REG - GSK PLC - Bepirovirsen accepted for review by the EMA

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RNS Number : 2764Y  GSK PLC  27 March 2026

Issued: 27(th) March 2026, London UK

 

Bepirovirsen accepted for review by the European Medicines Agency as a
potential first-in-class treatment for chronic hepatitis B

 

•   Submission supported by statistically significant and clinically
meaningful functional cure rates in pivotal PhIII B-Well trials.

•   Nearly 3.2 million people in Europe live with chronic hepatitis B
(CHB), a leading cause of liver cancer.[ (#_edn1) 1] (#_edn1)

 

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency
(EMA) has accepted for review the marketing authorisation application (MAA)
for the use of bepirovirsen, an investigational antisense oligonucleotide
(ASO), in the treatment of adults with chronic hepatitis B (CHB).

 

Chronic hepatitis B remains a public health concern in Europe, with an
estimated 3.2 million people living with CHB.(1)The current standard of care -
nucleos(t)ide analogues - often requires lifelong therapy and the functional
cure rates remain low, typically only 1%. 2  (#_edn2) Functional cure occurs
when the hepatitis B virus DNA and viral protein - hepatitis B surface antigen
(HBsAg) - are undetectable in the blood for at least 24 weeks after stopping
all treatment, indicative of the disease being controlled by the immune system
without medication. It is estimated that ~56% of liver cancer cases globally
are caused by CHB. 3  (#_edn3)

 

The regulatory submission to EMA is based on positive results from the B-Well
1 and B-Well 2 Phase III trials. Both trials met their primary endpoint, and
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. Results were statistically significant across all ranked endpoints,
including in patients with baseline surface antigen (HBsAg) <=1000 IU/ml
where an even greater effect was demonstrated. The trials demonstrated an
acceptable safety and tolerability profile consistent with what was reported
in other studies. These data will be presented at a congress and submitted for
scientific peer-reviewed publication in 2026.

 

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 globally 4  (#_edn4) , including an estimated 15,000 in Europe.(1)
Many patients require lifelong antiviral therapy for viral suppression, making
functional cure a critical goal in disease management. The European
Association for the Study of the Liver (EASL) guidelines identify functional
cure as the ultimate goal of treatment. 5  (#_edn5)

 

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.

About B-Well Clinical trial programmes
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 the durability of
functional cure in nucleos(t)ide analogue (NA)-treated 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 participants with baseline HBsAg ≤1000
IU/ml. Functional cure is defined as hepatitis B surface antigen (HBsAg) loss
and undetectable HBV DNA for at least 24 weeks after a finite course of
treatment.

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 Pharmaceuticals and collaborated with
them on its development. 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
(https://www.gsk.com) .

 

 GSK enquiries
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 Investor Relations:  Constantin Fest    +44 (0) 7831 826525   (London)
                      James Dodwell      +44 (0) 20 8047 2406  (London)
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                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 3126       (Philadelphia)

 

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.

 

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WC1A 1DG

 1  (#_ednref1) European Centre for Disease Prevention and Control. World
Hepatitis Day 2025: Hepatitis burden remains high across the EU/EEA. 28 July
2025. Available at :
https://www.ecdc.europa.eu/en/news-events/world-hepatitis-day-2025
(https://www.ecdc.europa.eu/en/news-events/world-hepatitis-day-2025) (last
accessed February 2026).

 2  (#_ednref2) 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)

 3  (#_ednref3) Maucort-Boulch, D., de Martel, C., Franceschi, S. and Plummer,
M. (2018), Fraction and incidence of liver cancer attributable to hepatitis B
and C viruses worldwide. Int. J. Cancer, 142: 2471-2477. Available at:
https://doi.org/10.1002/ijc.31280 (https://doi.org/10.1002/ijc.31280) (last
accessed March 2026)

(#_ednref4) 4 WHO Global Hepatitis Report 2024. Available at
https://www.who.int/publications/i/item/9789240091672
(https://www.who.int/publications/i/item/9789240091672) (last accessed March
2026)

 5  (#_ednref5) EASL Guidelines available at
https://easl.eu/publication/easl-guidelines-management-of-hepatitis-b/
(https://easl.eu/publication/easl-guidelines-management-of-hepatitis-b/) (last
accessed March 2026)

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