REG - GSK PLC - Collaboration with CTTQ for bepirovirsen

GSKAnnouncement

Mon 07:05

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RNS Number : 7646D  GSK PLC  11 May 2026

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 China(1) 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
(https://www.gsk.com) .

 

 GSK enquiries
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                      Sarah Clements     +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn     +1 202 603 5003       (Washington DC)
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 Investor Relations:  Constantin Fest    +44 (0) 7831 826525   (London)
                      James Dodwell      +44 (0) 20 8047 2406  (London)
                      Mick Readey        +44 (0) 7990 339653   (London)
                      Steph Mountifield  +44 (0) 7796 707505   (London)
                      Sam Piper          +44 (0) 7824 525779   (London)
                      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, and
GSK's Q1 Results for 2026.

 

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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/
(https://urldefense.com/v3/__https:/pmc.ncbi.nlm.nih.gov/articles/PMC9253580/__;!!AoaiBx6H!zVT5P3Sm6mo8byNFsmivwtieK6p0wmxnn3Xd0n43fOaFcYN_pdVqZGry9XO01Xxk6jfl8f6-A8KZV8Vyoldnq5z0$)
 (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)

 

 

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