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. In this article, 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 2022, China NMPA approved 14 new drugs, including 12 chemical drugs and 2 biological products.
1. Luye Pharma's Toludesvenlafaxine Hydrochloride Sustained-release Tablets
2. YL-Pharma's Linperlisib Tablets
3. Chase Sun Pharma's p-Toluenesulfonamide Injection
4. Vifor's Ferric Carboxymaltose Injection
5. Lantheus' Perflutren Lipid Microsphere Injection
6. Mundipharma's Oxycodone Hydrochloride and Naloxone Hydrochloride Dehydrate Prolonged-release Tablets
7. Zhejiang Heze Kunyuan Pharma's Potassium Chloride Oral Solution
8. Lepu Medical's Clopidogrel Bisulfate and Aspirin Tablets
9. Sichuan Meida Kangjiale Pharma's Tirofiban Hydrochloride Injection
10. CF PharmTech's Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray
11. Suzhou Xiehe Pharma's Eliglustat Capsules
12. Chimin Health Management's Sorbitol and Mannitol Irrigation Solution
13. Shanghai Institute of Biological Products' Influenza Vaccine (Split Virion)
14. MSD's Pembrolizumab Injection
The approval details are as follows.
1. Toludesvenlafaxine Hydrochloride Sustained-release Tablets
1 | Generic Name | Toludesvenlafaxine Hydrochloride Sustained-release Tablets |
2 | Brand Name | Ruo Xin Lin (若欣林) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA) |
5 | Marketing Authorization Holder (MAH) | Luye Pharma Group |
6 | Approval Date | Nov. 3, 2022 |
7 | Time from Application Acceptance to Approval | 437 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For treating depression. |
2. Linperlisib Tablets
1 | Generic Name | Linperlisib Tablets |
2 | Brand Name | Yin Ta Rui (因他瑞) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA |
5 | MAH | YL-Pharma |
6 | Approval Date | Nov. 9, 2022 |
7 | Time from Application Acceptance to Approval | 410 days |
8 | Priority Review | Yes (breakthrough therapy) |
9 | Target(s) | Phosphoinositide-3 kinase delta (PI3K-delta) |
10 | Indication(s) | For treating relapsed or refractory follicular lymphoma in adult patients who have received two or more systemic treatments. |
3. p-Toluenesulfonamide Injection
1 | Generic Name | p-Toluenesulfonamide Injection |
2 | Brand Name | PTS |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA |
5 | MAH | Chase Sun Pharmaceutical Co., Ltd. |
6 | Approval Date | Nov. 21, 2022 |
7 | Time from Application Acceptance to Approval | 774 days |
8 | Priority Review | Yes (innovative drug) |
9 | Target(s) | / |
10 | Indication(s) | For treating central-type non-small cell lung cancer (NSCLC) with severe airway obstruction. |
4. Ferric Carboxymaltose Injection
1 | Generic Name | Ferric Carboxymaltose Injection |
2 | Brand Name | Ferinject |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Vifor (International) Inc. |
6 | Approval Date | Nov. 29, 2022 |
7 | Time from Application Acceptance to Approval | 450 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For treating iron deficiency and/or iron deficiency anaemia in adult patients for whom oral iron is ineffective or cannot be used or when there is a clinical need to deliver iron rapidly. |
5. Perflutren Lipid Microsphere Injection
1 | Generic Name | Perflutren Lipid Microsphere Injection |
2 | Brand Name | DEFINITY |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Lantheus MI Canada Inc. |
6 | Approval Date | Nov. 21, 2022 |
7 | Time from Application Acceptance to Approval | 480 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | DEFINITY is an ultrasound contrast agent indicated for: use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. |
6. Oxycodone Hydrochloride and Naloxone Hydrochloride Dehydrate Prolonged-release Tablets
1 | Generic Name | Oxycodone Hydrochloride and Naloxone Hydrochloride Dehydrate Prolonged-release Tablets |
2 | Brand Name | Targin |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Mundipharma Gmbh |
6 | Approval Date | Nov. 29, 2022 |
7 | Time from Application Acceptance to Approval | 1,249 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | TARGIN tablets are used to relieve moderate to severe persistent pain when other forms of treatment have not been effective. The naloxone in TARGIN tablets will help prevent and treat opioid-induced constipation. |
7. Potassium Chloride Oral Solution
1 | Generic Name | Potassium Chloride Oral Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA) |
5 | MAH | Zhejiang Heze Kunyuan Pharmaceutical Co., Ltd. |
6 | Approval Date | Nov. 14, 2022 |
7 | Time from Application Acceptance to Approval | 343 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For the treatment and prophylaxis of hypokalemia. |
11 | Notes | First generic drug in China |
8. Clopidogrel Bisulfate and Aspirin Tablets
1 | Generic Name | Clopidogrel Bisulfate and Aspirin Tablets |
2 | Brand Name | Shuai Tai (帅泰) |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Lepu Medical Co., Ltd. |
6 | Approval Date | Nov. 21, 2022 |
7 | Time from Application Acceptance to Approval | 426 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For preventing atherothrombosis in patients who have acute coronary syndromes (e.g., myocardial infarction and unstable angina), ischemic stroke, and/or peripheral arterial disease. |
11 | Notes | First generic drug in China |
9. Tirofiban Hydrochloride Injection
1 | Generic Name | Tirofiban Hydrochloride Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Sichuan Meida Kangjiale Pharmaceutical Co., Ltd. |
6 | Approval Date | Nov. 7, 2022 |
7 | Time from Application Acceptance to Approval | 487 days |
8 | Priority Review | No |
9 | Target(s) | Glycoprotein IIb/IIIa receptor |
10 | Indication(s) | In combination with heparin for preventing myocardial ischemia events in patients with unstable angina or non-Q-wave myocardial infarction; For preventing cardiac ischemic complications related to acute arterial occlusion in patients with coronary ischemia syndrome in the process of coronary angioplasty or intracoronary plaque resection operation. |
11 | Notes | First generic drug in China |
10. Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray
1 | Generic Name | Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray |
2 | Brand Name | Shu Fei Min (舒霏敏) |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | CF PharmTech, Inc. |
6 | Approval Date | Nov. 7, 2022 |
7 | Time from Application Acceptance to Approval | 429 days |
8 | Priority Review | No |
9 | Target(s) | Histamine H1 receptor (HRH1); Leukotriene C4 (LTC4) |
10 | Indication(s) | For treating adolescent and adult patients with moderate to severe seasonal or perennial allergic rhinitis. |
11 | Notes | First generic drug in China |
11. Eliglustat Capsules
1 | Generic Name | Eliglustat Capsules |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Suzhou Xiehe Pharmaceutical Co., Ltd. |
6 | Approval Date | Nov. 3, 2022 |
7 | Time from Application Acceptance to Approval | 890 days |
8 | Priority Review | Yes (rare disease) |
9 | Target(s) | Glucosylceramide synthase (GCS) |
10 | Indication(s) | For the long-term treatment of Gaucher disease type 1 (GD1) in adults who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test. |
11 | Notes | First generic drug in China |
12. Sorbitol and Mannitol Irrigation Solution
1 | Generic Name | Sorbitol and Mannitol Irrigation Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Chimin Health Management Co., Ltd. |
6 | Approval Date | Nov. 14, 2022 |
7 | Time from Application Acceptance to Approval | 1,271 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For irrigation in transurethral resection of the prostate or other urology procedures. |
11 | Notes | First generic drug in China |
13. Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
1 | Generic Name | Influenza Vaccine (Split Virion), Inactivated, Quadrivalent |
2 | Brand Name | / |
3 | Classification | Class 3.2 prophylactic biological product |
4 | Application Type | Biologics license application (BLA) |
5 | MAH | Shanghai Institute of Biological Products |
6 | Approval Date | Nov. 29, 2022 |
7 | Time from Application Acceptance to Approval | 212 days |
8 | Priority Review | Yes (vaccine urgently needed for disease prevention and control) |
9 | Target(s) | / |
10 | Indication(s) | For immunization against four influenza virus strains to prevent influenza in patients at three years old or older. The vaccine is especially recommended for people susceptible to complications, such as children, the elderly, the infirm, and those in influenza-active areas. |
14. Pembrolizumab Injection
1 | Generic Name | Pembrolizumab Injection |
2 | Brand Name | Keytruda (可瑞达) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
6 | Approval Date | Nov. 7, 2022 |
7 | Time from Application Acceptance to Approval | 227 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 nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. 3. As a single agent indicated for thefirst-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. Newly approved on Nov. 7, 2022: 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. |
