a0542p
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 2023
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: 9 October 2023, London UK
GSK and Zhifei announce exclusive strategic vaccine partnership in
China
●
Partnership
will significantly extend availability of Shingrix in
China with co-promotion to healthcare professionals and over 30,000
points of vaccination
●
Partnership
also supports potential future co-development and commercialisation
of Arexvy,
GSK's respiratory syncytial virus (RSV) vaccine for older adults 60
years and older, in China
GSK plc (LSE/NYSE: GSK) announced
today that it has reached an exclusive agreement with Chongqing
Zhifei Biological Products, Ltd. (Zhifei) to co-promote GSK's
shingles vaccine, Shingrix,
in China for
an initial three-year period, with the potential to extend the
partnership should all parties agree. Zhifei, the largest Chinese
vaccine company by revenue, has a track record of driving access to
innovative vaccines in China. By bringing together the scale and
expertise of the two companies, the strategic partnership will
significantly extend the availability of Shingrix,
supporting the rapid expansion of patient access to the vaccine and
future potential indications.
Set to start on 1 January 2024, Zhifei will have exclusive rights
to import and distribute Shingrix in China - focusing on promoting the vaccine
through its extensive service network, which covers more than
30,000 vaccination points across the country. In partnership, GSK -
as the license holder for the product - will
co-promote Shingrix by raising awareness of the importance of
shingles vaccination amongst healthcare professionals within
community health centres and hospital settings.
In August 2023, GSK announced positive data from the ZOSTER-076
phase IV trial showing that Shingrix demonstrated
100% vaccine efficacy in preventing shingles in Chinese adults aged
50 and over. More details can be found here - https://www.gsk.com/en-gb/media/press-releases/new-shingrix-data-demonstrate-100-vaccine-efficacy-in-prevention-shingles/.
Luke Miels, Chief Commercial Officer, GSK, said: "This
partnership is consistent with our focus on products with a high
and durable level of differentiation. It materially expands the
number of Chinese adults who can benefit
from Shingrix and
includes the option to extend the collaboration to include our
novel RSV vaccine, Arexvy."
Financial considerations
Subject to the terms of the agreement, Zhifei will purchase agreed
volumes of Shingrix with a value to GSK of £2.5 billion in
total over the initial three-year period. These volumes are
expected to be phased over this time as demand is expected to
accelerate steadily through the period. There is potential to
extend the partnership should all parties agree. The partnership
supports and accelerates GSK's commitment to double
global Shingrix sales, reaching more than £4 billion by
2026.
Under the terms of the strategic partnership, Zhifei has granted
GSK the right of first refusal to be their exclusive partner for
any co-development and commercialisation of an RSV vaccine for
older adults in China, paving the way for the companies to
potentially partner on Arexvy upon approval in China.
About shingles
Shingles, also known as herpes zoster, is caused by a
reactivation of the varicella-zoster virus (VZV) - the same virus
that causes chickenpox.1 Globally,
most people aged 50 and over have the dormant VZV in their nervous
system and are at risk of developing shingles.2.3 As
people age, the immune system's strength wanes, leading to a
decreased response to infection and thus increasing the risk of
developing shingles.1,2,3,4,5 People
with a
suppressed or compromised immune system are also at risk of
shingles.6
Shingles typically present as a
rash with painful chest, abdomen, or face
blisters.1 The
pain is often described as aching, burning, stabbing or
shock-like.5 Following
the 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 years.5
PHN is
the most common complication of shingles, occurring in 5-30% of all
cases, depending on the individual's age.7
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 of June 2023, only around 1.2% of the current population has
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 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.8,9 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 Shingrix 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://portaldev2.igskapp.com/media/916483/欣安立适说明书.pdf
About RSV in older adults
RSV is a common contagious virus affecting the lungs and breathing
passages. Older adults are at high risk of severe disease due
partly to age-related immunity decline. Older adults with
underlying medical conditions are at even greater risk for severe
disease. RSV can exacerbate conditions, including chronic
obstructive pulmonary disease (COPD), asthma, and chronic heart
failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.
About Arexvy (RSV vaccine,
adjuvanted)
RSV vaccine, adjuvanted, contains recombinant glycoprotein F
stabilised in the prefusion conformation. This antigen is combined
with GSK's proprietary AS01E adjuvant.
The US FDA approved the vaccine on 3 May 2023 to prevent lower
respiratory tract disease (LRTD) caused by RSV in individuals 60
years of age and older.
In June 2023, the European Commission authorised the vaccine for
active immunisation to prevent LRTD caused by RSV in adults aged 60
years and older.
In September 2023, Japan's Ministry of Health, Labour and Welfare
approved Arexvy for the prevention of RSV for adults aged 60
years and above. The use of this vaccine should be in accordance
with official recommendations.
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.
GSK enquiries
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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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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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Mick Readey
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+44 (0) 7990 339653
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Josh Williams
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Steph Mountifield
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+44 (0) 7796 707505
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Jeff McLaughlin
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(Philadelphia)
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Frannie DeFranco
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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 the company's Annual Report on Form 20-F for
2022, and Q2 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
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.
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
9, 2023
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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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