Monthly Report: New Drug Approvals in China | April 2024

by Angelita Hu May 15, 2024

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.

Related Articles:


In April 2024, China NMPA approved 27 new drugs, among which 18 are chemical drugs and 9 are biological products. The details are shown as follows:

1. Iptacopan Hydrochloride Capsules

Generic name

Iptacopan Hydrochloride Capsules

Brand

飞赫达 (FABHALTA)

Classification

Class 1 chemical drug

Application type

NDA, domestic

Marketing authorization holder (MAH)

Novartis Pharma Schweiz AG

Approved

2024/4/24

Time from application acceptance to approval

315 days

Priority review

Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases; granted breakthrough therapy designation)

Target(s)

Complement factor B

Indication(s)

Indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)

 2. Entinostat Tablets

Generic name

Entinostat Tablets

Brand

景助达 (Jing Zhu Da)

Classification

Class 1 chemical drug

Application type

NDA, domestic

Marketing authorization holder (MAH)

EOC Pharma

Approved

2024/4/24

Time from application acceptance to approval

476 days

Priority review

No

Target(s)

Histone deacetylase

Indication(s)

Indicated for the treatment of locally advanced or metastatic breast cancer patients with hormone receptor (HR)-positive and human epidermal growth factor receptor-2 (HER-2)-negative disease who have experienced recurrence or progression following endocrine therapy

 3. Vebreltinib Enteric Capsules

Generic name

Vebreltinib Enteric Capsules

Brand

万比锐 (Wan Bi Rui)

Classification

Class 1 chemical drug

Application type

NDA, domestic

Marketing authorization holder (MAH)

Beijing Purun'ao Biotechnology Co.,Ltd.

Approved

2024/4/17

Time from application acceptance to approval

176 days

Priority review

Yes (with urgent needs and shortages, or for the treatment of major infectious diseases or rare diseases)

Target(s)

Hepatocyte growth factor receptor

Indication(s)

Indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with a MET exon 14 skipping (METex14) alteration

4. Unecritinib Fumarate Capsules

Generic name

Unecritinib Fumarate Capsules

Brand

安柏尼 (An Bo Ni)

Classification

Class 1 chemical drug

Application type

NDA, domestic

Marketing authorization holder (MAH)

CTTQ Pharma

Approved

2024/4/24

Time from application acceptance to approval

671 days

Priority review

No

Target(s)

ALK tyrosine kinase receptor

Hepatocyte growth factor receptor

Proto-oncogene tyrosine-protein kinase ROS1

Indication(s)

Indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)

5. Dexmedetomidine Hydrochloride Nasal Spray

Generic name

Dexmedetomidine Hydrochloride Nasal Spray

Brand

特美定 (Te Mei Ding)

Classification

Class 2.2 chemical drug

Application type

NDA, domestic

MAH

Sichuan Purity Pharmaceutical Co., LTD.

Approved

2024/4/24

Time from acceptance to approval

630 days

Priority review

No

Target(s)

Alpha-2 adrenergic receptor

Indication(s)

Indicated for reoperative sedation/anxiolysis for adults

Indicated for adjunctive sedation during adult regional anesthesia

6. Chidamide Tablets

Generic name

Chidamide Tablets

Brand

爱谱沙 (Epidaza)

Classification

Class 2.4 chemical drug

Application type

NDA, domestic

MAH

Chipscreen Biosciences

Approved

2024/4/24

Time from acceptance to approval

280 days

Priority review

Yes ( (eligible for conditional approval)

Target(s)

Histone deacetylase

Indication(s)

Indicated for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received at least one prior systemic chemotherapy regimen

7. Baricitinib Tablets

Generic name

Baricitinib Tablets

Brand

艾乐明 (OLUMIANT)

Classification

Class 2.4 chemical drug

Application type

NDA, imported

MAH

Eli Lilly Nederland B.V.

Approved

2024/4/29

Time from acceptance to approval

460 days

Priority review

No

Target(s)

Tyrosine-protein kinase JAK1

Tyrosine-protein kinase JAK2

Indication(s)

Indicated for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs)

8. Isavuconazonium Sulfate for Injection

Generic name

Isavuconazonium Sulfate for Injection

Brand

/

Classification

Class 4 chemical drug

Application type

ANDA, domestic

MAH

ASK Pharm

Approved

2024/4/30

Time from acceptance to approval

669 days

Priority review

No

Target(s)

Lanosterol 14-alpha demethylase

Indication(s)

Indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adult patients

Notes

First generic in China

9. Linezolid for Oral Suspension

Generic name

Linezolid for Oral Suspension

Brand

/

Classification

Class 4 chemical drug

Application type

ANDA, domestic

MAH

SSY Group Limited

Approved

2024/4/17

Time from acceptance to approval

545 days

Priority review

No

Target(s)

50S ribosomal subunit

Indication(s)

Indicated for the treatment of hospital-acquired pneumonia, community-acquired pneumonia, skin and soft tissue infections caused by specific susceptible strains of microorganisms, and vancomycin-resistant Enterococcus infections

Notes

First generic in China

10. Letermovir Tablets

Generic name

Letermovir Tablets

Brand

/

Classification

Class 4 chemical drug

Application type

ANDA, domestic

MAH

CTTQ Pharma

Approved

2024/4/7

Time from acceptance to approval

530 days

Priority review

No

Target(s)

Terminase

Indication(s)

Indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult recipients who are seropositive for cytomegalovirus (CMV) and are undergoing allogeneic hematopoietic stem cell transplantation (HSCT)

Notes

First generic in China

11. Metformin Hydrochloride and Empagliflozin Tablets(Ⅲ)

Generic name

Metformin Hydrochloride and Empagliflozin Tablets(Ⅲ)

Brand

/

Classification

Class 4 chemical drug

Application type

ANDA, domestic

MAH

Deyuan Pharm

Approved

2024/4/17

Time from acceptance to approval

457 days

Priority review

No

Target(s)

5'-AMP-activated protein kinase

sodium/glucose cotransporter 2

Indication(s)

Indicated for improving blood sugar control in patients with Type 2 diabetes

Notes

First generic in China

12. Bisoprolol Fumarate and Amlodipine Besilate Tablets

Generic name

Bisoprolol Fumarate and Amlodipine Besilate Tablets

Brand

/

Classification

Class 4 chemical drug

Application type

ANDA, domestic

MAH

Chengdu Shuode Pharmaceutical Co., Ltd.

Approved

2024/4/7

Time from acceptance to approval

452 days

Priority review

No

Target(s)

β-adrenoceptors

Indication(s)

Indicated as an alternative therapy for the treatment of hypertension in patients who are currently well-controlled on a single medication at the same dosage as the combination formulation

Notes

First generic in China

13. Oxcarbazepine Oral Suspension

Generic name

Oxcarbazepine Oral Suspension

Brand

/

Classification

Class 4 chemical drug

Application type

ANDA, domestic

MAH

ApicHope Pharmaceutical Co., Ltd.

Approved

2024/4/24

Time from acceptance to approval

520 days

Priority review

No

Target(s)

Sodium channel

Indication(s)

Indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 2 years and older, with or without secondary generalized seizures

Notes

First generic in China

14. Nicorandil for Injection

Generic name

Nicorandil for Injection

Brand

/

Classification

Class 5.1 chemical drug

Application type

NDA, imported

MAH

Chugai Pharmaceutical Co.,Ltd.

Approved

2024/4/24

Time from acceptance to approval

847 days

Priority review

No

Target(s)

Nitric oxide

Indication(s)

Indicated for the treatment of unstable angina

15. Cabotegravir Injection

Generic name

Cabotegravir Injection

Brand

/

Classification

Class 5.1 chemical drug

Application type

NDA, imported

MAH

ViiV Healthcare BV

Approved

2024/4/30

Time from acceptance to approval

549 days

Priority review

No

Target(s)

Integrase

Indication(s)

Indicated for the treatment of HIV infection

16. Cabotegravir Sodium Tablets

Generic name

Cabotegravir Sodium Tablets

Brand

/

Classification

Class 5.1 chemical drug

Application type

NDA, imported

MAH

ViiV Healthcare BV

Approved

2024/4/30

Time from acceptance to approval

549 days

Priority review

No

Target(s)

Integrase

Indication(s)

Indicated for the treatment of HIV infection

17. Perampanel Tablets

Generic name

Perampanel Tablets

Brand

卫克泰 (Fycompa)

Classification

Class 5.1 chemical drug

Application type

NDA, imported

MAH

Eisai Europe Limited

Approved

2024/4/30

Time from acceptance to approval

403 days

Priority review

No

Target(s)

Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor

Indication(s)

Indicated for the treatment of generalized tonic-clonic seizures in patients with epilepsy

18. Mavacamten Capsules

Generic name

Mavacamten Capsules

Brand

迈凡妥 (CAMZYOS)

Classification

Class 5.1 chemical drug

Application type

NDA, imported

MAH

Bristol-Myers Squibb Australia Pty Ltd

Approved

2024/4/24

Time from acceptance to approval

368 days

Priority review

Yes (granted breakthrough therapy designation)

Target(s)

Myosin

Indication(s)

Indicated for the treatment of symptomatic adults with class II-III obstructive hypertrophic cardiomyopathy (HCM) classified by New York Heart Association (NYHA), to improve functional capacity and symptoms

19. Benmelstobart Injection (TQB2450)

Generic name

Benmelstobart Injection (TQB2450)

Brand

安得卫 (An De Wei)

Classification

Class 1 therapeutic biological product

Application type

Biologics license application (BLA), domestic

MAH

CTTQ Pharma

Approved

2024/4/30

Time from acceptance to approval

473 days

Priority review

No

Target(s)

Programmed cell death 1 ligand 1

Indication(s)

Indicated for combination therapy with Anlotinib hydrochloride capsules, Carboplatin, and Etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer

20. Penpulimab Injection

Generic name

Penpulimab Injection

Brand

安尼可 (An Ni Ke)

Classification

Class 1 therapeutic biological product

Application type

BLA, domestic

MAH

CTTQ Pharma

Approved

2024/4/24

Time from acceptance to approval

993 days

Priority review

No

Target(s)

Programmed cell death protein 1

Indication(s)

Indicated for the treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed second-line or subsequent systemic therapies

21. Tislelizumab Injection

Generic name

Tislelizumab Injection

Brand

百泽安 (Bai Ze An)

Classification

Class 2.2 therapeutic biological product

Application type

BLA, domestic

MAH

BeiGene, Ltd.

Approved

2024/4/24

Time from acceptance to approval

238 days

Priority review

No

Target(s)

Programmed cell death protein 1

Indication(s)

Indicated for the first-line treatment for locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ), combining with fluoropyrimidine and platinum-based chemotherapy

22. Toripalimab Injection

Generic name

Toripalimab Injection

Brand

拓益 (Tuo Yi)

Classification

Class 2.2 therapeutic biological product

Application type

BLA, domestic

MAH

Junshi Biosciences

Approved

2024/4/2

Time from acceptance to approval

266 days

Priority review

No

Target(s)

Programmed cell death protein 1

Indication(s)

Indicated for the first-line treatment of locally advanced unresectable or metastatic renal cell carcinoma (RCC) in patients at intermediate to high risk, combining with axitinib

23. Faricimab Injection

Generic name

Faricimab Injection

Brand

罗视佳 (VABYSMO)

Classification

Class 2.2 therapeutic biological product

Application type

BLA, imported

MAH

Roche Pharma (Schweiz) AG

Approved

2024/4/24

Time from acceptance to approval

379 days

Priority review

No

Target(s)

Angiopoietin-2

Vascular endothelial growth factor A

Indication(s)

Indicated for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO)

24. Recombinant Human Thrombopoietin Injection

Generic name

Recombinant Human Thrombopoietin Injection

Brand

特比澳 (Te Bi Ao)

Classification

Class 2.2 therapeutic biological product

Application type

BLA, domestic

MAH

3SBio Group

Approved

2024/4/2

Time from acceptance to approval

517 days

Priority review

No

Indication(s)

Indicated for the treatment of persistent or chronic primary immune thrombocytopenia (ITP) in children and adolescents

25. Rituximab Injection (Subcutaneous Injection)

Generic name

Rituximab Injection (Subcutaneous Injection)

Brand

/

Classification

Class 3.1 therapeutic biological product

Application type

BLA, imported

MAH

Roche Pharma (Schweiz) AG

Approved

2024/4/2

Time from acceptance to approval

440 days

Priority review

No

Target(s)

Vascular endothelial growth factor receptor

Indication(s)

Indicated for the treatment of diffuse large B-cell lymphoma (DLBCL)

26. Human Follitropin delta Injection

Generic name

Human Follitropin delta Injection

Brand

贺可唯 (Rekovelle)

Classification

Class 3.1 therapeutic biological product

Application type

BLA, imported

MAH

Ferring Pharmaceuticals A/S

Approved

2024/4/30

Time from acceptance to approval

1,177 days

Priority review

No

Indication(s)

Indicated for controlled ovarian stimulation (COS) for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) cycle

27. Human Thyrotropin Injection

Generic name

Human Thyrotropin Injection

Brand

/

Classification

Class 3.2 therapeutic biological product

Application type

BLA, domestic

MAH

Suzhou Smartnuclide Biopharmaceutical Company

Approved

2024/4/2

Time from acceptance to approval

620 days

Priority review

No

Indication(s)

Indicated for patients with differentiated thyroid cancer without distant metastasis after total thyroidectomy or near-total thyroidectomy, to facilitate the clearance of residual thyroid tissue through the use iodine-131

Contact BaiPharm if you need more details of drug approvals in China.

Read More

Angelita Hu
ChemLinked Content Manager
+ FOLLOW
Copyright: unless otherwise stated all contents of this website are ©2024 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com
You May Also Like
Most Popular