REG - GSK PLC - GSK and Zhifei announce vaccine partnership

GSKAnnouncement

09/10/2023 07:00

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RNS Number : 0527P  GSK PLC  09 October 2023

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/
(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. (#_bookmark2) 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
(#_bookmark3)  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 (#_bookmark6) The pain is often described as aching, burning,
stabbing or shock-like.5 (#_bookmark5) 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.
(#_bookmark5) 5   (#_bookmark5) 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/
(https://portaldev2.igskapp.com/media/916483/%E6%AC%A3%E5%AE%89%E7%AB%8B%E9%80%82%E8%AF%B4%E6%98%8E%E4%B9%A6.pdf)
欣安立适
(https://portaldev2.igskapp.com/media/916483/%E6%AC%A3%E5%AE%89%E7%AB%8B%E9%80%82%E8%AF%B4%E6%98%8E%E4%B9%A6.pdf)
说
(https://portaldev2.igskapp.com/media/916483/%E6%AC%A3%E5%AE%89%E7%AB%8B%E9%80%82%E8%AF%B4%E6%98%8E%E4%B9%A6.pdf)
明
(https://portaldev2.igskapp.com/media/916483/%E6%AC%A3%E5%AE%89%E7%AB%8B%E9%80%82%E8%AF%B4%E6%98%8E%E4%B9%A6.pdf)
书
(https://portaldev2.igskapp.com/media/916483/%E6%AC%A3%E5%AE%89%E7%AB%8B%E9%80%82%E8%AF%B4%E6%98%8E%E4%B9%A6.pdf)
.pdf
(https://portaldev2.igskapp.com/media/916483/%E6%AC%A3%E5%AE%89%E7%AB%8B%E9%80%82%E8%AF%B4%E6%98%8E%E4%B9%A6.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.

 

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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.

 

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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.

 

 

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