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 December 2024
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: 5 December 2024, London UK
GSK and Zhifei revise and extend strategic vaccine collaboration in
China
●
Shingrix collaboration
extended to 2034
●
Expanded exclusive rights to explore collaboration
with Zhifei on Arexvy
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Creates
sustainable, long-term collaboration to bring innovative vaccines
to more than 500 million people in China
GSK plc (LSE/NYSE: GSK) today announced that it has entered into an
agreement with Chongqing Zhifei Biological Products, Ltd. (Zhifei)
to revise the terms on which Zhifei will commercialise GSK's
shingles vaccine, Shingrix, in mainland China. The revised agreement extends
the original 3-year period (2024-2026) during which Zhifei has
exclusive rights to import, distribute and co-promote the vaccine
in mainland China for an additional 8 years through to 2034, with
revised expected volumes. Under the revised agreement, Zhifei also
agrees to engage exclusively with GSK to explore a potential
collaboration, with an initial term of 10 years, on the
commercialisation of a respiratory syncytial virus (RSV) vaccine in
mainland China, subject to regulatory approval of the
vaccine.
Zhifei is the largest Chinese vaccine company by revenue, has an
extensive network which covers more than 30,000 vaccination points
across the country, and a strong track record of driving access to
innovative vaccines in China.
Luke Miels, Chief Commercial Officer, GSK, said: "This revised agreement with Zhifei puts our
collaboration on a sustainable footing, managing challenges in the
macro environment in the near-term, and helping us to reach even
more Chinese people with our innovative adult vaccines over the
long-term."
Financial Considerations
This agreement amends the agreement previously announced in October
2023. Subject to the terms of the revised agreement, the parties
expect Zhifei will purchase volumes of Shingrix, phased over time, with a potential total value
to GSK of £2.3bn (at current exchange rates) over the 6-year
period 2024-2029. Previously contracted minimum purchase levels no
longer apply.
About shingles
Shingles, also known as herpes zoster, is caused by a reactivation
of the varicella-zoster virus (VZV) - the same virus that causes
chickenpox1.
Globally, most people aged 50 and over have the dormant VZV in
their nervous system and are at risk of developing
shingles2,3.
As people age, the immune system's strength wanes, leading to a
decreased response to infection and thus increasing the risk of
developing shingles1, 2, 3, 4,
5. People with a suppressed or
compromised immune system are also at risk of
shingles6.
Shingles typically presents as a rash with painful chest, abdomen,
or face blisters1.
The pain is often described as aching, burning, stabbing or
shock-like5.
Following a rash, a person can also experience post-herpetic
neuralgia (PHN), a long-lasting nerve pain that can continue for
weeks or months and sometimes persist for several
years5.
PHN is the most common complication of shingles, occurring in 5-30%
of all cases, depending on the individual's age7.
Following expedited review, Shingrix was approved by China's National Medical
Products Administration (NMPA) to prevent shingles in adults aged
50 years or older in May 2019. Estimates suggest that by 2030,
there will be 570 million people over the age of 50 in China, yet
as at June 2023, only around 1.2% of the urban population of those
between 50-74 years old had been vaccinated against
shingles.
About Shingrix
Shingrix (Recombinant
Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine
indicated for the prevention of shingles in adults aged 50 and
over. It combines an antigen, glycoprotein E, with an adjuvant
system, AS01e, and may help overcome the natural age-related
decline in responses to immunisation that contributes to the
challenge of protecting adults ages 50 and over from
shingles8,9.
RZV is not indicated to prevent primary varicella infection
(chickenpox). In some counties, RZV is also approved for adults
aged 18 or over at increased risk for shingles. The use of the
vaccine should be in accordance with official
recommendations.
About RSV
RSV is a common contagious virus affecting the lungs and breathing
passages. Adults can be at increased risk for RSV disease due to
comorbidities, immune compromised status, or advanced age. RSV can
exacerbate conditions, including COPD, asthma, and chronic heart
failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.10 In
older adults, RSV is associated with similar rates of complications
and severe outcomes as influenza11.There
are approximately 297 million people aged 60+ in
China12 and
it is estimated that over ¾ of them suffer from at least one
chronic disease. That shows the potential significant disease
burden of RSV in 60+ Chinese population.
About GSK's RSV Vaccine
Respiratory Syncytial Virus Vaccine (recombinant), contains
recombinant RSV glycoprotein F stabilised in the prefusion
conformation (RSVPreF3). This antigen is combined with GSK's
proprietary AS01E adjuvant.
In May 2023, the US FDA approved GSK's RSV vaccine for the
prevention of lower respiratory tract disease (LRTD) caused by RSV
(RSV-LRTD) in individuals 60 years of age and older. In June 2024,
the FDA also approved the vaccine for individuals 50-59 who are at
increased risk for RSV-LRTD. The vaccine has also been approved for
the prevention of RSV-LRTD in individuals 60 years of age and older
in over 40 countries. Regulatory reviews for both the use of the
vaccine in individuals 60 years of age and older and those aged
50-59 at increased risk are ongoing in multiple countries. The
proposed trade name remains subject to regulatory approval in other
markets.
GSK has global clinical development programmes underway to evaluate
the safety and immunogenicity of Arexvy in adults aged 18+ at
increased risk of RSV disease.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21
adjuvant licensed from Antigenics LLC (formerly Antigenics Inc.), a
wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of
SaponiQx Inc., a subsidiary of Agenus.
The use of this vaccine should be in accordance with official
recommendations. As with any vaccine, a protective immune response
may not be elicited in all vaccinees.
The vaccine is not approved in China at this time.
About Zhifei
Chongqing Zhifei Biological Products Co., Ltd. is a fully
integrated biotechnology company that specialises in vaccine and
biopharmaceutical research, development, production, sales,
promotion, distribution, and import/export. Zhifei is committed to
the mission of "preventing diseases and safeguarding human
health".
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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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 GSK's Annual
Report on Form 20-F for 2023, and GSK's Q3 Results for
2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1
Mueller, NH et al. Varicella Zoster Virus Infection: Clinical
Features, Molecular Pathogenesis of Disease and Latency. Neurologic
Clinics, 2008; 26;675-697
2
Bollaerts K et al. A systematic review of varicella seroprevalence
in European countries before universal childhood immunization:
deriving incidence from seroprevalence data. Epidemiol Infect
2017;145:2666-2677.
3
Bricout H et al. Herpes zoster-associated mortality in Europe:
a systematic review. BMC Public Health 2015;15:466.
4 Johnson
RW et al. Herpes zoster epidemiology, management, and disease and
economic burden in Europe: a multidisciplinary perspective.
Therapeutic Advances in Vaccines. 2015;3(4):109-120.
5
Harpaz R et al. Advisory Committee on Immunization Practices
(ACIP), Centers for Disease Control and Prevention (CDC).
Prevention of herpes zoster:
6 Huang C-T et
al. Association
Between Diabetes Mellitus and the Risk of Herpes Zoster: A
Systematic Review and Meta-analysis. J Clin Endocrinol Metab
2022;107:586-597.
7
Kawai K, Gebremeskel BG, Acosta CJSystematic review of incidence
and complications of herpes zoster: towards a global perspectiveBMJ
Open 2014;4:e004833. doi: 10.1136/bmjopen-2014-004833
8
Cunningham et al. Vaccine profile of herpes zoster (HZ/su) subunit
vaccine. Expert Review of Vaccines. 2017;16:7;661-670.
9
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.
10 Zifeng Yang, et al. Projection of RSV BOD in 60+
population in China. Abstract published on World Influenza
Conference in July 2024.
11 Yulin Zhang, et al. Influenza
Other Respi Viruses. 2020;14:483-490; Tian J, et
al. BMC
Pulm Med. 2023 Sep 15;23(1):350]
12 http://big5.www.gov.cn/gate/big5/www.gov.cn/yaowen/liebiao/202403/content_6939370.htm
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: December
05, 2024
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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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