REG - GSK PLC - Bepirovirsen accepted for review in China

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RNS Number : 5258Y  GSK PLC  30 March 2026

30(th) March 2026, London UK

 

Bepirovirsen accepted for regulatory review in China as a potential
first-in-class functional cure for chronic hepatitis B

 

·   Submission supported by statistically significant and clinically
meaningful functional cure rates in pivotal Phase III B-Well trials

·   An estimated 75 million people in China live with chronic hepatitis
B 1  (#_edn1) , a leading cause of liver cancer 2  (#_edn2)

·   Bepirovirsen granted Breakthrough Therapy designation

 

 

GSK plc (LSE/NYSE: GSK) today announced that the China National Medical
Products Administration (NMPA) 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 an estimated 75 million people in China(1).
The current standard of care - typically nucleos(t)ide analogues - often
requires lifelong therapy and the functional cure rates remain low, typically
only 1%. 3  (#_edn3) 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. Functional
cure is associated with significant reduction in the risk of long-term liver
complications, including liver cancer. 4  (#_edn4) Each year, in China,
approximately 450,000 deaths are caused by CHB(1).

 

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. These data will be presented at a
congress and submitted for scientific peer-reviewed publication in 2026.

 

Bepirovirsen was granted Breakthrough Therapy designation in China in August
2021, which is intended to expedite the review of investigational drugs with
potential for substantial improvement over available therapies.

 

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. CHB affects more than 250
million people worldwide. Each year, the disease causes approximately 1.1
million deaths, and approximately 450,000 deaths in China.(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 Pharmaceuticals 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
(https://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.

 

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 1  (#_ednref1) 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)

 2  (#_ednref2) 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  (#_ednref3) 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)

 4  (#_ednref4) 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)

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