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 February 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: 26th February
2026, London UK
Bepirovirsen accepted for regulatory review in Japan as a potential
first-in-class treatment for chronic hepatitis B
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Submission
supported by statistically significant and clinically meaningful
functional cure rates demonstrated in pivotal phase III B-Well
trials
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Nearly
1 million people in Japan live with chronic hepatitis
B[1],
a leading cause of liver cancer[2]
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First
regulatory filing globally, with SENKU designation enabling
expedited review[3]
GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of
Health, Labour and Welfare (MHLW) has accepted for review a new
drug application (NDA) for bepirovirsen, an investigational
antisense oligonucleotide (ASO), for the treatment of adults with
chronic hepatitis B (CHB).
Chronic hepatitis B is a major public health challenge, affecting
more than 250 million people worldwide and nearly one million
people in Japan.1 The
current standard of care - nucleos(t)ide analogues - often requires
lifelong therapy and the functional cure rates remain low,
typically only 1%.[4] Functional
cure occurs when the hepatitis B virus DNA and viral protein -
hepatitis B surface antigen (HBsAg) - are at levels low enough to
be undetectable in the blood for at least 24 weeks after stopping
all treatment, and can be controlled by the immune system without
medication. Functional cure is associated with significant
reduction in the risk of long-term liver complications, including
liver cancer.[5] It
is estimated that ~56% of liver cancer cases globally are caused by
CHB.2
The regulatory submission is supported by positive results from the
B-Well 1 and B-Well 2 Phase III trials, where bepirovirsen
demonstrated a statistically significant and clinically meaningful
functional cure rate. Functional cure rates were significantly
higher with bepirovirsen plus standard of care compared with
standard of care alone across all ranked endpoints, including in
patients with lower baseline HBsAg levels where an even greater
effect was observed. Bepirovirsen demonstrated an acceptable safety
and tolerability profile consistent with previous
studies.[6] The
data are anticipated to be presented at a congress and submitted
for scientific peer-reviewed publication in
2026.
Bepirovirsen was granted SENKU designation in
Japan3 in
August 2024, reflecting its innovation and potential to address a
disease with high unmet medical need. SENKU designation is intended
to facilitate early patient access through an expedited regulatory
review process.
Clinical trial programme
B-Well 1 [NCT05630807] and B-Well 2 [NCT 05630820] trials are
global multi-centre, randomised, double-blind, placebo-controlled
trials conducted in 29 countries. They assessed the efficacy,
safety, pharmacokinetic profile, and the durability of functional
cure in nucleos(t)ide analogue (NA)-treated in non-cirrhotic
participants with CHB and baseline surface antigen (HBsAg)
≤3000 IU/ml. The primary endpoint assessed the proportion of
participants achieving functional cure in patients with baseline
surface antigen (HBsAg) ≤3000 IU/ml. A key ranked secondary
endpoint evaluated functional cure in patients with baseline HBsAg
≤1000 IU/ml.
About chronic hepatitis B
Hepatitis B is a viral infection that can cause both acute and
chronic liver disease. Chronic hepatitis B occurs when the immune
system is unable to clear the virus, resulting in long-lasting
infection that affects more than 250 million people worldwide. The
disease causes approximately 1.1 million deaths each
year[7],
and approximately 4000 deaths in Japan annually.1 Many
patients often require lifelong antiviral therapy for viral
suppression; making functional cure a critical goal in disease
management.
About bepirovirsen
Bepirovirsen is a triple action investigational antisense
oligonucleotide (ASO), designed to recognise and orchestrate the
destruction of the genetic components (i.e. mRNA and pregenomic
RNA) of the hepatitis B virus that can lead to chronic disease,
potentially allowing a person's immune system to regain control.
Bepirovirsen inhibits the replication of the viral genome in the
body, suppresses the level of hepatitis B surface antigen (HBsAg)
in the blood, and stimulates the immune system to increase the
chances of a durable and sustained response.
Bepirovirsen is also being evaluated as a potential backbone
therapy for future sequential treatment strategies aimed at
expanding functional cure to broader patient
populations.
GSK licensed bepirovirsen from Ionis and collaborated with them on
its development. Bepirovirsen has been recognised by global
regulatory authorities for its innovation and potential to address
significant unmet need in hepatitis B, with Fast Track designation
from the US FDA, Breakthrough Therapy designation in China and
SENKU designation in Japan. Bepirovirsen is currently not approved
anywhere in the world.
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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GSK enquiries
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Media:
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Kathleen
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Alison
Hunt
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+1 540 742 3391
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Investor
Relations:
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Constantin
Fest
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+44 (0)
7831 826525
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Frannie
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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 Q4 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[1] Polaris
Observatory Dashboard. Available
at https://cdafound.org/polaris/dashboard/ (last
accessed January 2026).
[2] Rumgay
H et al . Global burden of primary liver cancer in 2020 and
predictions to 2040. J Hepatol. 2022;77:1598-1606. doi:
10.1016/j.jhep.2022.08.021
[3] GSK
Press release, Bepirovirsen granted SENKU designation in Japan for
chronic hepatitis B, August 2024. Available at: https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-granted-senku-designation-in-japan-for-chronic-hepatitis-b/ (last
accessed: January 2026).
[4] Slaets,
L. et al. "Systematic review with meta-analysis: hepatitis B
surface antigen decline and seroclearance in chronic hepatitis B
patients on nucleos(t)ide analogues or pegylated interferon
therapy" in GastroHep 2, 106-116 (2020)
[5] EASL,
"Clinical Practice Guidelines on the management of hepatitis B
virus infection" in Journal of Hepatology Volume 83, Issue 2,
August 2025, Pages 502-583. Available at:
https://www.sciencedirect.com/science/article/pii/S0168827825001746
(last accessed: January 2026).
[6] GSK
Press release, GSK
announces positive results from B-Well 1 and B-Well 2 phase III
trials for bepirovirsen, a potential first-in-class treatment for
chronic hepatitis B, January 2026. Available
at: https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-b-well-1-and-b-well-2-phase-iii-trials-for-bepirovirsen-a-potential-first-in-class-treatment-for-chronic-hepatitis-b/ (last
accessed: January 2026).
[7] WHO.
Global hepatitis report 2024. Available
at: https://www.who.int/publications/i/item/9789240091672 (last
accessed: January 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: February
26, 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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