GSK Secures China Approval for Trelegy Ellipta in Asthma, Expanding Single Inhaler Triple Therapy Use

GSK Secures China Approval for Trelegy Ellipta in Asthma, Expanding Single Inhaler Triple Therapy Use

(IN BRIEF) GSK has secured approval in China for Trelegy Ellipta as a maintenance treatment for adults with asthma, adding to its existing indication in COPD and making it the only single inhaler triple therapy approved for both conditions in the country. Supported by results from the CAPTAIN study, the approval offers a new option for patients with uncontrolled asthma, a condition affecting tens of millions of adults in China. The decision strengthens GSK’s respiratory portfolio and underscores its commitment to improving long-term disease control and outcomes through simplified, once-daily treatment approaches.

(PRESS RELEASE) LONDON, 23-Jan-2026 — /EuropaWire/ — GSK plc has received regulatory approval in China for a new asthma indication for Trelegy Ellipta, expanding the medicine’s use beyond its existing licence in chronic obstructive pulmonary disease and making it the first and only single inhaler triple therapy approved in the country for the maintenance treatment of both asthma and COPD. The decision by China’s National Medical Products Administration applies to adult patients aged 18 years and older whose asthma remains uncontrolled despite current treatment, addressing a significant unmet medical need in one of the world’s largest asthma populations.

The approval is supported by data from the global CAPTAIN study, which demonstrated that the addition of a third bronchodilator in the FF/UMEC/VI combination delivered meaningful improvements in lung function compared with dual therapy in patients inadequately controlled on inhaled corticosteroids and long-acting beta agonists. By providing inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta2-agonist therapy in a single, once-daily inhalation, Trelegy Ellipta simplifies treatment while offering enhanced bronchodilation for suitable patients.

Asthma remains one of the most common chronic respiratory conditions in China, affecting an estimated 46 million adults, with around half experiencing persistent symptoms that increase the risk of exacerbations and negatively impact quality of life. The new asthma indication provides an additional treatment option for patients whose disease is not optimally managed and who may benefit from triple therapy delivered through a single inhaler.

Trelegy Ellipta is now approved in China at the 100/62.5/25 mcg dose for both asthma and COPD, with the 200/62.5/25 mcg strength approved for asthma only. The expanded indication reinforces GSK’s long-term commitment to respiratory medicine and its focus on improving outcomes for people living with chronic respiratory diseases through innovative, evidence-based therapies.

About the CAPTAIN Study

CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to patients whose asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance asthma medication. In the study, 2,436 patients were treated across 15 countries with approximately 400 patients randomly assigned to each of the six treatment arms.

Data from the study demonstrated mean (95% confidence interval) improvements in FEV1 change from baseline of 110ml for FF/UMEC/VI 100/62.5/25 μg versus FF/VI 100/25 μg (95% CI 66-153; p<0.0001) and 92ml for FF/UMEC/VI 200/62.5/25 μg versus FF/VI 200/25 μg (49-135; p<0.0001).

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. Huang K, Yang T, Xu J, et al. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019;394(10196):407-418. doi:10.1016/S0140-6736(19)31147-X
2. Huang K, Liu M, Wang W, et al. (2025), Asthma Control and Risk Factors for Poor Asthma Outcomes in Chinese Asthma Patients: Baseline Analysis of a Multi‐Centre, Single‐Arm Study (CARE4ALL). Allergy, 80:1487-1490. DOI:10.1111/all.16522
3. Peters SP, Ferguson G, Deniz Y, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006 Jul;100(7):1139–5. DOI:10.1016/j.rmed.2006.03.031
4. Pavord ID, Mathieson N, Scowcroft A, et al. The impact of poor asthma control among asthma patients treated with inhaled corticosteroids plus long-acting beta agonists in the United Kingdom: a cross-sectional analyis. NPJ Prim Care Respir Med 2017;27(1):17. DOI:10.1038/s41533-017-0014-1

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SOURCE: GlaxoSmithKline plc