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 term “first generic drug” is commonly used in the Chinese pharma industry but not specified in Chinese regulations.
Related Articles:
In August 2024, China NMPA approved 17 new drugs, among which 7 are chemical drugs and 10 are biological products. The details are shown as follows:
1. Fulzerasib Tablets
Generic name | Fulzerasib Tablets |
Brand | Da Bo Te (达伯特) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Innovent |
Approved | 2024/8/20 |
Time from application acceptance to approval | 270 days |
Priority review | Yes (granted breakthrough therapy designation, eligible for conditional approval) |
Target(s) | KRAS |
Indication(s) | Indicated for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have previously received at least one line of systemic therapy. |
2. Sodium Valproate Sustained-release Tablets（I）
Generic name | Sodium Valproate Sustained-release Tablets（I） |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Foyou Pharmaceutical |
Approved | 2024/8/27 |
Time from application acceptance to approval | 455 days |
Priority review | No |
Target(s) | GABAR; HDAC |
Indication(s) | Indicated for the treatment of epilepsy and mania. |
Notes | First generic in China |
3. Azilsartan Medoxomil Potassium Tablets
Generic name | Azilsartan Medoxomil Potassium Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Foyou Pharmaceutical |
Approved | 2024/8/20 |
Time from application acceptance to approval | 521 days |
Priority review | No |
Target(s) | AGTR |
Indication(s) | Indicated for the treatment of primary hypertension in adults. |
Notes | First generic in China |
4. Ropinirole Hydrochloride Sustained-release Tablets
Generic name | Ropinirole Hydrochloride Sustained-release Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Nanjing Hencer Pharmaceutical |
Approved | 2024/8/20 |
Time from application acceptance to approval | 447 days |
Priority review | No |
Target(s) | DRD2 |
Indication(s) | Indicated for the treatment of early, mid-to-late stage, and non-motor symptoms of Parkinson's disease in patients. |
Notes | First generic in China |
5. Aclidinium Bromide Powder for Inhalation
Generic name | Aclidinium Bromide Powder for Inhalation |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Covis Pharma Europe B.V. |
Approved | 2024/8/5 |
Time from application acceptance to approval | 551 days |
Priority review | No |
Target(s) | CHRM3 |
Indication(s) | Indicated for the treatment of chronic obstructive pulmonary disease (COPD). |
6. Estradiol and Dydrogesterone Tablets
Generic name | Estradiol and Dydrogesterone Tablets |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Abbott B.V. |
Approved | 2024/8/5 |
Time from application acceptance to approval | 830 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of estrogen deficiency symptoms in women who have been postmenopausal for at least 12 months. |
7. Atracurium Besilate Injection
Generic name | Atracurium Besilate Injection |
Brand | / |
Classification | Class 5.2 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Joint Stock Company “Kalceks” |
Approved | 2024/8/5 |
Time from application acceptance to approval | 1071 days |
Priority review | No |
Target(s) | CHRNA1; CHRNB1; CHRND; CHRNG |
Indication(s) | Indicated for patients with hepatic or renal impairment, jaundice, as well as those undergoing pheochromocytoma surgery or outpatient procedures. |
8. Vunakizumab Injection
Generic name | Vunakizumab Injection |
Brand | An Da Jing (安达静) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Suzhou Suncadia Biopharmaceuticals |
Approved | 2024/8/20 |
Time from application acceptance to approval | 481 days |
Priority review | No |
Target(s) | IL-17 |
Indication(s) | Indicated for the treatment of moderate to severe plaque psoriasis in adults who are appropriate candidates for systemic therapy or phototherapy. |
9. Xeligekimab Injection
Generic name | Xeligekimab Injection |
Brand | Jin Li Xi (金立希) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Genrix Bio |
Approved | 2024/8/20 |
Time from application acceptance to approval | 514 days |
Priority review | No |
Target(s) | IL17A |
Indication(s) | Indicated for the treatment of moderate to severe plaque psoriasis. |
10. Ciltacabtagene Autoleucel Injection
Generic name | Ciltacabtagene Autoleucel Injection |
Brand | Ka Wei Di (卡卫荻) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Legend Biotech |
Approved | 2024/8/20 |
Time from application acceptance to approval | 599 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | TNFRSF17 |
Indication(s) | Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received one proteasome inhibitor therapy and one immunomodulatory agent therapy. |
11. Polyethylene Glycol Recombinant Human Growth Hormone Injection
Generic name | Polyethylene Glycol Recombinant Human Growth Hormone Injection |
Brand | Jin Sai Zeng (金赛增) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Gensci Group |
Approved | 2024/8/13 |
Time from application acceptance to approval | 334 days |
Priority review | Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases) |
Target(s) | Growth hormone |
Indication(s) | Indicated for:
|
12. Relmacabtagene Autoleucel Injection
Generic name | Relmacabtagene Autoleucel Injection |
Brand | Bei Nuo Da (倍诺达) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | JW Therapeutics |
Approved | 2024/8/20 |
Time from application acceptance to approval | 229 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | CD19 |
Indication(s) | Indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. |
13. Benralizumab Injection
Generic name | Benralizumab Injection |
Brand | Fasenra |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | AstraZeneca AB |
Approved | 2024/8/13 |
Time from application acceptance to approval | 411 days |
Priority review | No |
Target(s) | IL5RA |
Indication(s) | Indicated for the treatment of severe eosinophilic asthma (SEA). |
14. Trastuzumab Deruxtecan for Injection
Generic name | Trastuzumab Deruxtecan for Injection |
Brand | Enhertu |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Daiichi Sankyo Europe GmbH |
Approved | 2024/8/5 |
Time from application acceptance to approval | 237 days |
Priority review | Yes (granted breakthrough therapy designation, eligible for conditional approval) |
Target(s) | HER2; Topo I |
Indication(s) | Indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received two or more lines of therapy. |
15. Enfortumab vedotin for Injection
Generic name | Enfortumab vedotin for Injection |
Brand | PADCEV |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Astellas Pharma Europe B.V. |
Approved | 2024/8/13 |
Time from application acceptance to approval | 522 days |
Priority review | No |
Target(s) | INS |
Indication(s) | Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who have previously been treated with PD-1/PD-L1 inhibitor and platinum-based chemotherapy. |
16. Insulin Degludec Injection
Generic name | Insulin Degludec Injection |
Brand | Hui You Da (惠优达) |
Classification | Class 3.3 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Huisheng Pharm |
Approved | 2024/8/5 |
Time from application acceptance to approval | 752 days |
Priority review | No |
Target(s) | INS |
Indication(s) | Indicated for the treatment of adult patients with type 2 diabetes. |
Notes | First biosimilar in China |
17. Ranibizumab Injections
Generic name | Ranibizumab Injections |
Brand | An Zhuo Ming (安卓明) |
Classification | Class 3.3 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Qilu Pharmaceutical |
Approved | 2024/8/13 |
Time from application acceptance to approval | 562 days |
Priority review | No |
Target(s) | VEGF-A |
Indication(s) | Indicated for the treatment of:
|
Notes | First biosimilar in China |
Contact BaiPharm if you need more details of drug approvals in China.
