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 March 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: 30 March 2026, London UK
Exdensur (depemokimab)
approved in China for the treatment of severe
asthma
● Exdensur is
the first and only ultra-long-acting biologic in China for the
treatment of severe asthma with an eosinophilic
phenotype
●
Approval based on
SWIFT trials showing significantly lower rates of exacerbations in
patients receiving depemokimab versus placebo
●
More than 2 million
people in China are affected by severe asthma and experience
increased risk of exacerbations requiring
hospitalisation
GSK plc (LSE/NYSE: GSK) today announced that China's National
Medical Products Administration (NMPA) has
approved Exdensur (depemokimab)
as add-on
maintenance treatment of severe asthma characterised by an
eosinophilic phenotype in adult and paediatric patients aged 12
years and older.
The approval of Exdensur in severe asthma is based on data from the
SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab
demonstrated sustained exacerbation reduction with two doses per
year versus placebo, both plus standard of care.1
Kaivan Khavandi, SVP, Global Head, Respiratory,
Immunology & Inflammation R&D, GSK,
said: "Today's
approval for Exdensur in China represents an important advance for
patients with severe asthma with an eosinophilic phenotype. By
providing sustained suppression of type 2 inflammation, an
underlying driver of exacerbations and disease
progression, Exdensur could redefine care in just two doses a
year. With Exdensur now approved in several major markets, we
are focused on transforming the treatment paradigm in severe
asthma."
Asthma is a major health burden in China affecting an estimated 46
million adults.2 Of
those, approximately 6% experience severe asthma, which is
associated with an increased risk of exacerbations requiring
hospitalisation, and higher likelihood of potentially fatal asthma
attacks.2-6 In
China, around 15% of people with asthma have experienced an
exacerbation requiring a hospital visit in the preceding 12
months.2
In the SWIFT-1 and SWIFT-2 trials, treatment with depemokimab
resulted in a significant 58% and 48% reduction in the rate of
annualised asthma exacerbations (asthma attacks) over 52 weeks,
respectively [rate ratio (95% confidence interval) p-value: SWIFT-1
0.42 (0.30, 0.59) p<0.001 and SWIFT-2 0.52 (0.36, 0.73)
p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46 vs. 1.11
and SWIFT-2 0.56 vs. 1.08 exacerbations per year). In addition,
efficacy and safety results from Chinese
patients participating
in SWIFT-1 were consistent with the overall
population analysis
(n=58).1
In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated
with depemokimab experienced numerically fewer exacerbations
requiring hospitalisation and/or emergency department visits (1%
and 4%) compared with placebo (8% and 10%), respectively. A
pre-specified pooled analysis of the two trials showed there was a
72% reduction in the annualised rate of clinically significant
exacerbations requiring hospitalisation and/or ED visits over 52
weeks for depemokimab compared with placebo [rate ratio 0.28, 95%
CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus
placebo 0.09).1 Across
these trials, depemokimab was well-tolerated, with patients
experiencing a similar rate and severity of side effects as those
receiving placebo.1 The
full results from the SWIFT trials were presented at
the 2024 European
Respiratory Society International Conference and published in
the New
England Journal of Medicine.1,7
The NMPA
is also reviewing Exdensur as
an add-on therapy with intranasal corticosteroids for the treatment
of adult patients with severe chronic rhinosinusitis with nasal
polyps (CRSwNP) for whom therapy with systemic corticosteroids
and/or surgery does not provide adequate disease
control. Exdensur has
been approved in the US for the treatment of severe asthma, as well
as in Japan, the EU, and UK for the treatment of severe asthma and
CRSwNP.8-11
About asthma
Asthma affects more than 260 million people globally, many of whom
continue to experience symptoms and exacerbations despite
treatment.12,13 Severe
asthma is defined as asthma that requires treatment with medium- to
high-dose inhaled corticosteroids plus a second therapy (i.e.,
systemic corticosteroid or biologic) to prevent it from becoming
uncontrolled, or which remains uncontrolled despite
therapy.14 Type
2 inflammation is the underlying cause of pathology in more than
80% of patients with severe asthma, in which patients exhibit
elevated levels of eosinophils (a type of white blood
cell).14
About Exdensur (depemokimab)
Exdensur is
the first ultra-long-acting biologic being evaluated for certain
respiratory diseases with underlying type 2 inflammation. It
combines high interleukin-5 (IL-5) binding affinity and high
potency with an extended half-life to enable twice-yearly dosing.
IL-5 is a key cytokine in type 2 inflammation.1
For product and important safety information please consult the
country's relevant summary of product characteristics.
The EU product information is available at: https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur
The US product information is available at: EXDENSUR-PI-PIL.PDF
About the SWIFT phase III trials
The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and
safety of depemokimab adjunctive therapy in 382 and 380
participants with severe asthma who were randomised to receive
depemokimab or a placebo, respectively, in addition to their
standard of care (SOC) treatment with medium to high-dose inhaled
corticosteroids plus at least one additional controller. The full
analysis set in SWIFT-1 included 250 patients in the depemokimab
plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252
patients were included in the depemokimab plus SOC arm and 128 in
the placebo plus SOC arm.1
About the depemokimab development programme
Depemokimab is currently being evaluated in phase III trials for
the treatment of other diseases with underlying type 2
inflammation, including OCEAN for eosinophilic granulomatosis with
polyangiitis (EGPA) and DESTINY for hyper eosinophilic syndrome
(HES).15,16 GSK
has also initiated the ENDURA-1, ENDURA-2 and VIGILANT phase III
trials assessing the efficacy and safety of depemokimab as an
add-on therapy in patients with uncontrolled moderate to severe
COPD with type 2 inflammation.17-19
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 www.gsk.com.
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Investor Relations:
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Jeff McLaughlin
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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
2025.
Registered in England & Wales:
No.
3888792
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New Oxford Street
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WC1A
1DG
References
1.
Jackson D., et al. Twice-Yearly Depemokimab in Severe Asthma with
an Eosinophilic Phenotype. NEJM.
September 2024. Vol. 391 No. 24.DOI: 10.1056/NEJMoa2406673.
2. Huang,
Kewu, et al. "Prevalence, risk factors, and management of asthma in
China: A national cross-sectional study." The Lancet, vol. 394, no.
10196, Aug. 2019, pp. 407-418, https://doi.org/10.1016/s0140-6736(19)31147-x.
3. Ding,
Bo, and Mark Small. "Disease burden of mild asthma in China."
Respirology, vol. 23, no. 4, 20 Oct. 2017, pp.
369-377, https://doi.org/10.1111/resp.13189 .
4.
National Heart, Lung, and Blood Institute. Guidelines for the
Diagnosis and Management of Asthma (EPR-3). [Online]. Available
at: https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma.
Accessed January 2025.
5.
Ambrosino, Nicolino, and Pierluigi Paggiaro. "The management of
asthma and chronic obstructive pulmonary disease: Current status
and future perspectives." Expert Review of Respiratory Medicine,
vol. 6, no. 1, Feb. 2012, pp. 117-127, https://doi.org/10.1586/ers.12.2.
6. Antonicelli,
L et al. "Asthma severity and medical resource utilisation." The
European respiratory journal vol. 23,5 (2004):
723-9. https://pubmed.ncbi.nlm.nih.gov/15176687/
7.
Jackson, D, et al. "Late breaking abstract - depemokimab
efficacy/safety in patients with asthma on medium/high-dose ICS:
The phase IIIA randomised SWIFT-1/2
studies." European
Respiratory Journal 2024, vol. 64, no. 68, 14 Sept.
2024, https://doi.org/10.1183/13993003.congress-2024.rct3718.
8.
"Exdensur (Depemokimab) Approved by US FDA for the Treatment of
Severe Asthma." GSK, 16 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/
9. "Exdensur
(depemokimab) approved in Japan for severe asthma and chronic
rhinosinusitis with nasal polyps." GSK, 6 Jan.
2026, https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/
10. "Exdensur
(Depemokimab) Approved by the European Commission for Severe Asthma
with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal
Polyps." GSK, 17 Feb. 2026, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-the-european-commission/.
11. "Exdensur
(Depemokimab) Approved in the UK for Treatment of Asthma with Type
2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps." GSK,
15 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-the-uk-for-treatment-of-asthma-with-type-2-inflammation-and-chronic-rhinosinusitis-with-nasal-polyps/
12. World
Health Organisation. Asthma Key Facts. Available
at: https://www.who.int/news-room/fact-sheets/detail/asthma. Accessed
February 2025.
13. Wang E, et
al. Characterization of Severe Asthma Worldwide: Data From the
International Severe Asthma Registry. CHEST,
Volume 157, Issue 4, 790 - 804. https://doi.org/10.1016/j.chest.2019.10.053.
14. Heaney, L,
et al. "Eosinophilic and noneosinophilic
asthma." CHEST,
vol. 160, no. 3, Sept. 2021, pp. 814-830, https://doi.org/10.1016/j.chest.2021.04.013.
15. "Efficacy
and Safety of Depemokimab Compared With Mepolizumab in Adults With
Relapsing or Refractory Eosinophilic Granulomatosis With
Polyangiitis (EGPA) (OCEAN)." Clinicaltrials.Gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05263934.
Accessed 23 Jan 2026.
16.
"Depemokimab in Participants With Hypereosinophilic Syndrome,
Efficacy, and Safety Trial (DESTINY)." Clinicaltrials.Gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05334368.
Accessed 23 Jan 2026.
17.
"Depemokimab as an Extended treatmeNt Duration Biologic in Adults
With Chronic Obstructive Pulmonary Disease (COPD) and Type 2
Inflammation (ENDURA -1) (ENDURA -1)." ClinicalTrials.Gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT06959095.
Accessed 23 Jan 2026.
18.
"Depemokimab as an Extended treatmeNt Duration Biologic in Adults
With Chronic Obstructive Pulmonary Disease (COPD) and Type 2
Inflammation (ENDURA-2) (ENDURA-2)."
Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06961214.
Accessed 23 Jan 2026.
19. "eValuating
the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN
Chronic Obstructive Pulmonary Disorder (COPD) With Type 2
Inflammation (VIGILANT)."
Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT07177339.
Accessed 23 Jan 2026.
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: March
30, 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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