REG - GSK PLC - Nucala for adults with COPD approved in China

GSKAnnouncement

05/01/2026 07:00

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RNS Number : 6236N  GSK PLC  05 January 2026

Issued: 5 January 2026, London UK

 

Nucala (mepolizumab) approved in China for use in adults with chronic
obstructive pulmonary disease (COPD)

 

·   Nucala is the first and only monthly biologic approved in China studied
in a wide COPD population with blood eosinophil count (BEC) starting as low as
150 cells/µL

·   Approval based on the positive MATINEE and METREX phase III trials

·   MATINEE data included reduction of exacerbations leading to
hospitalisation and/or emergency department visits

·   Of patients inadequately controlled on inhaled triple therapy, 67% have
a blood eosinophil count above 150 cells/µL

 

 

GSK plc (LSE/NYSE: GSK) today announced that China's National Medical Products
Administration (NMPA) has approved Nucala (mepolizumab) as add-on maintenance
treatment of adult patients with inadequately controlled COPD characterised by
raised blood eosinophils.

 

The approval was based on data from the positive MATINEE and METREX phase III
trials. Across these trials, mepolizumab showed a clinically meaningful and
statistically significant reduction in the annualised rate of moderate/severe
exacerbations versus placebo plus standard of care in a wide spectrum of COPD
patients with an eosinophilic phenotype. The incidence of adverse events was
similar between placebo and mepolizumab groups.

 

Mepolizumab is the first and only monthly biologic approved in China and
evaluated in COPD patients with a BEC starting as low as 150 cells/µL. Around
100 million people in China have COPD. Among those who continue to exacerbate
despite inhaled triple therapy, about 67% have a BEC above 150 cells/µL.(1,2)
Recurrent exacerbations accelerates disease progression, higher
hospitalisation and readmission rates, increased mortality and greater health
system burden.(3,4) COPD deaths in China represent over 30% of global COPD
mortality.(3)

 

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology &
Inflammation R&D, GSK said: "Given the high incidence of COPD in China and
a mortality rate that is above the global average, there is a clear need for
novel options to address COPD. The approval of Nucala offers patients in China
a monthly add-on maintenance treatment to reduce exacerbations, including
those leading to emergency department visits and/or hospitalisations which
account for a large proportion of annual direct medical costs."

 

In both MATINEE and METREX trials, mepolizumab demonstrated a statistically
significant reduction in the annualised rate of moderate or severe
exacerbations compared with placebo, in patients with an eosinophilic
phenotype, when added to triple inhaled therapy [MATINEE: rate ratio 0.79, 95%
confidence interval (0.66, 0.94), P=0.01] (AER mepolizumab = 0.80
exacerbations per year versus placebo = 1.01)] [METREX: rate ratio 0.82, 95%
CI 0.68, 0.98, adjusted P=0.04] (AER mepolizumab = 1.40 exacerbations per year
versus placebo = 1.71).(5,6) In a pre-defined secondary endpoint in MATINEE,
the annualised rate of COPD exacerbations requiring ED visits and/or
hospitalisation was reduced in the mepolizumab group when compared with
placebo [rate ratio 0.65; 95% CI (0.43, 0.96) nominally significant after
adjustment for multiplicity] (AER mepolizumab = 0.13 exacerbations per year
versus placebo = 0.20).

 

Mepolizumab is already approved in China as an add-on maintenance treatment
for severe eosinophilic asthma in adults and adolescents aged 12 years and
older, as well as for adults with chronic rhinosinusitis with nasal polyps and
eosinophilic granulomatosis with polyangiitis. It is currently approved for
use in COPD in the US. Regulatory submissions are under review globally,
including in Europe where mepolizumab was recently granted a positive CHMP
opinion in 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
(https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf)

 

The US Prescribing Information is available at NUCALA-PI-PIL-IFU-COMBINED.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/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.

 

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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.

 

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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
(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/
(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.

 

 

 

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