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.
Related Articles:
In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs and 7 are biological products.
1. eVENUS Pharma’s Oteseconazole Capsules (class 1 innovative drug)
2. XZenith Biopharm’s Anaprazole Sodium Enteric-coated Tablets (class 1 innovative drug)
3. Betta Pharma’s Vorolanib Tablets (class 1 innovative drug)
4. Jiangsu Hengrui Pharma’s Retagliptin Phosphate Tablets (class 1 innovative drug)
5. Jiangsu Hansoh Pharma’s Pegmolesatide Injection (class 1 innovative drug)
6. Qilu Pharma’s Iruplinalkib Tablets (class 1 innovative drug)
7. Jiangsu Hengrui Pharma’s Dalpiciclib Isethionate Tablets
8. Immedica Pharma’s Glycerol Phenylbutyrate Oral Liquid
9. Menarini’s Bilastine Tablets
10. Teva Pharmaceutical’s Glatiramer Acetate Injection
11. AstraZeneca’s Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets
12. Neurelis’ Diazepam Nasal Spray
13. Fresenius Kabi’s Compound Amino Acid (16AA), Glucose (12.6%) and Electrolyte Injection
14. Recordati Rare Diseases’ Carglumic Acid Dispersible Tablets
15. Shionogi’s Lusutrombopag Tablets
16. Genentech’s Pralsetinib Capsules
17. Ipsen Pharma’s Triptorelin Pamoate for Injection
18. Kelun Industry Group’s ω-3 Fish Oil Medium and Long Chain Fat Emulsion / Amino Acid (16) / Glucose (36%) Injection (first generic)
19. Jincheng Jinsu Pharma’s Amisulpride Oral Solution (first generic)
20. Yangtze River Pharma’s Amlodipine Besilate and Benazepril Hydrochloride Capsules (first generic)
21. Shenzhen Salubris Pharma’s Enarodustat Tablets (first generic)
22. CP Pharma Qingdao’s Calcitriol Oral Solution (first generic)
23. NJCTTQ’s Lubiprostone Soft Capsules (first generic)
24. Hefei Yifan Pharma’s Clofarabine Injection (first generic)
25. Jewim Pharma’s Minoxidil Topical Solution (first generic)
26. Hubei Yuanda Tianming Pharma's Balanced Salt Solution for Irrigating Eyes (first generic)
27. IASO Biotherapeutics’s Equecabtagene Autoleucel Injection (class 1 innovative drug)
28. Xiamen Amoytop Biotech’s Telpegfilgrastim Injection (class 1 innovative drug)
29. Biotech Pharmaceutical’s Nimotuzumab Injection
30. Novartis’ Omalizumab Injection
31. Alexion’s Eculizumab Injection
32. argenx’s Efgartigimod Alfa Injection
33. Fosun Kite’s Axicabtagene Ciloleucel Injection
The approval details are as follows.
1. Oteseconazole Capsules
1 | Generic Name | Oteseconazole Capsules |
2 | Brand Name | / |
3 | Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA), import |
5 | Marketing Authorization Holder (MAH) | eVENUS PHARMACEUTICAL LABORATORIES INC. |
6 | Approval Date | 27/06/2023 |
7 | Time from Application Acceptance to Approval | 538 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for the treatment of severe vulvovaginal candidiasis (VVC). |
2. Anaprazole Sodium Enteric-coated Tablets
1 | Generic Name | Anaprazole Sodium Enteric-coated Tablets |
2 | Brand Name | 安久卫 (An Jiu Wei) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 608 days |
8 | Priority Review | No |
9 | Target(s) | H+ K+ ATPase |
10 | Indication(s) | Indicated for the treatment of duodenal ulcer. |
3. Vorolanib Tablets
1 | Generic Name | Vorolanib Tablets |
2 | Brand Name | 伏美纳 (Fu Mei Na) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Betta Pharmaceuticals Co., Ltd. |
6 | Approval Date | 07/06/2023 |
7 | Acceptance to Approval | 512 days |
8 | Priority Review | No |
9 | Target(s) | Platelet-derived growth factor receptor (PDGFR); Vascular endothelial growth factor receptor (VEGFR) |
10 | Indication(s) | Used in combination with everolimus for patients with advanced renal cell carcinoma (RCC) for whom tyrosine kinase inhibitor (TKI) therapy has failed before. |
4. Retagliptin Phosphate Tablets
1 | Generic Name | Retagliptin Phosphate Tablets |
2 | Brand Name | 瑞泽唐 (Rui Ze Tang) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | 27/06/2023 |
7 | Acceptance to Approval | 1,002 days |
8 | Priority Review | No |
9 | Target(s) | Dipeptidyl peptidase 4 (DPP4) |
10 | Indication(s) | Indicated for improving glycemic control in adults with type 2 diabetes. |
5. Pegmolesatide Injection
1 | Generic Name | Pegmolesatide Injection |
2 | Brand Name | 圣罗莱 (Sheng Luo Lai) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Jiangsu Hansoh Pharmaceutical Group Co., Ltd. |
6 | Approval Date | 30/06/2023 |
7 | Acceptance to Approval | 223 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for adult patients who have not received erythropoiesis-stimulating agent (ESA) treatment and are not receiving dialysis, and for adult patients who are receiving short-acting erythropoietin (EPO) treatment and dialysis. *Not indicated for red blood cell transfusion in patients who require immediate correction of anemia. |
6. Iruplinalkib Tablets
1 | Generic Name | Iruplinalkib Tablets |
2 | Brand Name | 启欣可 (Qi Xin Ke) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Qilu Pharmaceutical Co., Ltd. |
6 | Approval Date | 27/06/2023 |
7 | Acceptance to Approval | 703 days |
8 | Priority Review | No |
9 | Target(s) | ALK tyrosine kinase receptor (ALK); Proto-oncogene tyrosine-protein kinase ROS (ROS1) |
10 | Indication(s) | Indicated for the treatment of ALK-positive, locally advanced or metastatic, non-small cell lung cancer (NSCLC) in patients who have disease progression after previous crizotinib treatment or are intolerant to crizotinib. |
7. Dalpiciclib Isethionate Tablets
1 | Generic Name | Dalpiciclib Isethionate Tablets |
2 | Brand Name | 艾瑞康 (Ai Rui Kang) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 244 days |
8 | Priority Review | No |
9 | Target(s) | Cyclin-dependent kinase 4 (CDK4); Cyclin-dependent kinase 6 (CDK6) |
10 | Indication(s) | Previously approved: Used in combination with fulvestrant for treating breast cancer patients who have hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative tumors with disease progression after endocrine therapy. Newly approved: Used in combination with aromatase inhibitors for the first-line treatment of patients with HR+/HER2- breast cancer that is locally advanced or metastatic. |
8. Glycerol Phenylbutyrate Oral Liquid
1 | Generic Name | Glycerol Phenylbutyrate Oral Liquid |
2 | Brand Name | Ravicti |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Immedica Pharma AB |
6 | Approval Date | 14/06/2023 |
7 | Acceptance to Approval | 302 days |
8 | Priority Review | Yes (meeting other conditions for priority review) |
9 | Target(s) | Glutamate |
10 | Indication(s) | Indicated for the long-term treatment of patients with urea cycle disorders (UCDs) that cannot be controlled by protein intake restriction and amino acid supplementation, or amino acid supplementation alone. UCDs here include
For patients taking glycerol phenylbutyrate, dietary protein must be restricted. In some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, non-protein energy supplements) should be taken. |
9. Bilastine Tablets
1 | Generic Name | Bilastine Tablets |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Menarini International Operations Luxembourg S.A. |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 541 days |
8 | Priority Review | No |
9 | Target(s) | Histamine H1 receptor (H1R) |
10 | Indication(s) | Indicated for the symptomatic treatment of urticaria in adults and adolescents aged 12 years and older. |
10. Glatiramer Acetate Injection
1 | Generic Name | Glatiramer Acetate Injection |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | TEVA PHARMACEUTICALS LTD |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 709 days |
8 | Priority Review | No |
9 | Target(s) | HLA class II histocompatibility antigen (MHC2); Major histocompatibility complex class I protein (Mhc-1) |
10 | Indication(s) | Indicated for the treatment of multiple sclerosis (MS). |
11. Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets
1 | Generic Name | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | AstraZeneca AB |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 498 days |
8 | Priority Review | No |
9 | Target(s) | AMPK subunit alpha-2; SLC5A2 |
10 | Indication(s) | Indicated for improving glycemic control in adults with type 2 diabetes who are suitable to receive the treatment of dapagliflozin and metformin hydrochloride. |
12. Diazepam Nasal Spray
1 | Generic Name | Diazepam Nasal Spray |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Neurelis, Inc. |
6 | Approval Date | 07/06/2023 |
7 | Acceptance to Approval | 701 days |
8 | Priority Review | No |
9 | Target(s) | Benzodiazepine receptor (BZR) |
10 | Indication(s) | Indicated for the acute treatment of cluster/acute recurrent seizures of epilepsy patients 6 years and older. |
13. Compound Amino Acid (16AA), Glucose (12.6%) and Electrolyte Injection
1 | Generic Name | Compound Amino Acid (16AA), Glucose (12.6%) and Electrolyte Injection |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Fresenius Kabi Austria GmbH |
6 | Approval Date | 07/06/2023 |
7 | Acceptance to Approval | 827 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Parenteral nutrition for adult patients when oral or enteral nutrition is impossible or insufficient or contraindicated. |
14. Carglumic Acid Dispersible Tablets
1 | Generic Name | Carglumic Acid Dispersible Tablets |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Recordati Rare Diseases |
6 | Approval Date | 27/06/2023 |
7 | Acceptance to Approval | 455 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | CPS1 |
10 | Indication(s) | Indicated for the treatment of adults and pediatric patients with hyperammonemia caused by
|
15. Lusutrombopag Tablets
1 | Generic Name | Lusutrombopag Tablets |
2 | Brand Name | MULPLETA (稳可达) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Shionogi Inc. |
6 | Approval Date | 27/06/2023 |
7 | Acceptance to Approval | 574 days |
8 | Priority Review | No |
9 | Target(s) | Thrombopoietin receptor (TPO-R) |
10 | Indication(s) | Indicated for adult patients who have chronic liver disease (CLD) with thrombocytopenia and are scheduled to receive surgery. |
16. Pralsetinib Capsules
1 | Generic Name | Pralsetinib Capsules |
2 | Brand Name | GAVRETO (普吉华) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Genentech Inc. (member of the Roche Group) |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 251 days |
8 | Priority Review | No |
9 | Target(s) | Proto-oncogene tyrosine-protein kinase receptor Ret (RET) |
10 | Indication(s) | Previously approved: 1. Indicated for the treatment of locally advanced or metastatic NSCLC that is RET fusion-positive. 2. Indicated for the treatment of - adults and pediatric patients aged 12 years and older who require systemic therapy for advanced or metastatic RET-mutant medullary thyroid carcinoma (MTC), and - adult and pediatric patients aged 12 years and older who require systemic therapy for advanced or metastatic RET fusion-positive thyroid cancer which is difficult to be treated by using radioactive iodine (if radioactive iodine is applicable). Newly approved: 3. Indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC which is RET fusion-positive. |
17. Triptorelin Pamoate for Injection
1 | Generic Name | Triptorelin Pamoate for Injection |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | IPSEN PHARMA |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 961 days |
8 | Priority Review | No |
9 | Target(s) | Gonadotropin-releasing hormone receptor (GnRH receptor) |
10 | Indication(s) | Indicated for the treatment of locally advanced or metastatic prostate cancer. |
18. ω-3 Fish Oil Medium and Long Chain Fat Emulsion / Amino Acid (16) / Glucose (36%) Injection
1 | Generic Name | ω-3 Fish Oil Medium and Long Chain Fat Emulsion / Amino Acid (16) / Glucose (36%) Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | Kelun Industry Group |
6 | Approval Date | 07/06/2023 |
7 | Acceptance to Approval | 866 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Used as a nutritional supplement for adult patients with moderate to severe catabolism who cannot take nutrition orally or enterally. |
11 | Notes | First generic drug in China |
19. Amisulpride Oral Solution
1 | Generic Name | Amisulpride Oral Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Jincheng Jinsu Pharmaceutical Co., Ltd. |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 561 days |
8 | Priority Review | No |
9 | Target(s) | 5-hydroxytryptamine receptor 7 (5-HT7); D (2) dopamine receptor (DRD2); D (3) dopamine receptor (DRD3) |
10 | Indication(s) | Indicated for the treatment of schizophrenia. |
11 | Notes | First generic drug in China |
20. Amlodipine Besilate and Benazepril Hydrochloride Capsules
1 | Generic Name | Amlodipine Besilate and Benazepril Hydrochloride Capsules |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Guangzhou Hairui Pharmaceutical, subsidiary of Yangtze River Pharmaceutical Group |
6 | Approval Date | 07/06/2023 |
7 | Acceptance to Approval | 594 days |
8 | Priority Review | No |
9 | Target(s) | Angiotensin-converting enzyme (ACE) |
10 | Indication(s) | Indicated for the treatment of hypertension patients whose conditions have not been sufficiently controlled by any single drug. |
11 | Notes | First generic drug in China |
21. Enarodustat Tablets
1 | Generic Name | Enarodustat Tablets |
2 | Brand Name | 恩那罗 (En Na Luo) |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Shenzhen Salubris Pharmaceuticals Co., Ltd. |
6 | Approval Date | 07/06/2023 |
7 | Acceptance to Approval | 519 days |
8 | Priority Review | No |
9 | Target(s) | Hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) |
10 | Indication(s) | Indicated for the treatment of anemia in adults with chronic kidney disease (CKD) and not on dialysis. The condition is also known as renal anemia. |
11 | Notes | First generic drug in China |
22. Calcitriol Oral Solution
1 | Generic Name | Calcitriol Oral Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | CP Pharmaceutical Qingdao |
6 | Approval Date | 14/06/2023 |
7 | Acceptance to Approval | 670 days |
8 | Priority Review | No |
9 | Target(s) | Vitamin D3 receptor (VDR) |
10 | Indication(s) | 1. Indicated for the treatment of rickets, including vitamin D-dependent rickets, hypophosphatemic vitamin D-resistant rickets, etc. 2. Indicated for the treatment of osteoporosis (mainly used on postmenopausal women and for treating senile osteoporosis). 3. Indicated for the treatment of idiopathic, pseudo and postoperative hypoparathyroidism. High-dose intravenous administration can be used for treating pseudohypoparathyroidism caused by renal failure. 4. Indicated for the treatment of renal osteodystrophy, such as renal osteodystrophy caused by chronic renal failure in patients (especially those undergoing hemodialysis or peritoneal dialysis). 5. Indicated for the treatment of osteomalacia. |
11 | Notes | First generic drug in China |
23. Lubiprostone Soft Capsules
1 | Generic Name | Lubiprostone Soft Capsules |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | 27/06/2023 |
6 | Approval Date | Nanjing Chia-Tai Tianqing Pharmaceutical Company (NJCTTQ) |
7 | Acceptance to Approval | 911 days |
8 | Priority Review | No |
9 | Target(s) | Chloride channel protein 2 (ClC-2) |
10 | Indication(s) | 1. Indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 2. Indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old. |
11 | Notes | First generic drug in China |
24. Clofarabine Injection
1 | Generic Name | Clofarabine Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Hefei Yifan Pharmaceutical Co., Ltd. |
6 | Approval Date | 27/06/2023 |
7 | Acceptance to Approval | 697 days |
8 | Priority Review | No |
9 | Target(s) | DNA; DNA pol |
10 | Indication(s) | Indicated for treating relapsed/refractory acute lymphoblastic leukemia (ALL) patients aged 1-21 years old who have received at least two regimens before cannot get sustained response from other treatments. |
11 | Notes | First generic drug in China |
25. Minoxidil Topical Solution
1 | Generic Name | Minoxidil Topical Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Jewim Pharmaceutical (Shandong) Co., Ltd. |
6 | Approval Date | 27/06/2023 |
7 | Acceptance to Approval | 719 days |
8 | Priority Review | No |
9 | Target(s) | Potassium channel (K+ channel); Voltage-gated potassium channel (VGKC) |
10 | Indication(s) | Indicated for hair regrowth treatment for men. |
11 | Notes | First generic drug in China |
26. Balanced Salt Solution for Irrigating Eyes
1 | Generic Name | Balanced Salt Solution for Irrigating Eyes |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Hubei Yuanda Tianming Pharmaceutical Co., Ltd. |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 1,469 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye, with an expected maximum duration of 60 minutes. |
11 | Notes | First generic drug in China |
27. Equecabtagene Autoleucel Injection
1 | Generic Name | Equecabtagene Autoleucel Injection |
2 | Brand Name | 福可苏 (FUCASO) |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | Biologics License Application (BLA) |
5 | MAH | IASO Biotherapeutics |
6 | Approval Date | 30/06/2023 |
7 | Acceptance to Approval | Not revealed |
8 | Priority Review | Yes (breakthrough therapy) |
9 | Target(s) | / |
10 | Indication(s) | Indicated for the treatment of adult patients with relapsed/refractory multiple myeloma who have previously received three or more lines of systemic therapy. |
28. Telpegfilgrastim Injection
1 | Generic Name | Telpegfilgrastim Injection |
2 | Brand Name | 珮金 (Pei Jin) |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Xiamen Amoytop Biotech Co., Ltd. |
6 | Approval Date | 30/06/2023 |
7 | Acceptance to Approval | Not revealed |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for reducing the incidence of infection manifested by febrile neutropenia in patients who have non-myeloid malignant tumors and are taking myelosuppressive anticancer drugs prone to cause febrile neutropenia. |
29. Nimotuzumab Injection
1 | Generic Name | Nimotuzumab Injection |
2 | Brand Name | 泰欣生 (Tai Xin Sheng) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | |
6 | Approval Date | 07/06/2023 |
7 | Acceptance to Approval | 408 days |
8 | Priority Review | No |
9 | Target(s) | Epidermal growth factor receptor (EGFR) |
10 | Indication(s) | Previously approved: 1. Used in combination with radiotherapy to treat stage III/IV EGFR-positive nasopharyngeal carcinoma. Newly approved: 2. Used in combination with gemcitabine for the treatment of patients with pancreatic cancer. |
30. Omalizumab Injection
1 | Generic Name | Omalizumab Injection |
2 | Brand Name | Xolair (茁乐) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Novartis Europharm Limited |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 337 days |
8 | Priority Review | No |
9 | Target(s) | Immunoglobulin E (IgE) |
10 | Indication(s) | Previously approved: 1. Indicated for treating moderate to severe, allergic asthma in adults and pediatric patients 6 years of age or older. Newly approved: 2. Indicated for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment. |
31. Eculizumab Injection
1 | Generic Name | Eculizumab Injection |
2 | Brand Name | Soliris (舒立瑞) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Alexion Europe SAS |
6 | Approval Date | 07/06/2023 |
7 | Acceptance to Approval | 324 days |
8 | Priority Review | No |
9 | Target(s) | Complement C5 |
10 | Indication(s) | Previously approved: 1. For the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and pediatric patients. Newly approved: 2. For the treatment of refractory generalized myasthenia gravis (gMG) in adult patients who are acetylcholine receptor (AChR) antibody-positive. |
32. Efgartigimod Alfa Injection
1 | Generic Name | Efgartigimod Alfa Injection |
2 | Brand Name | VYVGART (卫伟迦) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | argenx BV |
6 | Approval Date | 30/06/2023 |
7 | Acceptance to Approval | 351 days |
8 | Priority Review | No |
9 | Target(s) | Neonatal Fc receptor (FcRn) |
10 | Indication(s) | Used in combination with conventional drugs for the treatment of gMG adult patients who are AChR antibody-positive. |
33. Axicabtagene Ciloleucel Injection
1 | Generic Name | Axicabtagene Ciloleucel Injection |
2 | Brand Name | 奕凯达 (Yi Kai Da) |
3 | Classification | Class 3.2 therapeutic biological product |
4 | Application Type | BLA, domestic |
5 | MAH | Fosun Kite Biotechnology Co., Ltd. |
6 | Approval Date | 21/06/2023 |
7 | Acceptance to Approval | 239 days |
8 | Priority Review | No |
9 | Target(s) | B-lymphocyte antigen CD19 |
10 | Indication(s) | Previously approved: 1. Indicated for adult patients with relapsed/refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. Specific indications include diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Newly approved: 2. Indicated for the treatment of r/r LBCL adult patients for whom the first-line immunochemotherapy failed or the disease relapsed within 12 months after the first-line immunochemotherapy. |
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