Editor's Notes: New drugs in this article refer to any of the following drugs:
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 term “first generic drug” is commonly used in the Chinese pharma industry but not specified in Chinese regulations.
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In May 2024, China NMPA approved 24 new drugs, among which 19 are chemical drugs and 5 are biological products. The details are shown as follows:
1. Sulbactam Sodium for Injection / Durlobactam Sodium for Injection (co-packaged)
Generic name | Sulbactam Sodium for Injection / Durlobactam Sodium for Injection (co-packaged) |
Brand | XACDURO |
Classification | Class 1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Entasis Therapeutics, Inc. |
Approved | 2024/5/15 |
Time from application acceptance to approval | 446 days |
Priority review | Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases) |
Indication(s) | Indicated for the treatment of infections caused by Acinetobacter baumannii-calcoaceticus complex in adults (including multidrug-resistant and carbapenem-resistant strains). |
2. Repotrectinib Capsules
Generic name | Repotrectinib Capsules |
Brand | AUGTYRO |
Classification | Class 1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Bristol-Myers Squibb Company |
Approved | 2024/5/8 |
Time from application acceptance to approval | 314 days |
Priority review | Yes (granted breakthrough therapy designation; eligible for conditional approval) |
Target(s) | ALK tyrosine kinase receptor Proto-oncogene tyrosine-protein kinase ROS1 Tropomyosin-related kinase |
Indication(s) | Indicated for the treatment of adults with ROS1-positive non-small cell lung cancer that is locally advanced or metastatic. |
3. Rezivertinib Mesylate Capsules
Generic name | Rezivertinib Mesylate Capsules |
Brand | 瑞必达 (Rui Bi Da) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Beta Pharma |
Approved | 2024/5/15 |
Time from application acceptance to approval | 1104 days |
Priority review | No |
Target(s) | Epidermal growth factor receptor |
Indication(s) | Indicated for the treatment of adults with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) that is locally advanced or metastatic, as confirmed by testing, and with disease progression during or after treatment with an EGFR tyrosine kinase inhibitor (TKI). |
4. Crisugabalin Besilate Capsules
Generic name | Crisugabalin Besilate Capsules |
Brand | 思美宁 (Si Mei Ning) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Haisco Pharmaceutical Group |
Approved | 2024/5/15 |
Time from application acceptance to approval | 566 days |
Priority review | No |
Target(s) | Gamma-aminobutyric acid Voltage-dependent calcium channel subunit alpha-2/delta |
Indication(s) | Indicated for the treatment of diabetic peripheral neuropathic pain in adults. |
5. Lansoprazole and Sodium Bicarbonate Capsules
Generic name | Lansoprazole and Sodium Bicarbonate Capsules |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
MAH | Encheng Group |
Approved | 2024/5/28 |
Time from acceptance to approval | 629 days |
Priority review | No |
Indication(s) | Indicated for the treatment of peptic ulcers and gastroesophageal reflux disease (GERD). |
6. Esomeprazole Magnesium and Sodium Bicarbonate Capsules
Generic name | Esomeprazole Magnesium and Sodium Bicarbonate Capsules |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
MAH | Encheng Group |
Approved | 2024/5/8 |
Time from acceptance to approval | 585 days |
Priority review | No |
Target(s) | Hydrogen/potassium-transporting ATPase |
Indication(s) | Indicated for the treatment of peptic ulcers and gastroesophageal reflux disease (GERD). |
7. Allisartan Isoproxil and Amlodipine Besylate Tablets
Generic name | Allisartan Isoproxil and Amlodipine Besylate Tablets |
Brand | 复立坦 (Fu Li Tan) |
Classification | Class 2.3 chemical drug |
Application type | NDA, domestic |
MAH | Shenzhen Salubris Pharmaceuticals Co., Ltd. |
Approved | 2024/5/15 |
Time from acceptance to approval | 559 days |
Priority review | No |
Target(s) | Long-lasting type calcium channel Type-1 angiotensin II receptor |
Indication(s) | Indicated for the treatment of primary hypertension in adults who have not achieved adequate blood pressure control after receiving monotherapy of either azilsartan medoxomil or amlodipine alone. |
8. Zanubrutinib Capsules
Generic name | Zanubrutinib Capsules |
Brand | 百悦泽 (BRUKINSA) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
MAH | BeiGene, Ltd. |
Approved | 2024/5/8 |
Time from acceptance to approval | 322 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | Tyrosine-protein kinase BTK |
Indication(s) | Indicated in combination with Obinutuzumab for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. |
9. Anlotinib Hydrochloride Capsules
Generic name | Anlotinib Hydrochloride Capsules |
Brand | 福可维 (Fu Ke Wei) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
MAH | CTTQ Pharma |
Approved | 2024/5/8 |
Time from acceptance to approval | 481 days |
Priority review | No |
Indication(s) | Indicated for combination therapy with Benmelstobart Injection for the first-line treatment of patients with extensive-stage small cell lung cancer. |
10. Fluzoparib Capsules
Generic name | Fluzoparib Capsules |
Brand | 艾瑞颐 (Ai Rui Yi) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
Approved | 2024/5/15 |
Time from acceptance to approval | 266 days |
Priority review | No |
Target(s) | Poly [ADP-ribose] polymerase |
Indication(s) | Indicated for the maintenance treatment of patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have undergone first-line platinum-based chemotherapy. |
11. Fluocinolone acetonide, Hydroquinone and Tretinoin Cream
Generic name | Fluocinolone acetonide, Hydroquinone and Tretinoin Cream |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | Zhejiang Fonow Medicine Co., Ltd. |
Approved | 2024/5/28 |
Time from acceptance to approval | 734 days |
Priority review | No |
Indication(s) | Indicated for the treatment of reducing the appearance of dark spots associated with moderate-to-severe facial melasma. |
Notes | First generic in China |
12. Compound Sodium Acetate and Glucose Injection
Generic name | Compound Sodium Acetate and Glucose Injection |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | En Tai Pharmaceutical |
Approved | 2024/5/21 |
Time from acceptance to approval | 559 days |
Priority review | No |
Indication(s) | Indicated for supplementing and maintaining fluids and electrolytes, as well as providing energy when oral intake is not possible or insufficient. |
Notes | First generic in China |
13. Metoprolol Succinate Sustained-release Capsules
Generic name | Metoprolol Succinate Sustained-release Capsules |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | Cisen Pharmaceutical Co., Ltd. |
Approved | 2024/5/15 |
Time from acceptance to approval | 489 days |
Priority review | No |
Target(s) | Adrenergic receptor Beta adrenergic receptor Beta-1 adrenergic receptor |
Indication(s) | Indicated for the treatment of hypertension, angina pectoris, chronic heart failure with stable symptoms, and left ventricular systolic dysfunction. |
Notes | First generic in China |
14. Tacrolimus Granules
Generic name | Tacrolimus Granules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | Huadong Medicine Co.,Ltd |
Approved | 2024/5/21 |
Time from acceptance to approval | 490 days |
Priority review | No |
Target(s) | Calcineurin |
Indication(s) | Indicated for the treatment of graft rejection in children after receiving liver or kidney transplantation when other immunosuppressive medications fail to control the condition. |
Notes | First generic in China |
15. Pitolisant Hydrochloride Tablets
Generic name | Pitolisant Hydrochloride Tablets |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | Bioprojet Pharma |
Approved | 2024/5/21 |
Time from acceptance to approval | 327 days |
Priority review | Yes (Pediatric use) |
Target(s) | Histamine H3 receptor |
Indication(s) | Indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adolescents and children over 6 years old. |
16. Tirzepatide Injection
Generic name | Tirzepatide Injection |
Brand | MOUNJARO |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | Eli Lilly and Company |
Approved | 2024/5/15 |
Time from acceptance to approval | 616 days |
Priority review | No |
Target(s) | Gastric inhibitory polypeptide receptor Glucagon-like peptide 1 receptor |
Indication(s) | Indicated for blood glucose control in adult patients with type 2 diabetes. |
17. Lidocaine Cataplasms
Generic name | Lidocaine Cataplasms |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | Teikoku Pharma USA, Inc. |
Approved | 2024/5/8 |
Time from acceptance to approval | 676 days |
Priority review | No |
Target(s) | Sodium channel protein type 1 subunit alpha Sodium channel protein type 10 subunit alpha Sodium channel protein type 11 subunit alpha Sodium channel protein type 2 subunit alpha Sodium channel protein type 3 subunit alpha |
Indication(s) | Applied on intact skin for the relief of postherpetic neuralgia. |
18. Fludrocortisone Acetate Tablets
Generic name | Fludrocortisone Acetate Tablets |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | ASPEN PHARMA TRADING LIMITED |
Approved | 2024/5/21 |
Time from acceptance to approval | 404 days |
Priority review | Yes (Priority review) |
Target(s) | Glucocorticoid |
Indication(s) | Indicated for partial replacement therapy in Addison's disease (primary adrenocortical insufficiency) and for the treatment of salt-losing adrenogenital syndrome. |
19. Octreotide Acetate Injection
Generic name | Octreotide Acetate Injection |
Brand | Sandostatin |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
MAH | Novartis Pharma Schweiz AG |
Approved | 2024/5/28 |
Time from acceptance to approval | 570 days |
Priority review | No |
Target(s) | Somatostatin receptor type 2 Somatostatin receptor type 3 Somatostatin receptor type 5 |
Indication(s) | Indicated for the treatment of acromegaly, the relief of symptoms associated with functional gastroenteropancreatic endocrine tumors, the prevention of postoperative complications following pancreatic surgery, and the management of bleeding from esophageal varices. |
20. Ivonescimab Injection
Generic name | Ivonescimab Injection |
Brand | 依达方 (Yi Da Fang) |
Classification | Class 1 therapeutic biological product |
Application type | Biologics license application (BLA), domestic |
MAH | Akeso, Inc. |
Approved | 2024/5/21 |
Time from acceptance to approval | 294 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | Programmed cell death protein 1 Vascular endothelial growth factor |
Indication(s) | Indicated in combination with pemetrexed and carboplatin for the treatment of locally advanced or metastatic EGFR-mutated non-squamous non-small cell lung cancer that has progressed following treatment with an EGFR tyrosine kinase inhibitor (EGFR-TKI). |
21. Botulinum Toxin Type A for Injection
Generic name | Botulinum Toxin Type A for Injection |
Brand | / |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, imported |
MAH | AbbVie Limited |
Approved | 2024/5/28 |
Time from acceptance to approval | 343 days |
Priority review | No |
Target(s) | Botulinum neurotoxin type A |
Indication(s) | Indicated for the treatment of blepharospasm, hemifacial spasm, and associated focal dystonia in patients aged 12 years and older. Temporarily improves moderate to severe glabellar lines caused by corrugator and/or procerus muscle activity in adults aged 65 and younger. Temporarily improves moderate to severe lateral canthal lines (crow's feet) in adults. |
22. Denosumab Injection
Generic name | Denosumab Injection |
Brand | 博洛加 (Bo Luo Jia) |
Classification | Class 3.3 therapeutic biological product |
Application type | BLA, domestic |
MAH | Boan Biotech |
Approved | 2024/5/21 |
Time from acceptance to approval | 427 days |
Priority review | No |
Target(s) | Tumor necrosis factor ligand superfamily member 11 |
Indication(s) | Indicated for the treatment of giant cell tumor of bone in adults and skeletally mature adolescents for whom surgical resection is not feasible or may lead to significant functional impairment. |
23. Human Prothrombin Complex
Generic name | Human Prothrombin Complex |
Brand | / |
Classification | Class 3.4 therapeutic biological product |
Application type | BLA, imported |
MAH | Weiguang Biological |
Approved | 2024/5/21 |
Time from acceptance to approval | 550 days |
Priority review | No |
Target(s) | Coagulation factor IX Coagulation factor VII Coagulation factor X Thrombin |
Indication(s) | Indicated for the treatment of congenital and acquired deficiencies of coagulation factors II, VII, IX, and X, either alone or in combination with other therapies. |
24. Mixed Protamine Zinc Insulin Lispro Injection (50R)
Generic name | Recombinant Human Thrombopoietin Injection |
Brand | / |
Classification | Class 3.3 therapeutic biological product |
Application type | BLA, domestic |
MAH | Wanbang Biopharma |
Approved | 2024/5/21 |
Time from acceptance to approval | 659 days |
Priority review | No |
Indication(s) | Indicated for patients with diabetes requiring insulin treatment. |
Contact BaiPharm if you need more details of drug approvals in China.
