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.
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China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials
In Nov. 2021, China's NMPA approved seven new drugs, including three chemical drugs and four biological products.
1. Remimazolam Tosilate for Injection
1 | Generic Name | Remimazolam Tosilate for Injection |
2 | Brand Name | Rui Bei Ning (瑞倍宁) |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | New drug application (NDA) |
5 | Marketing Authorization Holder (MAH) | Jiangsu Hengrui Pharmaceutical Co., Ltd. |
6 | Approval Date | Nov. 12, 2021 |
7 | Time from Application Acceptance to Approval | 261 days |
8 | Priority Review | No |
9 | Target(s) | GABAA receptor |
10 | Indication(s) | Indicated for procedural sedation during gastroscopy. |
2. Olverembatinib Tablets
1 | Generic Name | |
2 | Brand Name | / |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | NDA |
5 | MAH | Ascentage Pharma Group |
6 | Approval Date | Nov. 26, 2021 |
7 | Time from Application Acceptance to Approval | 397 |
8 | Priority Review | Yes (qualified for conditional approval) |
9 | Target(s) | / |
10 | Indication(s) |
|
3. Sodium Phosphates Powder
1 | Generic Name | Sodium Phosphates Powder |
2 | Brand Name | / |
3 | Registration Classification | Class 2.2 chemical drug |
4 | Application Type | NDA |
5 | MAH | Sichuan Jewelland Pharmaceutical Co., Ltd. |
6 | Approval Date | Nov. 5 |
7 | Time from Application Acceptance to Approval | 1,733 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for cleansing intestines before a colon X-ray test, colonoscopy, or surgery. |
4. Toripalimab Injection
1 | Generic Name | Toripalimab Injection |
2 | Brand Name | Tuo Yi (拓益) |
3 | Registration Classification | Class 2.2 therapeutic biological product |
4 | Application Type | Biologics License Application |
5 | MAH | Shanghai Junshi Biosciences Co., Ltd. |
6 | Approval Date | Nov. 26, 2021 |
7 | Time from Application Acceptance to Approval | 273 days |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) | Indicated for first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma in combination with cisplatin and gemcitabine. |
5. Envafolimab Injection
1 | Generic Name | |
2 | Brand Name | En Wei Da (恩维达) |
3 | Registration Classification | Class 1 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Alphamab Oncology Co., Ltd. |
6 | Approval Date | Nov. 26, 2021 |
7 | Time from Application Acceptance to Approval | 326 days |
8 | Priority Review | Yes (qualified for conditional approval) |
9 | Target(s) | Programmed death-ligand 1 (PD-L1) |
10 | Indication(s) | Indicated for the treatment of
|
6. Bevacizumab Injection
1 | Generic Name | |
2 | Brand Name | Pu Bei Xi (普贝希) |
3 | Registration Classification | Class 2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Bio-Thera Solutions, Ltd. |
6 | Approval Date | Nov. 19, 2021 |
7 | Time from Application Acceptance to Approval | 502 days |
8 | Priority Review | No |
9 | Target(s) | Vascular endothelial growth factor (VEGF) |
10 | Indication(s) |
|
7. Bevacizumab Injection
1 | Generic Name | Bevacizumab Injection |
2 | Brand Name | Bei An Ting (贝安汀) |
3 | Registration Classification | Class 2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Zhejiang Hisun Pharmaceutical Co., Ltd. |
6 | Approval Date | Nov. 26, 2021 |
7 | Time from Application Acceptance to Approval | 518 days |
8 | Priority Review | No |
9 | Target(s) | Vascular endothelial growth factor (VEGF) |
10 | Indication(s) |
|
Welcome to contact BaiPharm if you need details of the approved drugs listed above or drug registration procedures in China.
We offer a full portfolio of China NMPA compliance consulting services. Our professionals have successfully carried out a great number of market entry projects of finished drugs, APIs, excipients and packaging materials.