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 October 2024, China NMPA approved 11 new drugs, among which 6 are chemical drugs and 5 are biological products. The details are shown as follows:
1. Pradefovir Mesylate Tablets
Generic name | Pradefovir Mesylate Tablets |
Brand | Xin Shu Mu (新舒沐) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Xintong Pharma |
Approved | 2024/10/22 |
Time from application acceptance to approval | 525 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of chronic hepatitis B. |
2. Niraparib Tosylate and Abiraterone Acetate Tablets
Generic name | Niraparib Tosylate and Abiraterone Acetate Tablets |
Brand | / |
Classification | Class 2.3 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Janssen-Cilag International NV |
Approved | 2024/10/16 |
Time from application acceptance to approval | 547 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of prostate cancer. |
3. Tegoprazan Tablets
Generic name | Tegoprazan Tablets |
Brand | Tai Xin Zan (泰欣赞) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Luoxin Pharmaceutical Group Stock Co., Ltd. |
Approved | 2024/10/16 |
Time from application acceptance to approval | 307 days |
Priority review | No |
Target(s) | H+/K+ ATPase |
Indication(s) | Indicated for the eradication of Helicobacter pylori in combination with appropriate antibiotics. |
4. Letermovir Injection
Generic name | Letermovir Injection |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Nanjing Chia-Tai Tianqing Pharmaceutical Company |
Approved | 2024/10/9 |
Time from application acceptance to approval | 666 days |
Priority review | No |
Target(s) | Terminase |
Indication(s) | Indicated for the treatment of cytomegalovirus (CMV) infections. |
Notes | First generic in China |
5. Bosentan Tablets
Generic name | Bosentan Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Beijing SHKB Pharmaceutical Co., Ltd. |
Approved | 2024/10/22 |
Time from application acceptance to approval | 585 days |
Priority review | No |
Target(s) | ET-B, EDNRA |
Indication(s) | Indicated for the treatment of pulmonary arterial hypertension (PAH). |
Notes | First generic in China |
6. Pirtobrutinib Tablets
Generic name | Pirtobrutinib Tablets |
Brand | Jaypirca (捷帕力) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Eli Lilly Nederland B.V. |
Approved | 2024/10/22 |
Time from application acceptance to approval | 322 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | BTK |
Indication(s) | Indicated for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in adult patients who have previously received Bruton's tyrosine kinase (BTK) inhibitor therapy. |
7. 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 Co., Ltd |
Approved | 2024/10/22 |
Time from application acceptance to approval | 257 days |
Priority review | No |
Target(s) | IL17A |
Indication(s) | Indicated for the treatment of active ankylosing spondylitis in adult patients. |
8. Ongericimab Injection
Generic name | Ongericimab Injection |
Brand | Jun Shi Da (君适达) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Junshi Biosciences |
Approved | 2024/10/9 |
Time from application acceptance to approval | 532 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated either alone or in combination with statins and ezetimibe for the treatment of primary hypercholesterolemia (non-familial) or mixed dyslipidemia in adult patients who, on a controlled diet, are unable to achieve their low-density lipoprotein cholesterol (LDL-C) targets despite receiving moderate to high doses of statins. |
9. Faricimab Injection
Generic name | Faricimab Injection |
Brand | VABYSMO (罗视佳) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Roche Pharma (Schweiz) AG |
Approved | 2024/10/9 |
Time from application acceptance to approval | 453 days |
Priority review | No |
Target(s) | ANG-2, VEGF-A |
Indication(s) | Indicated for the treatment of macular edema secondary to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). |
10. Tislelizumab Injection
Generic name | Tislelizumab Injection |
Brand | Bai Ze An (百泽安) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | BeiGene, Ltd. |
Approved | 2024/10/16 |
Time from application acceptance to approval | 271 days |
Priority review | No |
Target(s) | PD-1 |
Indication(s) | Indicated for perioperative treatment (including neoadjuvant and adjuvant therapy) in patients with resectable non-small cell lung cancer (NSCLC). |
11. Trastuzumab Deruxtecan for Injection
Generic name | Trastuzumab Deruxtecan for Injection |
Brand | You He De (优赫得) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Daiichi Sankyo Europe GmbH |
Approved | 2024/10/9 |
Time from application acceptance to approval | 244 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | HER2, Topo I |
Indication(s) | Indicated for the treatment of unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations in adult patients who have previously received at least one prior systemic therapy. |
Contact BaiPharm if you need more details of drug approvals in China.
