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 Sept. 2023, China NMPA approved 19 new drugs, among which 12 are chemical drugs and 7 are biological products.
1. Luye Life Sciences’ Goserelin Microspheres for Injection
2. HRA Pharma Rare Diseases’ Mitotane Tablets
3. N.V. Organon’s Ezetimibe and Atorvastatin Calcium Tablets
4. Napp Pharmaceuticals’ Fluticasone Propionate and Formoterol Fumarate Aerosol for Inhalation
5. Sinotau Pharmaceuticals’ Florbetaben [¹⁸F] Injection (Ouweining)
6. Grand Pharma’s Carglumic Acid Dispersible Tablets (Anweide)
7. CSPC Ouyi Pharmaceutical’s Irinotecan Hydrochloride Liposome Injection
8. Qilu Pharmaceutical’s Dolutegravir Sodium Tablets
9. Gowell Pharma’s ω-3 Fish Oil Fat Emulsion Injection
10. Acebright Pharma’s Neratinib Maleate Tablets
11. Brilliant Pharmaceuticals’ Dacomitinib Tablets
12. Grand Life Sciences’ Etomidate Injectable Emulsion
13. Shanghai JMT-Bio Technology’s Narlumosbart Injection
14. Henlius’ Serplulimab Injection (Hansizhuang)
15. Eli Lilly’s Insulin Lispro Injection (Youmile)
16. Sanofi’s Dupilumab Injection (Dupixent)
17. Eli Lilly’s Dulaglutide Injection (TRULICITY)
18. MSD’s Pembrolizumab Injection (Keytruda)
19. Novartis’ Erenumab Injection (Aimovig)
1. Goserelin Microspheres for Injection
1 | Generic name | Goserelin Microspheres for Injection |
2 | Brand | / |
3 | Classification | Class 2.2 chemical drug |
4 | Application type | New drug application (NDA), domestic |
5 | Marketing authorization holder (MAH) | |
6 | Approved | 05/09/2023 |
7 | Time from application acceptance to approval | 385 days |
8 | Priority review | No |
9 | Target(s) | Gonadotropin-releasing hormone receptor (GnRH receptor) |
10 | Indication(s) | For the treatment of breast cancer. |
2. Mitotane Tablets
1 | Generic name | Mitotane Tablets |
2 | Brand | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application type | NDA, import |
5 | MAH | |
6 | Approved | 05/09/2023 |
7 | Acceptance to approval | 229 days |
8 | Priority review | Yes |
9 | Target(s) | Cytochrome P450 3A4 (CYP3A4) |
10 | Indication(s) | For the symptomatic treatment of patients with advanced (irresectable, metastatic, or relapsed) adrenal cortical carcinoma. |
3. Ezetimibe and Atorvastatin Calcium Tablets
1 | Generic name | Ezetimibe and Atorvastatin Calcium Tablets |
2 | Brand | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application type | NDA, import |
5 | MAH | |
6 | Approved | 12/09/2023 |
7 | Acceptance to approval | 827 days |
8 | Priority review | No |
9 | Target(s) | 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoA reductase) |
10 | Indication(s) | For the treatment of high cholesterol and homozygous familial hypercholesterolemia (HoFH). |
4. Fluticasone Propionate and Formoterol Fumarate Aerosol for Inhalation
1 | Generic name | Fluticasone Propionate and Formoterol Fumarate Aerosol for Inhalation |
2 | Brand | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application type | NDA, import |
5 | MAH | |
6 | Approved | 12/09/2023 |
7 | Acceptance to approval | 1,083 days |
8 | Priority review | No |
9 | Target(s) | / |
10 | Indication(s) | For the treatment of asthma. |
5. Florbetaben [¹⁸F] Injection
1 | Generic name | Florbetaben [¹⁸F] Injection |
2 | Brand | 欧韦宁 (Ouweining) |
3 | Classification | Class 3 chemical drug |
4 | Application type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | |
6 | Approved | 12/09/2023 |
7 | Acceptance to approval | 428 days |
8 | Priority review | No |
9 | Target(s) | Amyloid-beta (Abeta) |
10 | Indication(s) | Used as an Aβ-PET agent for early, precision, and noninvasive diagnosis of patients with Alzheimer’s disease. |
11 | Notes | First generic in China |
6. Carglumic Acid Dispersible Tablets
1 | Generic name | Carglumic Acid Dispersible Tablets |
2 | Brand | 安维得 (Anweide) |
3 | Classification | Class 3 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 05/09/2023 |
7 | Acceptance to approval | 439 days |
8 | Priority review | Yes (pediatric drug) |
9 | Target(s) | Carbamoyl-phosphate synthase [ammonia], mitochondrial (CPS1) |
10 | Indication(s) | For the treatment of adults or children with hyperammonemia caused by N-acetylglutamate synthetase (NAGS) deficiency, isovaleric acidemia (IVA), methylmalonic acidemia (MMA), or propionic acidemia (PA). |
11 | Notes | First generic in China |
7. Irinotecan Hydrochloride Liposome Injection
1 | Generic name | Irinotecan Hydrochloride Liposome Injection |
2 | Brand | / |
3 | Classification | Class 4 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 12/09/2023 |
7 | Acceptance to approval | 503 days |
8 | Priority review | No |
9 | Target(s) | DNA topoisomerase 1 (Topo I) |
10 | Indication(s) | Indicated in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic pancreatic cancer who have progressed on gemcitabine. |
11 | Notes | First generic in China |
8. Dolutegravir Sodium Tablets
1 | Generic name | Dolutegravir Sodium Tablets |
2 | Brand | / |
3 | Classification | Class 4 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 05/09/2023 |
7 | Acceptance to approval | 499 days |
8 | Priority review | No |
9 | Target(s) | / |
10 | Indication(s) | Used in combination with other antiretroviral drugs for the treatment of adults and children 12 years of age and older infected with human immunodeficiency virus (HIV). |
11 | Notes | First generic in China |
9. ω-3 Fish Oil Fat Emulsion Injection
1 | Generic name | ω-3 Fish Oil Fat Emulsion Injection |
2 | Brand | / |
3 | Classification | Class 4 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 05/09/2023 |
7 | Acceptance to approval | 551 days |
8 | Priority review | No |
9 | Target(s) | / |
10 | Indication(s) | For supplementing patients with long-chain w-3 fatty acids, especially eicosapentaenoic acid and docosahexaenoic acid, when oral or enteral nutrition is not possible, inadequate, or contraindicated. |
11 | Notes | First generic in China |
10. Neratinib Maleate Tablets
1 | Generic name | Neratinib Maleate Tablets |
2 | Brand | / |
3 | Classification | Class 4 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 12/09/2023 |
7 | Acceptance to approval | 601 days |
8 | Priority review | No |
9 | Target(s) | Epidermal growth factor receptor (EGFR); Receptor tyrosine-protein kinase erbB-2 (HER2) |
10 | Indication(s) | For the extended adjuvant treatment of adult patients with early-stage human HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy. |
11 | Notes | First generic in China |
11. Dacomitinib Tablets
1 | Generic name | Dacomitinib Tablets |
2 | Brand | / |
3 | Classification | Class 4 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 12/09/2023 |
7 | Acceptance to approval | 608 days |
8 | Priority review | No |
9 | Target(s) | EGFR; HER2; Receptor tyrosine-protein kinase erbB-4 (ERBB4) |
10 | Indication(s) | Indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations。 |
11 | Notes | First generic in China |
12. Etomidate Injectable Emulsion
1 | Generic name | Etomidate Injectable Emulsion |
2 | Brand | / |
3 | Classification | Class 4 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 12/09/2023 |
7 | Acceptance to approval | 700 days |
8 | Priority review | No |
9 | Target(s) | Gamma-aminobutyric acid type A receptor (GABAAR) |
10 | Indication(s) | For general anesthesia; For anesthesia for short operative procedures. |
11 | Notes | First generic in China |
13. Narlumosbart Injection
1 | Generic name | Narlumosbart Injection |
2 | Brand | / |
3 | Classification | Class 1 therapeutic biological product |
4 | Application type | Biologics License Application (BLA), domestic |
5 | MAH | |
6 | Approved | 05/09/2023 |
7 | Acceptance to approval | 440 days |
8 | Priority review | Yes (eligible for conditional approval) |
9 | Target(s) | / |
10 | Indication(s) | For the treatment of giant cell tumor of bone that is unresectable or has low viability for operation. |
14. Serplulimab Injection
1 | Generic name | Serplulimab Injection |
2 | Brand | 汉斯状 (Hansizhuang) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application type | BLA, domestic |
5 | MAH | |
6 | Approved | 19/09/2023 |
7 | Acceptance to approval | 389 days |
8 | Priority review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) | Previously approved: 1) For treating unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy. 2) Indicated in combination with chemotherapy for treating locally advanced or metastatic squamous NSCLC. 3) In combination with chemotherapy for the first-time treatment of extensive-stage small cell lung cancer (ES-SCLC). Newly approved: In combination with cisplatin and fluorouracil (5-FU) as the first-line treatment for locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC). |
15. Insulin Lispro Injection
1 | Generic name | Insulin Lispro Injection |
2 | Brand | 优泌乐 (Youmile) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application type | BLA, import |
5 | MAH | Lilly Suzhou Pharmaceutical Co., Ltd. |
6 | Approved | 19/09/2023 |
7 | Acceptance to approval | 666 days |
8 | Priority review | No |
9 | Target(s) | Insulin (INS) |
10 | Indication(s) | For the treatment of diabetic patients who require insulin to maintain normal blood glucose homeostasis. |
16. Dupilumab Injection
1 | Generic name | Dupilumab Injection |
2 | Brand | 达必妥 (Dupixent) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application type | BLA, import |
5 | MAH | |
6 | Approved | 19/09/2023 |
7 | Acceptance to approval | 196 days |
8 | Priority review | Yes (other situations eligible for priority review) |
9 | Target(s) | Interleukin-4 receptor (IL4R) |
10 | Indication(s) | For the treatment of adult and pediatric patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids. |
17. Dulaglutide Injection
1 | Generic name | Dulaglutide Injection |
2 | Brand | 度易达 (TRULICITY) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application type | BLA, import |
5 | MAH | Eli Lilly Nederland B.V. |
6 | Approved | 12/09/2023 |
7 | Acceptance to approval | 244 days |
8 | Priority review | No |
9 | Target(s) | Glucagon-like peptide 1 receptor (GLP-1R) |
10 | Indication(s) | Previously approved: For blood sugar control in adults with type 2 diabetes: Used as monotherapy for patients who have inadequate control of blood glucose levels through diet and exercise alone. Used as part of combination therapy for adult patients with type 2 diabetes whose blood sugar is not adequately controlled despite treatment with metformin, sulfonylureas, or a combination of metformin and sulfonylureas, in addition to diet and exercise. Newly approved: Used in combination with insulin for the treatment of adult patients with type-2 diabetes. |
18. Pembrolizumab Injection
1 | Generic name | Pembrolizumab Injection |
2 | Brand | 可瑞达 (Keytruda) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application type | BLA, import |
5 | MAH | |
6 | Approved | 05/09/2023 |
7 | Acceptance to approval | 269 days |
8 | Priority review | No |
9 | Target(s) | PD-1 |
10 | Indication(s) | Previously approved: 1) For treating unresectable or metastatic melanoma after the failure of first-line treatment. 2) In combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. 3) As a single agent indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by NMPA-approved test, with no EGFR or ALK genomic tumor aberrations. 4) In combination with carboplatin and paclitaxel, for the first-line treatment of patients with metastatic squamous NSCLC. 5) As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by NMPA-approved test, with disease progression on or after platinum-containing chemotherapy. 6) In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. 7) As a single agent, for the first-line treatment of patients with head and neck squamous cell cancer (HNSCC) that is metastatic or with unresectable, recurrent whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by a validated test. 8) For the first-line treatment of patients with MSI-H or dMMR colorectal cancer (CRC) that is unresectable or metastatic, and with wild-type RAS, NRAS, and BRAF genes. 9) As a single agent for hepatocellular carcinoma (HCC) patients who have been previously treated with sorafenib or oxaliplatin-containing chemotherapy. 10) As neoadjuvant treatment in combination with chemotherapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by a validated test, and then continues to be used as a single agent in adjuvant treatment after surgery. Newly approved: 11) For the treatment of adult patients with unresectable or metastatic MSI-H or dMMR advanced solid tumors, including colorectal cancer patients whose disease has progressed after treatment with fluorouracil, oxaliplatin, and irinotecan, and patients with other solid tumors whose disease has progressed after previous treatment and who have no satisfactory alternative treatment options. |
19. Erenumab Injection
1 | Generic name | Erenumab Injection |
2 | Brand | 安默唯 (Aimovig) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application type | BLA, import |
5 | MAH | |
6 | Approved | 19/09/2023 |
7 | Acceptance to approval | 530 days |
8 | Priority review | No |
9 | Target(s) | Calcitonin gene-related peptide receptor (CGRP receptor) |
10 | Indication(s) | For the prevention of migraines in adults. |
Ask BaiPharm if you need more details of drug approvals in China.
