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 April 2022, China NMPA approved 23 new drugs, including 20 chemical drugs and 3 biological products.
1. Abrocitinib Tablets
1 | Generic Name | Abrocitinib Tablets |
2 | Brand Name | CIBINQO (希必可) |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA), import |
5 | Marketing Authorization Holder (MAH) | Pfizer Inc. |
6 | Approval Date | April 13, 2022 |
7 | Time from Application Acceptance to Approval | 421 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | Tyrosine-protein kinase JAK1 |
10 | Indication(s) | CIBINQO is indicated for treating moderate-to-severe atopic dermatitis (including relieving pruritus) in patients no younger than 12 who receive inadequate therapeutic response from topical therapies or for whom those therapies are inappropriate. The drug can be used with or without topical therapies. |
2. Tegoprazan Tablet
1 | Generic Name | Tegoprazan Tablets |
2 | Brand Name | Tai Xin Zan (泰欣赞) |
3 | Registration Classification | Class 1 chemical drug |
4 | Application Type | NDA |
5 | MAH | Luoxin Pharmaceutical Co., Ltd. |
6 | Approval Date | April 13, 2022 |
7 | Time from Application Acceptance to Approval | 449 days |
8 | Priority Review | No |
9 | Target(s) | H+ K+ ATPase |
10 | Indication(s) | Tai Xin Zan is indicated for treating reflux esophagitis. |
3. Lorlatinib Tablets
1 | Generic Name | Lorlatinib Tablets |
2 | Brand Name | LORBRENA |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Pfizer Inc. |
6 | Approval Date | April 29, 2022 |
7 | Time from Application Acceptance to Approval | 287 days |
8 | Priority Review | Yes (qualified for conditional approval) |
9 | Target(s) | ALK; Ros1 tyrosine kinase receptor |
10 | Indication(s) | LORBRENA is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive in patients who have received one or more ALK-tyrosine kinase inhibitor (TKI) therapies. |
4. Pemigatinib Tablets
1 | Generic Name | Pemigatinib Tablets |
2 | Brand Name | Pemazyre (达伯坦) |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Innovent Biologics (Suzhou) Co., Ltd. |
6 | Approval Date | April 6, 2022 |
7 | Time from Application Acceptance to Approval | 260 days |
8 | Priority Review | Yes (qualified for conditional approval) |
9 | Target(s) | Fibroblast Growth Factor 1 (FGF1) Fibroblast Growth Factor 2 (FGF2) Fibroblast Growth Factor 3 (FGF3) |
10 | Indication(s) | Pemazyre is indicated for the treatment of adults who have experienced at least one prior systemic therapy and are confirmed by test that they have unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. |
5. Larotrectinib Sulfate Capsules
1 | Generic Name | Larotrectinib Sulfate Capsules |
2 | Brand Name | VITRAKVI (维泰凯) |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Bayer AG |
6 | Approval Date | April 13, 2022 |
7 | Time from Application Acceptance to Approval | 323 days |
8 | Priority Review | Yes (qualified for conditional approval) |
9 | Target(s) | Neurotrophic Receptor Tyrosine Kinase 1 (NTRK1) |
10 | Indication(s) | VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: - have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion; - are locally advanced, metastatic, or where surgical resection is likely to result in severe complications, and - have no satisfactory treatment alternatives. |
6. Beclometasone Dipropionate, Formoterol Fumarate, and Glycopyrrolate Inhalation Aerosol
1 | Generic Name | Beclometasone Dipropionate, Formoterol Fumarate, and Glycopyrrolate Inhalation Aerosol |
2 | Brand Name | / |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Chiesi Farmaceutici S.p.A. |
6 | Approval Date | April 15, 2022 |
7 | Time from Application Acceptance to Approval | 530 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | This drug is indicated for the treatment of chronic obstructive pulmonary disease (COPD) and asthma in adult patients. |
7. Irinotecan Hydrochloride Liposome Injection
1 | Generic Name | Irinotecan Hydrochloride Liposome Injection |
2 | Brand Name | ONIVYDE |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Les Laboratoires Servier |
6 | Approval Date | April 15, 2022 |
7 | Time from Application Acceptance to Approval | 659 days |
8 | Priority Review | No |
9 | Target(s) | DNA topoisomerase 1 (TOP1) |
10 | Indication(s) | ONIVYDE, in combination with 5-Fluorouracil (5FU) and folinic acid (LV), is indicated for metastatic pancreatic cancer after gemcitabine therapy. |
8. Procarbazine Hydrochloride Capsules
1 | Generic Name | Procarbazine Hydrochloride Capsules |
2 | Brand Name | Matulane |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Leadiant GmbH |
6 | Approval Date | April 21, 2022 |
7 | Time from Application Acceptance to Approval | 708 days |
8 | Priority Review | No |
9 | Target(s) | deoxyribonucleic acid (DNA) |
10 | Indication(s) | Matulane is indicated for the treatment of advanced Hodgkin's disease. |
9. Tetrofosmin and Stannous Chloride for Injection
1 | Generic Name | Tetrofosmin and Stannous Chloride for Injection |
2 | Brand Name | MYOVIEW |
3 | Registration Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | GE Healthcare AS |
6 | Approval Date | April 6, 2022 |
7 | Time from Application Acceptance to Approval | 750 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin injection, a radioactive diagnostic drug. Two doses of the injection are used for the myocardial perfusion imaging under rest and pharmacologic stress conditions to reflect changes of myocardial blood flow and perfusion in patients with known or suspected coronary artery disease. |
10. Anlotinib Hydrochloride Capsules
1 | Generic Name | Anlotinib Hydrochloride Capsules |
2 | Brand Name | FOCUS V (福可维) |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | NDA |
5 | MAH | Chai Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ Co., Ltd.) |
6 | Approval Date | April 13, 2022 |
7 | Time from Application Acceptance to Approval | 336 days |
8 | Priority Review | No |
9 | Target(s) | Vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. |
10 | Indication(s) | Approved previously:
Approved on April 13, 2022:
|
11. Tofacitinib Citrate Tablets
1 | Generic Name | Tofacitinib Citrate Tablets |
2 | Brand Name | Xeljanz (尚杰) |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Pfizer Europe MA EEIG |
6 | Approval Date | April 15, 2022 |
7 | Time from Application Acceptance to Approval | 440 days |
8 | Priority Review | No |
9 | Target(s) | Janus kinase (JAK); Tyrosine-protein kinase JAK1 (JAK1); Tyrosine-protein kinase JAK3 (JAK3). |
10 | Indication(s) |
|
12. Upadacitinib Sustained-release Tablets
1 | Generic Name | Upadacitinib Sustained-release Tablets |
2 | Brand Name | RINVOQ (瑞福) |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | AbbVie Ireland NL B.V. |
6 | Approval Date | April 6, 2022 |
7 | Time from Application Acceptance to Approval | 440 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase JAK1 |
10 | Indication(s) | Approved previously:
Approved on April 6:
|
13. Posaconazole Enteric-coated Tablets
1 | Generic Name | Posaconazole Enteric-coated Tablets |
2 | Brand Name | Noxafil (诺科飞) |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Merck Sharp & Dohme Ltd |
6 | Approval Date | April 6, 2022 |
7 | Time from Application Acceptance to Approval | 470 days |
8 | Priority Review | No |
9 | Target(s) | Lanosterol 14-alpha demethylase (CYP51A1) |
10 | Indication(s) | Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. |
14. Dehydrated Alcohol Injection
1 | Generic Name | Dehydrated Alcohol Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Guorui Pharmaceutical Co., Ltd. (Parent company: Sinopharm) |
6 | Approval Date | April 29, 2022 |
7 | Time from Application Acceptance to Approval | 601 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | The dehydrated alcohol injection is indicated for reducing the volume of simple kidney cysts (diameter 5-10cm) with symptoms or imaging changes of compressing obstruction, and needing therapeutic intervention. The injection should be used after comprehensive evaluations by experienced medical specialists. |
15. Tofacitinib Citrate Extended-release Tablets
1 | Generic Name | Tofacitinib Citrate Extended-release Tablets |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA) |
5 | MAH | Qilu Pharmaceutical Co., Ltd. |
6 | Approval Date | April 21, 2022 |
7 | Time from Application Acceptance to Approval | 600 days |
8 | Priority Review | No |
9 | Target(s) | Janus kinase (JAK); Tyrosine-protein kinase JAK1 (JAK1); Tyrosine-protein kinase JAK3 (JAK3). |
10 | Indication(s) |
|
11 | Notes | First generic in China |
16. Midazolam Hydrochloride Oral Solution
1 | Generic Name | Midazolam Hydrochloride Oral Solution |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Jiangsu Nhwa Pharmaceutical Co., Ltd. |
6 | Approval Date | April 15, 2022 |
7 | Time from Application Acceptance to Approval | 679 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | Benzodiazepine receptor (BZR) |
10 | Indication(s) | The drug is indicated for
|
11 | Notes | First generic in China |
17. Levofolinic Acid Injection
1 | Generic Name | Levofolinic Acid Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Nanjing Healthnice Pharmaceutical Technology Co., Ltd. |
6 | Approval Date | April 29, 2022 |
7 | Time from Application Acceptance to Approval | 1,344 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | The drug is indicted for
|
11 | Notes | First generic in China |
18. Sodium Nitroprusside Injection
1 | Generic Name | Sodium Nitroprusside Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Hainan Poly Pharm Co., Ltd. |
6 | Approval Date | April 15, 2022 |
7 | Time from Application Acceptance to Approval | 774 days |
8 | Priority Review | No |
9 | Target(s) | Natriuretic Peptide Receptor 1 (NPR1) |
10 | Indication(s) | The drug is indicated for
|
11 | Notes | First generic in China |
19. Medium and Long Chain Fat Emulsion, Amino Acids (16) and Glucose (36%) Injection
1 | Generic Name | Medium and Long Chain Fat Emulsion, Amino Acids (16) and Glucose (36%) Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Kelun Industry Group |
6 | Approval Date | April 13, 2022 |
7 | Time from Application Acceptance to Approval | 1,074 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | The drug is indicated for providing nutrition to moderate-to-severe catabolic patients no younger than two years old with functional deficiency or inability to receive nutrients through mouth or intestine. |
11 | Notes | First generic in China |
20. Medium and Long Chain Fat Emulsion, Amino Acids (16) and Glucose (30%) Injection
1 | Generic Name | Medium and Long Chain Fat Emulsion, Amino Acids (16) and Glucose (30%) Injection |
2 | Brand Name | / |
3 | Registration Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Kelun Industry Group |
6 | Approval Date | April 13, 2022 |
7 | Time from Application Acceptance to Approval | 563 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | The drug is indicated for providing nutrition to moderate-to-severe catabolic patients at or over two years old with functional deficiency or inability to receive nutrients through mouth or intestine. |
11 | Notes | First generic in China |
21. Tislelizumab Injection
1 | Generic Name | Tislelizumab Injection |
2 | Brand Name | Bai Ze An (百泽安) |
3 | Registration Classification | Class 2.2 biological product |
4 | Application Type | Biologics License Application (BLA) |
5 | MAH | BeiGene (Shanghai) Biotechnology Co., Ltd. |
6 | Approval Date | April 13, 2022 |
7 | Time from Application Acceptance to Approval | 274 days |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) |
|
22. Blinatumomab for Injection
1 | Generic Name | Blinatumomab for Injection |
2 | Brand Name | BLINCYTO (倍利妥) |
3 | Registration Classification | Class 3.1 biological product |
4 | Application Type | BLA, import |
5 | MAH | Amgen Inc. |
6 | Approval Date | April 29, 2022 |
7 | Time from Application Acceptance to Approval | 392 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | B-lymphocyte antigen CD19; Myeloid cell surface antigen CD33. |
10 | ad | Approved previously:
Approved on April 29, 2022:
|
23. Omalizumab for Injection
1 | Generic Name | Omalizumab for Injection |
2 | Brand Name | Xolair (茁乐) |
3 | Registration Classification | Class 3.1 biological product |
4 | Application Type | BLA, import |
5 | MAH | Novartis Europharm Limited |
6 | Approval Date | April 13, 2022 |
7 | Time from Application Acceptance to Approval | 449 days |
8 | Priority Review | / |
9 | Target(s) | Immunoglobulin E (IgE) |
10 | Indication(s) | Approved previously:
Approved on April 13, 2022:
|
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