<SEC-DOCUMENT>0001654954-25-009314.txt : 20250811
<SEC-HEADER>0001654954-25-009314.hdr.sgml : 20250811
<ACCEPTANCE-DATETIME>20250811070424
ACCESSION NUMBER:		0001654954-25-009314
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20250811
FILED AS OF DATE:		20250811
DATE AS OF CHANGE:		20250811

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	COMPANY DATA:	
		COMPANY CONFORMED NAME:			GSK plc
		CENTRAL INDEX KEY:			0001131399
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
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		EIN:				000000000
		STATE OF INCORPORATION:			X0

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		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-15170
		FILM NUMBER:		251200113

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		STREET 1:		79 NEW OXFORD STREET
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		BUSINESS PHONE:		011442080475000

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		STREET 1:		79 NEW OXFORD STREET
		CITY:			LONDON
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		ZIP:			WC1A 1DG

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	GSK PLC
		DATE OF NAME CHANGE:	20220516

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	GLAXOSMITHKLINE PLC
		DATE OF NAME CHANGE:	20010105
</SEC-HEADER>
<DOCUMENT>
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<FILENAME>a6948u.htm
<DESCRIPTION>FDA TO REVIEW GONORRHEA INDICATION FOR GEPOTIDACIN
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<font style="font-family: Times New Roman; font-size: 13px">Issued:
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Gepotidacin accepted for priority review by the US FDA for the oral
treatment of uncomplicated urogenital gonorrhoea</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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<div style="text-align: left; margin-left: 84px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 16px">&#x25CF;&#xA0; &#xA0;</font> <font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 16px">Submission supported by positive phase III data
in patients with uncomplicated urogenital gonorrhoea in EAGLE 1
trial</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[1]</font></font></div>
<div style="text-align: left; margin-left: 84px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 16px">&#x25CF;&#xA0; &#xA0;</font> <font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 16px">Significant need for new antibiotics for
gonorrhoea, a priority pathogen for the World
Health</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 16px">Organization</font><a name="_ednref2"><!--anchor--></a><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[2]</font></font></div>
<div style="text-align: justify; margin-left: 84px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 16px">&#x25CF;&#xA0; &#xA0;</font> <font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 16px">If approved, gepotidacin would offer a new oral
option to US patients currently relying on injectable
treatments</font></font></div>
<div style="text-align: justify; margin-left: 84px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 16px">&#x25CF;&#xA0; &#xA0;</font> <font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 16px">US decision expected in December
2025</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: auto; margin-right: auto; margin-bottom: 6px; width: 100%; height: 1px; background-color: #000000">
<!--line--></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 13px">
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted for priority review a
supplemental New Drug Application for gepotidacin as an oral option
for the treatment of uncomplicated urogenital gonorrhoea in
patients 12 years of age and older (weighing</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">&#x2265;45 kg). The US FDA has assigned a
Prescription Drug User Fee Act action date in December 2025. In
March 2025, gepotidacin was approved by the US FDA under the
licensing name&#xA0;</font><font style="font-style: italic; font-size: 13px">Blujepa</font><font style="font-size: 13px">&#xA0;as oral treatment for female adult and
paediatric patients 12 years of age and older
(weighing</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">&#x2265;40 kg)</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">with uncomplicated urinary tract infection
(uUTI).</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[3]</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 13px">
Gonorrhoea is a common, sexually transmitted infection caused
by&#xA0;</font><font style="font-style: italic; font-size: 13px">Neisseria
gonorrhoeae</font><font style="font-size: 13px">, which has been
recognised by the World Health Organization as a priority
pathogen</font><font style="font-size: 70%; vertical-align: top">2</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">and an urgent public health threat by the US
Centers for Disease Control and Prevention
(CDC).</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[4]</font><font style="font-size: 13px">&#xA0;It
affects both men and women and if left untreated or inadequately
treated, it can lead to infertility and other sexual and
reproductive health complications. There were more than 600,000
cases of gonorrhoea reported in the United States in 2023 according
to the CDC, making it the second most commonly reported sexually
transmitted infection in the country.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[5]</font><font style="font-size: 13px">&#xA0;There
is currently no vaccine licensed in the US for the prevention of
gonorrhoea infection and the standard of care is injectable
treatment which may not be suitable or available for all
patients.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[6]</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 13px">
The US application is based on results from the EAGLE-1 phase III
trial recently published in&#xA0;</font><font style="font-style: italic; font-size: 13px">The Lancet</font><font style="font-size: 13px">, showing that gepotidacin (oral, two doses of
3,000mg) was non-inferior, with 92.6% (187/202,</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">[95% CI 88&#xB7;0 to 95&#xB7;8]) success rates at
urogenital site when compared to 91.2% (186/204,</font><font style="font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">[95% CI
86.4-94.7])</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">success rates for intramuscular ceftriaxone
(500mg) plus oral azithromycin (1,000mg) combined therapy, a
leading combination treatment regimen for gonorrhoea. Additionally,
there were no failures at the urogenital site due to bacterial
persistence of&#xA0;</font><font style="font-style: italic; font-size: 13px">N.
gonorrhoeae</font><font style="font-size: 13px">&#xA0;in either
treatment arm. The safety and tolerability profile of gepotidacin
in the EAGLE-1 trial was consistent with results seen in previous
clinical trials, with no serious drug related adverse events
observed in either the gepotidacin or the comparator arm. The most
common reported adverse reactions were mild to moderate
gastrointestinal</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">events.</font><font style="font-size: 70%; vertical-align: top">1</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">This is
the second major indication filed in the US for gepotidacin, and
review of regulatory submissions for the uUTI indication is also
ongoing in the UK and Australia.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">The
development of&#xA0;gepotidacin has been funded in part with
federal funds from the US Department of Health and Human Services,
Administration for Strategic Preparedness and Response, Biomedical
Advanced Research and Development Authority (BARDA), under Other
Transaction Agreement number HHSO100201300011C and with federal
funds awarded by the US Department of Defense's Threat Reduction
Agency under agreement number HDTRA1-07-9-0002.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About gepotidacin</font><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 13px">
Gepotidacin,</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">discovered by GSK scientists, is a bactericidal,
first-in-class triazaacenaphthylene antibiotic that inhibits
bacterial DNA replication by a distinct binding site, a novel
mechanism of action, and for most pathogens, provides well-balanced
inhibition of two different Type II topoisomerase enzymes. This
provides activity against&#xA0;</font><font style="font-style: italic; font-size: 13px">Neisseria
gonorrhoeae</font><font style="font-size: 13px">&#xA0;and most
target uropathogens (such as&#xA0;</font><font style="font-style: italic; font-size: 13px">Escherichia
coli</font><font style="font-size: 13px">&#xA0;and&#xA0;</font><font style="font-style: italic; font-size: 13px">Staphylococcus
saprophyticus</font><font style="font-size: 13px">), including
isolates resistant to current antibiotics. Due to this
well-balanced inhibition for most pathogens, a single
target-specific mutation may not significantly impact gepotidacin
activity.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">The US
Prescribing Information is available&#xA0;<font style="text-decoration: underline; color: #0000FF">here</font>.</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About the EAGLE clinical programme</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">The
EAGLE-1 trial (NCT04010539) is part of a comprehensive global phase
III clinical programme for gepotidacin in adults and adolescents
including:</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 13px">
EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the
efficacy and safety of gepotidacin (oral, two doses of
3,000mg)&#xA0;to</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">intramuscular</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">ceftriaxone</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">(500mg) plus oral azithromycin
(1,000mg)</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">in approximately 600 patients with uncomplicated
urogenital gonorrhoea. The data were presented at ESCMID in April
2024</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[7]</font><font style="font-size: 13px">&#xA0;and
published in&#xA0;</font><font style="font-style: italic; font-size: 13px">The Lancet</font><font style="font-size: 13px">&#xA0;in April 2025.</font><font style="font-size: 70%; vertical-align: top">1</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">EAGLE-2
and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and
safety of gepotidacin (1,500mg administered orally twice daily for
five days) to nitrofurantoin (100mg administered orally twice daily
for five days). The data were first presented at European Congress
of Clinical Microbiology and Infectious Diseases (ECCMID) in
2023.<font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[8]</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold">
GSK in infectious diseases</font>&#xA0;</font><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">GSK has
pioneered innovation in infectious diseases for over 70 years, and
the Company's pipeline of medicines and vaccines is one of the
largest and most diverse in the industry, with a goal of developing
preventive and therapeutic treatments for multiple disease areas or
diseases with high unmet needs globally. Our expertise and
capabilities in infectious disease strongly position us to help
prevent disease and mitigate the challenge of antimicrobial
resistance (AMR).</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About GSK</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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References</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">
[1]</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">Ross J et al, "Oral gepotidacin for the treatment
of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3
randomised, open-label, non-inferiority, multicentre study"
in&#xA0;</font><font style="font-style: italic; font-size: 13px">The Lancet</font><font style="font-size: 13px">, 2025; 405: 1608-20;&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://doi.org/10.1016/S0140-6736(25)00628-2</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">
[2]</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">WHO. bacterial priority pathogens list, 2024:
Bacterial pathogens of public health importance to guide research,
development and strategies to prevent and control antimicrobial
resistance. Available at:</font><font style="font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.who.int/publications/i/item/9789240093461</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">Last
accessed: August 2025</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">
[3]</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">GSK.&#xA0;</font><font style="font-style: italic; font-size: 13px">Blujepa</font><font style="font-size: 13px">&#xA0;approved by US FDA for treatment of
uncomplicated urinary tract infections. Available
at:</font><font style="font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">Last
accessed: August 2025</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">
[4]</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">CDC.&#x202F;Antibiotic Resistance Threats Report.
Available at:</font><font style="font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cdc.gov/antimicrobial-resistance/media/pdfs/covid19-impact-report-508.pdf</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">Last
accessed: August 2025</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">
[5]</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">CDC. National Overview of STIs in 2023. Available
at:</font><font style="font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cdc.gov/sti-statistics/annual/summary.html</font><font style="font-size: 13px">.
Last accessed: August 2025</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">
[6]</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">CDC. STI treatment guideline.
Available:</font><font style="font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cdc.gov/std/treatment-guidelines/default.htm</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">Last
accessed: August 2025</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">
[7]</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">GSK. EAGLE 1 phase III data show potential for
gepotidacin as a new oral treatment option for uncomplicated
urogenital gonorrhoea (GC) amid growing resistance to existing
treatments. Available at:</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.gsk.com/en-gb/media/press-releases/eagle-1-phase-iii-data-show-potential-for-gepotidacin-as-a-new-oral-treatment-option-for-uncomplicated-gc/</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">Last
accessed: August 2025.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">
[8]</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">GSK. Gepotidacin's positive phase III data shows
potential to be the first in a new class of oral antibiotics for
uncomplicated urinary tract infections in over 20 years. Available
at:</font><font style="font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.gsk.com/en-gb/media/press-releases/gepotidacin-s-positive-phase-iii-data-shows-potential-to-be-the-first-in-a-new-class-of-oral-antibiotics-for-uncomplicated-urinary-tract-infections/</font><font style="font-family: Times New Roman">&#xA0;</font><font style="font-size: 13px">Last
accessed: August 2025.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Registrant)</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:&#xA0;August
11, 2025</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By:/s/&#xA0;VICTORIA
WHYTE</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">--------------------------</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Victoria&#xA0;Whyte</font></div>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div style="text-align: right; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Authorised
Signatory for and on</font></div>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div style="text-align: right; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">behalf
of GSK plc</font></div>
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