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 October 2025
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: 14 October 2025, London UK
GSK's Shingrix approved in China for prevention of shingles
in adults aged 18 and over who are at increased risk due to
immunodeficiency or immunosuppression
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Shingrix (GSK's
Recombinant Zoster Vaccine or RZV) is the first and only vaccine
approved in this population in China
●
Approval
adds to existing indication in adults aged 50 and
over
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Approximately
six million cases of shingles occur in China
annually,[1] with
immunodeficient or immunosuppressed patients at a higher risk than
the general population
[2]
GSK plc (LSE/NYSE: GSK) today announced
that the China National Medical Products Administration (NMPA) has
approved Shingrix (GSK's
Recombinant Zoster Vaccine or RZV) for the prevention of shingles
(herpes zoster) in adults aged 18 years and over who are at
increased risk of shingles due to immunodeficiency or
immunosuppression caused by known disease or
therapy.
Shingles poses a significant health burden, with approximately six
million cases per year in China.1 Besides
advancing age, other factors can increase the risk of developing
shingles, including immunodeficiency or
immunosuppression[3] with
no other shingles vaccine approved for this population in
China.
Shingles-associated pain is often described as aching,
burning, stabbing
or shock-like[4] and
can have
a considerable impact on patients' quality of life, e.g.
affecting sleep, and ability to undertake activities of daily
living including work.[5],[6],[7] This
approval expands the reach of GSK's RZV, to ensure protection for
those patients most vulnerable to shingles.
Sanjay Gurunathan, Senior Vice President, Vaccines and Infectious
Diseases R&D, said: "This
approval marks a critical milestone in expanding access to GSK's
RZV for those
at a higher risk of what can be a disrupting and devastating
disease. Through close collaboration with regulatory bodies, we
continue to drive innovation that helps protect vulnerable patient
groups and shifting the focus of healthcare systems towards
preventing diseases, like shingles."
The NMPA application was informed by six clinical trials in
patients aged 18 years and over who had undergone recent
blood-forming cells (stem cell) transplantation, kidney transplant,
or have blood cancer, solid tumour, or HIV.[8],[9],[10],[11],[12],[13]
About shingles
Shingles is caused by the reactivation of the varicella zoster
virus (VZV), the same virus that causes
chickenpox.4 Shingles
typically presents as a rash, with painful blisters across the
chest, abdomen or face.[14] Following
the rash, a person can also experience post-herpetic neuralgia
(PHN), a long-lasting nerve pain that can last weeks or months and
can occasionally persist for several years.4 PHN
is the most common complication of shingles, occurring in 5-30% of
all shingles cases.[15]
About Shingrix
Shingrix (Recombinant
Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine
indicated for the prevention of shingles in adults 50 and over and
in several countries and regions. RZV is also approved for adults
aged 18 years or over at increased risk for shingles. It combines
an antigen, glycoprotein E, with an adjuvant system,
AS01B,
and may help overcome the natural age-related decline in responses
to immunisation that contributes to the challenge of protecting
adults aged 50 and over from shingles. RZV is not indicated to
prevent primary varicella infection (chickenpox). The use of RZV
should be in accordance with official recommendations and local
product label.
For product and important safety information please consult the
country relevant summary of product characteristics.
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 gsk.com.
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GSK enquiries
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Media:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Simon
Moore
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+44 (0)
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Alison
Hunt
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+1 540 742 3391
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(Washington
DC)
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Investor
Relations:
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Constantin
Fest
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+44 (0)
7831 826525
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 3126
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(Philadelphia)
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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 Q2 Results for 2025.
Registered in England &
Wales:
No.
3888792
Registered
Office:
79
New Oxford Street
London
WC1A
1DG
References
[1] Zhang, Z., et al. The incidence
of herpes zoster in China: A meta-analysis and evidence quality
assessment. Human
vaccines & immunotherapeutics.
2023;19(2):2228169.
[2] Zhenwei L, et al. Study on the
risk of recurrence of herpes zoster in adults based on a
retrospective cohort design. Zhejiang University of Traditional
Chinese Medicine Conference.
[3] Chen, S.Y., et al. Incidence of
herpes zoster in patients with altered immune
function. Infection.
2014;42(2):325-34.
[4] Harpaz, R., et al. Prevention of
herpes zoster: recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR Recomm
Rep 2008;57(Rr-5):1-30;
.
[5] van
Oorschot, D.A.M., et al. A Cross-Sectional Concept Elicitation
Study to Understand the Impact of Herpes Zoster on Patients'
Health-Related Quality of Life. Infectious
diseases and therapy. 2022;11:501 -
16.
[6] Gater, A., et al. The humanistic,
economic and societal burden of herpes zoster in Europe: a critical
review. BMC public
health.
2015;15:193.
[7] Panatto, D., et al. Evaluation of
the economic burden of Herpes Zoster (HZ)
infection. Human
vaccines & immunotherapeutics.
2015;11(1):245-62.
[8] Bastidas,
A., et al. Effect of Recombinant Zoster Vaccine on Incidence of
Herpes Zoster After Autologous Stem Cell Transplantation: A
Randomized Clinical Trial. JAMA.
2019;322(2):123-33.
[9] Vink,
P., et al. Immunogenicity and safety of the adjuvanted recombinant
zoster vaccine in patients with solid tumors, vaccinated before or
during chemotherapy: A randomized trial. Cancer.
2019;125(8):1301-12.
[10] Dagnew,
A.F., et al. Immunogenicity and safety of the adjuvanted
recombinant zoster vaccine in adults with haematological
malignancies: a phase 3, randomised, clinical trial and post-hoc
efficacy analysis. The Lancet
Infectious Diseases.
2019;19(9):988-1000.
[11] Stadtmauer,
E.A., et
al. A phase
1/2 study of an adjuvanted varicella-zoster virus subunit vaccine
in autologous hematopoietic cell transplant
recipients. Blood.
2014;124 (19):2921-9.
[12] Berkowitz,
E.M., et al. Safety and immunogenicity of an adjuvanted herpes
zoster subunit candidate vaccine in HIV-infected adults: a phase
1/2a randomized, placebo-controlled study. The Journal
of infectious diseases.
2015;211(8):1279-87.
[13] GSK. Abstract on
file.
[14] Mueller,
N.H., et al. Varicella zoster virus infection: clinical features,
molecular pathogenesis of disease, and
latency. Neurologic
clinics.
2008;26(3):675-97.
[15] Kawai, K., et al. Systematic
review of incidence and complications of herpes zoster: towards a
global perspective. BMJ
open.
2014;4(6).
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.
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GSK plc
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(Registrant)
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Date: October
14, 2025
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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