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.
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In November 2024, China NMPA approved 19 new drugs, among which 12 are chemical drugs and 7 are biological products. The details are shown as follows:
1. Garsorasib Tablets
Generic name | Garsorasib Tablets |
Brand | An Fang Ning (安方宁) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Chia Tai Tianging Pharmaceutical Group co., Ltd. |
Approved | 2024/11/05 |
Time from application acceptance to approval | 312 days |
Priority review | Yes (granted breakthrough therapy designation, eligible for conditional approval) |
Target(s) | KRAS |
Indication(s) | Indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed KRAS G12C mutation in patients who have experienced disease progression or intolerance following prior first-line systemic therapy. |
2. Zorifertinib Hydrochloride Tablets
Generic name | Zorifertinib Hydrochloride Tablets |
Brand | Ze Rui Ni (泽瑞尼) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Alpha Biopharma (Jiangsu)Co. Ltd. |
Approved | 2024/11/15 |
Time from application acceptance to approval | 656 days |
Priority review | No |
Target(s) | EGFR |
Indication(s) | Indicated as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by exon 19 deletion or exon 21 (L858R) substitution mutations of epidermal growth factor receptor (EGFR), with concurrent central nervous system (CNS) metastases. |
3. Benvitimod Cream
Generic name | Benvitimod Cream |
Brand | / |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Shanghai Thederma Pharmaceutical Technology Co., Ltd |
Approved | 2024/11/22 |
Time from application acceptance to approval | 330 days |
Priority review | Yes (pediatric drug) |
Target(s) | / |
Indication(s) | Indicated for topical treatment of atopic dermatitis in patients aged 2 years and older. |
4. Anlotinib Hydrochloride Capsules
Generic name | Anlotinib Hydrochloride Capsules |
Brand | Fu Ke Wei (福可维) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Chia Tai Tianging Pharmaceutical Group co., Ltd. |
Approved | 2024/11/22 |
Time from application acceptance to approval | 268 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | RET; PDGFRB; VEGFR-3; FLT1; FGFR2; KIT; FGFR3; FGFR4; FGFR1; VEGFR-2; PDGFRA |
Indication(s) | Indicated in combination with TQB2450 injection for the treatment of recurrent or metastatic endometrial cancer with non-microsatellite instability-high (non-MSI-H) or non-DNA mismatch repair deficiency (non-dMMR) in patients who have previously failed or are unable to tolerate first- or second-line chemotherapy treatments. |
5. Bilastine Tablets
Generic name | Bilastine Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Huayang Pharmaceutical Co., Ltd. |
Approved | 2024/11/05 |
Time from application acceptance to approval | 483 days |
Priority review | No |
Target(s) | H1R |
Indication(s) | Indicated for the treatment of allergic rhinitis and urticaria in adults and adolescents aged 12 years and older. |
Notes | First generic in China |
6. Tolterodine L-Tartrate Sustained-release Capsules
Generic name | Tolterodine L-Tartrate Sustained-release Capsules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Hunan Jiudian Pharmaceutical Co., Ltd. |
Approved | 2024/11/15 |
Time from application acceptance to approval | 401 days |
Priority review | No |
Target(s) | CHRM3 |
Indication(s) | Indicated for the treatment of overactive bladder. |
Notes | First generic in China |
7. Tolterodine Tartrate Sustained-release Capsules
Generic name | Tolterodine Tartrate Sustained-release Capsules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Yichang Humanwell Pharmaceutical Co.,Ltd. |
Approved | 2024/11/15 |
Time from application acceptance to approval | 645 days |
Priority review | No |
Target(s) | CHRM3 |
Indication(s) | Indicated for the treatment of overactive bladder. |
Notes | First generic in China |
8. Ruxolitinib Phosphate Tablets
Generic name | Ruxolitinib Phosphate Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Chengdu Easton Bio Pharmaceuticals Co., Ltd. |
Approved | 2024/11/15 |
Time from application acceptance to approval | 553 days |
Priority review | No |
Target(s) | JAK1; JAK2 |
Indication(s) | 1. Myelofibrosis: Indicated for the treatment of adult patients with intermediate- or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) through the management of disease-related splenomegaly and associated symptoms. 2. Graft-Versus-Host Disease (GVHD): Indicated for the treatment of acute graft-versus-host disease (acute GVHD) and chronic graft-versus-host disease (chronic GVHD) in patients aged 12 years and older, who have had an inadequate response to corticosteroids or other systemic therapies. |
Notes | First generic in China |
9. Belzutifan Tablets
Generic name | Belzutifan Tablets |
Brand | WELIREG (维利瑞) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | MERCK SHARP & DOHME (UK) LIMITED |
Approved | 2024/11/15 |
Time from application acceptance to approval | 244 days |
Priority review | Yes (other priority review situation) |
Target(s) | EPAS1 |
Indication(s) | Indicated for the treatment of renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) associated with Von Hippel-Lindau (VHL) disease. |
10. Varenicline Tartrate Nasal Spray
Generic name | Varenicline Tartrate Nasal Spray |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Oyster Point Pharma, Inc. |
Approved | 2024/11/22 |
Time from application acceptance to approval | 496 days |
Priority review | No |
Target(s) | α6β2 nAChR; α4β2 nAChR; α3α5β4 nAChR; α7 nAChR; α3β4 nAChR |
Indication(s) | Indicated to enhance tear production in patients with dry eye disease. |
11. Ambroxol Hydrochloride Spray
Generic name | Ambroxol Hydrochloride Spray |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | GMep Medical Technology GmbH |
Approved | 2024/11/15 |
Time from application acceptance to approval | 357 days |
Priority review | No |
Target(s) | GRIA2; SCN10A; CACNA1B; SCN2A |
Indication(s) | Indicated for the treatment of thick mucus and impaired expectoration in patients aged 6 years and older. |
12. Minocycline Hydrochloride Foam
Generic name | Minocycline Hydrochloride Foam |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Journey Medical Corporation |
Approved | 2024/11/05 |
Time from application acceptance to approval | 405 days |
Priority review | Yes (pediatric drug) |
Target(s) | EPAS1 |
Indication(s) | Indicated for the topical treatment of moderate to severe non-nodular inflammatory lesions of acne vulgaris in patients aged 9 years and older. |
13. Benmelstobart Injection
Generic name | Benmelstobart Injection |
Brand | An De Wei (安得卫) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Chia Tai Tianging Pharmaceutical Group co., Ltd. |
Approved | 2024/11/22 |
Time from application acceptance to approval | 268 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | PD-L1 |
Indication(s) | Indicated in combination with Anlotinib Hydrochloride Capsules for the treatment of recurrent or metastatic endometrial cancer with non-microsatellite instability-high (non-MSI-H) or non-DNA mismatch repair deficiency (non-dMMR) in patients who have failed or are intolerant to prior first- or second-line chemotherapy regimens. |
14. Sacituzumab Tirumotecan for Injection
Generic name | Sacituzumab Tirumotecan for Injection |
Brand | Jia Tai Lai (佳泰莱) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
Approved | 2024/11/22 |
Time from application acceptance to approval | 349 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | TACSTD2; Topo I |
Indication(s) | Indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies, including at least one regimen for the advanced or metastatic stage of the disease. |
15. Efgartigimod Alfa Injection (Subcutaneous Injection)
Generic name | Efgartigimod Alfa Injection (Subcutaneous Injection) |
Brand | VYVGART HYTRULO (卫力迦) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | argenx BV |
Approved | 2024/11/5 |
Time from application acceptance to approval | 174 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | FCGR; FCGRT |
Indication(s) | Indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients. |
16. Botulinum Toxin Type A for Injection
Generic name | Botulinum Toxin Type A for Injection |
Brand | / |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Revance Therapeutics, Inc. |
Approved | 2024/11/22 |
Time from application acceptance to approval | 505 days |
Priority review | No |
Target(s) | SNAP25 |
Indication(s) | Indicated for the treatment of cervical dystonia in adult patients. |
17. Rilonacept for Injection
Generic name | Rilonacept for Injection |
Brand | ARCALYST (炎朵) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Kiniksa Pharmaceuticals (UK)，Ltd. |
Approved | 2024/11/22 |
Time from application acceptance to approval | 374 days |
Priority review | Yes (other priority review situation) |
Target(s) | IL-1 alpha; IL-1 beta |
Indication(s) | Indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adult patients and adolescents aged 12 years and older. |
18. Mirvetuximab Soravtansine Injection
Generic name | Mirvetuximab Soravtansine Injection |
Brand | ELAHERE (爱拉赫) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | ImmunoGen, Inc. |
Approved | 2024/11/22 |
Time from application acceptance to approval | 393 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | FOLR1; Tubulin |
Indication(s) | Indicated for the treatment of platinum-resistant epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer in adult patients who are folate receptor alpha (FRα) positive and have received 1 to 3 prior systemic therapies. |
19. Recombinant Human Papillomavirus Quadrivalent Vaccine
Generic name | Recombinant Human Papillomavirus Quadrivalent Vaccine |
Brand | GARDASIL (佳达修) |
Classification | Class 3.1 preventive biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Merck Sharp & Dohme LLC |
Approved | 2024/11/05 |
Time from application acceptance to approval | 483 days |
Priority review | No |
Target(s) | HPV |
Indication(s) | Indicated for the prevention of HPV-related diseases in individuals aged 9 to 13 years. |
Contact BaiPharm if you need more details of drug approvals in China.
