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.
In January 2022, China NMPA approved 15 new drugs, including 10 chemical drugs and 5 biological products.
1. Dalpiciclib Isethionate Tablets
1 | Generic Name | Dalpiciclib Isethionate Tablets (SHR6390 Tablets) |
2 | Brand Name | Ai Rui Kang (艾瑞康) |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA) |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | Jan. 5, 2022 |
7 | Time from Application Acceptance to Approval | 248 days |
8 | Priority Review | Yes (reason: breakthrough therapy) |
9 | Target(s) | / |
10 | Indication(s) | The drug, in combination with fulvestrant, is indicated for treating breast cancer patients who have hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative tumors. The patients have disease progression after endocrine therapy. |
2. Henagliflozin Proline Tablets
1 | Generic Name | Henagliflozin Proline Tablets |
2 | Brand Name | Rui Qin (瑞沁) |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | NDA |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | Jan. 5, 2022 |
7 | Time from Application Acceptance to Approval | 457 days |
8 | Priority Review | No |
9 | Target(s) | Sodium/glucose cotransporter 2 (SLC5A2) |
10 | Indication(s) | The drug is indicated for adult patients with type 2 diabetes to improve the glycemic control. |
3. Mitoxantrone Hydrochloride Liposome Injection
1 | Generic Name | Mitoxantrone Hydrochloride Liposome Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 2.2 chemical drug |
4 | Application Type | NDA |
5 | MAH | CSPC Pharmaceutical Group Co., Ltd. |
6 | Approval Date | Jan. 11, 2022 |
7 | Time from Application Acceptance to Approval | 498 days |
8 | Priority Review | Yes (qualified for conditional approval) |
9 | Target(s) | DNA topoisomerase II (Topo II) |
10 | Indication(s) | The drug is indicated for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) after at least the first-line standard treatment. |
4. Abemaciclib Tablets
1 | Generic Name | Abemaciclib Tablets |
2 | Brand Name | Verzenios (唯择) |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | NDA |
5 | MAH | Eli Lilly Nederland B.V. |
6 | Approval Date | Jan. 5, 2022 |
7 | Time from Application Acceptance to Approval | 368 days |
8 | Priority Review | No |
9 | Target(s) | Cyclin-dependent kinase 4 (CDK4); Cyclin-dependent kinase 6 (CDK6); Serine/threonine-protein kinase pim-1 (PIM1). |
10 | Indication(s) | Jan. 5, 2021: The drug was approved for
Jan. 5, 2022:
|
5. Amlodipine Besilate and Losartan Potassium Tablets (I)
1 | Generic Name | Amlodipine Besilate and Losartan Potassium Tablets (I) |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA) |
5 | MAH | Hanmi Pharm. Co., Ltd. |
6 | Approval Date | Jan. 20, 2022 |
7 | Time from Application Acceptance to Approval | 868 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | As a compound preparation, the drug is indicated for treating patients with primary hypertension whose blood pressure levels cannot be fully controlled by a single agent. |
11 | Notes | First generic |
6. Sitagliptin Phosphate and Metformin Hydrochloride Sustained-release Tablets
1 | Generic Name | Sitagliptin Phosphate and Metformin Hydrochloride Sustained-release Tablets |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Nanjing Chia-Tai Tianqing Pharmaceutical Company (NJCTTQ) |
6 | Approval Date | Jan. 5, 2021 |
7 | Time from Application Acceptance to Approval | 889 days |
8 | Priority Review | No |
9 | Target(s) | 5'-AMP-activated protein kinase catalytic subunit alpha-2 (PRKAA2); Dipeptidyl peptidase 4 (DPP4). |
10 | Indication(s) | The drug is indicated as an adjunct to diet and exercise to improve glycemic control for adult patients with type 2 diabetes who receive the combination therapy of saxagliptin and metformin. |
11 | Notes | First generic |
7. Nimodipine Oral Solution
1 | Generic Name | Nimodipine Oral Solution |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | Jan. 20, 2022 |
7 | Time from Application Acceptance to Approval | 1,489 days |
8 | Priority Review | No |
9 | Target(s) | Calcium channel |
10 | Indication(s) | The drug is indicated for adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms. |
11 | Notes | First generic |
8. Compound Amino Acid Injection (17AA-II)
1 | Generic Name | Compound Amino Acid Injection (17AA-II) |
2 | Brand Name | / |
3 | Registration Classification | Class 3.2 chemical drug (according to the former classification rules) |
4 | Application Type | NDA |
5 | MAH | Hubei Tianyao Pharmaceuticals Co., Ltd. (parent company: Tianjin Kingyork Group) |
6 | Approval Date | Jan. 26, 2022 |
7 | Time from Application Acceptance to Approval | 2,069 |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | The drug is indicated for
|
9. Isavuconazonium Sulfate Capsules
1 | Generic Name | Isavuconazonium Sulfate Capsules |
2 | Brand Name | CRESEMBA (康新博) |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA |
5 | MAH | Basilea Pharmaceutica Deutschland GmbH |
6 | Approval Date | Jan. 5, 2022 |
7 | Time from Application Acceptance to Approval | 405 days |
8 | Priority Review | No |
9 | Target(s) | Lanosterol 14-alpha demethylase (CYP51A1) |
10 | Indication(s) | The drug is a new antifungal therapy with two indications: Dec. 16, 2021: Approved for treating invasive mucormycosis in adult patients; Jan. 5, 2022: Approved for invasive aspergillosis in adult patients. |
10. Letermovir Tablets
1 | Generic Name | Letermovir Tablets |
2 | Brand Name | Prevymis (普瑞明) |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA |
5 | MAH | Merck Sharp & Dohme B.V. |
6 | Approval Date | Jan. 5, 2022 |
7 | Time from Application Acceptance to Approval | 408 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 the allogeneic hematopoietic stem cell transplant (HSCT). |
11. Recombinant Human Anti-rabies Monoclonal Antibody Injection
1 | Generic Name | Recombinant Human Anti-rabies Monoclonal Antibody Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 1 therapeutic biological product |
4 | Application Type | Biologics License Application (BLA) |
5 | MAH | Huabei Pharmaceutical Jintan Biotechnology Co., Ltd. |
6 | Approval Date | Jan. 26, 2022 |
7 | Time from Application Acceptance to Approval | 570 days |
8 | Priority Review | Yes (reason: it is an innovative/improved drug in shortage, with urgent clinical needs, and for treating major infectious diseases or rare diseases.) |
9 | Target(s) | / |
10 | Indication(s) | The drug is indicated for passive immunization of adult patients exposed to rabies virus. |
12. Adalimumab Solution for Injection
1 | Generic Name | Adalimumab Solution for Injection |
2 | Brand Name | Tai Bo Wei (泰博维) |
3 | Registration Classification | Class 2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Nanjing Chia-Tai Tianqing Pharmaceutical Company (NJCTTQ) |
6 | Approval Date | Jan. 20, 2022 |
7 | Time from Application Acceptance to Approval | 540 days |
8 | Priority Review | No |
9 | Target(s) | Tumor necrosis factor (TNF) |
10 | Indication(s) | Rheumatoid arthritis: The drug, in combination with methotrexate, is indicated for inhibiting the progression of structural damage, and improving the physical function of adult patients with moderately to severely active rheumatoid arthritis who do not have effective response to methotrexate and other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Ankylosing spondylitis: The drug is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis who do not have effective response to routine treatment. Psoriasis: The drug is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and are not responsive to other systemic therapies (including ciclosporin, methotrexate, and photochemotherapy). The drug should only be administered to patients who will be closely monitored and have regular follow-up visits with physician. For treating polyarticular juvenile ldiopathic arthritis (PJIA). |
13. Disitamab Vedotin for Injection
1 | Generic Name | Disitamab Vedotin for Injection |
2 | Brand Name | Ai Di Xi (爱地希) |
3 | Registration Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Rongchang Biopharmaceuticals (Yantai) Co., Ltd. |
6 | Approval Date | Jan. 5, 2022 |
7 | Time from Application Acceptance to Approval | 170 days |
8 | Priority Review | Yes (reason: breakthrough therapy) |
9 | Target(s) | / |
10 | Indication(s) | June 8, 2021: The drug was approved as an antibody-drug conjugate indicated for locally advanced or metastatic gastric (including gastroesophageal) cancer which is HER2-positive and have received at least two types of systemic chemotherapy. Jan. 5, 2022: The drug was approved for treating locally advanced or metastatic urothelial cancer with 2+ or 3+ HER2 expression who have received prior chemotherapy. |
14. Tislelizumab Injection
1 | Generic Name | Tislelizumab Injection |
2 | Brand Name | Bai Ze An (百泽安) |
3 | Registration Classification | Class 2.2 therapeutic drug |
4 | Application Type | BLA |
5 | MAH | BeiGene (Shanghai) Biotechnology Co., Ltd. |
6 | Approval Date | Jan. 5, 2022 |
7 | Time from Application Acceptance to Approval | 297 days |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) | 1. Dec. 31, 2019 The drug received the conditional approval for second-line treatment for relapsed or refractory classic Hodgkin lymphoma (cHL) patients who have received at least the second-line chemotherapy. 2. April 13, 2020 The drug received the conditional approval for urothelial cancer (UC) or small lymphocytic lymphoma (SLL) patients with high PD-L1 expression, prior failure of platinum chemotherapy, and disease progression within 12 months after the neoadjuvant or adjuvant chemotherapy. 3. Jan. 18, 2021 The drug received the full approval for being used in combination with paclitaxel and platinum in the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) that is unresectable by surgery. 4. June 22, 2021 The drug received the conditional approval for hepatocellular carcinoma (HCC) patients who have received at least one type of systemic therapy. 5. June 22, 2021 The drug received the full approval for being used with pemetrexed and platinum chemotherapy in the first-line treatment for NSCLC that are EGFR-negative, ALK-negative and unresectable by surgery. 6. Jan. 5, 2022 The drug received the full approval for being used in the second-line or third-line treatment for NSCLC patients who have disease progression after platinum chemotherapy. |
15. Luspatercept for Injection
1 | Generic Name | Luspatercept for Injection |
2 | Brand Name | REBLOZYL (利布洛泽) |
3 | Registration Classification | Class 3.2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Patheon Italia S.p.A. |
6 | Approval Date | Jan. 26, 2022 |
7 | Time from Application Acceptance to Approval | 353 days |
8 | Priority Review | Yes (reason: qualified for conditional approval) |
9 | Target(s) | Growth/differentiation factor (GDF); Transforming growth factor-beta (TGF-beta); TGF beta receptor (TGF beta receptor). |
10 | Indication(s) | The drug is indicated for treating adult patients with beta thalassemia who require regular red blood cell transfusions. |
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