According to public information released on the website of China’s National Medical Products Administration (NMPA), 38 innovative drugs had been approved in China as of July 14, 2026.

Chinese pharmaceutical wholesaler DengYueMed has compiled an overview of these newly approved innovative drugs, summarizing their Marketing Authorization Holders (MAHs) and approved indications to provide professional market information that supports greater global accessibility of high-quality medicines from China.

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1. Sonrotoclax Tablets

Marketing Authorization Holder: BeiGene, Ltd.

Approved under the Priority Review and Conditional Approval pathway for:

• Adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor.
• Adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior systemic therapies, including a BTK inhibitor.

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2. Plozasiran Sodium Injection

Marketing Authorization Holder: Arrowhead Pharmaceuticals, Inc.

Indicated, in combination with dietary control, to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS).

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3. Retlirafusp Alfa Injection

Marketing Authorization Holder: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Indicated in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of patients with PD-L1-positive (CPS ≥1), locally advanced unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by a validated diagnostic test.

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4. Olorigliflozin Capsules

Marketing Authorization Holder: Yi Chang HEC Chang Jiang Pharmaceutical Co., Ltd.

Indicated for improving glycemic control in adults with type 2 diabetes mellitus.

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5. Libevitug Injection

Marketing Authorization Holder: Huahui Health Ltd.

Approved under the Priority Review and Conditional Approval pathway for the treatment of adult patients with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis.

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6. Ecnoglutide Injection

Marketing Authorization Holder: Hangzhou Sciwind Biosciences Co., Ltd.

Indicated for improving glycemic control in adults with type 2 diabetes mellitus.

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7. Amdokitug Injection

Marketing Authorization Holder: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

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8. Rovadicitinib Tablets

Marketing Authorization Holder: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Indicated as first-line treatment for adult patients with:

• Intermediate-2 or high-risk primary myelofibrosis (PMF)
• Post-polycythemia vera myelofibrosis (PPV-MF)
• Post-essential thrombocythemia myelofibrosis (PET-MF)

For the treatment of disease-related splenomegaly or disease-related symptoms.

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9. Sosimerasib Tablets

Marketing Authorization Holder: Zhejiang Hangyu Pharmaceutical Co., Ltd.

Approved under the Priority Review and Conditional Approval pathway for adult patients with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have received at least one prior systemic therapy.

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10. Recombinant Erythropoietin Stimulating Protein Injection

Marketing Authorization Holder: Guangdong Sansheng Pharmaceutical Co., Ltd.

Indicated for the treatment of anemia due to chronic kidney disease in patients receiving hemodialysis who are undergoing erythropoiesis-stimulating agent therapy.

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11. Depemokimab Injection

Marketing Authorization Holder: GlaxoSmithKline Trading Services Limited

Indicated as maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older.

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12. Higenamine Hydrochloride Injection

Marketing Authorization Holder: Zhuhai Rundu Pharmaceutical Co., Ltd.

Indicated as a pharmacologic stress agent for myocardial perfusion imaging (MPI) to evaluate myocardial ischemia.

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13. 99mTc-3PRGD2 Injection

Marketing Authorization Holder: Foshan Rui Diao Pharmaceutical Co., Ltd.

A radiopharmaceutical targeting integrin αvβ3 for SPECT/CT imaging, indicated as an adjunctive diagnostic agent for assessing regional lymph node metastasis in patients with suspected lung cancer.

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14. Sevabertinib Tablets

Marketing Authorization Holder: Bayer HealthCare Pharmaceuticals Inc.

Approved under the Priority Review and Conditional Approval pathway as monotherapy for adult patients with unresectable locally advanced or metastatic NSCLC harboring activating HER2 (ERBB2) mutations who have received at least one prior systemic therapy.

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15. Bezacitinib Tablets

Marketing Authorization Holder: Hangzhou Bangshun Pharmaceutical Co., Ltd.

Indicated as first-line treatment for adult patients with:

• Intermediate-2 or high-risk PMF
• PPV-MF
• PET-MF

To treat disease-related splenomegaly or improve disease-related symptoms.

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16. Andamertinib Capsules

Marketing Authorization Holder: Avistone (Ningbo) Biotechnology Co., Ltd.

Approved under the Priority Review and Conditional Approval pathway for adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed during or after platinum-based chemotherapy or who are intolerant to platinum-based chemotherapy.

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17. Firsekibart Injection

Marketing Authorization Holder: Changchun GeneScience Pharmaceuticals Co., Ltd.

Indicated for the treatment of acute gout flares in adults who have contraindications to, intolerance of, or inadequate response to NSAIDs and/or colchicine, and for whom repeated corticosteroid therapy is not appropriate.

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18. Nipocalimab-aahu Injection

Marketing Authorization Holder: Janssen-Cilag International NV

Indicated in combination with standard therapy for adult and adolescent patients (12 years and older) with generalized myasthenia gravis (gMG) who are anti-AChR antibody-positive or anti-MuSK antibody-positive.

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19. Fazamorexant Tablets

Marketing Authorization Holder: Jiangsu COAST PHARMACEUTICAL CO., LTD.

Indicated for the treatment of insomnia characterized by difficulty with sleep onset and/or sleep maintenance in adults.

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20. Anbenitamab Injection

Marketing Authorization Holder: Shanghai JMT Biological Technology Co., Ltd.

Indicated in combination with chemotherapy for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing regimen.

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21. Donaperminogene Seltoplasmid Injection

Marketing Authorization Holder: Beijing Northland Biotech Co., Ltd.

Indicated for the treatment of limb ulcers caused by severe lower limb ischemia (including arteriosclerosis obliterans, thromboangiitis obliterans, and diabetic lower limb ischemia) in patients unsuitable for or inadequately treated by revascularization surgery.

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22. Ruzinurad Tablets

Marketing Authorization Holder: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Indicated for patients with gout accompanied by hyperuricemia.

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23. Rocbrutinib Tablets

Marketing Authorization Holder: Guangzhou Lupeng Pharmaceutical Co., Ltd.

Approved under the Priority Review and Conditional Approval pathway for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior systemic therapies, including a BTK inhibitor.

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24. Eratrectinib Capsules

Marketing Authorization Holder: Jiangsu Vcare PharmaTech Co., Ltd.

Approved under the Priority Review and Conditional Approval pathway for adult and adolescent patients (≥12 years) with locally advanced or metastatic solid tumors harboring NTRK gene fusions without known acquired resistance mutations, who have no satisfactory alternative treatment options or whose disease has progressed following prior therapy.

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25. Sibeprenlimab Injection (Subcutaneous)

Marketing Authorization Holder: Otsuka Pharmaceutical Co., Ltd.

Approved under the Priority Review and Conditional Approval pathway to reduce proteinuria in adult patients with primary IgA nephropathy (IgAN) who are at risk of disease progression.

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26. Bemiltenase Alfa for Injection

Marketing Authorization Holder: Jiangsu BioJeTay Biotechnology Co., Ltd.

Approved under the Priority Review and Conditional Approval pathway for the treatment of bleeding episodes in adults with congenital hemophilia A or B who have factor VIII or IX inhibitors exceeding 5 Bethesda Units (BU).

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27. Zaoren Ningxin Pills

Marketing Authorization Holder: Tasly Pharmaceutical Group Co., Ltd.

A Traditional Chinese Medicine (TCM) developed from a clinically experienced prescription, indicated for improving insomnia characterized by frequent awakenings in patients diagnosed with Heart-Liver Blood Deficiency Syndrome according to TCM theory, accompanied by symptoms such as dizziness and dry eyes.

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28. Gumokimab Injection

Marketing Authorization Holder: Zhongshan Kangfang Biology Medicine Co., Ltd.

Indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

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29. Clesrovimab Injection

Marketing Authorization Holder: Merck Sharp & Dohme B.V.

Indicated for the prevention of respiratory syncytial virus (RSV)-associated lower respiratory tract infection in newborns and infants entering or born during their first RSV season.

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30. Conteltinib Granules

Marketing Authorization Holder: Shouyao Holdings (Beijing) Co., Ltd.

Indicated as monotherapy for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.

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31. Lanoracopan Hydrochloride Tablets

Marketing Authorization Holder: Wuhan Createrna Science and Technology Co., Ltd.

Indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.

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32. Imlunestrant Tosylate Tablets

Marketing Authorization Holder: Eli Lilly Nederland B.V.

Indicated as:

• Monotherapy for adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following endocrine therapy.
• Combination therapy with abemaciclib for patients with the same disease characteristics.

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33. Peceleganan Spray

Marketing Authorization Holder: ProteLight Pharmaceuticals (Jiangsu) Co., Ltd.

A topical antibacterial agent indicated for the treatment of wound infections secondary to first-degree or superficial second-degree burns caused by:

• Staphylococcus epidermidis
• Staphylococcus haemolyticus
• Acinetobacter baumannii

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34. Suvizumab Injection

Marketing Authorization Holder: Chongqing Genrix Biopharmaceutical Co., Ltd.

Indicated for passive immunization of adults following exposure to the rabies virus.

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35. Izalontamab Brengitecan for Injection

Marketing Authorization Holder: Baili Bio Chengdu Pharmaceutical Co., Ltd.

Approved under the Priority Review and Conditional Approval pathway for adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy.

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36. Satricabtagene Autoleucel Injection

Marketing Authorization Holder: Kaixing Life Technology (Shanghai) Co., Ltd.

Indicated for the treatment of patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma following failure of at least second-line therapy.

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37. Octahydroaminoacridine Succinate Tablets

Marketing Authorization Holder: Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd.

A cholinesterase inhibitor indicated for the treatment of mild-to-moderate Alzheimer’s disease.

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38. Adamgammadex Sodium Injection

Marketing Authorization Holder: Hangzhou Adamerck Pharmlabs, Inc.

Indicated for the reversal of rocuronium-induced neuromuscular blockade.

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Key Highlights of China’s Innovative Drug Approvals in H1 2026

The first half of 2026 demonstrates the continued acceleration of China’s pharmaceutical innovation ecosystem. Several notable trends emerged from this year’s approvals.

Oncology Continues to Dominate

Cancer therapies accounted for the largest proportion of newly approved innovative drugs, covering indications such as:

• Non-small cell lung cancer (NSCLC)
• Gastric cancer
• Gastroesophageal junction cancer
• Nasopharyngeal carcinoma
• Mantle cell lymphoma
• Chronic lymphocytic leukemia
• Breast cancer
• NTRK fusion-positive solid tumors

Many approvals involved precision medicine based on molecular biomarkers including:

• HER2
• EGFR Exon 20 insertion
• KRAS G12C
• ALK
• NTRK
• ESR1
• CLDN18.2

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Continued Expansion of Biologics

Numerous monoclonal antibodies and recombinant biologics received approval across multiple therapeutic areas, including:

• Oncology
• Autoimmune diseases
• Respiratory diseases
• Infectious diseases
• Neurology
• Rare diseases

This reflects China’s growing strength in innovative biologic drug development.

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Rare Disease Innovation Accelerates

Several approvals addressed significant unmet medical needs in rare diseases, including:

• Familial Chylomicronemia Syndrome (FCS)
• Chronic Hepatitis D Virus (HDV) Infection
• Primary IgA Nephropathy (IgAN)
• Generalized Myasthenia Gravis (gMG)
• Paroxysmal Nocturnal Hemoglobinuria (PNH)
• Hemophilia A and B with inhibitors

The increasing number of orphan drug approvals demonstrates China’s ongoing commitment to improving access for patients with rare diseases.

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Expansion of Cell and Gene Therapies

The approval of Satricabtagene Autoleucel Injection highlights China’s continued advancement in cell therapy.

As CAR-T, TCR-T, TIL therapy, and gene therapies continue to mature, cellular immunotherapy is expected to play an increasingly important role in China’s innovative pharmaceutical landscape.

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Broader Therapeutic Coverage

Beyond oncology, innovative drugs approved in H1 2026 addressed a wide range of disease areas, including:

• Diabetes
• Gout
• Psoriasis
• Asthma
• Alzheimer’s disease
• Insomnia
• Cardiovascular imaging
• Burn infections
• RSV prevention

This diversified pipeline reflects the rapid evolution of China’s biopharmaceutical industry.

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Conclusion

The approval of 38 innovative drugs during the first half of 2026 highlights the continued momentum of pharmaceutical innovation in China.

From precision oncology and rare diseases to autoimmune disorders, metabolic diseases, neurological conditions, infectious diseases, and advanced cell therapies, China’s innovative drug pipeline continues to expand rapidly while addressing numerous unmet clinical needs.

With ongoing regulatory reform, accelerated review pathways, and increasing global collaboration, China is emerging as one of the world’s leading sources of innovative medicines. Many of these newly approved therapies are expected to further improve treatment options for patients both within China and internationally.

As a professional pharmaceutical wholesaler and international sourcing platform, DengYueMed remains committed to monitoring the latest developments in China’s pharmaceutical industry, helping healthcare institutions, pharmacies, distributors, and compliant partners gain timely access to information on innovative medicines, regulatory approvals, and cross-border pharmaceutical supply solutions.

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Disclaimer:
This article is intended solely for pharmaceutical industry information exchange and educational purposes. It does not constitute medical advice, diagnosis, or treatment recommendations. Patients should consult qualified healthcare professionals before making any treatment decisions.