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.
Related Articles:
In Feb. 2023, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products.
1. Carephar’s Keverprazan Hydrochloride Tablets
2. Novartis’ Revolade
3. Pfizer’s Xeljanz XR
4. Vifor Fresenius’ Velphoro
5. Swedish Orphan Biovitrum’s Orfadin (capsule)
6. Swedish Orphan Biovitrum’s Orfadin (oral suspension)
7. Gilead Sciences’ AmBisome
8. AbbVie’s RINVOQ
9. Tide Pharma’s Limaprost Alfadex Tablets
10. BeiGene’s Tislelizumab Injection
11. Daiichi-Sankyo’s ENHERTU
12. Amgen’s Prolia
13. Sanofi Pasteur’s Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
The details are as follows.
1. Keverprazan Hydrochloride Tablets
1 | Generic Name | Keverprazan Hydrochloride Tablets |
2 | Brand Name | Bei Wen (倍稳) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA), domestic |
5 | Marketing Authorization Holder (MAH) | Jiangsu Carephar Pharmaceutical Co., Ltd. |
6 | Approval Date | 14/2/2023 |
7 | Time from Application Acceptance to Approval | 502 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For the treatment of duodenal ulcer and reflux esophagitis. |
2. Eltrombopag Olamine Tablets
1 | Generic Name | Eltrombopag Olamine Tablets |
2 | Brand Name | Revolade (瑞弗兰) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Novartis Pharma Schweiz AG |
6 | Approval Date | 21/2/2023 |
7 | Time from Application Acceptance to Approval | 273 days |
8 | Priority Review | No |
9 | Target(s) | Thrombopoietin receptor (TPO-R) |
10 | Indication(s) | Previously approved: 1. For the treatment of patients with severe aplastic anemia (SAA) who previously had insufficient response to immunosuppressive therapy. Newly approved on Feb. 21, 2023: 2. For the treatment of chronic immune thrombocytopenia (ITP) in adult patients (≥18 years old) who previously had insufficient response to therapies such as corticosteroids and immunoglobulins. The drug is used for increasing the platelet count and reducing/preventing bleeding. * The drug should only be used only in patients with ITP whose risk of bleeding increase due to thrombocytopenia degree and clinical condition. |
3. Tofacitinib Citrate Sustained-release Tablets
1 | Generic Name | Tofacitinib Citrate Sustained-release Tablets |
2 | Brand Name | Xeljanz XR (尚杰) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Pfizer Inc. |
6 | Approval Date | 7/2/2023 |
7 | Time from Application Acceptance to Approval | 302 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase JAK1 Tyrosine-protein kinase JAK3 |
10 | Indication(s) | 1. For the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who previously had inadequate response or intolerance to one or more TNF blockers. * Limitation of use: the drug is not recommended to be used in combination with biologic-disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine. 2. For the treatment of adult patients with active psoriatic arthritis (PsA) who had previously inadequate response or intolerance to one or more TNF blockers. The drug can be used in combination with methotrexate (MTX). 3. For the treatment of adult patients with active ankylosing spondylitis who previously had inadequate response or intolerance to one or more TNF blockers. * Limitation of use: the drug is not recommended to be used with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine. |
4. Sucroferric Oxyhydroxide Chewable Tablets
1 | Generic Name | Sucroferric Oxyhydroxide Chewable Tablets |
2 | Brand Name | Velphoro |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Vifor Fresenius Medical Care Renal Pharma Ltd |
6 | Approval Date | 21/2/2023 |
7 | Time from Application Acceptance to Approval | 399 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | / |
10 | Indication(s) | 1. For the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) who are receiving hemodialysis (HD) or peritoneal dialysis (PD). 2. For the treatment of hyperphosphatemia in pediatric patients (≥ 12 years old) with phase 4-5 CKD (glomerular filtration rate < 30 mL/min/1.73 m2) or on dialysis. |
5. Nitisinone Capsules
1 | Generic Name | Nitisinone Capsules |
2 | Brand Name | Orfadin |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Swedish Orphan Biovitrum International AB |
6 | Approval Date | 14/2/2023 |
7 | Time from Application Acceptance to Approval | 792 days |
8 | Priority Review | Yes (reason not revealed yet) |
9 | Target(s) | 4-hydroxyphenylpyruvate dioxygenase (HPPD) |
10 | Indication(s) | For the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. |
6. Nitisinone Oral Suspension
1 | Generic Name | Nitisinone Oral Suspension |
2 | Brand Name | Orfadin |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Swedish Orphan Biovitrum International AB |
6 | Approval Date | 14/2/2023 |
7 | Time from Application Acceptance to Approval | 792 days |
8 | Priority Review | Yes (reason not revealed yet) |
9 | Target(s) | HPPD |
10 | Indication(s) | For the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. |
7. Amphotericin B Liposome for Injection
1 | Generic Name | Amphotericin B Liposome for Injection |
2 | Brand Name | AmBisome |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Gilead Sciences Ireland UC |
6 | Approval Date | 14/2/2023 |
7 | Time from Application Acceptance to Approval | 857 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | 1. For treating patients with systemic fungal infections; 2. For treating patients with disease progression or no response to other anti-fundal therapies. For example, the patient has septicemia, endocarditis, meningitis (due to cryptococcus and/or other fungi), peritoneal infections (including those related to dialysis), pulmonary infections, urinary tract infection, etc. 3. For treating patients who cannot be treated with amphotericin B deoxycholate due to renal impairment or drug toxicity. |
8. Upadacitinib Sustained-release Tablets
1 | Generic Name | Upadacitinib Sustained-release Tablets |
2 | Brand Name | RINVOQ (瑞福) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | AbbVie Deutschland GmbH & Co. KG |
6 | Approval Date | 14/2/2023 |
7 | Time from Application Acceptance to Approval | 403 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase JAK1 |
10 | Indication(s) | Previously approved: 1. For the treatment of adult and pediatric patients (≥ 12 years old) with refractory, moderate to severe atopic dermatitis. 2. For the treatment of adults with moderately to severely active rheumatoid arthritis who previously had inadequate response or intolerance to one or more TNF blockers. 3. For the treatment of adults with active psoriatic arthritis who previously had inadequate response or intolerance to one or more DMARDs. Newly approved on Feb. 14, 2023: 4. For the treatment of adult patients with moderately to severely active ulcerative colitis who previously had inadequate response, intolerance, or contra-indication to one or more TNF blockers. |
9. Limaprost Alfadex Tablets
1 | Generic Name | Limaprost Alfadex Tablets |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | Beijing Tide Pharmaceutical Co., Ltd. |
6 | Approval Date | 14/2/2023 |
7 | Time from Application Acceptance to Approval | 568 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | 1. For the improvement of various ischemic symptoms such as ulcer, pain and feeling of coldness associated with thromboangiitis obliterans; 2. For the improvement of subjective symptoms (pain and numbness of lower legs) and gait ability associated with acquired lumbar spinal canal stenosis (in patients with bilateral intermittent claudication showing normal SLR test result) as an additional indication. |
11 | Note | First generic drug in China |
10. Tislelizumab Injection
1 | Generic Name | Tislelizumab Injection |
2 | Brand Name | Bai Ze An (百泽安) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | Biologics License Application (BLA), domestic |
5 | MAH | BeiGene, Inc. |
6 | Approval Date | 21/2/2023 |
7 | Time from Application Acceptance to Approval | 244 days |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) | Previously approved: 1. For the second-line treatment of relapsed or refractory classic Hodgkin lymphoma (cHL) patients who have received at least the second-line chemotherapy; 2. For 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. In combination with paclitaxel and platinum for the first-line treatment for patients with advanced squamous NSCLC that is unresectable by surgery; 4. For treating hepatocellular carcinoma (HCC) patients who have received at least one type of systemic therapy; 5. In combination with pemetrexed and platinum chemotherapy for the first-line treatment for NSCLC that are EGFR-negative, ALK-negative and unresectable by surgery. 6. For the second-line or third-line treatment for NSCLC patients who have disease progression after platinum chemotherapy. 7. 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. For the treatment of esophageal squamous cell carcinoma (ESCC) that is unresectable, relapsed, locally advanced or metastatic after prior systemic treatment. 9. For the first-line treatment of relapsed or metastatic nasopharyngeal carcinoma. Newly approved on Feb. 21, 2022: 10. For treating advanced or metastatic gastric/gastroesophageal junction (G/GEJ) cancer. |
11. Trastuzumab Deruxtecan for Injection
1 | Generic Name | Trastuzumab Deruxtecan for Injection |
2 | Brand Name | ENHERTU |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Daiichi-Sankyo |
6 | Approval Date | 21/2/2022 |
7 | Time from Application Acceptance to Approval | 337 days |
8 | Priority Review | Yes (breakthrough therapy) |
9 | Target(s) | Receptor tyrosine-protein kinase erbB-2 (HER2) |
10 | Indication(s) | The drug as a single therapy is indicated for treating adult patients who have HER2-positive breast cancer that cannot be removed by surgery or is metastatic, and who have received a prior treatment of anti-HER2 breast cancer. |
12. Denosumab Injection
1 | Generic Name | Denosumab Injection |
2 | Brand Name | Prolia (普罗力) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Amgen Europe B.V. |
6 | Approval Date | 21/2/2023 |
7 | Time from Application Acceptance to Approval | 253 days |
8 | Priority Review | No |
9 | Target(s) | Tumor necrosis factor ligand superfamily member 11 (TNFSF11) |
10 | Indication(s) | Previously approved: 1. For the treatment of postmenopausal osteoporosis at high risk for fracture. The drug can reduce the incidence of vertebral, nonvertebral, and hip fractures in postmenopausal women. Approved on Feb. 21, 2023: 2. For the treatment of osteoporosis in men at high risk for fracture. |
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 | BLA, domestic |
5 | MAH | Shenzhen Sanofi Pasteur Biological Products Co., Ltd. |
6 | Approval Date | 21/2/2023 |
7 | Time from Application Acceptance to Approval | 377 days |
8 | Priority Review | Yes (vaccine urgently needed for disease prevention and control) |
9 | Target(s) | Influenza virus |
10 | Indication(s) | For active immunization of influenza on people between 6 and 35 months of age, especially those who are susceptible to flu complications. |
Welcome to contact BaiPharm if you need more details of drug approvals in China.
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Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023
