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 June 2024, China NMPA approved 59 new drugs, among which 47 are chemical drugs and 12 are biological products. The details are shown as follows:
1. Rilertinib Mesylate Tablets
Generic name | Rilertinib Mesylate Tablets |
Brand | 圣瑞沙（Sheng Rui Sha） |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Nanjing Sanhome Pharmaceutical Co., Ltd. |
Approved | 2024/6/11 |
Time from application acceptance to approval | 896 days |
Priority review | No |
Target(s) | Epidermal growth factor receptor |
Indication(s) | Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have both experienced disease progression during or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), and confirmed to have the EGFR T790M mutation. |
2. Golidocitinib Capsules
Generic name | Golidocitinib Capsules |
Brand | 高瑞哲（Gao Rui Zhe） |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Dizal Pharmaceutical Co.,Ltd. |
Approved | 2024/6/18 |
Time from application acceptance to approval | 278 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | Tyrosine-protein kinase JAK1 |
Indication(s) | Indicated for adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have previously received at least one standard treatment. |
3. Fultagliptin Benzoate Tablets
Generic name | Fultagliptin Benzoate Tablets |
Brand | 信立汀(Xin Li Ting) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Shenzhen Salubris Pharmaceuticals Co., Ltd |
Approved | 2024/6/28 |
Time from application acceptance to approval | 504 days |
Priority review | No |
Target(s) | Dipeptidyl peptidase 4 |
Indication(s) | Indicated for improving glycemic control in adult patients with type 2 diabetes. |
4. Bevifibatide Citrate Injection
Generic name | Bevifibatide Citrate Injection |
Brand | 贝塔宁（BETAGRIN） |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Bio-Thera Solutions Inc. |
Approved | 2024/6/25 |
Time from application acceptance to approval | 1350 days |
Priority review | No |
Target(s) | Integrin alpha IIb beta 3 |
Indication(s) | Indicated for patients with acute coronary syndrome undergoing percutaneous coronary intervention (including coronary stent implantation) to reduce the risk of acute occlusion, in-stent thrombosis, no-reflow, and slow flow. |
5. Envonalkib Citrate Capsules
Generic name | Envonalkib Citrate Capsules |
Brand | 安洛晴（An Luo Qing） |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
Approved | 2024/6/11 |
Time from application acceptance to approval | 753 days |
Priority review | No |
Target(s) | ALK tyrosine kinase receptor Hepatocyte growth factor receptor |
Indication(s) | Indicated for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and without ALK inhibitor treatment before. |
6. Cofrogliptin Tablets
Generic name | Cofrogliptin Tablets |
Brand | 倍长平（Bei Chang Ping） |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Haisco Pharmaceutical Group Co., Ltd.; |
Approved | 2024/6/18 |
Time from application acceptance to approval | 506 days |
Priority review | No |
Target(s) | Dipeptidyl peptidase 4 |
Indication(s) | Indicated for improving glycemic control in adult patients with type 2 diabetes. |
7. Rotigotine Microspheres for Injection
Generic name | Rotigotine Microspheres for Injection |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Luye Jiaao (Shijiazhuang) Pharmaceutical Co., Ltd. |
Approved | 2024/6/18 |
Time from application acceptance to approval | 321 days |
Priority review | Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases) |
Target(s) | 5-HTR, Adrenergic receptor, DA receptor, DRD1, DRD2, DRD3, DRD4, DRD5 |
Indication(s) | Indicated for the treatment of Parkinson's disease. |
8. Chloral Hydrate Syrup
Generic name | Chloral Hydrate Syrup |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Hainan Pengkang Pharmaceutical Group Co., Ltd |
Approved | 2024/6/28 |
Time from application acceptance to approval | 827 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated as a sedative and hypnotic. |
9. Naltrexone Hydrochloride Implants
Generic name | Naltrexone Hydrochloride Implants |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | SciencienCare Pharmaceutical Technology Co.,Ltd. |
Approved | 2024/6/25 |
Time from application acceptance to approval | 504 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | Opioid receptor |
Indication(s) | Indicated for the prevention of relapse in patients with opioid dependence following detoxification. |
10. Alectinib Hydrochloride Capsules
Generic name | Alectinib Hydrochloride Capsules |
Brand | Alecensa |
Classification | Class 2.4 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Roche Registration GmbH; |
Approved | 2024/6/28 |
Time from application acceptance to approval | 211 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | ALK tyrosine kinase receptor Proto-oncogene tyrosine-protein kinase receptor Ret |
Indication(s) | Indicated for adjuvant treatment after complete tumor resection in patients with ALK-positive non-small cell lung cancer. |
11. Henagliflozin Proline Tablets
Generic name | Henagliflozin Proline Tablets |
Brand | 瑞沁(Rui Qin) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
Approved | 2024/6/25 |
Time from application acceptance to approval | 272 days |
Priority review | No |
Target(s) | Sodium/glucose cotransporter 2 |
Indication(s) | Indicated in combination with metformin hydrochloride and sitagliptin phosphate: When metformin hydrochloride alone does not achieve adequate blood glucose control, this product can be used together with metformin hydrochloride and sitagliptin phosphate, along with dietary changes and exercise, to enhance glycemic control in adult patients with type 2 diabetes mellitus. |
12. Osimertinib Mesylate Tablets
Generic name | Osimertinib Mesylate Tablets |
Brand | TAGRISSO |
Classification | Class 2.4 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | AstraZeneca AB; |
Approved | 2024/6/18 |
Time from application acceptance to approval | 271 days |
Priority review | No |
Target(s) | EGFR T790M mutation |
Indication(s) | Indicated as first-line treatment in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, in combination with pemetrexed and platinum-based chemotherapy. |
13. Levofloxacin Oral Solution
Generic name | Levofloxacin Oral Solution |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Hubei Jinluo Silk Cloth Co., Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 409 days |
Priority review | No |
Target(s) | Bacterial DNA topoisomerase II |
Indication(s) | Indicated for the treatment of various bacterial infections. |
Notes | First generic in China |
14. Rivastigmine Bitartrate Oral Solution
Generic name | Rivastigmine Bitartrate Oral Solution |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Shandong Loncom Pharmaceutical Co., Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 476 days |
Priority review | No |
Target(s) | Acetylcholinesterase |
Indication(s) | Indicated as a first-line treatment for mild to moderate Alzheimer's disease. |
Notes | First generic in China |
15. Cetirizine Hydrochloride Injection
Generic name | Cetirizine Hydrochloride Injection |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Shandong Cosci Med-tech Co., Ltd.; |
Approved | 2024/6/28 |
Time from application acceptance to approval | 479 days |
Priority review | No |
Target(s) | Histamine H1 receptor |
Indication(s) | Indicated for the treatment of acute urticaria in adults. |
Notes | First generic in China |
16. Fexofenadine Hydrochloride for Suspension
Generic name | Fexofenadine Hydrochloride for Suspension |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Jumpcan Pharmaceutical Group Co., Ltd. |
Approved | 2024/6/11 |
Time from application acceptance to approval | 578 days |
Priority review | No |
Target(s) | Histamine H1 receptor |
Indication(s) | Indicated for alleviating symptoms of seasonal allergic rhinitis in individuals aged 6 months and older. It is also used to relieve skin symptoms of chronic idiopathic urticaria in those 6 months and older individuals. |
Notes | First generic in China |
17. Progesterone Injection（II）
Generic name | Progesterone Injection（II） |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Changchun GeneScience Pharmaceutical Co., Ltd.; |
Approved | 2024/6/18 |
Time from application acceptance to approval | 452 days |
Priority review | No |
Target(s) | PGR |
Indication(s) | Indicated for supplemental progesterone therapy in assisted reproductive technology (ART), specifically for women who are unable to use or tolerate vaginal formulations. |
Notes | First generic in China |
18. Pregabalin Orally Disintegrating Tablet
Generic name | Pregabalin Orally Disintegrating Tablet |
Brand | \ |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | DiQi Pharmaceuticals Co.,Ltd.; |
Approved | 2024/6/28 |
Time from application acceptance to approval | 628 days |
Priority review | No |
Target(s) | CACNA2D1 CACNA2D2 |
Indication(s) | Indicated for neuropathic pain and pain associated with fibromyalgia. |
Notes | First generic in China |
19. Phloroglucinol Orally Disintegrating Tablets
Generic name | Phloroglucinol Orally Disintegrating Tablets |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Renhe Yikang Group Co., Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 533 days |
Priority review | Yes |
Target(s) | / |
Indication(s) | Indicated for acute spasmodic pain caused by gastrointestinal and biliary tract dysfunction. |
Notes | First generic in China |
20. Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules
Generic name | Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Harvest(Hunan) Pharmaceuticals Co.,Ltd |
Approved | 2024/6/4 |
Time from application acceptance to approval | 386 days |
Priority review | Yes (Pediatric drug) |
Target(s) | / |
Indication(s) | Indicated for the treatment of hypophosphatemia. |
Notes | First generic in China |
21. Technetium [⁹⁹ᵐTc] Tetrofosmin Injection
Generic name | Technetium [⁹⁹ᵐTc] Tetrofosmin Injection |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Nanjing JYAMS Electronic Research & Development Co., Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 661 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for myocardial perfusion imaging under both drug-induced and resting conditions. |
Notes | First generic in China |
22. Brivaracetam Tablets
Generic name | Brivaracetam Tablets |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Qingfeng Pharmaceutical Group Co.Ltd |
Approved | 2024/6/28 |
Time from application acceptance to approval | 489 days |
Priority review | No |
Target(s) | Synaptic vesicle glycoprotein 2A |
Indication(s) | Indicated for monotherapy and adjunctive therapy of partial seizures in patients aged 16 and older with epilepsy. |
Notes | First generic in China |
23. Olmesartan Medoxomil Orally Disintegrating Tablets
Generic name | Olmesartan Medoxomil Orally Disintegrating Tablets |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | ApicHope Pharmaceutical Co., Ltd |
Approved | 2024/6/25 |
Time from application acceptance to approval | 545 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of hypertension. |
Notes | First generic in China |
24. Valganciclovir Hydrochloride Tablets
Generic name | Valganciclovir Hydrochloride Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Shanghai Zhongxi Sunve Pharmaceutical Co.,Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 680 days |
Priority review | No |
Target(s) | viral polymerase |
Indication(s) | Indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). |
Notes | First generic in China |
25. Estradiol Valerate Tablets
Generic name | Estradiol Valerate Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Zhejiang Xianju Pharmaceutical Co., Ltd |
Approved | 2024/6/28 |
Time from application acceptance to approval | 675 days |
Priority review | No |
Target(s) | Estrogen |
Indication(s) | Indicated for supplementing estrogen deficiency primarily associated with natural or surgical menopause. |
Notes | First generic in China |
26. Telmisartan and Amlodipine Tablets
Generic name | Telmisartan and Amlodipine Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Jiangxi Shimei Pharmaceutical Co., Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 507 days |
Priority review | No |
Target(s) | Calcium channel Type-1 angiotensin II receptor |
Indication(s) | Indicated for the treatment of primary hypertension. |
Notes | First generic in China |
27. Ticagrelor Dispersible Tablets
Generic name | Ticagrelor Dispersible Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Honghe Pharmaceutical Co., Ltd.; |
Approved | 2024/6/18 |
Time from application acceptance to approval | 692 days |
Priority review | No |
Target(s) | P2Y purinoceptor 12 |
Indication(s) | Indicated for acute coronary syndrome (ACS). |
Notes | First generic in China |
28. Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation
Generic name | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Joincare Pharmaceutical Group Industry Co.,Ltd.; |
Approved | 2024/6/4 |
Time from application acceptance to approval | 481 days |
Priority review | No |
Target(s) | Beta-2 adrenergic receptor |
Indication(s) | Indicated for the regular treatment of reversible obstructive airway diseases, including asthma, in adults and children. |
Notes | First generic in China |
29. Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-Release Tablets
Generic name | Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-Release Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Shandong Luye Pharmaceutical Co., Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 503 days |
Priority review | No |
Target(s) | 12-oxophytodienoate reductase |
Indication(s) | Indicated for the management of severe pain in adults that requires opioid analgesics for adequate control, including both cancer-related pain and non-cancer pain. |
Notes | First generic in China |
30. Palbociclib Tablets
Generic name | Palbociclib Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | CSPC Ouyi Pharmaceutical Co., Ltd. |
Approved | 2024/6/25 |
Time from application acceptance to approval | 549 days |
Priority review | No |
Target(s) | Cyclin-dependent kinase 4 Cyclin-dependent kinase 6 |
Indication(s) | Indicated in combination with an aromatase inhibitor for the initial endocrine treatment of locally advanced or metastatic breast cancer in postmenopausal women with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative disease. |
Notes | First generic in China |
31. Carbidopa and Levodopa Sustained-release Tablets
Generic name | Carbidopa and Levodopa Sustained-release Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | SJZ No.4 Pharmaceutical Co., Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 514 days |
Priority review | No |
Target(s) | Aromatic-L-amino-acid decarboxylase Dopamine receptor |
Indication(s) | Indicated for the treatment of primary Parkinson's disease, post-encephalitic Parkinsonism, symptomatic Parkinsonism, Parkinson's disease, or Parkinsonism in patients taking vitamin preparations containing pyridoxine (vitamin B6). |
Notes | First generic in China |
32. Calcipotriol Scalp Solution
Generic name | Calcipotriol Scalp Solution |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Sinomune Pharmaceutical Co., Ltd |
Approved | 2024/6/28 |
Time from application acceptance to approval | 513 days |
Priority review | No |
Target(s) | vitamin D3 |
Indication(s) | Indicated for the treatment of scalp psoriasis. |
Notes | First generic in China |
33. Calcitriol Injection
Generic name | Calcitriol Injection |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Chengdu Gowell Biopharmaceutical Co., Ltd. |
Approved | 2024/6/11 |
Time from application acceptance to approval | 579 days |
Priority review | No |
Target(s) | vitamin D3 |
Indication(s) | Indicated for the treatment of hypocalcemia and/or secondary hyperparathyroidism in patients undergoing chronic renal dialysis. |
Notes | First generic in China |
34. Metformin Hydrochloride and Empagliflozin Tablets（Ⅵ）
Generic name | Metformin Hydrochloride and Empagliflozin Tablets（Ⅵ） |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Qilu Pharmaceutical Co., Ltd. |
Approved | 2024/6/18 |
Time from application acceptance to approval | 516 days |
Priority review | No |
Target(s) | 5'-AMP-activated protein kinase sodium/glucose cotransporter 2 |
Indication(s) | Indicated for improving glycemic control in adults with type 2 diabetes. |
Notes | First generic in China |
35. Tafamidis Meglumine Soft Capsules
Generic name | Tafamidis Meglumine Soft Capsules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Qilu Pharmaceutical Co., Ltd. |
Approved | 2024/6/11 |
Time from application acceptance to approval | 517 days |
Priority review | No |
Target(s) | Transthyretin |
Indication(s) | Indicated for treating symptomatic stage I transthyretin amyloid polyneuropathy (ATTR-PN) in adults, and effectively slowing the progression of peripheral nerve damage. |
Notes | First generic in China |
36. Evocalcet Tablets
Generic name | Evocalcet Tablets |
Brand | ORKEDIA |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Kyowa Kirin Co., Ltd. |
Approved | 2024/6/4 |
Time from application acceptance to approval | 657 days |
Priority review | No |
Target(s) | Extracellular calcium-sensing receptor |
Indication(s) | Indicated for the treatment of secondary hyperparathyroidism associated with chronic kidney disease. |
37. Capmatinib Hydrochloride Tablets
Generic name | Capmatinib Hydrochloride Tablets |
Brand | Tabrecta |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Novartis Pharma Schweiz AG; |
Approved | 2024/6/11 |
Time from application acceptance to approval | 472 days |
Priority review | No |
Target(s) | Hepatocyte growth factor receptor |
Indication(s) | Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping mutations and without prior systemic therapy. |
38. Methylthioninium Chloride Enteric-coated Sustained-release Tablets
Generic name | Methylthioninium Chloride Enteric-coated Sustained-release Tablets |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Alfasigma S.p.A.; |
Approved | 2024/6/11 |
Time from application acceptance to approval | 481 days |
Priority review | No |
Target(s) | Microtubule-associated protein tau |
Indication(s) | Indicated for enhancing the visualization of colorectal lesions in adult patients undergoing colonoscopy for screening or monitoring. |
39. Selinexor Tablets
Generic name | Selinexor Tablets |
Brand | XPOVIO |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Karyopharm Therapeutics Inc.; |
Approved | 2024/6/28 |
Time from application acceptance to approval | 261 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | Exportin-1 |
Indication(s) | Indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who have received at least two lines of systemic therapy, including DLBCL that has been transformed from follicular lymphoma. |
40. Avatrombopag Maleate Tablets
Generic name | Avatrombopag Maleate Tablets |
Brand | DOPTELET |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | AkaRx Inc.; |
Approved | 2024/6/18 |
Time from application acceptance to approval | 545 days |
Priority review | No |
Target(s) | Thrombopoietin receptor |
Indication(s) | Indicated for adult patients with chronic liver disease-related thrombocytopenia undergoing elective diagnostic procedures or surgery. |
41. Ruxolitinib Phosphate Tablets
Generic name | Ruxolitinib Phosphate Tablets |
Brand | Jakavi |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Novartis Pharma Schweiz AG; |
Approved | 2024/6/11 |
Time from application acceptance to approval | 355 days |
Priority review | No |
Target(s) | Tyrosine-protein kinase JAK1 Tyrosine-protein kinase JAK2 |
Indication(s) | Indicated for the treatment of chronic graft-versus-host disease (cGVHD) in patients aged 12 years and older who have not responded adequately to corticosteroids or other systemic therapies. |
42. Glucagon Nasal Powder
Generic name | Glucagon Nasal Powder |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Amphastar Pharmaceuticals, Inc. |
Approved | 2024/6/4 |
Time from application acceptance to approval | 673 days |
Priority review | No |
Target(s) | Glucagon receptor |
Indication(s) | Indicated for the treatment of severe hypoglycemia in diabetes patients aged 4 years and older. |
43. Icosapent Ethyl Soft Capsules
Generic name | Icosapent Ethyl Soft Capsules |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Amarin Pharmaceuticals Ireland Ltd. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 226 days |
Priority review | No |
Target(s) | Apolipoprotein B Phospholipase A2 |
Indication(s) | Indicated in combination with statins to prevent and reduce the risk of cardiovascular events in adult patients with diagnosed cardiovascular disease or diabetes with ≥2 other cardiovascular risk factors, and also with hypertriglyceridemia. |
44. Enzalutamide Soft Capsules
Generic name | Enzalutamide Soft Capsules |
Brand | XTANDI |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Astellas Pharma Europe B.V.; |
Approved | 2024/6/25 |
Time from application acceptance to approval | 280 days |
Priority review | No |
Target(s) | Androgen receptor |
Indication(s) | Indicated for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). |
45. Brexpiprazole Tablets
Generic name | Brexpiprazole Tablets |
Brand | REXULTI |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Otsuka Pharmaceutical Co.，Ltd. |
Approved | 2024/6/25 |
Time from application acceptance to approval | 549 days |
Priority review | No |
Target(s) | 5-HT1A 5-HT2A 5-HT2B 5-HT7 ADRA1A |
Indication(s) | Indicated for the treatment of schizophrenia and as an adjunctive therapy for major depressive disorder (MDD). |
46. Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol
Generic name | Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | AstraZeneca AB |
Approved | 2024/6/28 |
Time from application acceptance to approval | 340 days |
Priority review | No |
Target(s) | Glucocorticoid receptor |
Indication(s) | Indicated for the long-term maintenance treatment to reduce exacerbations of chronic obstructive pulmonary disease (COPD) and treat airflow obstruction in patients with COPD (including chronic bronchitis and/or emphysema) who are not adequately treated by a combination of an ICS/LABA or a combination of a LAMA/LABA. |
47. Mirogabalin Besilate Tablets
Generic name | Mirogabalin Besilate Tablets |
Brand | Tarlige |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | DAIICHI SANKYO CO., LTD. |
Approved | 2024/6/28 |
Time from application acceptance to approval | 531 days |
Priority review | No |
Target(s) | CACNA2D GABA |
Indication(s) | Indicated for the treatment of diabetic peripheral neuropathic pain in adults. |
48. Enlonstobart Injection
Generic name | Enlonstobart Injection |
Brand | 恩舒幸(En Shu Xing) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | CSPC Megalith Biopharmaceutial Co., Ltd. |
Approved | 2024/6/25 |
Time from application acceptance to approval | 473 days |
Priority review | No |
Target(s) | / |
Indication(s) | Intended for treating recurrent or metastatic cervical cancer patients who are PD-L1 positive and have not responded to at least one line of platinum-based chemotherapy. |
49. Insulin icodec Injection
Generic name | Insulin icodec Injection |
Brand | Awiqli |
Classification | Class 1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Novo Nordisk A/S; |
Approved | 2024/6/18 |
Time from application acceptance to approval | 408 days |
Priority review | No |
Target(s) | INS; InsR |
Indication(s) | Indicated for the treatment of type 2 diabetes in adults. |
50. Zamerovimab and Mazorelvimab Injection
Generic name | Zamerovimab and Mazorelvimab Injection |
Brand | 克瑞毕(Ke Ru Bi) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Synermore Biologics (Suzhou) Co., Ltd. |
Approved | 2024/6/4 |
Time from application acceptance to approval | 739 days |
Priority review | No |
Target(s) | Env gp |
Indication(s) | Indicated for passive immunization of adults exposed to rabies virus. |
51. Toripalimab Injection
Generic name | Toripalimab Injection |
Brand | 拓益(Tuo Yi) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Shanghai Junshi Biosciences Co., Ltd.; |
Approved | 2024/6/4 |
Time from application acceptance to approval | 321 days |
Priority review | No |
Target(s) | PD-1 |
Indication(s) | Indicated for the treatment of extensive-stage small cell lung cancer (SCLC). |
52. Tislelizumab Injection
Generic name | Tislelizumab Injection |
Brand | 百泽安(Bai ze An) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | BeiGene Ltd. |
Approved | 2024/6/25 |
Time from application acceptance to approval | 256 days |
Priority review | No |
Target(s) | PD-1 |
Indication(s) | Indicated for first-line treatment of extensive-stage small cell lung cancer (SCLC). |
53. Perfluoropropane-albumin Microspheres for Injection
Generic name | Perfluoropropane-albumin Microspheres for Injection |
Brand | / |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Xiamen Lizhuo Pharmaceutical Co., Ltd. |
Approved | 2024/6/18 |
Time from application acceptance to approval | 347 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for enhancing image clarity in situations where routine echocardiography is unclear, improving lesion detection and characterization, as well as better delineating the endocardial borders of the left ventricle. |
54. Cetuximab Beta Injection
Generic name | Cetuximab Beta Injection |
Brand | 恩立妥(En Li Tuo) |
Classification | Class 2.4 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Taizhou Mabtech Pharmaceutical Co. Ltd. |
Approved | 2024/6/18 |
Time from application acceptance to approval | 462 days |
Priority review | No |
Target(s) | EGFR |
Indication(s) | Indicated as a first-line treatment in combination with standard therapy for patients with metastatic colorectal cancer (mCRC). |
55. Ropeginterferon alfa-2b Injection
Generic name | Ropeginterferon alfa-2b Injection |
Brand | 百斯锐明(Bai Si Rui Ming) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | PharmaEssentia Corporation |
Approved | 2024/6/28 |
Time from application acceptance to approval | 500 days |
Priority review | No |
Target(s) | IFNA |
Indication(s) | Indicated for the treatment of polycythemia vera. |
56. Pembrolizumab Injection
Generic name | Pembrolizumab Injection |
Brand | Keytruda |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Merck Sharp & Dohme LLC |
Approved | 2024/6/18 |
Time from application acceptance to approval | 480 days |
Priority review | No |
Target(s) | PD-1 |
Indication(s) | Indicated for the treatment of unresectable or metastatic melanoma that has failed first-line therapy. |
57. Semaglutide Injection
Generic name | Semaglutide Injection |
Brand | Ozempic |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Novo Nordisk Pharma AG |
Approved | 2024/6/18 |
Time from application acceptance to approval | 381 days |
Priority review | No |
Target(s) | GLP-1R |
Indication(s) | Indicated as an adjunct to alow-calorie diet and increased physical activity for adult patients with an initial body mass index (BMI) ≥30 kg/m² (obesity) or ≥27 kg/m² and<30 kg/m² (overweight) with at least one weight-related comorbidity. |
58. Teclistamab Injection
Generic name | Teclistamab Injection |
Brand | TECVAYLI |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Janssen-Cilag International NV |
Approved | 2024/6/18 |
Time from application acceptance to approval | 304 days |
Priority review | Yes (granted breakthrough therapy designation; eligible for conditional approval) |
Target(s) | CD3 TNFRSF17 TNFSF13 |
Indication(s) | Indicated for the treatment of relapsed or refractory multiple myeloma in adult patients who have previously received at least three lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. |
59. Turoctocog alfa pegol for injection
Generic name | Turoctocog alfa pegol for injection |
Brand | Esperoct |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Novo Nordisk A/S |
Approved | 2024/6/28 |
Time from application acceptance to approval | 339 days |
Priority review | Yes(/) |
Target(s) | Factor VIII |
Indication(s) | Indicated for both preventive and acute treatment of hemophilia A in adults and children. |
Contact BaiPharm if you need more details of drug approvals in China.
