Editor's Notes: New drugs in this article refer to
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 May 2023, China NMPA approved 27 new drugs, among which 16 are chemical drugs while 11 are biological products.
1. Betta Pharmaceuticals’ Befotertinib Mesylate Capsules
2. Sanhome Pharmaceutical’s Alfosbuvir Tablets
3. Novartis’ Ribociclib Succinate Tablets
4. Boehringer Ingelheim’s Empagliflozin Tablets
5. Eisai’s Perampanel Oral Suspension
6. Mirum Pharmaceuticals’ Maralixibat Chloride Oral Solution
7. ViiV Healthcare’s Dolutegravir Sodium Dispersible Tablets
8. Amgen’s Etelcalcetide Hydrochloride Injection
9. Otsuka’s Aripiprazole for Injection
10. Bayer’s Copanlisib Hydrochloride for Injection
11. Amarin’s Icosapent Ethyl Soft Capsules
12. Livzon’s Triptorelin Acetate Microspheres for Injection
13. Bayer’s Finerenone Tablets
14. Hangzhou Shanghe’s Terbutaline Sulfate Oral Solution
15. Nanjing Zenkom’s Dexketoprofen Trometamol Injection
16. Hanmi Pharm’s Dexibuprofen Suspension
17. AB&B Bio-tech’s Quadrivalent Subunit Influenza Vaccine
18. Yifan Pharmaceutical’s Efbemalenograstim alfa Injection
19. Wolwo Pharma’s Skin Prick Solution for Humulus japonicus Pollen Allergens
20. Wolwo Pharma’s Skin Prick Solution for Artemisia annua Pollen Allergens
21. Wolwo Pharma’s Skin Prick Solution for Betula platyphylla Suk. Pollen Allergens
22. BioRay Biopharmaceutical’s Zuberitamab Injection
23. BeiGene’s Tislelizumab Injection
24. Innovent’s Bevacizumab Injection
25. Innovent’s Sintilimab Injection
26. Janssen-Cilag’s Daratumumab Injection (Subcutaneous Injection)
27. Sun Pharmaceutical’s Tildrakizumab Injection
The approval details are as follows.
1. Befotertinib Mesylate Capsules
1 | Generic Name | Befotertinib Mesylate Capsules |
2 | Brand Name | Surmana (赛美纳) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA), domestic |
5 | Marketing Authorization Holder (MAH) | Betta Pharmaceuticals Co., Ltd. |
6 | Approval Date | 29/05/2023 |
7 | Time from Application Acceptance to Approval | 816 days |
8 | Priority Review | No |
9 | Target(s) | EGFR T790M |
10 | Indication(s) | Indicated for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received epidermal growth factor receptor (EGFR)- tyrosine kinase inhibitor (TKI) therapy and have disease progression with positive EGFR T790M mutation. |
2. Alfosbuvir Tablets
1 | Generic Name | Alfosbuvir Tablets |
2 | Brand Name | Shengnuodi (圣诺迪) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Sanhome Pharmaceutical |
6 | Approval Date | 12/05/2023 |
7 | Acceptance to Approval | 906 days |
8 | Priority Review | Yes (innovative/improved new drug that is in shortage and urgently needed for clinical use, or is indicated for treating major infectious diseases and rare diseases.) |
9 | Target(s) | / |
10 | Indication(s) | Indicated in combination with daclatasvir hydrochloride to treat adult patients with genotype 1, 2, 3, or 6 chronic hepatitis C virus (HCV) infection who are either treatment-naive or have received interferon therapy, with or without compensated cirrhosis. |
3. Ribociclib Succinate Tablets
1 | Generic Name | Ribociclib Succinate Tablets |
2 | Brand Name | Kisqali (凯丽隆) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Novartis Pharma Schweiz AG |
6 | Approval Date | 19/05/2023 |
7 | Acceptance to Approval | 237 days |
8 | Priority Review | No |
9 | Target(s) | GnRH receptor |
10 | Indication(s) | Indicated for the treatment of female patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer together with aromatase inhibitor as the initial endocrine-based therapy. For premenopausal or perimenopausal females, luteinizing hormone–releasing hormone (LHRH) agonists should be used with endocrine-based therapy. |
4. Empagliflozin Tablets
1 | Generic Name | Empagliflozin Tablets |
2 | Brand Name | Jardiance (欧唐静) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Boehringer Ingelheim International GmbH |
6 | Approval Date | 26/05/2023 |
7 | Acceptance to Approval | 281 days |
8 | Priority Review | No |
9 | Target(s) | Sodium/glucose cotransporter 2 (SLC5A2) |
10 | Indication(s) | Previously approved: Indicated for treating adult patients with type 2 diabetes. Newly approved: Indicated for treating heart failure in adult patients with reduced ejection fraction and with/without diabetes. |
5. Perampanel Oral Suspension
1 | Generic Name | Perampanel Oral Suspension |
2 | Brand Name | FYCOMPA |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Eisai Europe Limited |
6 | Approval Date | 12/05/2023 |
7 | Acceptance to Approval | 389 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPAR) |
10 | Indication(s) | Indicated for treating partial-onset seizures with or without secondarily generalized seizures in epilepsy patients at 4 years of age and older. |
6. Maralixibat Chloride Oral Solution
1 | Generic Name | Maralixibat Chloride Oral Solution |
2 | Brand Name | Livmarli (迈芮倍) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Mirum Pharmaceuticals, Inc. |
6 | Approval Date | 29/05/2023 |
7 | Acceptance to Approval | 495 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | / |
10 | Indication(s) | Indicated for treating cholestatic pruritus in Alagille syndrome (ALGS) patients at 1 year of age and older. |
7. Dolutegravir Sodium Dispersible Tablets
1 | Generic Name | Dolutegravir Sodium Dispersible Tablets |
2 | Brand Name | Tivicay |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | ViiV Healthcare BV |
6 | Approval Date | 29/05/2023 |
7 | Acceptance to Approval | 623 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated in combination with other antiretroviral agents for treating HIV‑1 infection in adults and pediatric patients aged at least 4 weeks and weighing at least 3 kg. |
8. Etelcalcetide Hydrochloride Injection
1 | Generic Name | Etelcalcetide Hydrochloride Injection |
2 | Brand Name | Parsabiv (旁必福) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Amgen Europe B.V. |
6 | Approval Date | 06/05/2023 |
7 | Acceptance to Approval | 718 days |
8 | Priority Review | No |
9 | Target(s) | Extracellular calcium-sensing receptor (CASR) |
10 | Indication(s) | Indicated for treating secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) and on hemodialysis. |
9. Aripiprazole for Injection
1 | Generic Name | Aripiprazole for Injection |
2 | Brand Name | Abilify Maintena |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Otsuka Pharmaceutical Co., Ltd. |
6 | Approval Date | 19/05/2019 |
7 | Acceptance to Approval | 798 days |
8 | Priority Review | No |
9 | Target(s) | 5-HT1A; 5-HT2A; DRD2 |
10 | Indication(s) | Indicated for treating schizophrenia. |
10. Copanlisib Hydrochloride for Injection
1 | Generic Name | Copanlisib Hydrochloride for Injection |
2 | Brand Name | ALIQOPA (奥罗巴) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Bayer HealthCare Pharmaceuticals Inc. |
6 | Approval Date | 19/05/2023 |
7 | Acceptance to Approval | 800 days |
8 | Priority Review | Yes (eligible for conditional approval) |
9 | Target(s) | PI3K-delta; PIK3CA |
10 | Indication(s) | Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two types of systemic therapies. |
11. Icosapent Ethyl Soft Capsules
1 | Generic Name | Icosapent Ethyl Soft Capsules |
2 | Brand Name | VAZKEPA |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Amarin Pharmaceuticals Ireland Ltd. |
6 | Approval Date | 29/05/2023 |
7 | Acceptance to Approval | 840 days |
8 | Priority Review | No |
9 | Target(s) | Apolipoprotein B; Phospholipase A2 |
10 | Indication(s) | Indicated for lowering triglyceride levels in adult patients with severe hypertriglyceridemia (≥500mg/dL). |
12. Triptorelin Acetate Microspheres for Injection
1 | Generic Name | Triptorelin Acetate Microspheres for Injection |
2 | Brand Name | / |
3 | Classification | Class 2.2 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Livzon Pharmaceutical Group Inc. |
6 | Approval Date | 06/05/2023 |
7 | Acceptance to Approval | 597 days |
8 | Priority Review | No |
9 | Target(s) | GnRH receptor |
10 | Indication(s) | Indicated for treating patients with prostate cancer who require androgen deprivation therapy. |
13. Finerenone Tablets
1 | Generic Name | Finerenone Tablets |
2 | Brand Name | Kerendia (可申达) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Bayer AG |
6 | Approval Date | 12/05/2023 |
7 | Acceptance to Approval | 485 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Previously approved: Indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Newly approved: Indicated for the early-stage treatment of CKD associated with T2D. |
14. Terbutaline Sulfate Oral Solution
1 | Generic Name | Terbutaline Sulfate Oral Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | Hangzhou Shanghe Health Technology Co., Ltd. |
6 | Approval Date | 29/05/2023 |
7 | Acceptance to Approval | 567 days |
8 | Priority Review | No |
9 | Target(s) | Beta-2 adrenergic receptor (ADRB2) |
10 | Indication(s) | Indicated as a bronchodilator for treating bronchospasm caused by bronchial asthma, chronic bronchitis, emphysema, and other lung diseases. |
11 | Notes | First generic drug in China |
15. Dexketoprofen Trometamol Injection
1 | Generic Name | Dexketoprofen Trometamol Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Nanjing Zenkom Pharmaceutical Co., Ltd. |
6 | Approval Date | 29/05/2023 |
7 | Acceptance to Approval | 839 days |
8 | Priority Review | No |
9 | Target(s) | Cyclooxygenase (COX) |
10 | Indication(s) | Indicated as an adjuvant to opioid analgesics for acute poisoning and severe postoperative pain in adults who are not suitable for oral dosage forms. |
11 | Notes | First generic drug in China |
16. Dexibuprofen Suspension
1 | Generic Name | Dexibuprofen Suspension |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Hanmi Pharm Co., Ltd. |
6 | Approval Date | 26/05/2023 |
7 | Acceptance to Approval | 1,915 days |
8 | Priority Review | Yes (generic drug whose ANDA complies with the standards for quality and therapeutic equivalence evaluation) |
9 | Target(s) | Cyclooxygenase |
10 | Indication(s) | This product is a non-steroidal anti-inflammatory drug with antipyretic, analgesic, and anti-inflammatory effects. It is indicated for: 1. Fever and headache caused by colds and other conditions; 2. Relieving or eliminating mild to moderate pain and inflammation caused by the following diseases: ① Sprains, strains, lower back pain, shoulder periarthritis, bursitis, tendinitis, and tenosynovitis; ② Dysmenorrhea, gout, toothache, and postoperative pain; ③ Rheumatoid arthritis, osteoarthritis, and other seronegative (non-rheumatic) joint diseases. |
11 | Notes | First generic drug in China |
17. Quadrivalent Subunit Influenza Vaccine
1 | Generic Name | Quadrivalent Subunit Influenza Vaccine |
2 | Brand Name | Hui’erkangxin (慧尔康欣) |
3 | Classification | Class 1.4 prophylactic biological product |
4 | Application Type | Biologics License Application (BLA), domestic |
5 | MAH | AB&B Bio-tech Co., Ltd. |
6 | Approval Date | 12/05/2023 |
7 | Acceptance to Approval | 427 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for the prevention of influenza virus infection in population aged 3 years and older. |
18. Efbemalenograstim alfa Injection
1 | Generic Name | Efbemalenograstim alfa Injection |
2 | Brand Name | Yilishu (亿立舒) |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Yifan Pharmaceutical |
6 | Approval Date | 06/05/2023 |
7 | Acceptance to Approval | 435 days |
8 | Priority Review | No |
9 | Target(s) | Granulocyte colony-stimulating factor (G-CSF) |
10 | Indication(s) |
|
19. Skin Prick Solution for Humulus japonicus Pollen Allergens
1 | Generic Name | Skin Prick Solution for Humulus japonicus Pollen Allergens |
2 | Brand Name | / |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Wolwo Pharma |
6 | Approval Date | 06/05/2023 |
7 | Acceptance to Approval | 478 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Used in skin prick test to assist in the diagnosis of type I allergic diseases induced by Humulus japonicus pollen. |
20. Skin Prick Solution for Artemisia annua Pollen Allergens
1 | Generic Name | Skin Prick Solution for Artemisia annua Pollen Allergens |
2 | Brand Name | / |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Wolwo Pharma |
6 | Approval Date | 06/05/2023 |
7 | Acceptance to Approval | 495 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Used in desensitization therapy for adult patients with allergic rhinitis (with or without conjunctivitis and asthma) induced by Artemisia pollen. |
21. Skin Prick Solution for Betula platyphylla Suk. Pollen Allergens
1 | Generic Name | Skin Prick Solution for Betula platyphylla Suk. Pollen Allergens |
2 | Brand Name | / |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Wolwo Pharma |
6 | Approval Date | 06/05/2023 |
7 | Acceptance to Approval | 495 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Used in skin prick test to assist in the diagnosis of type I allergic diseases induced by Betula platyphylla Suk. pollen. |
22. Zuberitamab Injection
1 | Generic Name | Zuberitamab Injection |
2 | Brand Name | Anruixi (安瑞昔) |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | BioRay Biopharmaceutical |
6 | Approval Date | 12/05/2023 |
7 | Acceptance to Approval | 486 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated in combination with standard cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) therapy for adult patients with CD20-positive diffuse large B-cell lymphoma (DLBCL, NOS), not otherwise specified . |
23. Tislelizumab Injection
1 | Generic Name | Tislelizumab Injection |
2 | Brand Name | Baize’an (百泽安) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | BeiGene, Inc. |
6 | Approval Date | 19/05/2023 |
7 | Acceptance to Approval | 269 days |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) | Previously approved: 1. Indicated for the second-line treatment of relapsed or refractory classic Hodgkin lymphoma (cHL) patients who have received at least the second-line chemotherapy; 2. Indicated or treating urothelial cancer (UC) and small lymphocytic lymphoma (SLL) patients with high PD-L1 expression, prior failure of platinum chemotherapy, and disease progression within 12 months after the neoadjuvant or adjuvant chemotherapy; 3. Indicated in combination with paclitaxel and platinum for the first-line treatment for patients with advanced squamous NSCLC that is unresectable by surgery; 4. Indicated for treating hepatocellular carcinoma (HCC) patients who have received at least one type of systemic therapy; 5. Indicated with combination with pemetrexed and platinum chemotherapy for the first-line treatment for NSCLC that are EGFR-negative, ALK-negative and unresectable by surgery. 6. Indicated for the second-line or third-line treatment for NSCLC patients who have disease progression after platinum chemotherapy. 7. Indicated for the treatment of locally advanced, unresectable or metastatic, microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) solid tumors after prior treatment. 8. Indicated for the treatment of esophageal squamous cell carcinoma (ESCC) that is unresectable, relapsed, locally advanced or metastatic after prior systemic treatment. 9. Indicated for the first-line treatment of relapsed or metastatic nasopharyngeal carcinoma. 10. Indicated for treating advanced or metastatic gastric/gastroesophageal junction (G/GEJ) cancer. Newly approved: 11. Indicated in combination with (1) paclitaxel and platinum drugs or (2) fluorouracil and platinum drugs for the first-line treatment of unresectable, locally advanced, recurrent or metastatic, esophageal squamous cell carcinoma. |
24. Bevacizumab Injection
1 | Generic Name | Bevacizumab Injection |
2 | Brand Name | Dayoutong (达攸同) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Innovent Biologics Suzhou Co., Ltd. |
6 | Approval Date | 06/05/2023 |
7 | Acceptance to Approval | 498 days |
8 | Priority Review | No |
9 | Target(s) | Vascular endothelial growth factor A (VEGF-A) |
10 | Indication(s) | Previously approved: 1. Indicated in combination with fluoropyrimidine-based chemotherapy for patients with metastatic colorectal cancer. 2. Indicated in combination with platinum-based chemotherapy for the first-line treatment of patients with unresectable, advanced, metastatic or recurrent, non-squamous non-small cell lung cancer (NSCLC). 3. Indicated for the treatment of adult patients with recurrent glioblastoma. 4. Indicated in combination with atezolizumab for treating patients with unresectable hepatocellular carcinoma who have not received systemic therapy. 5. Indicated in combination with carboplatin and paclitaxel for the first-line treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer after their first-time surgical resection. 6. Indicated in combination with (1) paclitaxel and cisplatin or (2) paclitaxel and topotecan for treating patients with persistent, recurrent or metastatic cervical cancer. 7. Indicated in combination with sintilimab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma in patients who have not received prior systemic treatment. Newly approved: 8. Indicated in combination with bevacizumab, pemetrexed, and cisplatin, for treating EGFR mutation-positive, locally advanced or metastatic, non-squamous NSCLC in patients for whom EGFR-TKI therapy has failed. |
25. Sintilimab Injection
1 | Generic Name | Sintilimab Injection |
2 | Brand Name | Tyvyt (达伯舒) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Innovent Biologics Suzhou Co., Ltd. |
6 | Approval Date | 06/05/2023 |
7 | Acceptance to Approval | 498 days |
8 | Priority Review | No |
9 | Target(s) | PD-1 |
10 | Indication(s) | Previously approved: 1. Indicated for treating relapsed or refractory classical Hodgkin's lymphoma. 2. Indicated In combination with pemetrexed and platinum for the first-line treatment of locally advanced or metastatic non-squamous NSCLC. 3. Indicated in combination with gemcitabine and platinum-based chemotherapy for the first-line treatment of locally advanced or metastatic squamous NSCLC. 4. Indicated in combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma. 5. Indicated in combination of fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma. 6. Indicated in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma in patients who have not received prior systemic treatment. Newly approved: 7. Indicated in combination with sintilimab, pemetrexed, and cisplatin, for treating EGFR mutation-positive, locally advanced or metastatic, non-squamous NSCLC in patients for whom EGFR-TKI therapy has failed. |
26. Daratumumab Injection (Subcutaneous Injection)
1 | Generic Name | Daratumumab Injection (Subcutaneous Injection) |
2 | Brand Name | DARZALEX FASPRO (兆珂速) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Janssen-Cilag International NV |
6 | Approval Date | 19/05/2023 |
7 | Acceptance to Approval | 399 days |
8 | Priority Review | No |
9 | Target(s) | CD38 Molecule |
10 | Indication(s) |
|
27. Tildrakizumab Injection
1 | Generic Name | Tildrakizumab Injection |
2 | Brand Name | ILUMETRI (益路取) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Sun Pharmaceutical Industries Limited |
6 | Approval Date | 26/05/2023 |
7 | Acceptance to Approval | 584 days |
8 | Priority Review | No |
9 | Target(s) | Interleukin-23 subunit alpha (IL23A) |
10 | Indication(s) | Indicated for the treatment of patients with moderate to severe plaque psoriasis. |
Ask BaiPharm if you need more details of drug approvals in China.
