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 April 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: 8 April 2026, London UK
Exdensur (depemokimab)
approved in China for the treatment of chronic rhinosinusitis with
nasal polyps (CRSwNP)
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Exdensur is
the first and only ultra-long-acting biologic in China for
CRSwNP
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Approval
based on ANCHOR trials showing clinically meaningful and
statistically significant improvements in nasal polyp size and
nasal obstruction
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Patients
with CRSwNP continue to face debilitating daily symptoms,
underscoring need for novel treatments
GSK plc (LSE/NYSE: GSK) today announced that China's National
Medical Products Administration (NMPA) has
approved Exdensur (depemokimab)
as an add-on therapy with intranasal corticosteroids for the
treatment of adult patients with CRSwNP for whom therapy with
systemic corticosteroids and/or surgery do not provide adequate
disease control. This follows the NMPA's recent approval
for Exdensur as an add-on maintenance treatment of severe
asthma characterised by an eosinophilic phenotype in adult and
paediatric patients aged 12 years and older.1
The approval of Exdensur in CRSwNP is based on data from the ANCHOR-1
and ANCHOR-2 phase III trials, which showed an improvement
(reduction) from baseline in nasal polyp score (scale: 0-8) at 52
weeks [treatment difference (95% confidence interval) p-value:
ANCHOR-1 -0.7 (-1.1, -0.3) p<0.001 and ANCHOR-2 -0.6 (-1.0,
-0.2) p=0.004] and in nasal obstruction verbal response scale
(scale: 0-3) over weeks 49-52 [ANCHOR-1 -0.23 (-0.46, <0.00)
p=0.047 and ANCHOR-2 -0.25 (-0.46, -0.03)
p=0.025].4 Across
these trials, depemokimab was well-tolerated, with patients
experiencing a similar rate and severity of side effects as those
receiving placebo plus standard of care.2
Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology &
Inflammation (RI&I), and Head of Translational &
Development Sciences, GSK, said: "Given
the continued unmet need amongst patients with CRSwNP, today's
approval of Exdensur could redefine care by protecting from the
debilitating symptoms of this disease in just two doses a year.
This builds on Exdensur's recent approval in severe asthma, which means
more patients in China could have access to this first and only
ultra-long-acting biologic."
Almost half of all patients with CRSwNP remain uncontrolled and up
to 85% have underlying type 2 inflammation, which is associated
with more severe disease.3-5 An
ultra-long-acting therapeutic option that provides sustained
suppression of type 2 inflammation could support these patients who
continue to face daily symptoms.
Exdensur has
also been approved in the US and China for the treatment of severe
asthma, as well as in Japan, the EU, and UK for the treatment of
severe asthma and CRSwNP.1,6-9
About CRSwNP
CRSwNP is caused by inflammation of the nasal lining that can lead
to soft tissue growths, known as nasal polyps.3,10 People
with CRSwNP experience symptoms such as nasal obstruction, loss of
smell, facial pain, sleep disturbance, infections and nasal
discharge that can significantly affect their emotional and
physical well-being.3,10 Similar
to asthma, the majority of cases of CRSwNP are driven by chronic
type 2 inflammation, which is strongly associated with
comorbidities, more severe disease, recurring symptoms and tissue
remodelling.3,5,10-13
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.2
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 ANCHOR phase III trials
Full results from the ANCHOR trials were presented
at the 2025 American Academy
of Allergy, Asthma and Immunology (AAAAI) and World Allergy
Organization (WAO) Joint Congress and published in The
Lancet.2,14
ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and
128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were
included in the depemokimab plus SOC arm and 128 in the placebo
plus SOC arm. All 528 patients had inadequately controlled CRSwNP,
including nasal polyps in both nasal cavities (an endoscopic
bilateral NPS ≥5), and had either undergone previous surgery
for CRSwNP, had received previous treatment with SCS or were
intolerant to SCS. Patients received depemokimab or placebo at
six-monthly intervals (26 weeks) in addition to SOC (maintenance
intranasal corticosteroids).2
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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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
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1. "Exdensur
(depemokimab) approved in China for the treatment of severe
asthma." GSK, 30 Mar. 2026, https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-china-for-the-treatment-of-severe-asthma/
2. Gevaert,
P, et al. "Efficacy and safety of twice per year depemokimab in
chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2):
Phase 3, randomised, double-blind, Parallel Trials." The Lancet,
vol. 405, no. 10482, Mar. 2025, pp. 911-926, https://doi.org/10.1016/s0140-6736(25)00197-7.
3. Bachert,
C, et al. "Burden of disease in chronic rhinosinusitis with nasal
polyps." Journal of Asthma and Allergy, Volume 14, Feb. 2021, pp.
127-134, https://doi.org/10.2147/jaa.s290424.
4. Seys,
S, et al. "Real-life assessment of chronic rhinosinusitis patients
using mobile technology: The mysinusitiscoach project by Euforea."
Allergy, vol. 75, no. 11, 19 June 2020, pp. 2867-2878, https://doi.org/10.1111/all.14408.
5. Bernstein,
J. "Use of patient-reported outcome measures and inflammatory
biomarkers to differentiate chronic rhinosinusitis with nasal polyp
endotypes: Is it feasible?" Annals of
Allergy, Asthma & Immunology, vol. 130, no. 4, Apr. 2023, pp.
409-410, https://doi.org/10.1016/j.anai.2023.01.004
6. "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/
7. "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/
8. "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/.
9. "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/
10. Bachert,
C, et al. "EUFOREA expert board meeting on uncontrolled severe
chronic rhinosinusitis with nasal polyps (CRSwNP) and Biologics:
Definitions and management." Journal of Allergy and Clinical
Immunology, vol. 147, no. 1, Jan. 2021, pp.
29-36, https://doi.org/10.1016/j.jaci.2020.11.013.
11. Laidlaw,
T, et al. "Chronic rhinosinusitis with nasal polyps and asthma."
The Journal of Allergy and Clinical Immunology: In Practice, vol.
9, no. 3, Mar. 2021, pp. 1133-1141, https://doi.org/10.1016/j.jaip.2020.09.063.
12. De
Corso, E, et al. "How
to manage recurrences after surgery in CRSWNP patients in the
biologic era: A narrative review." Acta Otorhinolaryngologica
Italica, vol. 43, no. 2 (Suppl. 1), Apr. 2023, https://doi.org/10.14639/0392-100x-suppl.1-43-2023-01
13. Chen,
S, et al. "Systematic literature review of the epidemiology and
clinical burden of chronic rhinosinusitis with nasal polyposis."
Current Medical Research and Opinion, vol. 36, no. 11, 25 Sept.
2020, pp. 1897-1911, https://doi.org/10.1080/03007995.2020.1815682.
14. Han,
J, et al. Efficacy and Safety of Twice-Yearly Depemokimab in
Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP):
The Phase III Randomized, Double-Blind, Placebo-Controlled
Replicate ANCHOR-1/2 Trials. Journal of Allergy and Clinical
Immunology, Volume 155, Issue 2, AB443. www.jacionline.org.
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: April
08, 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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