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.
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In November 2023, China NMPA approved 20 new drugs, among which 15 are chemical drugs and 5 are biological products.
1. Fujian Guangsheng Zhonglin Biotech’s Atilotrelvir Tablets/Ritonavir Tablets (co-packaged) (class 1 innovative drug)
2. Jingxin Pharma’s Dimdazenil Capsules (class 1 innovative drug)
3. Beijing Pearl Biotech’s Vebreltinib Enteric Capsules (class 1 innovative drug)
4. Shandong Kecheng Pharma’s Ambroxol Hydrochloride Direct Oral Granules
5. Guangzhou Shunjian Biopharma’s Olverembatinib Tablets
6. Luoxin Pharma’s Tegoprazan Tablets
7. Boehringer Ingelheim’s Empagliflozin Tablets
8. Calliditas Therapeutics’ Budesonide Enteric Capsules
9. Takeda’s Vonoprazan Fumarate Tablets
10. Nabriva Therapeutics’ Lefamulin Acetate Concentrated Solution for Injection
11. Ferrer Internacional’s Loxapine for Inhalation
12. Kanion Group’s Perampanel Tablets
13. Sichuan Purity Pharma’s Budesonide Nasal Spray
14. Nanchang Baiji Pharma’s Budesonide Nasal Spray
15. Wanbang Biopharma’s Crizotinib Capsules
16. Wuhan Hiteck Biopharma’s Aponermin for Injection (class 1 innovative biologic)
17. Juventas Cell Therapy’s Inaticabtagene Autoleucel Injection (class 1 innovative biologic)
18. Roche’s Glofitamab Injection (class 1 innovative biologic)
19. Sanofi-aventis’ Dupilumab Injection
20. AstraZeneca’s Durvalumab Injection
1. Atilotrelvir Tablets/Ritonavir Tablets（co-packaged）
Generic name | Atilotrelvir Tablets/Ritonavir Tablets (co-packaged) |
Brand | 泰中定 (Tai Zhong Ding) |
Classification | Class 1 chemical drug |
Application type | New drug application (NDA), domestic |
Marketing authorization holder (MAH) | Fujian Guangsheng Zhonglin Biotechnology Co., Ltd. |
Approved | 23/11/2023 |
Time from application acceptance to approval | Not revealed |
Special Approval | Yes |
Target(s) | / |
Indication(s) | Indicated for the treatment of adult patients with mild-to-moderate COVID-19 infections. |
2. Dimdazenil Capsules
Generic name | Dimdazenil Capsules |
Brand | / |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
MAH | |
Approved | 30/11/2023 |
Time from application acceptance to approval | 282 days |
Priority review | No |
Target(s) | Gamma-aminobutyric acid type A receptor (GABAAR) |
Indication(s) | Indicated for the short-term treatment of patients with insomnia. |
3. Vebreltinib Enteric Capsules
Generic name | Vebreltinib Enteric Capsules |
Brand | / |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
MAH | Beijing Pearl Biotechnology (manufacturer: Asymchem) |
Approved | 14/11/2023 |
Time from application acceptance to approval | 416 days |
Priority review | Yes (breakthrough therapy) |
Target(s) | Hepatocyte growth factor receptor (MET) |
Indication(s) | Indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET Exon 14 skipping. |
4. Ambroxol Hydrochloride Direct Oral Granules
Generic name | Ambroxol Hydrochloride Direct Oral Granules |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
MAH | Shandong Kecheng Pharmaceutical Technology |
Approved | 14/11/2023 |
Acceptance to approval | 553 days |
Priority review | No |
Target(s) | Na+ channel subunit alpha |
Indication(s) | Indicated for acute and chronic respiratory diseases accompanied by abnormal sputum secretion and impaired sputum discharge function. |
5. Olverembatinib Tablets
Generic name | Olverembatinib Tablets |
Brand | 耐立克 (Nai Li Ke) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
MAH | Guangzhou Shunjian Biopharmaceutical Technology |
Approved | 14/11/2023 |
Acceptance to approval | 483 days |
Priority review | Yes (breakthrough therapy) |
Target(s) | Bcr-Abl T315 mutation; Fibroblast growth factor receptor 1 (FGFR1); Mast/stem cell growth factor receptor Kit (KIT); Platelet-derived growth factor receptor alpha (PDGFRA); Receptor-type tyrosine-protein kinase FLT3 (FLT3) |
Indication(s) | Previously approved: 1. Indicated for the treatment of adult patients with chronic myeloid leukemia of chronic phase (CML-CP) or CML of accelerated-phase (CML-AP), who are tyrosine kinase inhibitor (TKI)-resistant and have been diagnosed with the T315I mutation, using a thoroughly validated detection method. Newly approved: 2. Indicated for the treatment of adult patients with CML-CP who are resistant and/or intolerant to first and second-generation TKIs. |
6. Tegoprazan Tablets
Generic name | Tegoprazan Tablets |
Brand | 泰欣赞 (Tai Xin Zan) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
MAH | |
Approved | 14/11/2023 |
Acceptance to approval | 267 days |
Priority review | No |
Target(s) | H+ pump |
Indication(s) | Previously approved: Indicated for the treatment of reflux esophagitis. Newly approved: Indicated for the treatment of duodenal ulcer. |
7. Empagliflozin Tablets
Generic name | Empagliflozin Tablets |
Brand | 欧唐静 (Jardiance) |
Classification | Class 2.4 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 21/11/2023 |
Acceptance to approval | 320 days |
Priority review | No |
Target(s) | Sodium/glucose cotransporter 2 (SLC5A2) |
Indication(s) | Previously approved: 1. Indicated for the treatment of adults with type 2 diabetes. 2. Indicated for the treatment of heart failure patient with reduced ejection fraction, with or without diabetes. 3. Indicated for the treatment of adults with heart failure with preserved ejection fraction (HFpEF). 4. Indicated in combination with insulins (with or without oral anti-glycemic drugs) for improving the glycemic control for patients with type 2 diabetes on the basis of diet and exercise. Newly approved: 5. Indicated for the treatment of chronic kidney disease (CKD). |
8. Budesonide Enteric Capsules
Generic name | Budesonide Enteric Capsules |
Brand | NEFECON |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 21/11/2023 |
Acceptance to approval | 371 days |
Priority review | Yes (breakthrough therapy) |
Target(s) | Glucocorticoid |
Indication(s) | Indicated for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. |
9. Vonoprazan Fumarate Tablets
Generic name | Vonoprazan Fumarate Tablets |
Brand | 沃克 (Vocinti) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | Takeda Pharmaceutical Company Limited |
Approved | 21/11/2023 |
Acceptance to approval | 468 days |
Priority review | No |
Target(s) | H+ pump |
Indication(s) | Previously approved: 1. Indicated for the first-line treatment for reflux esophagitis. 2. Indicated for the maintenance treatment of patients with recurrent reflux esophagitis. Newly approved: 3. Indicated in combination with appropriate antibiotics to eradicate Helicobacter pylori. |
10. Lefamulin Acetate Concentrated Solution for Injection
Generic name | Lefamulin Acetate Concentrated Solution for Injection |
Brand | 信乐妥 (XENLETA) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 14/11/2023 |
Acceptance to approval | 720 days |
Priority review | No |
Target(s) | 50S ribosomal subunit |
Indication(s) | Indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP). |
11. Loxapine for Inhalation
Generic name | Loxapine for Inhalation |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 21/11/2023 |
Acceptance to approval | 818 days |
Priority review | No |
Target(s) | 5-hydroxytryptamine receptor 2A (5-HT2A); D(2) dopamine receptor (DRD2) |
Indication(s) | Indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. |
12. Perampanel Tablets
Generic name | Perampanel Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | Abbreviated new drug application (ANDA), domestic |
MAH | |
Approved | 07/11/2023 |
Acceptance to approval | 809 days |
Priority review | No |
Target(s) | alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPAR) |
Indication(s) | Indicate for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients 4 year of age and older. |
Notes | First generic in China |
13. Budesonide Nasal Spray
Generic name | Budesonide Nasal Spray |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 21/11/2023 |
Acceptance to approval | 546 days |
Priority review | No |
Target(s) | Glucocorticoid |
Indication(s) | l Indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis. l Indicated for the prevention of nasal polyps after nasal polypectomy and provides symptomatic relief for nasal polyps. |
Notes | First generic in China |
14. Budesonide Nasal Spray
Generic name | Budesonide Nasal Spray |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | Nanchang Baiji Pharmaceutical |
Approved | 21/11/2023 |
Acceptance to approval | 546 days |
Priority review | No |
Target(s) | Glucocorticoid |
Indication(s) | l Indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis. l Indicated for the prevention of nasal polyps after nasal polypectomy and provides symptomatic relief for nasal polyps. |
Notes | First generic in China |
15. Crizotinib Capsules
Generic name | Crizotinib Capsules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | Wanbang Biopharmaceuticals, a Fosun Pharma company |
Approved | 21/11/2023 |
Acceptance to approval | 1,042 days |
Priority review | No |
Target(s) | ALK; MET; ROS1 |
Indication(s) | 1. Indicated for the treatment of patients with locally advanced or metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive. 2. Indicated for the treatment of patients with advanced NSCLC whose tumors are ROS1-positive. |
Notes | First generic in China |
16. Aponermin for Injection
Generic name | Aponermin for Injection |
Brand | 沙艾特 (Sha Ai Te) |
Classification | Class 1 therapeutic biological product |
Application type | Biologics License Application (BLA), domestic |
MAH | |
Approved | 01/11/2023 |
Acceptance to approval | 681 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated in combination with thalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior systemic therapies. |
17. Inaticabtagene Autoleucel Injection
Generic name | Inaticabtagene Autoleucel Injection |
Brand | 源瑞达 (Yuan Rui Da) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
MAH | |
Approved | 07/11/2023 |
Acceptance to approval | 327 days |
Priority review | Yes (breakthrough therapy) |
Target(s) | B-lymphocyte antigen CD19 |
Indication(s) | Indicated for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). |
18. Glofitamab Injection
Generic name | Glofitamab Injection |
Brand | 高罗华 (Columvi) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 07/11/2023 |
Acceptance to approval | 279 days |
Priority review | Yes (breakthrough therapy; conditional approval) |
Target(s) | B-lymphocyte antigen CD20; T-cell surface glycoprotein CD3 |
Indication(s) | Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after at least two lines of systemic therapies. |
19. Dupilumab Injection
Generic name | Dupilumab Injection |
Brand | 达必妥 (Dupixent) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 14/11/2023 |
Acceptance to approval | 306 days |
Priority review | No |
Target(s) | Interleukin-4 receptor subunit alpha |
Indication(s) | Previously approved: 1. Indicated for the treatment of moderate-to-severe atopic dermatitis in adult and pediatric patients aged 6 months and older. 2. Indicated for the treatment of moderate-to-severe prurigo nodularis in adults. Newly approved: 3. Indicated as a maintenance treatment of adult and pediatric patients aged 12 years and older. |
20. Durvalumab Injection
Generic name | Durvalumab Injection |
Brand | 英飞凡 (IMFINZI) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 07/11/2023 |
Acceptance to approval | 241 days |
Priority review | / |
Target(s) | No |
Indication(s) | Previously approved: 1. Indicated for the treatment of patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. 2. Indicated in combination with etoposide and platinum (carboplatin or cisplatin) chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). Newly approved: 3. Indicated in combination with gemcitabine and cisplatin for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). |
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