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: the first generic chemical drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization. The definition of “first generic drug” is commonly used in the Chinese pharma industry but not written in Chinese regulations.
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In January 2023, China NMPA approved 15 new drugs, including 8 chemical drugs and 7 biological products.
1. Simcere's Simnotrelvir Tablets / Ritonavir Tablets
2. Shanghai Vinnerna Biosciences' Deuremidevir Hydrobromide Tablets
3. Takeda's Mobocertinib Succinate Capsules
4. Novartis' Ribociclib Succinate Tablets
5. Hengrui Pharmaceuticals' Cyclophosphamide Capsules
6. Zhejiang Er Ying Medical Products' Esomeprazole Magnesium for Delayed-release Oral Suspension
7. Guangzhou Hairui Pharmaceutical's Neticonazole Hydrochloride Cream
8. Beijing Yiling Medical Technology Development's Sodium Potassium Magnesium and Calcium Concentrated Solution for Injection
9. CTTQ Akeso's Penpulimab Injection
10. Henlius' Serplulimab Injection
11. Hengrui Pharmaceuticals' Camrelizumab for Injection
12. Roche's Polatuzumab Vedotin for Injection
13. BMS' Nivolumab Injection
14. Sanofi's Insulin Glargine and Lixisenatide Injection
15. Changchun BCHT Biotechnology's Herpes Zoster Vaccine, Live
The details are as follows.
1. Simnotrelvir Tablets / Ritonavir Tablets
1 | Generic Name | Simnotrelvir Tablets / Ritonavir Tablets (co-packaged) |
2 | Brand Name | Xian Nuo Xin (先诺欣) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA), domestic |
5 | Marketing Authorization Holder (MAH) | Simcere Pharmaceutical Group |
6 | Approval Date | Jan. 28, 2023 |
7 | Time from Application Acceptance to Approval | Not revealed |
8 | Special approval | Yes (conditional approval) |
9 | Target(s) | 3CL protease |
10 | Indication(s) | For treating adult patients with mild-to-moderate COVID-19 infection. |
2. Deuremidevir Hydrobromide Tablets
1 | Generic Name | Deuremidevir Hydrobromide Tablets |
2 | Brand Name | Min De Wei (民得维) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Shanghai Vinnerna Biosciences (joint venture of Shanghai Junshi Biosciences and Suzhou Wangshan Wangshui Biomedicine) |
6 | Approval Date | Jan. 28, 2023 |
7 | Time from Application Acceptance to Approval | Not revealed |
8 | Special Approval | Yes (conditional approval) |
9 | Target(s) | RNA-dependent RNA polymerase (RdRp) |
10 | Indication(s) | For treating adult patients with mild-to-moderate COVID-19 infection. |
3. Mobocertinib Succinate Capsules
1 | Generic Name | Mobocertinib Succinate Capsules |
2 | Brand Name | EXKIVITY (安卫力) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Takeda Pharmaceuticals U.S.A., Inc. |
6 | Approval Date | Jan. 10, 2023 |
7 | Time from Application Acceptance to Approval | 547 days |
8 | Priority Review | Yes (breakthrough therapy) |
9 | Target(s) | EGFR exon 20; HER2 exon 20 |
10 | Indication(s) | For the treatment of adult patients who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, and the disease has progressed during or after platinum-based chemotherapy. |
4. Ribociclib Succinate Tablets
1 | Generic Name | Ribociclib Succinate Tablets |
2 | Brand Name | KISQALI |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Novartis |
6 | Approval Date | Jan. 19, 2023 |
7 | Time from Application Acceptance to Approval | 454 days |
8 | Priority Review | No |
9 | Target(s) | Cyclin-dependent kinase 4 (CDK4); CDK6 |
10 | Indication(s) | In combination with aromatase inhibitor for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer in adult female patients who are experiencing perimenopause or before perimenopause. |
5. Cyclophosphamide Capsules
1 | Generic Name | Cyclophosphamide Capsules |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | Jan. 10, 2023 |
7 | Time from Application Acceptance to Approval | 459 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | Deoxyribonucleic acid (DNA) |
10 | Indication(s) | For the treatment of adult and pediatric patients no younger than 6 years old, with any of the following diseases: - malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma - multiple myeloma; |
11 | Note | First generic drug in China |
6. Esomeprazole Magnesium for Delayed-release Oral Suspension
1 | Generic Name | Esomeprazole Magnesium for Delayed-release Oral Suspension |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Zhejiang Er Ying Medical Products Co., Ltd. (subsidiary of Zhejiang Jianfeng Pharmaceutical Co., Ltd.) |
6 | Approval Date | Jan. 10, 2023 |
7 | Time from Application Acceptance to Approval | 564 days |
8 | Priority Review | No |
9 | Target(s) | H+ K+ ATPase |
10 | Indication(s) | - For treating erosive esophagitis (EE); - For reducing the risk of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer; - In combination with appropriate antimicrobial therapy for reducing the risk of duodenal ulcer recurrence; - For treating pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. |
11 | Note | First generic drug in China |
7. Neticonazole Hydrochloride Cream
1 | Generic Name | Neticonazole Hydrochloride Cream |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Guangzhou Hairui Pharmaceutical Co., Ltd. (subsidiary of Yangzijiang Pharmaceutical Group) |
6 | Approval Date | Jan. 19, 2023 |
7 | Time from Application Acceptance to Approval | 1,247 days |
8 | Priority Review | No |
9 | Target(s) | Cytochrome P450 2C9 (CYP2C9) |
10 | Indication(s) | For treating tinea (athlete's foot, tinea cruris, tinea corporis), skin candidiasis, and tinea versicolor. |
11 | Note | First generic drug in China |
8. Sodium Potassium Magnesium and Calcium Concentrated Solution for Injection
1 | Generic Name | Sodium Potassium Magnesium and Calcium Concentrated Solution for Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Beijing Yiling Medical Technology Development Co., Ltd. |
6 | Approval Date | Jan. 19, 2023 |
7 | Time from Application Acceptance to Approval | 1,360 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For supplying extracellular fluid and treating metabolic acidosis. |
11 | Note | First generic drug in China |
9. Penpulimab Injection
1 | Generic Name | Penpulimab Injection |
2 | Brand Name | An Ni Ke (安尼可) |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | Biologics License Application (BLA), domestic |
5 | MAH | CTTQ Akeso Biomedical Technology Co., Ltd. |
6 | Approval Date | Jan. 10, 2023 |
7 | Time from Application Acceptance to Approval | 546 days |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) | For treating patients with relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL) after at least second-line systemic chemotherapy. *This indication is granted conditional approval based on the objective response rate (ORR) and response duration in a single-arm clinical trial. The full approval will depend on if the ongoing randomized controlled trial can prove that the drug has more clinical benefit than the standard therapy. |
10. Serplulimab Injection
1 | Generic Name | Serplulimab Injection |
2 | Brand Name | Han Si Zhuang (汉斯状) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Shanghai Henlius Biotech, Inc. |
6 | Approval Date | Jan. 16, 2023 |
7 | Time from Application Acceptance to Approval | 280 days |
8 | Priority Review | No |
9 | Target(s) | PD-1 |
10 | Indication(s) | Previously approved: 1) For treating unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy. 2) Indicated in combination with chemotherapy for treating locally advanced or metastatic NSCLC. Newly approved on Jan. 16, 2023: 3) In combination with chemotherapy for the first-time treatment of extensive-stage small cell lung cancer (ES-SCLC). |
11. Camrelizumab for Injection
1 | Generic Name | Camrelizumab for Injection |
2 | Brand Name | Ai Rui Ka (艾瑞卡) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Suzhou Shengdiya Biomedicine (subsidiary of Jiangsu Hengrui Pharmaceuticals) |
6 | Approval Date | Jan. 29, 2023 |
7 | Time from Application Acceptance to Approval | 410 days |
8 | Priority Review | No |
9 | Target(s) | PD-1 |
10 | Indication(s) | Previously approved: 1) For treating relapsed or refractory classical Hodgkin’s Lymphoma; 2) For second-line treatment of hepatocellular carcinoma (HCC); 3) In combination with pemetrexed and carboplatin for treating EGFR/ALK wild-type non-squamous NSCLC that is locally advanced or metastatic; 4) For treating esophageal squamous cell carcinoma that is progressive or the patient gets intolerant after the first-line standard chemotherapy. 5) For treating advanced nasopharyngeal carcinoma that is progressive or the patient gets intolerant after two or more lines of chemotherapy; 6) In combination with cisplatin and gemcitabine for the first-line treatment of locally lapsed or metastatic nasopharyngeal carcinoma; 7) In combination with chemotherapy for the first-line treatment of advanced metastatic squamous NSCLC; 8) In combination with paclitaxel and cisplatin for the first-line treatment of esophageal carcinoma; Newly approved on Jan. 29, 2023: 9) In combination with apatinib mesylate for the first-line treatment of unresectable or metastatic hepatocellular carcinoma. |
12. Polatuzumab Vedotin for Injection
1 | Generic Name | Polatuzumab Vedotin for Injection |
2 | Brand Name | Polivy (优罗华) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Roche Pharma (Schweiz) AG |
6 | Approval Date | Jan. 10, 2023 |
7 | Time from Application Acceptance to Approval | 376 days |
8 | Priority Review | Yes (conditional approval) |
9 | Target(s) | B-cell antigen receptor complex-associated protein beta chain (CD79B) |
10 | Indication(s) | For treating relapsed or refractory diffuse large B-cell lymphoma in adult patients. |
13. Nivolumab Injection
1 | Generic Name | Nivolumab Injection |
2 | Brand Name | OPDIVO (欧狄沃) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Bristol-Myers Squibb Pharma EEIG |
6 | Approval Date | Jan. 18, 2023 |
7 | Time from Application Acceptance to Approval | 446 days |
8 | Priority Review | No |
9 | Target(s) | PD-1 |
10 | Indication(s) | Previously approved: 1) For the treatment of adult patients with locally advanced or metastatic NSCLC with disease progression or intolerance after platinum-containing chemotherapy, and with no EGFR or ALK genomic tumor aberrations. 2) For the treatment of PD-L1 positive (≥1% tumor cells with positive PD-L1 expression) patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 3) For the treatment of advanced or recurrent gastroesophageal junction adenocarcinoma in patients who have received two or more systemic treatments; 4) In combination with Ipilimumab in the initial treatment of unresectable non-epithelioid malignant pleural mesothelioma; 5) In combination with fluorouracil and platinum-based chemotherapy for first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. 6) As adjuvant therapy for treating patients with esophageal cancer or gastroesophageal junction cancer and pathological residues after neoadjuvant chemoradiotherapy (CRT) and complete surgical resection; 7) In combination with fluoropyrimidines and platinum-based chemotherapy for first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma. Newly approved on Jan. 18, 2023: 8) As a neoadjuvant therapy in combination with platinum-doublet chemotherapy for treating resectable NSCLC in adult patients. |
14. Insulin Glargine and Lixisenatide Injection
1 | Generic Name | Insulin Glargine and Lixisenatide Injection |
2 | Brand Name | SOLIQUA (赛益宁) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Sanofi |
6 | Approval Date | Jan. 10, 2023 |
7 | Time from Application Acceptance to Approval | 468 days |
8 | Priority Review | No |
9 | Target(s) | Glucagon-like peptide 1 receptor (GLP1R); insulin |
10 | Indication(s) | For treating type 2 diabetes mellitus (T2DM) in adult patients with insufficient glycemic control. |
15. Herpes Zoster Vaccine, Live
1 | Generic Name | Herpes Zoster Vaccine, Live |
2 | Brand Name | / |
3 | Classification | Class 3.2 prophylactic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Changchun BCHT Biotechnology Co. |
6 | Approval Date | Jan. 29, 2023 |
7 | Time from Application Acceptance to Approval | 297 days |
8 | Priority Review | Yes (vaccine urgently needed for disease prevention and control) |
9 | Target(s) | / |
10 | Indication(s) | For preventing shingles. |
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