Notes | First generic drug in China |
11. Eplerenone Tablets
1 | Generic name | Eplerenone Tablets |
2 | Brand | / |
3 | Classification | Class 3 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | Nanjing Cawendi Bioengineering Technology Co., Ltd. |
6 | Approved | 01/08/2023 |
7 | Acceptance to approval | 592 days |
8 | Priority review | No |
9 | Target(s) | Aldosterone; NR3C2 |
10 | Indication(s) | Indicated for the treatment of heart failure and hypertension. |
11 | Notes | First generic drug in China |
12. Haloperidol Oral Solution
1 | Generic name | Haloperidol Oral Solution |
2 | Brand | / |
3 | Classification | Class 3 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | Xinjiang Tefeng Pharmaceutical Co., Ltd. |
6 | Approved | 01/08/2023 |
7 | Acceptance to approval | 656 days |
8 | Priority review | No |
9 | Target(s) | Dopamine receptor |
10 | Indication(s) | Indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. |
11 | Notes | First generic drug in China |
13. Dimethyl Fumarate Enteric Capsules
1 | Generic name | Dimethyl Fumarate Enteric Capsules |
2 | Brand | / |
3 | Classification | Class 4 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 01/08/2023 |
7 | Acceptance to approval | 45 days |
8 | Priority review | No |
9 | Target(s) | Nuclear factor erythroid 2-related factor 2 (NFE2L2) |
10 | Indication(s) | Indicated for the treatment of relasped multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. |
11 | Notes | First generic drug in China |
14. Voriconazole for Oral Suspension
1 | Generic name | Voriconazole for Oral Suspension |
2 | Brand | / |
3 | Classification | Class 4 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | Zhejiang Poly Pharmaceutical Co., Ltd. |
6 | Approved | 22/08/2023 |
7 | Acceptance to approval | 594 days |
8 | Priority review | No |
9 | Target(s) | Lanosterol 14-alpha demethylase (CYP51A1) |
10 | Indication(s) | This product is a broad-spectrum triazole antifungal drug, indicated for the treatment of the following fungal infections in adults and children 2 years of age and older: 1. Invasive aspergillosis. 2. Candidemia in non-neutropenic patients. 3. Severe invasive infections caused by fluconazole-resistant Candida species (including Candida krusei). 4. Severe infections caused by Actinomyces species and Fusarium species. This product is mainly used for the treatment of patients with progressive and potentially life-threatening fungal infections. The product indicated for the prevention of invasive fungal infections in high-risk patients who receive allogeneic hematopoietic stem cell transplantation (HSCT). |
11 | Notes | First generic drug in China |
15. Tafolecimab Injection
1 | Generic name | Tafolecimab Injection |
2 | Brand | 信必乐 (Xinbile) |
3 | Classification | Class 1 therapeutic biological product |
4 | Application type | Biologics License Application (BLA), domestic |
5 | MAH | |
6 | Approved | 15/08/2023 |
7 | Acceptance to approval | 428 days |
8 | Priority review | No |
9 | Target(s) | Proprotein convertase subtilisin/kexin type 9 (PCSK9) |
10 | Indication(s) | Indicated for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia. |
16. Tocilizumab Injection (Subcutaneous Injection)
1 | Generic name | Tocilizumab Injection (Subcutaneous Injection) |
2 | Brand | 雅美罗 (ACTEMRA) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application type | BLA, import |
5 | MAH | Roche Registration GmbH |
6 | Approved | 22/08/2023 |
7 | Acceptance to approval | 274 days |
8 | Priority review | No |
9 | Target(s) | Interleukin-6 receptor (IL6R) |
10 | Indication(s) | Previously approved: 1. Indicated for the treatment of systemic juvenile idiopathic arthritis (sJIA); 2. Indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. 3. Indicated as a single therapy for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs), and who had an inadequate response to methotrexate (MTX) or are intolerant to MTX therapy. |
17. Margetuximab Injection
1 | Generic name | Margetuximab Injection |
2 | Brand | 麦甘乐 (MARGENZA) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application type | BLA, import |
5 | MAH | |
6 | Approved | 29/08/2023 |
7 | Acceptance to approval | 599 days |
8 | Priority review | No |
9 | Target(s) | Receptor tyrosine-protein kinase erbB-2 (HER2) |
10 | Indication(s) | Indicated for the third-line or above treatment of patients with metastatic HER2-positive breast cancer. |
Ask BaiPharm if you need more details of drug approvals in China.
