[6-K] GSK plc Current Report (Foreign Issuer)

Rhea-AI Filing Summary

GSK reports that Japan's Ministry of Health, Labour and Welfare has accepted for review a new drug application for bepirovirsen as a treatment for adults with chronic hepatitis B. This is the first regulatory filing globally for the drug and follows positive phase III B-Well trial results showing statistically significant and clinically meaningful functional cure rates when added to standard therapy.

Bepirovirsen, an investigational antisense oligonucleotide, targets hepatitis B viral RNA to reduce viral replication and surface antigen levels, while stimulating the immune system. It has SENKU designation in Japan, which enables expedited review, and has also received Fast Track or similar designations in other major markets, but it is not yet approved anywhere.

Insights

Biopharma regulatory and pipeline analyst

Japan’s review of bepirovirsen marks a key first-in-class hepatitis B regulatory milestone for GSK.

The acceptance of the bepirovirsen new drug application in Japan, supported by phase III B-Well data, moves this chronic hepatitis B candidate into formal regulatory evaluation. The filing is described as the first globally and follows statistically significant functional cure outcomes versus standard of care alone.

SENKU designation in Japan provides expedited review for therapies addressing high unmet medical need, which aligns with hepatitis B’s role in liver cancer and ongoing reliance on lifelong antiviral therapy. The drug also holds special designations in the US and China, reinforcing its perceived innovation.

Future impact will depend on the outcome of the Japanese review and subsequent decisions in other regions. The company plans to present full phase III results at a scientific congress and submit them to peer-reviewed journals in 2026, which should give investors clearer visibility into durability, safety and potential positioning in chronic hepatitis B treatment.

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

●    Submission supported by statistically significant and clinically meaningful functional cure rates demonstrated in pivotal phase III B-Well trials

●    Nearly 1 million people in Japan live with chronic hepatitis B[1], a leading cause of liver cancer[2]

●    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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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.

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[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.

GSK plc

(Registrant)

Date: February 26, 2026

By:/s/ VICTORIA WHYTE

--------------------------

Victoria Whyte

Authorised Signatory for and on

behalf of GSK plc

FAQ

What did GSK (GSK) announce about bepirovirsen in Japan?

GSK announced that Japan’s Ministry of Health, Labour and Welfare accepted a new drug application for bepirovirsen to treat adults with chronic hepatitis B, supported by positive phase III B-Well trial results showing statistically significant and clinically meaningful functional cure rates versus standard of care alone.

Why is bepirovirsen important for chronic hepatitis B patients in Japan?

Bepirovirsen targets chronic hepatitis B, which affects nearly one million people in Japan and drives many liver cancer cases. Current nucleos(t)ide analogue therapies often require lifelong treatment with low functional cure rates, so a first-in-class option focused on functional cure could meaningfully change disease management.

What clinical data support GSK’s bepirovirsen filing in Japan?

The filing is supported by phase III B-Well 1 and B-Well 2 trials, which showed statistically significant and clinically meaningful functional cure rates when bepirovirsen was added to standard of care compared with standard of care alone, with even higher responses in patients with lower baseline hepatitis B surface antigen levels.

What is SENKU designation and how does it affect GSK’s bepirovirsen review?

SENKU designation in Japan recognises innovative medicines for serious diseases with high unmet need and is intended to facilitate early patient access through expedited regulatory review, meaning bepirovirsen’s application may move more quickly through Japan’s evaluation process than under standard timelines.

Is GSK’s bepirovirsen already approved for chronic hepatitis B anywhere?

Bepirovirsen is not approved anywhere in the world. It remains an investigational antisense oligonucleotide, although it has received special designations such as Fast Track in the US, Breakthrough Therapy in China and SENKU in Japan to recognise its potential in chronic hepatitis B.

How does bepirovirsen work against chronic hepatitis B according to GSK?

Bepirovirsen is a triple-action antisense oligonucleotide designed to destroy hepatitis B viral RNA, inhibit replication of the viral genome, suppress hepatitis B surface antigen levels in blood, and stimulate the immune system, with the goal of achieving a durable functional cure in chronic hepatitis B.