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Hepatitis B push: GSK (NYSE: GSK) signs China bepirovirsen launch deal

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6-K

Rhea-AI Filing Summary

GSK has entered an exclusive strategic collaboration with Sino Biopharmaceutical’s subsidiary CTTQ to support the launch of bepirovirsen for chronic hepatitis B in mainland China, where the disease affects an estimated 75 million people. Bepirovirsen is a potential first-in-class treatment under priority regulatory review in China, supported by positive phase III B-Well 1 and B-Well 2 trial results showing functional cure rates.

CTTQ, a hepatology leader with access to more than 5,000 medical centres, will handle importation, distribution, hospital access, and promotional activities. GSK will remain marketing authorisation holder and book sales of bepirovirsen supplied to CTTQ under agreed supply terms for an initial 5.5-year period. The agreement also allows GSK to review certain SBP Group early-stage pipeline assets for possible collaborations outside China.

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Insights

GSK secures a local partner to commercialise bepirovirsen in China’s large hepatitis B market.

GSK is pairing its investigational hepatitis B therapy bepirovirsen with CTTQ’s established commercial platform in China. CTTQ will manage distribution, hospital access, and promotion across more than 5,000 medical centres, while GSK retains marketing authorisation and books product sales.

The agreement runs for an initial 5.5-year term, indicating a medium‑term commitment around launch and early adoption. Bepirovirsen holds Priority Review and earlier Breakthrough Therapy status in China, backed by phase III data showing functional cure, a key goal in national hepatitis policy.

The collaboration targets a very large disease burden, with chronic hepatitis B affecting about 75 million people in China and causing roughly 450,000 deaths annually. Financial terms and expected volumes are not detailed, so the ultimate revenue impact will depend on regulatory outcomes, pricing, and uptake once approvals and launch timing are confirmed in future disclosures.

Initial collaboration term 5.5 years CTTQ supply and commercial agreement duration
CHB patients in China 75 million people Estimated chronic hepatitis B burden in China
CTTQ medical centre coverage over 5,000 medical centres Commercial footprint across care settings in China
Global CHB prevalence more than 250 million people Worldwide chronic hepatitis B burden
Global CHB deaths approximately 1.1 million deaths annually Worldwide annual mortality from chronic hepatitis B
China CHB deaths approximately 450,000 deaths annually Annual mortality from chronic hepatitis B in China
Liver cancer link in China 84.4% of cases Proportion of liver cancer associated with CHB in China
chronic hepatitis B medical
"Bepirovirsen is a potential first-in-class treatment for chronic hepatitis B (CHB) under priority regulatory review in China."
Chronic hepatitis B is a long-term viral infection of the liver where the hepatitis B virus persists and causes ongoing liver inflammation and damage, like a smoldering fire that can slowly weaken the organ over years. It matters to investors because it defines a steady, large market for treatments and diagnostics, shapes regulatory and clinical trial risks, and influences healthcare costs and the potential value of companies developing new therapies.
functional cure medical
"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 6 months after stopping all treatment."
A functional cure is a medical outcome in which a chronic disease is controlled so effectively that symptoms and progression are halted without completely removing the underlying cause; think of silencing a smoke alarm and removing the visible fire while some embers remain. For investors, a functional cure can change a treatment’s commercial value and market demand by reducing the need for continuous therapy, altering pricing, reimbursement and long-term revenue expectations for companies developing or selling the therapy.
Priority Review regulatory
"Bepirovirsen was granted Breakthrough Therapy designation in China in August 2021 and accepted for Priority Review in April 2026."
Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.
Breakthrough Therapy designation regulatory
"Bepirovirsen was granted Breakthrough Therapy designation in China in August 2021 and accepted for Priority Review in April 2026."
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
antisense oligonucleotide medical
"Bepirovirsen is a triple action investigational antisense oligonucleotide (ASO), designed to inhibit the replication of viral DNA in the body."
An antisense oligonucleotide is a small piece of synthetic genetic material designed to attach to specific molecules in the body’s cells, effectively blocking or modifying how genes are expressed. This technology is important because it can be used to develop targeted treatments for certain diseases, which may influence the value of biotech companies and the broader healthcare sector. Its development reflects advances in personalized medicine and gene-based therapies.
marketing authorisation holder regulatory
"GSK will remain the marketing authorisation holder and retain responsibility for regulatory, quality, pharmacovigilance and global medical strategy."

 
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 May 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: 11 May 2026, London, UK
 
GSK enters exclusive collaboration with SBP Group, a market leader in hepatology in China, to accelerate bepirovirsen at launch
 
Bepirovirsen is a potential first-in-class treatment for chronic hepatitis B, under priority regulatory review in China
Chronic hepatitis B affects 75 million people in China and is a national health priority
Collaboration provides scaled access to over 5,000 medical centres in China at launch
Agreement gives GSK the ability to review SBP Group's early-stage pipeline for potential collaboration opportunities
 
 
GSK plc (LSE/NYSE: GSK) today announced that it has entered into an exclusive strategic collaboration with Sino Biopharmaceutical, (SBP Group), through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), to accelerate bepirovirsen in mainland China at launch. Bepirovirsen is a potential first-in-class treatment for chronic hepatitis B (CHB) under priority regulatory review in China. CTTQ is a market leader in hepatitis B in China with one of the country's most comprehensive liver disease portfolios and a broad commercial footprint covering more than 5,000 medical centres across care settings. CTTQ has played a significant role in advancing the diagnosis and treatment of hepatitis B in China. 
 
The collaboration combines GSK innovation with CTTQ's local scale and in-market execution to reach more patients, more quickly. Under the agreement, CTTQ will be responsible for importation, distribution, hospital access, and promotional and non-promotional activities for bepirovirsen in mainland China. GSK will remain the marketing authorisation holder and retain responsibility for regulatory, quality, pharmacovigilance and global medical strategy. The agreement also grants GSK the ability to review certain early-stage pipeline assets of the SBP Group to evaluate the potential for collaboration opportunities outside China.
 
Mike Crichton, President International, GSK, said: "Chronic hepatitis B affects 75 million people in China1 and is a leading cause of liver cancer in the country.2 By combining GSK's innovation with CTTQ's extensive local scale and execution, we want to reach more patients, deliver greater impact, and directly address one of China's most pressing healthcare priorities."
 
Chronic hepatitis B is a national health priority in China. The latest National Action Plan for the Prevention and Treatment of Viral Hepatitis (2025-2030) has set out functional cure as a treatment goal for Hepatitis B. 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 6 months after stopping all treatment. Functional cure is associated with a meaningful reduction in the risk of long-term complications, including liver cancer.3
 
Bepirovirsen was granted Breakthrough Therapy designation in China in August 2021 and accepted for Priority Review in April 2026. The regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 phase III trials, which demonstrated statistically significant and clinically meaningful functional cure rates.
 
Collaboration terms
Under the terms of the agreement, CTTQ will purchase bepirovirsen from GSK under agreed supply terms for an initial term of 5.5 years. The term may be extended thereafter by mutual agreement. GSK will book sales of bepirovirsen supplied to CTTQ through the collaboration.
 
GSK also has the ability to review certain early-stage pipeline assets of the SBP Group to evaluate potential collaboration opportunities outside China.
 
About chronic hepatitis B
Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic Hepatitis B (CHB) 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.1 Many patients often require lifelong antiviral therapy for viral suppression; making functional cure a critical goal in disease management.
 
CHB remains a significant public health challenge in China, affecting an estimated 75 million people and causing approximately 450,000 deaths annually.1 84.4% of patients with liver cancer in China are associated with CHB infection.2 Functional cures are associated with a significant reduction in the risk of long-term liver complications, including liver cancer.3
 
About bepirovirsen
Bepirovirsen is a triple action investigational antisense oligonucleotide (ASO), designed to inhibit the replication of viral DNA in the body, suppress the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulate 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 Priority Review, Fast Track and Breakthrough Designations from the US FDA, Priority Review and Breakthrough Therapy designation in China and SENKU designation in Japan.
 
About SBP Group and CTTQ
Sino Biopharmaceutical Limited ("SBP Group", Stock Code: 1177.HK) is a leading, innovative R&D-driven pharmaceutical group in China, with fully integrated end-to-end capabilities spanning drug R&D, intelligent manufacturing, and commercial sales. The company holds a strong leadership position across oncology, liver, cardiometabolic, respiratory and autoimmune diseases.
 
Through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co. Ltd. ("CTTQ"), the SBP Group is a recognised leader in hepatology in China and has built one of the country's most comprehensive liver disease portfolios, covering the full continuum of care. They have advanced the diagnosis and treatment of hepatitis B in China and made meaningful contributions to public awareness and disease education, with substantial social impact.
 
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.
 
 
GSK enquiries
 
 
 
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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 Q1 Results for 2026.
 
Registered in England & Wales:
No. 3888792

Registered Office:
79 New Oxford Street
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WC1A 1DG
 
 
1.
WHO Global Hepatitis Report 2024. Available at https://www.who.int/publications/i/item/9789240091672 (last accessed March 2026)
2.
Lin J et al. Epidemiological characteristics of primary liver cancer in mainland China from 2003 to 2020: A representative multicenter study. Front Oncol. 2022;12:906778. doi:10.3389/fonc.2022.906778 Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9253580/ (last accessed May 2026)
3.
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 March 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: May 11, 2026
 
 
 
 
By:/s/ VICTORIA WHYTE
--------------------------
 
 
 
Victoria Whyte
 
Authorised Signatory for and on
 
behalf of GSK plc

FAQ

What collaboration did GSK (GSK) announce regarding hepatitis B in China?

GSK announced an exclusive collaboration with Sino Biopharmaceutical’s subsidiary CTTQ to commercialise bepirovirsen for chronic hepatitis B in mainland China. CTTQ will handle importation, distribution, hospital access, and promotion, while GSK remains marketing authorisation holder and books sales supplied to CTTQ.

What is bepirovirsen in GSK’s new China collaboration?

Bepirovirsen is GSK’s triple‑action investigational antisense oligonucleotide for chronic hepatitis B. It aims to inhibit viral DNA replication, reduce hepatitis B surface antigen levels, and stimulate the immune system to achieve functional cure, and is under Priority Review in China with supporting phase III data.

How large is the chronic hepatitis B burden GSK targets in China?

Chronic hepatitis B affects an estimated 75 million people in China and causes about 450,000 deaths annually. The filing also notes that 84.4% of liver cancer cases in China are associated with chronic hepatitis B infection, highlighting the scale and severity of the target population.

What roles will GSK and CTTQ play in commercialising bepirovirsen?

CTTQ will be responsible for importation, distribution, hospital access, and promotional and non‑promotional activities for bepirovirsen in mainland China. GSK will remain the marketing authorisation holder, overseeing regulatory, quality, pharmacovigilance, global medical strategy, and booking product sales to CTTQ.

How long does the GSK–CTTQ bepirovirsen agreement last?

CTTQ will purchase bepirovirsen from GSK under agreed supply terms for an initial 5.5‑year term. The agreement may be extended by mutual consent after that period, allowing the companies to continue collaborating based on launch experience and market conditions in chronic hepatitis B.

What additional pipeline opportunities are included in GSK’s deal with SBP Group?

Beyond bepirovirsen, GSK gains the right to review certain early‑stage pipeline assets from SBP Group. This review right lets GSK evaluate potential collaboration opportunities for those assets outside China, creating a framework for broader partnership if promising programs are identified.