Editor's Notes: New drugs in this article refer to any of the following drugs:
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 July 2023, China NMPA approved 5 new drugs, among which 3 are chemical drugs and 2 are biological products.
1. ViiV Healthcare’s Cabotegravir Injection (brand: VOCABRIA)
2. SJZ No.4 Pharma’s Stiripentol for Suspension (first generic)
3. Beijing RuiYe Pharma’s Cefoperazone Sodium and Sulbactam Sodium for Injection and Sodium Chloride Injection (first generic)
4. Daiichi Sankyo’s Trastuzumab Deruxtecan for Injection (Enhertu)
5. Shanghai Banemae Biopharma’s Beinaglutide Injection
The approval details are as follows.
1. Cabotegravir Injection
1 | Generic name | Cabotegravir Injection |
2 | Brand | VOCABRIA/万凯锐 |
3 | Classification | Class 5.1 chemical drug |
4 | Application type | New drug application (NDA), import |
5 | Marketing authorization holder (MAH) | |
6 | Approved | 11/07/2023 |
7 | Time from application acceptance to approval | 593 days |
8 | Priority review | No |
9 | Target(s) | Integrase |
10 | Indication(s) | Indicated for the treatment of HIV-1 infection and HIV-1 pre-exposure prophylaxis. |
2. Stiripentol for Suspension
1 | Generic name | Stiripentol for Suspension |
2 | Brand | / |
3 | Classification | Class 3 chemical drug |
4 | Application type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | |
6 | Approved | 25/07/2023 |
7 | Acceptance to approval | 460 days |
8 | Priority review | Yes (pediatric drug) |
9 | Target(s) | Gamma-aminobutyric acid receptor (GABAR); Cytochrome P450 reductase (P450) |
10 | Indication(s) | Indicated in combination with clobazam and valproate as an adjuvant therapy for the treatment of seizures in patients with severe myoclonic epilepsy in infancy (SMEI) and Dravet syndrome (DS), when the seizures cannot be fully controlled by clobazam and valproate together. |
11 | Notes | First generic drug in China |
3. Cefoperazone Sodium and Sulbactam Sodium for Injection and Sodium Chloride Injection
1 | Generic name | Cefoperazone Sodium and Sulbactam Sodium for Injection and Sodium Chloride Injection |
2 | Brand | / |
3 | Classification | Class 3 chemical drug |
4 | Application type | ANDA, domestic |
5 | MAH | |
6 | Approved | 25/07/2023 |
7 | Acceptance to approval | 519 days |
8 | Priority review | No |
9 | Target(s) | Beta-lactamase |
10 | Indication(s) | Indicated for respiratory tract infections, urinary tract infection, peritonitis, cholecystitis, cholangitis and other intra-abdominal infections, as well as septicemia, meningitis, skin and soft tissue infections, bone and joint infections, pelvic infections, endometritis, gonorrhea and other genital infections. |
11 | Notes | First generic drug in China |
4. Trastuzumab Deruxtecan for Injection
1 | Generic name | Trastuzumab Deruxtecan for Injection |
2 | Brand | Enhertu/优赫得 |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application type | Biologics License Application (BLA), import |
5 | MAH | |
6 | Approved | 11/07/2023 |
7 | Acceptance to approval | 327 |
8 | Priority review | No |
9 | Target(s) | Receptor tyrosine-protein kinase erbB-2 (HER2) |
10 | Indication(s) | Indicated for the treatment of patients with unresectable or metastatic HER2-low breast cancer, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months after completing adjuvant chemotherapy |
5. Beinaglutide Injection
1 | Generic Name | Beinaglutide Injection |
2 | Brand | / |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application type | BLA, domestic |
5 | MAH | |
6 | Approved | 25/07/2023 |
7 | Acceptance to approval | 498 days |
8 | Priority review | No |
9 | Target(s) | Glucagon-like peptide 1 receptor (GLP-1R) |
10 | Indication(s) | Indicated for the glycemic control for adult patient with type-2 diabetes, who has inadequate response to metformin alone. |
Ask BaiPharm if you need more details of drug approvals in China.
