GSK Secures China Approval for Nucala in Broad COPD Patient Population

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GSK Secures China Approval for Nucala in Broad COPD Patient Population

(IN BRIEF) GSK has received approval from China’s National Medical Products Administration for Nucala as an add-on maintenance therapy for adults with inadequately controlled COPD and elevated blood eosinophils. Supported by positive MATINEE and METREX phase III trial data, the approval makes Nucala the first monthly biologic in China studied in a broad COPD population with blood eosinophil counts as low as 150 cells/µL. The treatment demonstrated significant reductions in moderate to severe exacerbations, including those requiring hospitalization, offering a new option for a large and high-risk patient population in China.

(PRESS RELEASE) LONDON, 6-Jan-2026 — /EuropaWire/ — GSK announced that China’s National Medical Products Administration has approved Nucala as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils. The decision marks the first approval in China of a monthly biologic therapy for a broad COPD population with blood eosinophil counts starting from 150 cells/µL.

The regulatory approval is supported by positive results from the phase III MATINEE and METREX clinical trials, which demonstrated that mepolizumab significantly reduced the annualized rate of moderate to severe COPD exacerbations when added to standard inhaled triple therapy. Across both studies, treatment with mepolizumab showed clinically meaningful and statistically significant reductions in exacerbations compared with placebo, with a safety profile comparable between treatment groups.

Notably, data from the MATINEE trial showed a reduction in exacerbations leading to hospitalization and emergency department visits, outcomes that represent a major driver of healthcare utilization and costs. In patients whose COPD remains poorly controlled despite inhaled triple therapy, approximately 67 percent have blood eosinophil levels above 150 cells/µL, highlighting a substantial population that may benefit from targeted biologic treatment.

COPD represents a significant public health challenge in China, affecting an estimated 100 million people. Recurrent exacerbations accelerate disease progression, increase hospitalization and readmission rates, and contribute to higher mortality. COPD-related deaths in China account for more than 30 percent of global mortality associated with the disease.

Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology and Inflammation Research and Development at GSK, said the approval reflects the urgent need for new treatment options in China, where COPD prevalence and mortality exceed global averages. He noted that Nucala offers a monthly add-on therapy capable of reducing exacerbations, including those requiring hospital-based care.

Mepolizumab is already approved in China for several eosinophil-driven conditions, including severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic granulomatosis with polyangiitis. It is currently approved for COPD in the United States, with regulatory submissions under review globally, including in Europe, where it has recently received a positive opinion from the Committee for Medicinal Products for Human Use.

Nucala is a monoclonal antibody targeting interleukin-5, a key cytokine involved in type 2 inflammation. By reducing eosinophilic inflammation, the therapy is designed to modify disease activity and prevent progression in patients with eosinophilic COPD.

About MATINEE and METREX

Both MATINEE and METREX are phase III, randomised (1:1), double-blind, parallel-group trials assessing the efficacy and safety of mepolizumab 100 mg as add-on therapy, administered subcutaneously every 4 weeks versus placebo in addition to optimal inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroid).5

MATINEE assessed the efficacy and safety of mepolizumab for 52–104 weeks, in 804 patients with COPD with evidence of type 2 inflammation, characterised by an elevated blood eosinophil count (≥300 cells/µL at screening and ≥150 cells/µL in the past year). Patients could participate with a range of clinical presentations of COPD including chronic bronchitis only, emphysema only or a combination of both.

In METREX, the efficacy and safety of mepolizumab was evaluated for 52 weeks in 836 patients randomised (1:1) to mepolizumab or placebo across two groups, the eosinophilic phenotype group (blood eosinophil count of ≥150 cells/µl at study entry or ≥ 300 cells/µl within the past year) or the non-eosinophilic phenotype group (blood eosinophil count of <150 cells/µl at study entry and no evidence of ≥300 cells/µl within the past year).

About COPD

Affecting more than 390 million people globally, COPD is a progressive and heterogeneous inflammatory lung disease that includes chronic bronchitis and/or emphysema.6 Despite inhaled triple therapy, many patients experience persistent symptoms and exacerbations.7 Exacerbations are acute episodes of worsening COPD symptoms, which can result in hospitalisation and irreversible lung damage.6 Early intervention is important in preventing exacerbations and cumulative lung damage.6

About Nucala

Nucala is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has been developed for the treatment of a range of diseases with underlying type 2 inflammation. In addition to COPD, it is currently approved for use in China across three other diseases.

For product and important safety information, please consult the country’s relevant summary of product characteristics.

The EU and UK Prescribing Information is available at: NUCALA-EPAR-PRODUCT-INFORMATION_EN.PDF 

The US Prescribing Information is available at NUCALA-PI-PIL-IFU-COMBINED.PDF

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q3 Results for 2025.

References

  1. Wang C, et al. Lancet. 2018 Apr 28; 391(10131):1706-1717. 2.Yin P, et al. Chest. 2016; 150(6):1269-1280.
  2. GSK, Optum Analysis DOF (DOF 2024N562932_00).
  3. Yin P, et al. The Burden of COPD in China and Its Provinces: Findings From the Global Burden of Disease Study 2019. Front Public Health. 2022 Jun 3;10:859499. DOI: 10.3389/fpubh.2022.859499.
  4. World Health Organisation (WHO). Advancing COPD care in China through a comprehensive approach. Available at: https://www.who.int/news-room/feature-stories/detail/advancing-copd-care-in-china-through-a-comprehensive-approach#:~:text=China%20has%20almost%20100%20million%20people%20living%20with,for%20more%20than%200.9%20million%20deaths%20in%202013. Last accessed December 2025.
  5. Sciurba F, et al. Mepolizumab to prevent exacerbations in COPD with an eosinophilic phenotype. N Engl J Med. Apr 2025;392:1710-1720. Available at nejm.org.
  6. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2025 Gold Report. Available at: https://goldcopd.org/2026-gold-report-and-pocket-guide/. Last accessed December 2025.
  7. Chen S, et al. Patients with Chronic Obstructive Pulmonary Disease and Evidence of Eosinophilic Inflammation Experience Exacerbations Despite Receiving Maximal Inhaled Maintenance Therapy. Int J Chron Obstruct Pulmon Dis. 2022 Sep 9;17:2187–2200. DOI: 10.2147/COPD.S378649.

Media contact:
Email: corporate.media@gsk.com
Phone: +44 (0)20 8047 5502

SOURCE: GlaxoSmithKline plc

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