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 September 2024, China NMPA approved 21 new drugs, among which 14 are chemical drugs and 7 are biological products. The details are shown as follows:
1. Rilertinib Mesylate Tablets
Generic name | Rilertinib Mesylate Tablets |
Brand | Sheng Rui Sha (圣瑞沙) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Sanhome Pharmaceutical Limited Company |
Approved | 2024/9/3 |
Time from application acceptance to approval | 263 days |
Priority review | No |
Target(s) | EGFR |
Indication(s) | Indicated for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations. |
2. Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
Generic name | Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets |
Brand | Fu Bang De (复邦德) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Aidea Pharmaceutical Co., Ltd |
Approved | 2024/9/26 |
Time from application acceptance to approval | 292 days |
Priority review | No |
Target(s) | Rtase |
Indication(s) |
|
3. Triptorelin Acetate Microspheres for Injection
Generic name | Triptorelin Acetate Microspheres for Injection |
Brand | / |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Livzon Pharmaceutical Group |
Approved | 2024/9/26 |
Time from application acceptance to approval | 399 days |
Priority review | No |
Target(s) | GnRH receptor |
Indication(s) | Indicated for the treatment of endometriosis. |
4. Sodium Fluoride[18F]
Generic name | Sodium Fluoride[18F] |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | HTA Co., Ltd. |
Approved | 2024/9/3 |
Time from application acceptance to approval | 615 days |
Priority review | No |
Target(s) | DRD2 |
Indication(s) | Indicated for positron emission tomography (PET) to identify areas of altered osteoblastic activity in bone imaging. |
Notes | First generic in China |
5. Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid Powder
Generic name | Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid Powder |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Staidson (Beijing) Biopharmaceuticals Co., Ltd |
Approved | 2024/9/26 |
Time from application acceptance to approval | 762 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for bowel cleansing in adult patients prior to procedures requiring a clean bowel (e.g., endoscopy, radiological examination). |
Notes | First generic in China |
6. Sildenafil Citrate for Suspension
Generic name | Sildenafil Citrate for Suspension |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Nanjing Healthnice Pharmaceutical Technology Co., Ltd |
Approved | 2024/9/19 |
Time from application acceptance to approval | 685 days |
Priority review | No |
Target(s) | PDE5 |
Indication(s) | Indicated for pulmonary arterial hypertension (PAH) (as per BE trial registration indication). |
Notes | First generic in China |
7. Compound Glucose / Electrolytes Irrigation Solution for Craniocerebral Surgery
Generic name | Compound Glucose / Electrolytes Irrigation Solution for Craniocerebral Surgery |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Guangdong Otsuka |
Approved | 2024/9/19 |
Time from application acceptance to approval | 701 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for irrigation during cranial drilling, craniotomy, and spinal surgery, as well as perfusion during neuroendoscopic procedures. |
Notes | First generic in China |
8. Cetirizine Hydrochloride Eye Drops
Generic name | Cetirizine Hydrochloride Eye Drops |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Ocumension Therapeutics |
Approved | 2024/9/10 |
Time from application acceptance to approval | 516 days |
Priority review | Yes (Pediatric Drug) |
Target(s) | H1R |
Indication(s) | Indicated for the treatment of ocular itching associated with allergic conjunctivitis. |
Notes | First generic in China |
9. Metformin Hydrochloride and Empagliflozin Tablets (V)
Generic name | Metformin Hydrochloride and Empagliflozin Tablets (V) |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Zhejiang Huaihai Pharmaceutical Co., Ltd |
Approved | 2024/9/19 |
Time from application acceptance to approval | 527 days |
Priority review | No |
Target(s) | AMPK; SLC5A2 |
Indication(s) | Indicated for use in conjunction with dietary modifications and physical activity to enhance glycemic control in adult patients with type 2 diabetes receiving empagliflozin and metformin hydrochloride treatment. |
Notes | First generic in China |
10. Crisaborole Ointment
Generic name | Crisaborole Ointment |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Nanjing Wanrong Jiancheng Pharmaceutical Technology Co., Ltd. |
Approved | 2024/9/26 |
Time from application acceptance to approval | 573 days |
Priority review | No |
Target(s) | PDE4 |
Indication(s) | Indicated for the treatment of moderate to severe atopic dermatitis in patients aged 2 years and older. |
Notes | First generic in China |
11. Rivastigmine Transdermal Patch
Generic name | Rivastigmine Transdermal Patch |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Beijing Tide Pharmaceutical Co., Ltd. |
Approved | 2024/9/19 |
Time from application acceptance to approval | 1163 days |
Priority review | No |
Target(s) | AChE; BCHE |
Indication(s) | Indicated for the treatment of symptoms associated with mild to moderate Alzheimer's disease. |
Notes | First generic in China |
12. Osilodrostat Phosphate Tablets
Generic name | Osilodrostat Phosphate Tablets |
Brand | Shi Rui Sa (适锐飒) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Recordati Rare Diseases |
Approved | 2024/9/19 |
Time from application acceptance to approval | 324 days |
Priority review | Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases) |
Target(s) | CYP11B1; CYP11B2 |
Indication(s) | Indicated for the treatment of Cushing's syndrome (hypercortisolism) in adults. |
13. Ponatinib Tablets
Generic name | Ponatinib Tablets |
Brand | ICLUSIG (英可欣) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Otsuka Pharmaceutical Co., Ltd. |
Approved | 2024/9/3 |
Time from application acceptance to approval | 480 days |
Priority review | Yes (other priority review situation) |
Target(s) | BCR/ABL1 |
Indication(s) | Indicated for:
|
14. Tofersen Injection
Generic name | Tofersen Injection |
Brand | Qalsody (凯盛迪) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Biogen MA Inc. |
Approved | 2024/9/26 |
Time from application acceptance to approval | 440 days |
Priority review | No |
Target(s) | SOD1 |
Indication(s) | Indicated for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with SOD1 gene mutations. |
15. Iparomlimab and Tuvonralimab Injection
Generic name | Iparomlimab and Tuvonralimab Injection |
Brand | Qi Bei An (齐倍安) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Qilu Pharmaceutical |
Approved | 2024/9/26 |
Time from application acceptance to approval | 411 days |
Priority review | No |
Target(s) | CTLA4; PD-1 |
Indication(s) | Indicated for the treatment of patients with recurrent or metastatic cervical cancer who have previously failed platinum-based chemotherapy. |
16. Stapokibart Injection
Generic name | Stapokibart Injection |
Brand | Kang Yue Da (康悦达) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Keymed Biosciences |
Approved | 2024/9/10 |
Time from application acceptance to approval | 278 days |
Priority review | Yes (granted breakthrough therapy designation |
Target(s) | IL4RA |
Indication(s) | Indicated for the treatment of moderate to severe atopic dermatitis in adults who have inadequate control with topical therapies and for whom topical treatment is not appropriate. |
17. Ebronucimab Injection
Generic name | Ebronucimab Injection |
Brand | Yi Xi Ning (伊喜宁) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | AD Pharmaceuticals Co., Ltd. |
Approved | 2024/9/26 |
Time from application acceptance to approval | 482 days |
Priority review | No |
Target(s) | PCSK9 |
Indication(s) | Indicated for the treatment of primary hypercholesterolemia, mixed dyslipidemia, and heterozygous familial hypercholesterolemia (HeFH). |
18. Cadonilimab Injection
Generic name | Cadonilimab Injection |
Brand | Kai Tan Ni (开坦尼) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Akeso, Inc. |
Approved | 2024/9/26 |
Time from application acceptance to approval | 265 days |
Priority review | No |
Target(s) | CTLA4; PD-1 |
Indication(s) | Indicated for the first-line treatment of unresectable locally advanced or metastatic gastric adenocarcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJC). |
19. Pembrolizumab Injection
Generic name | Pembrolizumab Injection |
Brand | Keytruda (可瑞达) |
Classification | Class 3 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Merck Sharp & Dohme LLC |
Approved | 2024/9/10 |
Time from application acceptance to approval | 307 days |
Priority review | No |
Target(s) | PD-1 |
Indication(s) | Indicated for the first-line treatment of unresectable or metastatic melanoma. |
20. Turoctocog alfa pegol for injection
Generic name | Turoctocog alfa pegol for injection |
Brand | Esperoct |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Novo Nordisk A/S |
Approved | 2024/9/10 |
Time from application acceptance to approval | 413 days |
Priority review | No |
Target(s) | Factor VIII |
Indication(s) | The new indication has not yet been disclosed. |
21. Omalizumab for Injection
Generic name | Omalizumab for Injection |
Brand | En Yi Tan (恩益坦) |
Classification | Class 3.3 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | CSPC Pharmaceutical Group Co., Ltd. |
Approved | 2024/9/26 |
Time from application acceptance to approval | 463 days |
Priority review | No |
Target(s) | IgE |
Indication(s) | Indicated for the management of chronic spontaneous urticaria in adults and adolescents (ages 12 years and older) who remain symptomatic despite prior treatment with H1 antihistamines. |
Notes | First biosimilar in China |
Contact BaiPharm if you need more details of drug approvals in China.
