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.
Related Articles:
1. Vericiguat Tablets
1 | Generic Name | Vericiguat Tablets |
2 | Brand Name | Verquvo (唯可同) |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | New Drug Application (NDA), import |
5 | Marketing Authorization Holder (MAH) | Bayer AG |
6 | Approval Date | May 20, 2022 |
7 | Time from Application Acceptance to Approval | 628 days |
8 | Priority Review | Yes (innovative/improved drug that is urgently needed in clinical settings, in shortage, and can prevent diseases such as major infectious diseases and rare diseases. |
9 | Target(s) | Guanylate cyclase |
10 | Indication(s) | This drug is indicated to reduce the risk of heart failure (HF) hospitalization or need for intravenous (IV) diuretics in adults who were recently hospitalized due to HF and whose conditions have been stabilized (with less than 45% ejection fraction) after IV treatment. |
2. Rivaroxaban Granules
1 | Generic Name | Rivaroxaban Granules |
2 | Brand Name | XARELTO (拜瑞妥) |
3 | Registration Classification | Class 2.2 and Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Bayer AG |
6 | Approval Date | May 7, 2022 |
7 | Time from Application Acceptance to Approval | 581 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | Coagulation Factor X (F10) |
10 | Indication(s) | This drug is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from full-term infants to less than 18-year-old adolescents who have started receiving standard anticoagulant treatment. |
3. Fenofibric Acid Tablets
1 | Generic Name | Fenofibric Acid Tablets |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated New Drug Application (ANDA) |
5 | MAH | Changchun Haiyue Pharmaceutical Co., Ltd. |
6 | Approval Date | May 13, 2022 |
7 | Time from Application Acceptance to Approval | 577 days |
8 | Priority Review | No |
9 | Target(s) | Peroxisome proliferator-activated receptor alpha (PPARA) |
10 | Indication(s) | On the basis of a diet, this drug is indicated for 1. reducing the triglyceride (TG) in hypertriglyceridemia (≥500mg/dL) adult patients; 2. the treatment of adult patients with primary hypercholesterolemia (PH) or mixed dyslipidemia. |
12 | Notes | First generic in China |
4. Deferasirox Tablets
1 | Generic Name | Deferasirox Tablets |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Jiangsu Hansoh Pharmaceutical Group Co., Ltd. |
6 | Approval Date | May 13, 2022 |
7 | Time from Application Acceptance to Approval | 532 days |
8 | Priority Review | No |
9 | Target(s) | Ferritin |
10 | Indication(s) | This drug is indicated for 1. the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients no younger than 2 years old. 2. the treatment of chronic iron overload in patients no less than 10 years old with non-transfusion-dependent thalassemia (NTDT) syndromes. |
12 | Notes | First generic in China |
5. Vigabatrin Powder for Oral Solution
1 | Generic Name | Vigabatrin Powder for Oral Solution |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Easton Biopharmaceuticals Co., Ltd. |
6 | Approval Date | May 13, 2022 |
7 | Time from Application Acceptance to Approval | 722 days |
8 | Priority Review | No |
9 | Target(s) | 4-aminobutyrate aminotransferase GabT |
10 | Indication(s) | This drug is indicated 1. as an adjuvant treatment for patients who do not adequately respond to other anti-seizure drugs, especially who have complex partial seizures. 2. for the treatment of West syndrome (infantile spasm) in infants. |
12 | Notes | First generic in China |
6. Hemofiltration Replacement Fluid of Sodium Bicarbonate
1 | Generic Name | Hemofiltration Replacement Fluid of Sodium Bicarbonate |
2 | Brand Name | / |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Gambro Lundia AB |
6 | Approval Date | May 20, 2022 |
7 | Time from Application Acceptance to Approval | 963 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | This drug is indicated as displacement fluid for the treatment of acute kidney injury (AKI) during continuous renal replacement therapy (CRRT). |
7. Omega-3-acid Ethyl Ester 90 Soft Capsules
1 | Generic Name | Omega-3-acid Ethyl Ester 90 Soft Capsules |
2 | Brand Name | / |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Abbott Laboratories Trading (Shanghai) Co., Ltd. |
6 | Approval Date | May 7, 2022 |
7 | Time from Application Acceptance to Approval | 683 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) |
|
8. Letermovir Injection
1 | Generic Name | Letermovir Injection |
2 | Brand Name | PREVYMIS |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Merck Sharp & Dohme B.V. |
6 | Approval Date | May 13, 2022 |
7 | Time from Application Acceptance to Approval | 538 days |
8 | Priority Review | No |
9 | Target(s) | Terminase, large subunit |
10 | Indication(s) | The drug is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). |
9. Lamivudine and Dolutegravir Sodium Tablets
1 | Generic Name | Lamivudine and Dolutegravir Sodium Tablets |
2 | Brand Name | DOVATO |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | ViiV Healthcare B.V. |
6 | Approval Date | May 7, 2022 |
7 | Time from Application Acceptance to Approval | 287 days |
8 | Priority Review | No |
9 | Target(s) | DNA polymerase; In HIV; HIV-1 Reverse Transcriptase; Nucleoside reverse transcriptase. |
10 | Indication(s) | This drug is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and no known substitutions associated with resistance to the individual components of the drug. |
10. Cyclosporine Ophthalmic Emulsion
1 | Generic Name | Cyclosporine Ophthalmic Emulsion |
2 | Brand Name | VERKAZIA |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Santen Pharmaceutical Co., Ltd. |
6 | Approval Date | May 7, 2022 |
7 | Time from Application Acceptance to Approval | 371 days |
8 | Priority Review | Yes |
9 | Target(s) | / |
10 | Indication(s) | This drug is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children (≥ 4 years old) and adolescents. |
11. Human Papillomavirus (Types 16,18) Vaccine, Adsorbed
1 | Generic Name | Human Papillomavirus (Types 16,18) Vaccine, Adsorbed |
2 | Brand Name | CERVARIX (希瑞适) |
3 | Registration Classification | Class 3.1 biological product |
4 | Application Type | Biologics License Application (BLA) |
5 | MAH | GlaxoSmithKline Biologicals S.A. |
6 | Approval Date | May 13, 2022 |
7 | Time from Application Acceptance to Approval | 439 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | The vaccine is recommended to be used on females at 9-45 years old for the prevention of following diseases induced by Human Papillomavirus (HPV) types 16 and 18: 1. cervical cancer; 2. Level 2/3 cervical intra-epithelial neoplasia (CIN 2/3) and adenocarcinoma in situ (AIS); 3. Level 1 cervical intra-epithelial neoplasia (CIN1). |
12. Conbercept Ophthalmic Injection
1 | Generic Name | Conbercept Ophthalmic Injection |
2 | Brand Name | Lang Mu (朗沐) |
3 | Registration Classification | Class 2.2 biological product |
4 | Application Type | BLA |
5 | MAH | Kanghong Pharmaceutical Co., Ltd. |
6 | Approval Date | May 7, 2022 |
7 | Time from Application Acceptance to Approval | 459 days |
8 | Priority Review | No |
9 | Target(s) | Vascular endothelial growth factor receptor (VEGFR) |
10 | Indication(s) | The drug is indicated for the treatment of 1. neovascular age-related macular degeneration (nAMD); 2. visual impairment caused by choroidal neovascularization secondary to pathologic myopia (mCNV); 3. visual impairment caused by diabetic macular edema (DME); 4. visual impairment secondary to renal vein occlusion (RVO). * The first three are previously approve indications; the fourth is the indication newly approved on May 7, 2022. |
Recommended Report
Download for Free | 2021 China CDE Drug Evaluation Report
