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:
In October 2022, China NMPA approved 17 new drugs, including 11 chemical drugs and 6 biological products.
Hua Medicine's Dorzagliatin Tablets
Hidragon Pharma's Lansoprazole Capsules
Nanjing Haina Pharmaceutical's Levofolinic Acid Solution for Injection
Changchun Haiyue Pharmaceutical's Esomeprazole Magnesium and Sodium Bicarbonate Capsules
Haiscol's Ciprofol Injection
Joincare's Tobramycin Inhalation Solution
Pfizer's Tofacitinib Citrate Sustained-release Tablets
Pfizer's Tofacitinib Citrate Tablets
Eli Lilly's Selpercatinib Capsules
Cabot Norit Nederland's Pharmaceutical Charcoal Granules for Suspension
ViiV Healthcare's Dolutegravir Sodium and Rilpivirine Hydrochloride Tablets
Shanghai Henlius Biotech's Serplulimab Injection
JW Therapeutics' Relmacabtagene Autoleucel Injection
MSD's Pembrolizumab Injection
Eli Lilly's Ramucirumab Injection
Kyowa Kirin's Mogamulizumab Injection
Roche's Trastuzumab Injection
The approval details are as follows.
1. Dorzagliatin Tablets
1 | Generic Name | Dorzagliatin Tablets |
2 | Brand Name | Hua Tang Ning (华堂宁) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA) |
5 | Marketing Authorization Holder (MAH) | Hua Medicine (Shanghai) Co., Ltd. |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 522 days |
8 | Priority Review | No |
9 | Target(s) | Glucokinase (GCK) |
10 | Indication(s) | For improving glycemic control in type 2 diabetes adult patients. |
2. Lansoprazole Capsules
1 | Generic Name | Lansoprazole Capsules |
2 | Brand Name | / |
3 | Classification | Class 2.2 chemical drug |
4 | Application Type | NDA |
5 | MAH | Hidragon Pharma |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 1,141 days |
8 | Priority Review | No |
9 | Target(s) | H+ K+ ATPase |
10 | Indication(s) | For treating gastric ulcer, duodenum ulcer, reflux esophagitis, and Zollinger-Ellison syndrome. |
3. Levofolinic Acid Solution for Injection
1 | Generic Name | Levofolinic Acid Solution for Injection |
2 | Brand Name | / |
3 | Classification | Class 2.2 chemical drug |
4 | Application Type | NDA |
5 | MAH | Nanjing Haina Pharmaceutical Co., Ltd. |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 1,299 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | 1. For offsetting the toxicity of antifol (e.g., methotrexate) in chemotherapy or when overused; 2. Used in combination with fluorouracil drugs in chemotherapy for treating gastric cancer and colorectal cancer. |
4. Esomeprazole Magnesium and Sodium Bicarbonate Capsules
1 | Generic Name | Esomeprazole Magnesium and Sodium Bicarbonate Capsules |
2 | Brand Name | Hai Yue Mei Ao (海悦美奥) |
3 | Classification | Class 2.3 chemical drug |
4 | Application Type | NDA |
5 | MAH | Changchun Haiyue Pharmaceutical Co., Ltd. |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 758 days |
8 | Priority Review | No |
9 | Target(s) | H+ K+ ATPase |
10 | Indication(s) | For treating gastroesophageal reflux, erosive reflux esophagitis, gastric ulcer, heartburn, and acid reflux. |
5. Ciprofol Injection
1 | Generic Name | Ciprofol Injection |
2 | Brand Name | Si Shu Ning (思舒宁) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA |
5 | MAH | Liaoning Haisco Pharmaceutical Co., Ltd. |
6 | Approval Date | Oct. 14, 2022 |
7 | Time from Application Acceptance to Approval | 263 days |
8 | Priority Review | No |
9 | Target(s) | GABAA receptor |
10 | Indication(s) | Previously approved: 1. For sedation and anesthesia in non-tracheal-incubation surgeries/operations. 2. For the induction and maintenance of general anesthesia. 3. For sedation for patients in intensive care units (ICUs). Newly approved on Oct. 14, 2022: 4. For sedation and anesthesia in gynecological outpatient procedures. |
6. Tobramycin Inhalation Solution
1 | Generic Name | Tobramycin Inhalation Solution |
2 | Brand Name | / |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA |
5 | MAH | Joincare Pharmaceutical Group Industry Co., Ltd. |
6 | Approval Date | Oct. 14, 2022 |
7 | Time from Application Acceptance to Approval | 405 days |
8 | Priority Review | No |
9 | Target(s) | 30S ribosomal subunit (pbp2) |
10 | Indication(s) | For controlling the infections and improving the symptoms of bronchiectasis caused by pulmonary Pseudomonas aeruginosa in adult patients. |
7. Tofacitinib Citrate Sustained-release Tablets
1 | Generic Name | Tofacitinib Citrate Sustained-release Tablets |
2 | Brand Name | Xeljanz XR |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Pfizer Inc. |
6 | Approval Date | Oct. 21, 2022 |
7 | Time from Application Acceptance to Approval | 285 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase JAK1; Tyrosine-protein kinase JAK3 |
10 | Indication(s) | Previously approved: For the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to methotrexate. Permitted to be used in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Limitations of use: Not recommended to be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine. Newly approved on Oct. 21, 2022: For active psoriatic arthritis (PsA) patients who have inadequate response or intolerance to one or multiple anti-rheumatic drugs for improving symptoms. |
8. Tofacitinib Citrate Tablets
1 | Generic Name | Tofacitinib Citrate Tablets |
2 | Brand Name | Xeljanz (尚杰) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Pfizer Europe MA EEIG |
6 | Approval Date | Oct. 14, 2022 |
7 | Time from Application Acceptance to Approval | 278 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase JAK1; Tyrosine-protein kinase JAK3 |
10 | Indication(s) | Previously approved: For the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to methotrexate. Permitted to be used in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Limitations of use: Not recommended to be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine. Newly approved on Oct. 21, 2022: For active psoriatic arthritis (PsA) patients who have inadequate response or intolerance to one or multiple anti-rheumatic drugs for improving symptoms. |
9. Selpercatinib Capsules
1 | Generic Name | Selpercatinib Capsules |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Eli Lilly Nederland B.V. |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 325 days |
8 | Priority Review | No |
9 | Target(s) | Proto-oncogene tyrosine-protein kinase receptor Ret |
10 | Indication(s) | 1. For treating adult and pediatric patients no younger than 12 years old who need systemic treatment for advanced or metastatic thyroid cancer with rearranged during transfection (RET) gene fusion. 2. For treating adult and pediatric patients no younger than 12 years old who need systemic treatment and radioactive iodine treatment (if appropriate) for advanced or metastatic thyroid cancer with RET gene fusion. 3. For treating patients who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with RET gene fusion. |
10. Pharmaceutical Charcoal Granules for Suspension
1 | Generic Name | Pharmaceutical Charcoal Granules for Suspension |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Cabot Norit Nederland B.V. |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 331 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | / |
10 | Indication(s) | Indicated as an oral detoxification drug for treating acute poisoning or drug overdose. |
11. Dolutegravir Sodium and Rilpivirine Hydrochloride Tablets
1 | Generic Name | Dolutegravir Sodium and Rilpivirine Hydrochloride Tablets |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | ViiV Healthcare BV |
6 | Approval Date | Oct. 21, 2022 |
7 | Time from Application Acceptance to Approval | 648 days |
8 | Priority Review | Yes (other situations for priority review) |
9 | Target(s) | / |
10 | Indication(s) | For treating human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months. The patients should have no history of treatment failure and no suspected/known resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase inhibitors (INIs). |
12. Serplulimab Injection
1 | Generic Name | Serplulimab Injection |
2 | Brand Name | Han Si Zhuang (汉斯状) |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | Biologics License Application (BLA) |
5 | MAH | Shanghai Henlius Biotech, Inc., a subsidiary of Fosun Pharma |
6 | Approval Date | Oct. 31, 2022 |
7 | Time from Application Acceptance to Approval | 404 days |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) | Previously approved: For treating unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy. Newly approved on Oct. 31, 2022: Indicated in combination with chemotherapy for treating locally advanced or metastatic NSCLC. |
13. Relmacabtagene Autoleucel Injection
1 | Generic Name | Relmacabtagene Autoleucel Injection |
2 | Brand Name | 倍诺达 (Carteyva) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | JW Therapeutics (Shanghai) Co., Ltd. |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 212 days |
8 | Priority Review | Yes (for breakthrough therapy) |
9 | Target(s) | B-lymphocyte antigen CD19 |
10 | Indication(s) | Previously approved: For treating adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. The applicable r/rLBCL includes diffuse large B-cell lymphoma (DLBCL), DLBCL transformed from follicular lymphoma, grade 3b follicular lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphomas (HGBLs) with MYC and BCL2 and/or BCL6 rearrangements (so-called double/triple-hit lymphomas). Newly approved on Oct. 9, 2022: For treating relapsed or refractory follicular lymphoma (including histologic grade 1, 2, and 3a) after two or more lines of systemic treatment. |
14. Pembrolizumab Injection
1 | Generic Name | Pembrolizumab Injection |
2 | Brand Name | Keytruda (可瑞达) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 308 days |
8 | Priority Review | No |
9 | Target(s) | PD-1 |
10 | Indication(s) | Previously approved: For treating unresectable or metastatic melanoma after the failure of first-line treatment. This indication is granted conditional marketing authorization in China based on the overall response rate (ORR) result of a single-arm clinical trial. Whether this indication will receive full approval depends on the ongoing confirmatory clinical trial which explores whether the therapy can realize the long-term clinical value for patients in China. Newly approved on Oct. 9, 2022: Indicated as a single agent for hepatocellular carcinoma (HCC) patients who have been previously treated with sorafenib or oxaliplatin-containing chemotherapy. |
15. Ramucirumab Injection
1 | Generic Name | Ramucirumab Injection |
2 | Brand Name | Cyramza (希冉择) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Eli Lilly and Company |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 403 days |
8 | Priority Review | No |
9 | Target(s) | Vascular endothelial growth factor receptor 2 |
10 | Indication(s) | Previously approved: In combination with paclitaxel for treating patients with advanced, gastric or gastro-esophageal junction adenocarcinoma with disease progression during or after prior fluropyrimidin- or platinum-containing chemotherapy. Newly approved on Oct. 9, 2022: For treating HCC patients who have an alpha fetoprotein (AFP) of ≥400 ng/Ml and have been treated with sorafenib. |
16. Mogamulizumab Injection
1 | Generic Name | Mogamulizumab Injection |
2 | Brand Name | Poteligeo (惠尔金) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Kyowa Kirin Co., Ltd. |
6 | Approval Date | Oct. 14, 2022 |
7 | Time from Application Acceptance to Approval | 466 days |
8 | Priority Review | Yes (for conditional marketing authorization) |
9 | Target(s) | C-C chemokine receptor type 4 (CCR4) |
10 | Indication(s) | For treating adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. |
17. Trastuzumab Injection (Subcutaneous Injection)
1 | Generic Name | Trastuzumab Injection (Subcutaneous Injection) |
2 | Brand Name | Herceptin (赫赛汀) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Roche Pharma (Schweiz) AG |
6 | Approval Date | Oct. 9, 2022 |
7 | Time from Application Acceptance to Approval | 527 days |
8 | Priority Review | No |
9 | Target(s) | human epidermal growth factor receptor 2 (HER2) |
10 | Indication(s) | Indicated in combination with chemotherapy for early-stage and metastatic breast cancer that is HER2-positive. |
