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 December 2024, China NMPA approved 45 new drugs, among which 30 are chemical drugs and 15 are biological products. The details are shown as follows:
1. Linaprazan Glurate Capsules
Generic name | Linaprazan Glurate Capsules |
Brand | Xin Li An (信立安) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Sinorda Biomedicine |
Approved | 2024/12/01 |
Time from application acceptance to approval | 659 days |
Priority review | No |
Target(s) | H+/K+ ATPase |
Indication(s) | Indicated for the treatment of reflux esophagitis |
2. Taletrectinib Adipate Capsules
Generic name | Taletrectinib Adipate Capsules |
Brand | Da Bo Le (达伯乐) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | AnHeart Therapeutics |
Approved | 2024/12/17 |
Time from application acceptance to approval | 391 days |
Priority review | Yes (granted breakthrough therapy designation, eligible for conditional approval) |
Target(s) | ROS1; Trk |
Indication(s) | Indicated for the treatment of adult patients with ROS1-positive, locally advanced, or metastatic non-small cell lung cancer (NSCLC) following disease progression on or after ROS1 tyrosine kinase inhibitor (TKI) therapy |
3. Sentagliptin Phosphate Tablets
Generic name | Sentagliptin Phosphate Tablets |
Brand | Sheng Jie Wei (盛捷维) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | CGeneTech (Suzhou,China) Co., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 668 days |
Priority review | No |
Target(s) | DPP4 |
Indication(s) | Indicated for the treatment of type 2 diabetes |
4. Edaravone and Dexborneol Sublingual Tablets
Generic name | Edaravone and Dexborneol Sublingual Tablets |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Simcere Pharmaceutical Group Limited |
Approved | 2024/12/01 |
Time from application acceptance to approval | 521 days |
Priority review | No |
Target(s) | Free radical; Inflammatory cytokine |
Indication(s) | Indicated for the improvement of neurological symptoms, functional disabilities, and activities of daily living associated with acute ischemic stroke |
5. Osimertinib Mesylate Tablets
Generic name | Osimertinib Mesylate Tablets |
Brand | TAGRISSO (泰瑞沙) |
Classification | Class 2.4 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | AstraZeneca AB |
Approved | 2024/12/25 |
Time from application acceptance to approval | 187 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | EGFR T790M |
Indication(s) | Indicated for the treatment of adult patients with locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC) characterized by epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, who have not shown disease progression following platinum-based chemoradiotherapy |
6. Apatinib Mesylate Tablets
Generic name | Apatinib Mesylate Tablets |
Brand | Ai Tan (艾坦) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 222 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | VEGFR-2 |
Indication(s) | Indicated in combination with fluzoparib for the treatment of HER2-negative breast cancer with germline BRCA mutations (gBRCAm) |
7. Fluzoparib Capsules
Generic name | Fluzoparib Capsules |
Brand | Ai Rui Yi (艾瑞颐) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 222 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | PARP |
Indication(s) | Indicated as monotherapy or in combination with apatinib mesylate for the treatment of patients with HER2-negative breast cancer harboring germline BRCA mutations (gBRCAm) |
8. Fruquintinib Capsules
Generic name | Fruquintinib Capsules |
Brand | Elunate (爱优特) |
Classification | Class 2.4 chemical drug |
Application type | NDA, domestic |
Marketing authorization holder (MAH) | Hutchison MediPharma Limited |
Approved | 2024/12/01 |
Time from application acceptance to approval | 247 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | FLT1; VEGFR-2; VEGFR-3 |
Indication(s) | Indicated in combination with sintilimab injection for the treatment of patients with advanced pMMR or non-MSI-H endometrial carcinoma who have experienced disease progression following prior systemic anti-cancer therapy and are not candidates for curative surgery or radiotherapy |
9. Fexofenadine Hydrochloride Oral Suspension
Generic name | Fexofenadine Hydrochloride Oral Suspension |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Hunan Nucien Pharmaceutical Co., Ltd. |
Approved | 2024/12/25 |
Time from application acceptance to approval | 691 days |
Priority review | No |
Target(s) | H1R |
Indication(s) | 1. Indicated for the relief of symptoms associated with seasonal allergic rhinitis in individuals aged 2 years and older |
Notes | First generic in China |
10. Lanthanum Carbonate Granules
Generic name | Lanthanum Carbonate Granules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Hunan Mingrui Pharmaceutical Co., Ltd. |
Approved | 2024/12/25 |
Time from application acceptance to approval | 438 days |
Priority review | No |
Target(s) | Phosphate |
Indication(s) | Indicated for the control of hyperphosphatemia in patients with chronic renal failure undergoing dialysis |
Notes | First generic in China |
11. Flurbiprofen Sodium Eye Drops
Generic name | Flurbiprofen Sodium Eye Drops |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Wuhan Leadpharm Pharmaceutical Technology Co., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 912 days |
Priority review | No |
Target(s) | COX |
Indication(s) | Indicated for postoperative anti-inflammatory treatment, including the management of inflammatory responses following laser trabeculoplasty and other anterior segment inflammations; for the prevention and treatment of macular cystoid edema following cataract intraocular lens implantation; for the treatment of giant papillary conjunctivitis; and for the inhibition of pupillary constriction during intraocular surgery. |
Notes | First generic in China |
12. Baclofen Oral Solution
Generic name | Baclofen Oral Solution |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Jiangsu Tasly Diyi Pharmaceutical CO., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 593 days |
Priority review | No |
Target(s) | GABABR |
Indication(s) | Indicated for the treatment of severe but reversible muscle spasms associated with multiple sclerosis, and may provide efficacy in spasms resulting from infectious, degenerative, traumatic, neoplastic, or idiopathic spinal cord conditions |
Notes | First generic in China |
13. Eltrombopag Olamine For Suspension
Generic name | Eltrombopag Olamine For Suspension |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Shandong Zezheng Pharmaceutical Technology Co., Ltd. |
Approved | 2024/12/17 |
Time from application acceptance to approval | 383 days |
Priority review | Yes (pediatric drug) |
Target(s) | TPO-R |
Indication(s) | Indicated for the treatment of chronic immune (idiopathic) thrombocytopenia (ITP) in adults and children aged 6 years and older |
Notes | First generic in China |
14. Travoprost and Timolol Maleate Eye Drops
Generic name | Travoprost and Timolol Maleate Eye Drops |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 496 days |
Priority review | No |
Target(s) | beta-AR; PGF2-alpha |
Indication(s) | Indicated for the treatment of glaucoma |
Notes | First generic in China |
15. Perindopril Arginine and Amlodipine Besylate Tablets (Ⅲ)
Generic name | Perindopril Arginine and Amlodipine Besylate Tablets (Ⅲ) |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Guangzhou Lianrui Pharmaceutical Co., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 610 days |
Priority review | No |
Target(s) | ACE; Ca2+ channel |
Indication(s) | Indicated as monotherapy for the treatment of hypertension in adults whose blood pressure is not adequately controlled, or as a replacement therapy for essential hypertension in patients already stabilized on the same doses of perindopril and amlodipine administered separately |
Notes | First generic in China |
16. Macrogol Sodium Potassium Powder
Generic name | Macrogol Sodium Potassium Powder |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Shandong Lukang Pharmaceutical Group Co., Ltd. |
Approved | 2024/12/17 |
Time from application acceptance to approval | 790 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of chronic constipation |
Notes | First generic in China |
17. Lobitridol Injection
Generic name | Lobitridol Injection |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Chongqing Shenghuaxi Pharmaceutical CO., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 683 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for use in intravenous urography, arteriography, cranial and whole-body computed tomography (CT), and intravenous digital subtraction angiography (DSA) |
Notes | First generic in China |
18. Apalutamide Tablets
Generic name | Apalutamide Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Qilu Pharmaceutical (Hainan) Co., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 439 days |
Priority review | No |
Target(s) | AR |
Indication(s) | Indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) |
Notes | First generic in China |
19. Pediatric Faropenem Sodium Granules
Generic name | Pediatric Faropenem Sodium Granules |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
Marketing authorization holder (MAH) | Hubei Jumpcan Pharmaceutical Co.,Ltd. |
Approved | 2024/12/06 |
Time from application acceptance to approval | 555 days |
Priority review | No |
Target(s) | PBPs |
Indication(s) | Indicated for the treatment of pediatric infectious diseases caused by bacteria sensitive to faropenem |
Notes | First generic in China |
20. Imipenem, Cilastatin Sodium and Relebactam for Injection
Generic name | Imipenem, Cilastatin Sodium and Relebactam for Injection |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Merck Sharp & Dohme B.V. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 508 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of ventilator-associated bacterial pneumonia (VABP) and hospital-acquired bacterial pneumonia (HABP) |
21. Lurbinectedin for Injection
Generic name | Lurbinectedin for Injection |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | PharmaMar AG |
Approved | 2024/12/01 |
Time from application acceptance to approval | 543 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | MCL1; DNA; RNAP II |
Indication(s) | Indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have experienced disease progression during or after platinum-based chemotherapy |
22. Safinamide Mesylate Tablets
Generic name | Safinamide Mesylate Tablets |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Zambon S.p.A. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 969 days |
Priority review | No |
Target(s) | MAOB |
Indication(s) | Indicated as an adjunctive treatment to levodopa/carbidopa for the management of 'off' episodes in patients with Parkinson's disease |
23. Pretomanid Tablets
Generic name | Pretomanid Tablets |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Mylan Ireland Limited |
Approved | 2024/12/01 |
Time from application acceptance to approval | 355 days |
Priority review | No |
Target(s) | EPAS1 |
Indication(s) | Indicated for the treatment of patients with pulmonary tuberculosis |
24. Lenacapavir Sodium Injection
Generic name | Lenacapavir Sodium Injection |
Brand | SUNLENCA (萨兰卡) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Gilead Sciences Ireland UC |
Approved | 2024/12/25 |
Time from application acceptance to approval | 454 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of HIV infection |
25. Lenacapavir Sodium Tablets
Generic name | Lenacapavir Sodium Tablets |
Brand | SUNLENCA (萨兰卡) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Gilead Sciences Ireland UC |
Approved | 2024/12/25 |
Time from application acceptance to approval | 459 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the treatment of HIV infection |
26. Dotinurad Tablets
Generic name | Dotinurad Tablets |
Brand | URECE (优乐思) |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | FUJI YAKUHIN CO., LTD. |
Approved | 2024/12/06 |
Time from application acceptance to approval | 321 days |
Priority review | No |
Target(s) | SLC22A12 |
Indication(s) | Indicated for the treatment of gout |
27. Beclometasone Dipropionate and Formoterol Fumarate Powder for Inhalation
Generic name | Beclometasone Dipropionate and Formoterol Fumarate Powder for Inhalation |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Chiesi Farmaceutici S.p.A. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 520 days |
Priority review | No |
Target(s) | ADRB2 |
Indication(s) | Indicated for the treatment of bronchial asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis, angioedema and dermatitis |
28. Olaparib Tablets
Generic name | Olaparib Tablets |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | M/s Natco Pharma Limited |
Approved | 2024/12/25 |
Time from application acceptance to approval | 351 days |
Priority review | No |
Target(s) | PARP |
Indication(s) | Indicated as adjuvant therapy for patients with high-risk, early-stage HER2-negative breast cancer harboring germline BRCA mutations (gBRCAm) who have undergone neoadjuvant or adjuvant chemotherapy |
29. Vamorolone Oral Suspension
Generic name | Vamorolone Oral Suspension |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Santhera Pharmaceuticals（Deutschland）GmbH |
Approved | 2024/12/06 |
Time from application acceptance to approval | 254 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | GR |
Indication(s) | Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older |
30. Odevixibat Capsules
Generic name | Odevixibat Capsules |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, imported |
Marketing authorization holder (MAH) | Ipsen Pharma |
Approved | 2024/12/01 |
Time from application acceptance to approval | 254 days |
Priority review | Yes (pediatric drug) |
Target(s) | SLC10A2 |
Indication(s) | Indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months and older |
31. Donanemab Injection
Generic name | Donanemab Injection |
Brand | Kisunla (记能达) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Eli Lilly and Company |
Approved | 2024/12/17 |
Time from application acceptance to approval | 413 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | Abeta |
Indication(s) | Indicated for the treatment of early-stage Alzheimer’s disease |
32. Skin Prick Solution for Blattella germanica Allergens
Generic name | Skin Prick Solution for Blattella germanica Allergens |
Brand | / |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. |
Approved | 2024/12/17 |
Time from application acceptance to approval | 503 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated as an aid in the diagnosis of type I hypersensitivity disorders associated with German cockroach sensitization |
33. Skin Prick Solution for Cat Hair and Dander Allergens
Generic name | Skin Prick Solution for Cat Hair and Dander Allergens |
Brand | / |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. |
Approved | 2024/12/17 |
Time from application acceptance to approval | 503 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated as an aid in the diagnosis of type I hypersensitivity disorders associated with alder pollen sensitization |
34. Stapokibart Injection
Generic name | Stapokibart Injection |
Brand | Kang Yue Da (康悦达) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Chengdu Kangnuoxing Biopharma, Inc. |
Approved | 2024/12/17 |
Time from application acceptance to approval | 194 days |
Priority review | Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases) |
Target(s) | IL4RA |
Indication(s) | Indicated for the treatment of chronic sinusitis with nasal polyps |
35. Tagitanlimab Injection
Generic name | Tagitanlimab Injection |
Brand | Ke Tai Lai (科泰莱) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
Approved | 2024/12/25 |
Time from application acceptance to approval | 1132 days |
Priority review | No |
Target(s) | PD-L1 |
Indication(s) | Indicated for the treatment of patients with recurrent or metastatic nasopharyngeal cancer who have previously failed second-line or higher chemotherapy |
36. Skin Prick Solution for Platanus Acerifolia Pollen Allergens
Generic name | Skin Prick Solution for Platanus Acerifolia Pollen Allergens |
Brand | / |
Classification | Class 1 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. |
Approved | 2024/12/17 |
Time from application acceptance to approval | 503 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated as an aid in the diagnosis of type I hypersensitivity disorders associated with cat dander sensitization |
37. Zolbetuximab for Injection
Generic name | Zolbetuximab for Injection |
Brand | VYLOY (威络益) |
Classification | Class 1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Astellas Pharma Europe B.V. |
Approved | 2024/12/25 |
Time from application acceptance to approval | 512 days |
Priority review | No |
Target(s) | CLDN18.2; CLDN18 |
Indication(s) | Indicated in combination with fluoropyrimidine- and platinum-based chemotherapy as first-line therapy for patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma |
38. Pembrolizumab Injection
Generic name | Pembrolizumab Injection |
Brand | / |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Merck Sharp & Dohme LLC |
Approved | 2024/12/06 |
Time from application acceptance to approval | 370 days |
Priority review | No |
Target(s) | PD-1 |
Indication(s) | Indicated for use in patients with resectable stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC) |
39. Serplulimab Injection
Generic name | Serplulimab Injection |
Brand | Han Si Zhuang (汉斯状) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Shanghai Henlius Biotech Co., Ltd. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 355 days |
Priority review | No |
Target(s) | PD-1 |
Indication(s) | Indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) |
40. Sintilimab Injection
Generic name | Sintilimab Injection |
Brand | Da Bo Shu (达伯舒) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Innovent Biologics, Inc. |
Approved | 2024/12/01 |
Time from application acceptance to approval | 237 days |
Priority review | Yes (granted breakthrough therapy designation) |
Target(s) | PD-1 |
Indication(s) | Indicated in combination with fruquintinib capsules for the treatment of patients with advanced pMMR or non-MSI-H endometrial cancer who have progressed following prior systemic anti-tumor therapy and are deemed unsuitable for curative surgery or radiotherapy |
41. Recombinant Human Tissue-type Plasminogen Activator Derivative for Injection
Generic name | Recombinant Human Tissue-type Plasminogen Activator Derivative for Injection |
Brand | Rui Tong Li (瑞通立) |
Classification | Class 2.2 therapeutic biological product |
Application type | BLA, domestic |
Marketing authorization holder (MAH) | Shandong E-Hua Biotech Pharmaceutical Co., Ltd. |
Approved | 2024/12/17 |
Time from application acceptance to approval | 316 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for thrombolytic therapy in patients with acute ischemic stroke |
42. Loncastuximab Tesirine For Injection
Generic name | Loncastuximab Tesirine For Injection |
Brand | Zynlonta (泽路泰) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | ADC Therapeutics SA |
Approved | 2024/12/06 |
Time from application acceptance to approval | 512 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | CD19 |
Indication(s) | Indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma following second-line or subsequent systemic therapies |
43. Mepolizumab Injection
Generic name | Mepolizumab Injection |
Brand | NUCALA (新可来) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | GlaxoSmithKline Trading Services Limited |
Approved | 2024/12/25 |
Time from application acceptance to approval | 323 days |
Priority review | No |
Target(s) | IL5 |
Indication(s) | Indicated as an adjunctive maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD) |
44. Mosunetuzumab Injection
Generic name | Mosunetuzumab Injection |
Brand | Lunsumio (皓罗华) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Roche Pharma (Schweiz) AG |
Approved | 2024/12/17 |
Time from application acceptance to approval | 376 days |
Priority review | Yes (eligible for conditional approval) |
Target(s) | CD20; CD3 |
Indication(s) | Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have previously received at least two systemic therapies |
45. Rilonacept for injection
Generic name | Rilonacept for injection |
Brand | ARCALYST (炎朵) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, imported |
Marketing authorization holder (MAH) | Kiniksa Pharmaceuticals (UK), Ltd. |
Approved | 2024/12/06 |
Time from application acceptance to approval | 279 days |
Priority review | Yes (pediatric drug) |
Target(s) | IL-1 alpha; IL-1 beta |
Indication(s) | Indicated for the treatment of recurrent pericarditis (RP) in adults and adolescents aged 12 years and older, and for the reduction of recurrence risk |
Contact BaiPharm if you need more details of drug approvals in China.
