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*.
*"First generic drug in China" refers to the first generic drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.
In Dec 2021, China's NMPA approved 11 new drugs, including 7 chemical drugs and 4 biological products.
1. Omadacycline Tablets
1 | Generic Name | Omadacycline Tablets |
2 | Brand Name | NUZYRA® |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA) |
5 | MAH | Zai Lab Limited |
6 | Approval Date | Dec. 16, 2021 |
7 | Time from Application Acceptance to Approval | 661 days |
8 | Priority Review | Yes (innovative drug) |
9 | Target(s) | / |
10 | Indication(s) | 1. Community-acquired bacterial pneumonia (CABP); 2. Acute bacterial skin/skin structure infections (ABSSSIs). |
2. Omadacycline for Injection
1 | Generic Name | Omadacycline for Injection |
2 | Brand Name | NUZYRA® |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | NDA |
5 | MAH | Zai Lab Limited |
6 | Approval Date | Dec. 16, 2021 |
7 | Time from Application Acceptance to Approval | 661 days |
8 | Priority Review | Yes (innovative drug) |
9 | Target(s) | / |
10 | Indication(s) | 1. Community-acquired bacterial pneumonia (CABP); 2. Acute bacterial skin/skin structure infections (ABSSSIs). |
3. Almonertinib Mesilate Tablets
1 | Generic Name | Almonertinib Mesilate Tablets |
2 | Brand Name | Ameile® (阿美乐) |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | NDA |
5 | MAH | Jiangsu Hansoh Pharmaceutical Group Co., Ltd. |
6 | Approval Date | Dec. 16, 2021 |
7 | Time from Application Acceptance to Approval | 208 days |
8 | Priority Review | Yes (Breakthrough Therapy Designation) |
9 | Target(s) | Receptor tyrosine kinases (RTKs) |
10 | Indication(s) | 1. Indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are EGFR 790 mutation-positive and have disease progression during or after a prior epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy. This indication was approved on March 18, 2020. 2. Indicated for the first-line treatment for locally advanced or metastatic NSCLC adult patients with EGFR exon 19 deficiency or exon 21 L858R mutation. This indication was approved this time. |
4. Ciprofol Injection
1 | Generic Name | Ciprofol Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | NDA |
5 | MAH | Liaoning Haisco Pharmaceutical Co., Ltd. |
6 | Approval Date | Dec. 10, 2021 |
7 | Time from Application Acceptance to Approval | 305 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | 1. Sedation in gastrointestinal endoscopy. This indication was approved on Aug. 12, 2021. 2. Sedation in bronchoscopy. This indication was approved this time. |
5. Selinexor Tablets
1 | Generic Name | |
2 | Brand Name | XPOVIO® |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA |
5 | MAH | Antengene Corporation Limited |
6 | Approval Date | Dec. 16, 2021 |
7 | Time from Application Acceptance to Approval | 316 days |
8 | Priority Review | Yes (conditional approval) |
9 | Target(s) | Exportin-1 (XPO1) |
10 | Indication(s) | In combination with dexamethasone for the treatment of relapsing or refractory multiple myeloma patients who have received prior therapy and whose disease is refractory to at least one proteasome inhibitors, at least one immunomodulatory agents, and at least one anti‐CD38 monoclonal antibody. |
6. Dronedarone Hydrochloride Tablets
1 | Generic Name | Dronedarone Hydrochloride Tablets |
2 | Brand Name | MULTAQ® |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | Import |
5 | MAH | Sanofi (China) Investment Co., Ltd. |
6 | Approval Date | Dec. 22, 2021 |
7 | Time from Application Acceptance to Approval | 316 days |
8 | Priority Review | No |
9 | Target(s) | Sodium channel; adrenergic receptor; calcium channel; potassium channel. |
10 | Indication(s) | Dronedaroneis an anti-arrhythmia drug indicated to reduce the risk of hospitalization for patients with atrial fibrillation (AF) or atrial flutter (AFL). It is also indicated for patients with recent paroxysmal AF/AFL and cardiovascular risk factors, and patients can restore a normal sinus rhythm or heart rhythm. |
7. Isavuconazonium Sulfate Capsules
1 | Generic Name | Isavuconazonium Sulfate Capsules |
2 | Brand Name | Cresemba® (康新博) |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | Import |
5 | MAH | Basilea Pharmaceutica Deutschland GmbH |
6 | Approval Date | Dec. 16, 2021 |
7 | Time from Application Acceptance to Approval | 517 days |
8 | Priority Review | No |
9 | Target(s) | Lanosterol 14-alpha demethylase (CYP51A1) |
10 | Indication(s) | Cresemba is a new antifungal drug indicated for adult patients for the treatment of invasive mucormycosis. |
8. Sugemalimab Injection
1 | Generic Name | Sugemalimab Injection |
2 | Brand Name | Cejemly (择捷美) |
3 | Registration Classification | Class 1 therapeutic biological product |
4 | Application Type | Biologics License Application (BLA) |
5 | MAH | CStone Pharmaceuticals |
6 | Approval Date | Dec. 22, 2021 |
7 | Time from Application Acceptance to Approval | 392 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) |
|
9. Camrelizumab for Injection
1 | Generic Name | Camrelizumab for Injection |
2 | Brand Name | AiRuiKa™ (艾瑞卡) |
3 | Registration Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Suzhou Shengdiya Bipharmaceutical Co., Ltd. |
6 | Approval Date | Dec. 10, 2021 |
7 | Time from Application Acceptance to Approval | 392 |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) |
|
10. Ofatumumab Injection
1 | Generic Name | Ofatumumab Injection |
2 | Brand Name | Kesimpta® |
3 | Registration Classification | Class 3.1 therapeutic biological product |
4 | Application Type | Import |
5 | MAH | Novartis |
6 | Approval Date | Dec. 22, 2021 |
7 | Time from Application Acceptance to Approval | 405 |
8 | Priority Review | Yes (other qualified conditions) |
9 | Target(s) | / |
10 | Indication(s) | Indicated for treating adult patients with relapsing multiple sclerosis (RMS), including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS). |
11. Siltuximab for Injection
1 | Generic Name | Siltuximab for Injection |
2 | Brand Name | Sylvant (萨温珂) |
3 | Registration Classification | Class 3.1 therapeutic biological product |
4 | Application Type | Import |
5 | MAH | EUSA Pharma (Netherlands) B.V. |
6 | Approval Date | Dec. 2, 2021 |
7 | Time from Application Acceptance to Approval | 303 days |
8 | Priority Review | Yes (other qualified conditions) |
9 | Target(s) | Interleukin-6 receptor subunit alpha (IL6R); heat shock protein. |
10 | Indication(s) | Indicated for the treatment of multicentric Castleman's disease (MCD) in adult patients who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. |
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