a1543c
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 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(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: 6 February 2024, London UK
GSK's regulatory application
for Shingrix for the prevention of shingles in at-risk
adults aged 18 and over accepted for review by China National
Medical Products Administration
● Shingrix already
approved in China for adults aged 50 years and
over
● Application
could expand populations eligible to benefit from protection
against shingles to include adults with an increased risk of the
disease
● Approximately
six million cases of shingles in China each year, with the
incidence over three times higher for adults at increased risk
compared to the general population
GSK plc (LSE/NYSE: GSK) today announced that the Center for Drug
Evaluation (CDE) of the China National Medical Products
Administration (NMPA) has accepted for review the regulatory
application of Shingrix (Recombinant Zoster Vaccine or RZV) for the
prevention of shingles (herpes zoster) in adults aged 18 years and
over at increased risk.
Recombinant Zoster Vaccine (RZV) is a non-live, recombinant subunit
adjuvanted vaccine given intramuscularly in two doses and was
initially approved in 2019 by the NMPA to prevent shingles in
adults aged 50 years and over.1-3
Globally, shingles will affect up to 1 in 3 people in their
lifetime.4-7 A
variety of factors can increase the risk of developing shingles,
including advancing age
and immunodeficiency or immunosuppression,8 as
well as other chronic conditions such as COPD, diabetes, and
asthma.9 It
is estimated that there are approximately 6 million cases of
shingles in China each year,10 with
the incidence in people who are at increased risk, including people
who are immunocompromised either due to disease or therapeutic
treatment, being over three times higher than the general
population.11
The NMPA application
is 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.12-17
About shingles
Shingles is caused by the reactivation of the varicella-zoster
virus (VZV), the same virus that causes
chickenpox.4 A
variety of factors can increase the risk of developing shingles,
including advancing age and immunodeficiency or
immunosuppression,8 as
well as other chronic conditions such as COPD, diabetes, and
asthma.9
Shingles typically presents as a rash, with painful blisters across
the chest, abdomen, or face.18 The
pain is often described as aching, burning, stabbing or
shock-like.4 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 from findings in various
studies.19
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. 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.1,2 RZV
is not indicated to prevent primary varicella infection
(chickenpox). In some countries, RZV is also approved for adults
aged 18 years or over at increased risk for shingles. The use of
RZV should be in accordance with official
recommendations.
Please refer to the Product Information (PI) for important dosage,
administration and safety information in China available at this
link: https://www.gsk-china.com/media/6506/4-说明书-pdf-145m-ppc-0025427-v3-clean.pdf
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.
GSK enquiries
|
|
|
|
Media:
|
Tim Foley
|
+44 (0) 20 8047 5502
|
(London)
|
|
Simon Moore
|
+44 (0) 20 8047 5502
|
(London)
|
|
Kathleen Quinn
|
+1 202 603 5003
|
(Washington DC)
|
|
Alison Hunt
|
+1 540 742 3391
|
(Washington DC)
|
|
|
|
|
Investor Relations:
|
Nick Stone
|
+44 (0) 7717 618834
|
(London)
|
|
James Dodwell
|
+44 (0) 20 8047 2406
|
(London)
|
|
Mick Readey
|
+44 (0) 7990 339653
|
(London)
|
|
Josh Williams
|
+44 (0) 7385 415719
|
(London)
|
|
Camilla Campbell
|
+44 (0) 7803 050238
|
(London)
|
|
Steph Mountifield
|
+44 (0) 7796 707505
|
(London)
|
|
Jeff McLaughlin
|
+1 215 751 7002
|
(Philadelphia)
|
|
Frannie DeFranco
|
+1 215 751 4855
|
(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 under Item 3.D
"Risk factors" in the company's Annual Report on Form 20-F for
2022, and Q4 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1. Cunningham, A.L., et al. Efficacy of the Herpes Zoster Subunit
Vaccine in Adults 70 Years of Age or Older. New England Journal of
Medicine. 2016;375(11):1019-1032.
2. The GSK proprietary AS01 adjuvant system contains QS-21
Stimulon® adjuvant licensed from Antigenics LLC, a wholly
owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and
liposomes.
3. GSK. GSK announces approval of Shingrix in China for prevention
of shingles in adults aged 50 and over. Available
at: https://www.gsk.com/en-gb/media/press-releases/gsk-announces-approval-of-shingrix-in-china-for-prevention-of-shingles-in-adults-aged-50-and-over/.
Last accessed: January 2024.
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. Shingles in Australia. Australian Institute of Health and
Welfare [Available from:
https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx
Last Accessed: November 2023
6. Lee, C., et al. Lifetime risk of herpes zoster in the population
of Beijing, China. Public health in practice (Oxford, England).
2023;5:100356.
7. Curran, D., et al. Meta-Regression of Herpes Zoster Incidence
Worldwide. Infectious diseases and therapy.
2022;11(1):389-403.
8. Chen S-Y, et al. Incidence of herpes zoster in patients with
altered immune function. Infection. 2014; 42: 325-334.
9. Marra F, et al. Risk Factors for Herpes Zoster Infection: A
Meta-Analysis. Open Forum Infect Dis
2020;7(1):ofaa005.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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):2921-2929.
16. 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):1279-1287.
17. GSK. Abstract on file.
18. Mueller, N.H., et al. Varicella zoster virus infection:
clinical features, molecular pathogenesis of disease, and latency.
Neurologic clinics. 2008;26(3):675-697.
19. 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.
|
GSK plc
|
|
(Registrant)
|
|
|
Date: February
06, 2024
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GSK plc
|