Editor's Notes: New drugs in this article refer to
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*.
*"First generic drug in China" refers to the first generic drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.
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In Oct. 2021, China's NMPA granted 11 new drug approvals1:
1. Chiglitazar Sodium Tablets
1 | Generic Name | Chiglitazar Sodium Tablets2 |
2 | Brand Name | 双洛平/Bilessglu |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | Marketing authorization |
5 | Marketing Authorization Holder (MAH) | Chengdu Chipscreen Pharmaceutical Co., Ltd. |
6 | Approval Date | Oct. 20, 2021 |
7 | Time from Application Acceptance to Approval | 748 days |
8 | Priority Review | No |
9 | Target(s) | Peroxisome Proliferator Activated Receptor Gamma (PPARG); Peroxisome Proliferator Activated Receptor Alpha (PPARA) |
10 | Indication(s) | Chiglitazar Sodium Tablets as a single agent is indicated as an adjunct to diet and exercise to improve glycemic control of adults with type 2 diabetes mellitus.3 |
11 | Notes | Innovative new drug in China |
2. Polymeric Micellar Paclitaxel for Injection
1 | Generic Name | Polymeric Micellar Paclitaxel for Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 2.2 chemical drug |
4 | Application Type | Marketing authorization |
5 | MAH | Shanghai Yizhong Biotechnology Co., Ltd. |
6 | Approval Date | Oct. 28, 2021 |
7 | Time from Application Acceptance to Approval | 820 days |
8 | Priority Review | No |
9 | Target(s) | Cytochrome P450 2C8 (CYP2C8); Microtubule-associated protein 2 (MAP2); Bile salt export pump (ABCB11); Microtubule Associated Protein Tau (MAPT); Multidrug resistance-associated protein 1 (ABCC1); Tubulin beta-1 chain (TUBB1); Cytochrome P450 1B1 (CYP1B1); Canalicular multispecific organic anion transporter 1 (ABCC2); ATP Binding Cassette Subfamily G Member 2 (ABCG2); BCL2 Apoptosis Regulator (BCL2); Cytochrome P450 Family 19 Subfamily A Member 1 (CYP19A1); Microtubule-associated protein 4 (MAP4); Nuclear receptor subfamily 1 group I member 2 (NR1I2); Solute carrier organic anion transporter family member 1B3 (SLCO1B3); Tubulin; Cytochrome P450 2C9 (CYP2C9); Cytochrome P450 Family 3 Subfamily A Member 4 (CYP3A4); Cytochrome P450 Family 3 Subfamily A Member 5 (CYP3A5); Cytochrome P450 Family 3 Subfamily A Member 7 (CYP3A7); Multidrug resistance protein 1 (MRP1). |
10 | Indication(s) | The drug, in combination with platinum, is indicated for the first-line treatment for patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) that is EGFR mutation-negative and ALK-negative.4 |
11 | Notes | Improved new drug in China |
3. Cefotaxime Sodium and Tazobactam Sodium for Injection
1 | Generic Name | Cefotaxime Sodium and Tazobactam Sodium for Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 2.3 chemical drug |
4 | Application Type | Marketing authorization |
5 | MAH | Nanjing Youke Pharmaceutical Co., Ltd. |
6 | Approval Date | Oct. 20, 2021 |
7 | Time from Application Acceptance to Approval | 952 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for patients with moderate-to-severe infections who are resistant and sensitive to cefotaxime. The infection can be lower respiratory tract infections (LSTIs), urinary tract infections (UTIs), gynecological infections, bacteremia/septicemia, skin and/or soft tissue infections (SSTIs), abdominal infections, central nervous system infections, etc.5 |
11 | Notes | Improved new drug in China |
4. Vonoprazan Fumarate Tablets
1 | Generic Name | Vonoprazan Fumarate Tablets |
2 | Brand Name | 沃克/VOCINTI |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | Drug import |
5 | MAH | Takeda Pharmaceutical Company Limited |
6 | Approval Date | Oct. 13, 2021 |
7 | Time from Application Acceptance to Approval | 525 days |
8 | Priority Review | No |
9 | Target(s) | Potassium-transporting ATPase alpha chain 1 (ATP4A); H+ K+ ATPase |
10 | Indication(s) | Indicated for treating reflux esophagitis. |
11 | Notes | Improved new drug imported to China |
5. Clopidogrel Bisulfate and Aspirin Tablets
1 | Generic Name | Clopidogrel Bisulfate and Aspirin Tablets |
2 | Brand Name | / |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | Drug import |
5 | MAH | Sanofi K.K. |
6 | Approval Date | Oct. 11, 2021 |
7 | Time from Application Acceptance to Approval | 557 days |
8 | Priority Review | No |
9 | Target(s) | Prostaglandin-Endoperoxide Synthase 2 (PTGS2); P2Y purinoceptor 12 (P2RY12) |
10 | Indication(s) | Indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome who have already been taking both clopidogrel hydrogen sulfate and acetylsalicylic acid (aspirin).6 |
11 | Notes | Innovative new drug imported to China |
6. Bezafibrate Sustained-release Tablets
1 | Generic Name | Bezafibrate Sustained-release Tablets |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | Marketing authorization |
5 | MAH | Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. |
6 | Approval Date | Marketing authorization |
7 | Time from Application Acceptance to Approval | 661 days |
8 | Priority Review | No |
9 | Target(s) | Cytochrome P450 1A1 (CYP1A1); Cytochrome P450 2C8 (CYP2C8); Nuclear receptor subfamily 1 group I member 2 (NR1I2); Peroxisome Proliferator Activated Receptor Alpha (PPARA); Peroxisome Proliferator Activated Receptor Delta (PPARD); Peroxisome Proliferator Activated Receptor Gamma (PPARG); Solute carrier organic anion transporter family member 1B1 (SLCO1B1); Peroxisome proliferator activated receptor (PPAR); Cytochrome P450 Family 3 Subfamily A Member 4 (CYP3A4); Retinoid X Receptor Alpha (RXRA); Retinoic acid receptor RXR-beta (RXRB); Retinoic acid receptor RXR-gamma (RXRG) |
10 | Indication(s) | The drug is indicated for lipid metabolism disorders after the failure of food therapy, exercise enhancement, weight loss and other methods to control the lipid metabolism disorders. lipid metabolism disorders that is induced by primary diseases (e.g. diabetes) and still exists after appropriate therapy for the primary diseases. |
11 | Notes | First generic drug in China |
7. Succinylated Gelatin, Multiple Electrolytes and Sodium Acetate Injection
1 | Generic Name | Succinylated Gelatin, Multiple Electrolytes and Sodium Acetate Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | Marketing authorization |
5 | MAH | B. Braun Medical (Suzhou) Co., Ltd. |
6 | Approval Date | Oct. 13, 2021 |
7 | Time from Application Acceptance to Approval | 1,009 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | As a colloidal volume substitute for - prophylaxis and treatment of absolute and relative hypovolemia (e.g. following shock due to hemorrhage, trauma, perioperative blood losses, burns, or sepsis); - prophylaxis of hypotension (e.g. in connection with induction of epidural or spinal anesthesia). - hemodilution; - extra-corporeal circulation (heart-lung machine, hemodialysis).7 |
11 | Notes | First generic drug in China |
8. Colistimethate Sodium for Injection
1 | Generic Name | Colistimethate Sodium for Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | Marketing authorization |
5 | MAH | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
6 | Approval Date | Oct. 13, 2021 |
7 | Time from Application Acceptance to Approval | 1,386 days |
8 | Priority Review | Yes (Reason: major special project or major research & development plan) |
9 | Target(s) | Outer membrane protein |
10 | Indication(s) |
|
11 | Notes | First generic drug in China |
9. Regadenoson Injection
1 | Generic Name | Regadenoson Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | Marketing authorization |
5 | MAH | Nanjing Heron Pharmaceutical Science and Technology Co., Ltd. |
6 | Approval Date | Oct. 28, 2021 |
7 | Time from Application Acceptance to Approval | 478 days |
8 | Priority Review | No |
9 | Target(s) | Adenosine A2a Receptor (ADORA2A) |
10 | Indication(s) | Indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.8 |
11 | Notes | First generic drug in China |
10. Daratumumab Injection (Subcutaneous Injection)
1 | Generic Name | Daratumumab Injection (Subcutaneous Injection) |
2 | Brand Name | 兆珂速/DARZALEX FASPRO |
3 | Registration Classification | Class 2.2 therapeutic biological product |
4 | Application Type | Drug import |
5 | MAH | Janssen-Cilag International NV |
6 | Approval Date | Oct. 11, 2021 |
7 | Time from Application Acceptance to Approval | 324 days |
8 | Priority Review | Yes (Reason: innovative/improved new drug which is in urgent clinical need for preventing or treating severe infectious diseases or rare diseases) |
9 | Target(s) | CD38 Molecule |
10 | Indication(s) |
|
11 | Notes | Improved new drug imported to China |
11. Insulin Degludec and Liraglutide Injection
1 | Generic Name | Insulin Degludec and Liraglutide Injection |
2 | Brand Name | Xultophy |
3 | Registration Classification | Class 3.1 therapeutic biological product |
4 | Application Type | Drug import |
5 | MAH | Novo Nordisk |
6 | Approval Date | Oct. 28, 2021 |
7 | Time from Application Acceptance to Approval | 384 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. |
11 | Notes | Biological products that are manufactured outside China and imported to China |
If you need details of the approved drugs listed above or drug registration procedures in China, welcome to send an email to contact@chemlinked.com.