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 Apr. 2023, China NMPA approved 13 new drugs, among which 11 are chemical drugs while 2 are biological products.
1. AstraZeneca’s Selumetinib Hydrogen Sulfate Capsules
2. Novartis’ Ruxolitinib Phosphate Tablets
3. Janssen-Cilag’s Esketamine Hydrochloride Nasal Spray
4. Hengrui Pharma’s Pyrotinib Maleate Tablets
5. InnoCare Pharma’s Orelabrutinib Tablets
6. Livzon Pharma’s Ilaprazole Sodium for Injection
7. BeiGene’s Zanubrutinib Capsules
8. Nhwa Pharma’s Oliceridine Fumarate Injection
9. Heze Pharma’s Desmopressin Acetate Oral Solution
10. Beijing Baiao Pharma’s Omeprazole and Sodium Bicarbonate Capsules (II)
11. Tianjin Jinyao Pharma’s Diflucortolone Valerate Cream
12. Pfizer’s 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
13. Lanzhou Institute of Biological Products’ 3-valent Rotavirus Gene Recombination Vaccine
The approval details are as follows.
1. Selumetinib Hydrogen Sulfate Capsules
1 | Generic Name | Selumetinib Hydrogen Sulfate Capsules |
2 | Brand Name | KOSELUG/科赛优 |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | New drug application (NDA), import |
5 | Marketing Authorization Holder (MAH) | ASTRAZENECA UK LIMITED |
6 | Approval Date | 28/04/2023 |
7 | Time from Application Acceptance to Approval | 319 days |
8 | Priority Review | Yes (pediatric use) |
9 | Target(s) | Dual specificity mitogen-activated protein kinase kinase 1 (MAP2K1); Dual specificity mitogen-activated protein kinase kinase 2 (MAP2K2) |
10 | Indication(s) | For treating children 3 years of age and older with neurofibromatosis type 1 (NF1) and symptomatic and inoperable plexiform neurofibromas (PN). |
2. Ruxolitinib Phosphate Tablets
1 | Generic Name | Ruxolitinib Phosphate Tablets |
2 | Brand Name | Jakavi/捷恪卫 |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Novartis Pharma Schweiz AG |
6 | Approval Date | 11/04/2023 |
7 | Time from Application Acceptance to Approval | 319 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase JAK1; Tyrosine-protein kinase JAK2 |
10 | Indication(s) | Previously approved For the treatment of intermediate or high-risk primary myelofibrosis (PMF), also known as chronic idiopathic myelofibrosis, post-polycythemia vera myelofibrosis (PPV-MF), and essential thrombocythemia myelofibrosis (PET-MF) in adult patients with disease-related symptoms, especially splenomegaly.
Newly approved: For the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in patients 12 years and older who have inadequate response to glucocorticoid or other systemic therapies. |
3. Esketamine Hydrochloride Nasal Spray
1 | Generic Name | Esketamine Hydrochloride Nasal Spray |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Janssen-Cilag International NV |
6 | Approval Date | 17/04/2023 |
7 | Time from Application Acceptance to Approval | 445 days |
8 | Priority Review | No |
9 | Target(s) | N-Methyl-D-Aspartate receptor (NMDAR) |
10 | Indication(s) | Indicated, in conjunction with an oral antidepressant, for the treatment of depressive symptoms in adults who have major depressive disorder (MDD) with acute suicidal ideation or behavior. |
4. Pyrotinib Maleate Tablets
1 | Generic Name | Pyrotinib Maleate Tablets |
2 | Brand Name | 艾瑞妮 (Ai Rui Ni) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | 17/04/2023 |
7 | Time from Application Acceptance to Approval | 190 days |
8 | Priority Review | Yes (breakthrough therapy) |
9 | Target(s) | Epidermal growth factor receptor (EGFR); Receptor tyrosine-protein kinase erbB-2 (HER2) |
10 | Indication(s) | Previously approved: 1. Conditional approval: In combination with capecitabine for the treatment of HER2-positive, relapsed or metastatic breast cancer in patients with/without prior trastuzumab therapy. Patients should receive anthracycline or taxane chemotherapy therapy before using pyrotinib. 2. As a neoadjuvant therapy, in combination with trastuzumab and docetaxel, for HER2-positive, primary or locally advanced breast cancer patients. Newly approved: 3. Indicated, in combination with trastuzumab and docetaxel, for the treatment of HER2-postive, relapsed or metastatic breast cancer patients who have not received anti-HER2 therapy in the advanced stage. |
5. Orelabrutinib Tablets
1 | Generic Name | Orelabrutinib Tablets |
2 | Brand Name | 宜诺凯 (Yi Nuo Kai) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | InnoCare Pharma Limited |
6 | Approval Date | 17/04/2023 |
7 | Time from Application Acceptance to Approval | 245 days |
8 | Priority Review | Yes (conditional approval) |
9 | Target(s) | Tyrosine-protein kinase BTK |
10 | Indication(s) | Previously approved: 1. For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one therapy. 2. For the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in adult patients who have received at least one therapy. Newly approved: 3. For the treatment of relapsed/refractory marginal zone lymphoma (MZL). |
6. Ilaprazole Sodium for Injection
1 | Generic Name | Ilaprazole Sodium for Injection |
2 | Brand Name | 壹丽安 (Yi Li An) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Livzon Pharmaceutical Group Inc. |
6 | Approval Date | 28/04/2023 |
7 | Time from Application Acceptance to Approval | 283 days |
8 | Priority Review | No |
9 | Target(s) | H+ K+ ATPase |
10 | Indication(s) | For the treatment of peptic ulcer and reflux esophagitis. |
7. Zanubrutinib Capsules
1 | Generic Name | Zanubrutinib Capsules |
2 | Brand Name | 百悦泽/BRUKINSA |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | BeiGene (Suzhou) Biotech Co., Ltd. |
6 | Approval Date | 28/04/2023 |
7 | Time from Application Acceptance to Approval | 455 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase BTK |
10 | Indication(s) | Previously approved: 1. For the treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) in adult patients who have received at least one therapy. 2. For the treatment of waldenstrom macroglobulinemia (WM) in adult patients who have received at least one therapy. Newly approved: 3. For the treatment of newly diagnosed (not treated before) CLL/SLL in adult patients; 4. For the treatment of newly diagnosed (not treated before) WM patients. |
8. Oliceridine Fumarate Injection
1 | Generic Name | Oliceridine Fumarate Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | Jiangsu Nhwa Pharmaceutical Co., Ltd. |
6 | Approval Date | 28/04/2023 |
7 | Time from Application Acceptance to Approval | 392 days |
8 | Priority Review | No |
9 | Target(s) | Mu-type opioid receptor (OPRM1) |
10 | Indication(s) | Indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. |
11 | Note | First generic in China |
9. Desmopressin Acetate Oral Solution
1 | Generic Name | Desmopressin Acetate Oral Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Heze Pharmaceutical Co., Ltd. |
6 | Approval Date | 28/04/2023 |
7 | Time from Application Acceptance to Approval | 462 days |
8 | Priority Review | No |
9 | Target(s) | Vasopressin receptor |
10 | Indication(s) | 1. For the treatment of central diabetes insipidus. 2. For the treatment of primary nocturnal enuresis in patients (over 5 years of age) normal urine concentrating ability. |
11 | Note | First generic in China |
10. Omeprazole and Sodium Bicarbonate Capsules (II)
1 | Generic Name | Omeprazole and Sodium Bicarbonate Capsules(II) |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Beijing Baiao Pharmaceuticals Co., Ltd. |
6 | Approval Date | 04/04/2023 |
7 | Time from Application Acceptance to Approval | 467 days |
8 | Priority Review | No |
9 | Target(s) | H+ K+ ATPase |
10 | Indication(s) | Indicated in adults for the: 1. short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. 2. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. 3. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. 4. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. 5. maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months. |
11 | Note | First generic in China |
11. Diflucortolone Valerate Cream
1 | Generic Name | Diflucortolone Valerate Cream |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Tianjin Jinyao Pharmaceutical Co., Ltd. |
6 | Approval Date | 28/04/2023 |
7 | Time from Application Acceptance to Approval | 850 days |
8 | Priority Review | No |
9 | Target(s) | Glucocorticoid receptor (GR) |
10 | Indication(s) | For the treatment of eczema, allergic contact dermatitis, neurodermatitis, psoriasis, seborrheic dermatitis, diaper rash, and heat rash. |
11 | Note | First generic in China |
12. 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
1 | Generic Name | 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine |
2 | Brand Name | 沛儿13/Prevenar 13 |
3 | Classification | Class 3.1 prophylactic biological product |
4 | Application Type | Biologics License Application (BLA), import |
5 | MAH | Pfizer Europe MA EEIG |
6 | Approval Date | 17/04/2023 |
7 | Time from Application Acceptance to Approval | 782 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Prevenar 13 is used for active immunization in infants and young children to prevent invasive diseases (including Bacteremic pneumonia, meningitis, sepsis, bacterimia, etc.) caused by serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, or 23F of Streptococcus pneumoniae. Pneumococcus is the most common cause of invasive diseases, pneumonia, and upper respiratory tract infections. Prevenar 13 can only provide prevention against the pneumococcal serotypes contained in the vaccine, but cannot prevent invasive diseases, pneumonia, or otitis media caused by serotypes or microorganisms not contained in this product. |
13. 3-valent Rotavirus Gene Recombination Vaccine
1 | Generic Name | 3-valent Rotavirus Gene Recombination Vaccine |
2 | Brand Name | / |
3 | Classification | Class 1 biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Lanzhou Institute of Biological Products Co., Ltd. |
6 | Approval Date | 17/04/2023 |
7 | Time from Application Acceptance to Approval | 2,342 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For the prevention of rotavirus gastroenteritis in infants and young children caused by rotavirus. |
Please contact BaiPharm if you need more details of drug approvals in China.