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 December 2022, China NMPA approved 7 new drugs, including 6 chemical drugs and 1 biological product.
1. MSD’s Molnupiravir Capsules (Lagevrio);
2. UCB Pharma’s Lacosamide Tablets (VIMPAT);
3. Jiangsu Hengrui Pharmaceuticals’ Remimazolam Tosilate for Injection;
4. Kanghong Pharmaceutical’s Escitalopram Oxalate Oral Solution;
5. Nanjing Haina Medical Technology’s Tenofovir Disoproxil Fumarate Granules;
6. Jiangxi Yiyou Pharmaceutical’s Bromhexine Hydrochloride Oral Solution;
7. Boehringer Ingelheim’s Spesolimab Injection (Spevigo).
The details are as follows.
1. Molnupiravir Capsules
1 | Generic Name | Molnupiravir Capsules |
2 | Brand Name | Lagevrio |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | New drug application (NDA), import |
5 | Marketing Authorization Holder (MAH) | Merck Sharp & Dohme (MSD) |
6 | Approval Date | Dec. 29, 2022 |
7 | Time from Application Acceptance to Approval | Not revealed |
8 | Special approval | Yes (conditional approval) |
9 | Target(s) | RNA-dependent RNA polymerase (RdRp) |
10 | Indication(s) | For treating patients who have mild-to-moderate COVID-19 infections and high risks to develop into severe conditions. The risks can be advanced age, obesity or overweightness, chronic kidney disease, diabetes, severe cardiovascular disease, chronic obstructive pulmonary disease (COPD), active cancer, etc. |
2. Lacosamide Tablets
1 | Generic Name | Lacosamide Tablets |
2 | Brand Name | VIMPAT (维派特) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | UCB Pharma SA |
6 | Approval Date | Dec. 20, 2022 |
7 | Time from Application Acceptance to Approval | 425 days |
8 | Priority Review | No |
9 | Target(s) | Dihydropyrimidinase-related protein 2 (DPYSL2); Sodium channel |
10 | Indication(s) | For the combination treatment of partial-onset seizures in patients 16 years of age or older. |
3. Remimazolam Tosilate for Injection
1 | Generic Name | Remimazolam Tosilate for Injection |
2 | Brand Name | Rui Bei Ning (瑞倍宁) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | Dec. 20, 2022 |
7 | Time from Application Acceptance to Approval | 586 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Previously approved: 1. For anesthesia in gastroscopy. 2. For anesthesia in colonoscopy. 3. For induction and maintenance of general anesthesia. Newly approved: 4. For anesthesia in bronchoscopy. |
4. Escitalopram Oxalate Oral Solution
1 | Generic Name | Escitalopram Oxalate Oral Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA) |
5 | MAH | Kanghong Pharmaceutical Co., Ltd. |
6 | Approval Date | Dec. 20, 2022 |
7 | Time from Application Acceptance to Approval | 491 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | 1. For treating depression. 2. For treating panic disorder with/without agoraphobia. |
11 | Note | First generic drug in China |
5. Tenofovir Disoproxil Fumarate Granules
1 | Generic Name | Tenofovir Disoproxil Fumarate Granules |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Nanjing Haina Medical Technology Co., Ltd. |
6 | Approval Date | Dec. 20, 2022 |
7 | Time from Application Acceptance to Approval | 504 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | DNA polymerase; HIV-1 Reverse Transcriptase |
10 | Indication(s) | 1. In combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and pediatric patients no younger than 2 years old and weighing at least 10 kg . 2. For treating chronic hepatitis B in adults and pediatric patients no younger than 2 years old and weighing at least 10 kg. |
11 | Note | First generic drug in China |
6. Bromhexine Hydrochloride Oral Solution
1 | Generic Name | Bromhexine Hydrochloride Oral Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Jiangxi Yiyou Pharmaceutical Co., Ltd. |
6 | Approval Date | Dec. 30, 2022 |
7 | Time from Application Acceptance to Approval | 298 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For treating patients who are difficult to expectorate phlegm due to acute or chronic bronchitis, asthma, bronchiectasis, and pneumoconiosis. |
11 | Note | First generic drug in China |
7. Spesolimab Injection
1 | Generic Name | Spesolimab Injection |
2 | Brand Name | Spevigo |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | Biologics License Application (BLA), import |
5 | MAH | Boehringer Ingelheim |
6 | Approval Date | Dec. 13, 2022 |
7 | Time from Application Acceptance to Approval | 390 days |
8 | Priority Review | Yes |
9 | Target(s) | Interleukin 1 Receptor Like 2 (IL1RL2) |
10 | Indication(s) | For treating generalized pustular psoriasis (GPP) flares in adults. |
