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 December 2023, China NMPA approved 8 new drugs, among which 6 are chemical drugs and 2 are biological products.
1. Sanofi’s Rosuvastatin and Ezetimibe Tablets
2. Takeda’s Maribavir Tablets (Livtencity)
3. Tris Pharma’s Methylphenidate Hydrochloride Extended-release Chewable Tablets
4. Merck’s Tepotinib Hydrochloride Tablets (Tepmetko)
5. Aurobindo Pharma’s Fampridine Sustained-release Tablets (first generic in China)
6. Jiangsu Hengrui Pharmaceuticals’ 10% Fat Emulsion (OO)/5.5% Amino Acids (15)/Glucose (20%) Injection (first generic in China)
7. Lee’s Pharm’s Socazolimab Injection
8. Pfizer’s Sugemalimab Injection (Cejemly)
1. Rosuvastatin and Ezetimibe Tablets
Generic name | Rosuvastatin and Ezetimibe Tablets |
Brand | 旨立达 (Zhi Li Da) |
Classification | Class 5.1 chemical drug |
Application type | New drug application (NDA), import |
Marketing authorization holder (MAH) | |
Approved | 27/12/2023 |
Time from application acceptance to approval | Not revealed |
Priority review | No |
Target(s) | 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoA reductase); NPC1-like intracellular cholesterol transporter 1 (NPC1L1) |
Indication(s) | Indicated for the treatment of in patients with hypercholesterolemia (HoFH) and homozygous familial HoFH. |
2. Maribavir Tablets
Generic name | Maribavir Tablets |
Brand | 抑泰之 (Livtencity) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 19/12/2023 |
Time from acceptance to approval | 364 days |
Priority review | Yes (breakthrough therapy) |
Target(s) | Serine/threonine protein kinase UL97 |
Indication(s) | Livtencity is indicated for the treatment of adults with cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet following the hematopoietic stem cell or solid organ transplantation. |
3. Methylphenidate Hydrochloride Extended-release Chewable Tablets
Generic name | Methylphenidate Hydrochloride Extended-release Chewable Tablets |
Brand | 优宁睿 (You Ning Rui) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | NextWave Pharmaceuticals Inc, a subsidiary of Tris Pharma Inc |
Approved | 13/12/2023 |
Time from acceptance to approval | 520 days |
Priority review | Yes (pediatric drug) |
Target(s) | Sodium-dependent noradrenaline transporter (SLC6A2) |
Indication(s) | Indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD), in pediatric patients 6 years of age or older. |
4. Tepotinib Hydrochloride Tablets
Generic name | Tepotinib Hydrochloride Tablets |
Brand | 拓得康 (Tepmetko) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | Merck (Schweiz) AG |
Approved | 05/12/2023 |
Time from acceptance to approval | 615 days |
Priority review | No |
Target(s) | Hepatocyte growth factor receptor (MET) |
Indication(s) | Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. |
5. Fampridine Sustained-release Tablets
Generic name | Fampridine Sustained-release Tablets |
Brand | / |
Classification | Class 5.2 chemical drug |
Application type | Abbreviated new drug application (ANDA), import |
MAH | |
Approved | 05/12/2023 |
Time from acceptance to approval | 693 days |
Priority review | No |
Target(s) | Potassium channel; Voltage-gated potassium channel |
Indication(s) | Indicated for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 4-7). |
Notes | First generic in China |
6. 10% Fat Emulsion (OO)/5.5% Amino Acids (15)/Glucose (20%) Injection
Generic name | 10% Fat Emulsion (OO)/5.5% Amino Acids (15)/Glucose (20%) Injection |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | Fujian Shengdi Pharma, a subsidiary of Jiangsu Hengrui Pharmaceuticals |
Approved | 13/12/2023 |
Time from acceptance to approval | 721 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for parenteral nutrition in adults and children aged 2 years and older when enteral nutrition is not feasible, insufficient, or contraindicated. |
Notes | First generic in China |
7. Socazolimab Injection
Generic name | Socazolimab Injection |
Brand | 善克钰 (Shan Ke Yu) |
Classification | Class 1 therapeutic biological product |
Application type | Biologics License Application (BLA), domestic |
MAH | Zhaoke (Guangzhou) Oncology Pharmaceutical, owned by Lee’s Pharm |
Approved | 19/12/2023 |
Time from acceptance to approval | 783 days |
Priority review | No |
Target(s) | Programmed cell death 1 ligand 1 (PD-L1) |
Indication(s) | Indicated for the treatment of recurrent or metastatic cervical cancer. |
8. Sugemalimab Injection
Generic name | Sugemalimab Injection |
Brand | 择捷美 (Cejemly) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
MAH | |
Approved | 05/12/2023 |
Time from acceptance to approval | 244 days |
Priority review | No |
Target(s) | PD-L1 |
Indication(s) | Previously approved: (1) Indicated in combination with pemetrexed and carboplatin for the first-line treatment of non-small cell lung cancer (NSCLC) that is EGFR mutation-negative, ALK-negative, metastatic, and non-squamous. In combination with paclitaxel and carboplatin, the drug is indicated for the first-line treatment of metastatic squamous NSCLC. (2) Indicated for the treatment of patients with unresectable stage III NSCLC which didn't progress after platinum-based concurrent or sequential chemoradiotherapy. (3) Indicated for treating relapsed or refractory extranodal natural killer (NK) T-cell lymphoma (R/R ENKTL). Newly approved: (4) Indicated in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). |
