UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of January 2026
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
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
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.
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Investor
Relations:
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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.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: January
05, 2026
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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