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 August 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 . . . . . . . .
24th August
2026, London UK
Hibsago (bepirovirsen)
approved in Japan as first and only functional cure for chronic
hepatitis B
●
First
global approval for Hibsago
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Chronic
hepatitis B affects nearly one million people
in Japan[1] with
nationwide efforts for screening and treatment[2]
●
Approval
accelerated by SENKU designation, granted to innovative medicines
with potential to address high unmet medical
need[3]
GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of
Health, Labour and Welfare (MHLW) has
approved Hibsago (bepirovirsen), an antisense oligonucleotide
(ASO), as a functional cure for chronic hepatitis B (CHB) virus
infection in
adult patients who have received at least 6 months of prior
nucleos(t)ide analogue therapy and meet pre-defined viral
markersi.
This is the first global approval for bepirovirsen, and the first
and only functional cure treatment for CHB approved in
Japan.
CHB is a major public health challenge and a leading cause of liver
cancer globally.[4] In
Japan, nearly one million people live with the disease and it
contributes to around 4,000 deaths
annually.1 The
Japanese government has demonstrated strong commitment to tackling
CHB including through
nationwide screening and treatment programmes.2
Tony Wood, Chief Scientific Officer, GSK, said:
"For the first time, a treatment approved for functional cure is
available to people living with chronic hepatitis B in Japan
with Hibsago. After 6-months of treatment
with Hibsago, patients could be freed from life-long
therapy[5] and
reduce their risk of long-term liver complications. This is a major
advance for CHB management and our innovative hepatology portfolio,
and we look forward to further regulatory decisions in other
countries."
Approval in Japan was supported by results from the B-Well phase
III trials showing unprecedented functional cure rates of 19%
in adults
with ≤3000 IU/ml HBsAg, compared
to current
standard of care alone which typically only achieves a 1%
functional cure rate after one year of
treatment.[6] Functional
cure occurs when the hepatitis B virus DNA and viral protein -
HBsAg - are undetectable for at least 24 weeks after stopping all
treatment. This
indicates the disease is controlled by the immune system without
medication. A
loss in HBsAg is associated with up to an 89% reduction in risk of
liver cancer and a 62% reduction in risk of all-cause
mortality.[7]
This approval was accelerated by SENKU designation, granted to
innovative medicines with potential to address high unmet medical
need.3
GSK continues to advance regulatory submissions for bepirovirsen
across multiple geographies with decisions, including the US,
expected in the coming months. Development of bepirovirsen in
future sequential treatment strategies is also
ongoing.
Results from the B-Well
phase III trials
Pooled data from the B-Well phase III trials showed that 6-month
treatment with bepirovirsen achieved a statistically significant
and clinically meaningful 19% functional cure response rate (233 of
1,220 vs. 0 of 614 in the placebo group; p<0.001 in both trials)
in the overall study population (adults with ≤3000 IU/ml
HBsAg level), meeting the primary endpoint. In a key secondary
endpoint, a functional cure rate of 26% (200 of 768 vs. 0 of 393 in
the placebo group; p<0.001 in both trials) was achieved in
participants with ≤1000 IU/ml HBsAg level, a group that
represents approximately 45% of diagnosed CHB cases
globally.[8]
Separately, exploratory analyses showed bepirovirsen reduced HBsAg
to ≤100 IU/ml in 49% of recipients (598 of 1220) in the
overall study population and in 62% of recipients in the
≤1000 IU/ml (476 of 768) sub-group[9] as
of the week 72 visit. Medical literature has linked this level of
low surface antigen with increased immune control and improved
patient outcomes.[10],[11],[12]
The trials showed an acceptable safety and tolerability profile
consistent with other studies of bepirovirsen. The three most
frequently observed adverse events were injection site erythema,
local pain and temporary rise in the blood level of a liver
enzyme.
About bepirovirsen
Bepirovirsen is an antisense oligonucleotide (ASO) designed to
recognise and inhibit the production of the genetic components
(i.e. RNA) of the hepatitis B virus that can lead to chronic
disease, potentially allowing a person's immune system to regain
control. Bepirovirsen reduces the production of RNA and viral
proteins associated with HBV, 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.
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 and
Breakthrough Designations from the US FDA, Breakthrough Therapy and
Priority Review designation in China and SENKU designation in
Japan.
About the B-Well trials
The B-Well 1 and B-Well 2 trials are global multi-centre,
randomised, double-blind, placebo-controlled trials conducted in 29
countries. They assessed the efficacy, safety, pharmacokinetic
profile, and durability of functional cure in nucleos(t)ide
analogue-treated adult participants with chronic hepatitis B and
baseline surface antigen (HBsAg) ≤3000 IU/ml. The primary
endpoint assessed the proportion of participants achieving
functional cure in patients with baseline HBsAg ≤3000 IU/ml.
A key ranked secondary endpoint evaluated functional cure in
participants with baseline HBsAg ≤1000 IU/ml. Functional cure
is defined as HBsAg being undetectable in the blood for at least 24
weeks after stopping all treatment, indicating that the disease is
controlled by the immune system without medication.
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 240 million people
worldwide. The disease causes approximately 1.1 million deaths
each year[13],
and is a leading cause of liver cancer cases
globally4.
Currently, many patients often require lifelong antiviral therapy
for viral suppression, making functional cure a critical goal in
disease management.
About GSK's hepatology portfolio
GSK is extending its expertise in inflammation to develop a next
wave of innovation for the millions of people affected by chronic
and life-threatening fibro-inflammatory liver conditions. GSK has a
growing hepatology pipeline, harnessed by the science of the immune
system and advanced technologies, with a focus on chronic hepatitis
B, metabolic dysfunction-associated steatohepatitis (MASH) and
alcohol-associated liver disease (ALD).
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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Tim
Foley
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(London)
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Sarah
Clements
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+44 (0)
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Alison
Hunt
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+1 540 742 3391
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(Washington
DC)
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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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Joanna
Tuplin
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+44 (0)
7788 351650
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(London)
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James
Dodwell
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+44 (0)
7881 269066
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Sam
Piper
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+44 (0)
7824 525779
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(London)
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Dan
Smith
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+44 (0)
7823 523885
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 3126
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(Philadelphia)
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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, and
GSK's Q2 Results for 2026.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
Footnote
[i] Hibsago
(bepirovirsen) has been approved as a functional cure in chronic
hepatitis B (CHB) virus infection in patients who have received
nucleos (t) ide analogue therapy for at least 6 months before
starting this drug and whose HBs antigen level at starting this
drug is ≤ 3000 IU/mL and HBV DNA level is < 90 IU/mL
(1.95logIU/mL).
References
[1] Polaris
Observatory Dashboard. Available at https://cdafound.org/polaris/dashboard (last
accessed August 2026)
[2] Korenaga
M, Kanto T. Testing, diagnosis of viral hepatitis, and the
follow-up policy in Japan. Glob Health Med. 2021 Oct
31;3(5):308-313. doi: 10.35772/ghm.2021.01072. PMID: 34782874;
PMCID: PMC8562087.
[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 July 2026)
[4] 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
[5] Hou
J, Lim S-G, Buti M, et al. Phase 3 results of bepirovirsen
treatment for chronic hepatitis B virus infection. N Engl J Med
2026;394:2395-406. DOI: 10.1056/NEJMoa2515131
[6] 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)
[7] Drysdale
M, Chang R, Wang S, Coutinho A, Gielen V, Man T, Song R, Duh MS,
Khalili M, Theodore D. Hepatitis B Surface Antigen Loss and
Improved Clinical Outcomes in US Individuals With Chronic Hepatitis
B Virus Infection. J Viral Hepat. 2026 Jun;33(6):e70184. doi:
10.1111/jvh.70184. PMID: 42141794; PMCID:
PMC13179525.
[8] GSK
data on file, 2026
[9] Hou
J, EASL 2026. Oral presentation. Slides available upon
request.
[10] Tseng
TC et al. Gut 2025;74:1896-1906
[11] Zhou
K et al. Lancet Gastroenterol Hepatol
2019;4:227-238
[12] Tseng
TC et al. Hepatology 2012;55:68-76
[13] WHO
Global Hepatitis Report 2026. Available at : https://www.who.int/publications/i/item/9789240122383 (last
accessed August 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: August
24, 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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