<SEC-DOCUMENT>0001654954-25-011999.txt : 20251021
<SEC-HEADER>0001654954-25-011999.hdr.sgml : 20251021
<ACCEPTANCE-DATETIME>20251021074909
ACCESSION NUMBER:		0001654954-25-011999
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20251021
FILED AS OF DATE:		20251021
DATE AS OF CHANGE:		20251021

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			GSK plc
		CENTRAL INDEX KEY:			0001131399
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				000000000
		STATE OF INCORPORATION:			X0

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-15170
		FILM NUMBER:		251405380

	BUSINESS ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		79 NEW OXFORD STREET
		CITY:			LONDON
		PROVINCE COUNTRY:   	X0
		BUSINESS PHONE:		44 20 8047 5000

	MAIL ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		79 NEW OXFORD STREET
		CITY:			LONDON
		PROVINCE COUNTRY:   	X0

	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>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a1154e.htm
<DESCRIPTION>POSITIVE CHMP OPINION FOR GSK ON SHINGRIX PFS
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GSK plc</font></div>
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Issued: 21 October 2025, London UK</font></div>
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<font style="color: #000000">GSK's&#xA0;</font><font style="font-style: italic; color: #000000">Shingrix</font><font style="color: #000000">&#xA0;new prefilled syringe presentation receives
positive CHMP opinion</font></font></div>
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&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000">&#x25CF;&#xA0;&#xA0;</font><font style="color: #000000">Prefilled syringe offers a convenient ready-to-use
administration option to healthcare
professionals</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 16px">&#x25CF;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font>
<font style="color: #000000; font-size: 16px">Marketing
authorisation in EU expected in December 2025</font></font></div>
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<font style="color: #000000; font-size: 16px">Shingles affects
approximately 1.7 million people in Europe each
year</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[1]</font></font></div>
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<!--line--></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">
GSK plc (LSE/NYSE: GSK) today announced that the European Medicine
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) has issued a positive opinion to support the approval
of&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Shingrix</font><font style="color: #000000; font-size: 13px">&#xA0;(GSK's
Recombinant Zoster Vaccine or RZV) in a prefilled syringe.
Currently, the vaccine presentation consists of two vials, a
lyophilised powder antigen and a liquid adjuvant, which are
combined prior to administration. After approval</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">by
the European Commission, expected in December 2025, the new
prefilled syringe will remove the need to reconstitute separate
vials, simplifying the vaccine administration process for
healthcare professionals.</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-weight: bold; color: #000000; font-size: 13px">
Tony Wood, Chief Scientific Officer, GSK, said:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">"At
GSK, we are dedicated to driving innovation to continually enhance
our world-class vaccines. The CHMP</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">positive</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">opinion</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">on</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">our
new</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">presentation
of</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Shingrix</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">reflects
our commitment to supporting the healthcare
community,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">making</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">it
easier for healthcare professionals to provide protection against
shingles, a painful disease affecting well over a million people in
Europe each year."</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="color: #000000; font-size: 13px">
GSK's shingles vaccine has been approved in the European Union for
the prevention of herpes zoster (HZ) and post-herpetic neuralgia
(PHN) in adults aged 50 years or older since 2018; and in adults 18
years or older at increased risk of HZ, since 2020. GSK's RZV is
specifically designed to enhance the varicella-zoster virus
(VZV)-specific immune response of a declining or compromised immune
system.</font><a name="_ednref2">
<!--anchor--></a><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[2]</font><font style="font-size: 70%; vertical-align: top; color: #000000">,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[3]</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">This
positive CHMP opinion is based on data confirming technical
comparability between the prefilled syringe and the existing
vaccine presentation.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[4]</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About shingles</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="color: #000000; font-size: 13px">
Shingles is caused by the reactivation of the varicella-zoster
virus (VZV), the same virus that causes
chickenpox.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[5]</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Globally,
up to 1 in 3 adults will develop shingles in their
lifetime.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[6]</font><font style="font-size: 70%; vertical-align: top; color: #000000">,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[7]</font><font style="font-size: 70%; vertical-align: top; color: #000000">,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[8]</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Over
90% of adults have the varicella-zoster virus (VZV) dormant in
their nervous system, waiting to reactivate.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[9]</font><font style="font-size: 70%; vertical-align: top; color: #000000">,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[10]</font><font style="font-size: 70%; vertical-align: top; color: #000000">,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[11]</font><font style="color: #000000; font-size: 13px">&#xA0;In
addition to advancing age, chronic conditions like cardiovascular
disease, chronic kidney disease, chronic obstructive pulmonary
disease, asthma, and diabetes are all linked to higher risk of
shingles.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[12]</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; 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="color: #000000">
Shingles typically presents as a rash, with painful blisters across
the chest, abdomen or face.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</font><font style="color: #000000">&#xA0;Following
the rash, up to 30% of people experience PHN,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[13]</font><font style="color: #000000">&#xA0;a
long-lasting nerve pain that can last weeks or months and can
occasionally persist for several years.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;Shingles
is also associated with significant healthcare and human cost, with
one in three patients with shingles taking an average of 12.5 days
of sick leave and patients with PHN taking sick leave for an
average of two months.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[14]</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">About&#xA0;</font><font style="font-style: italic; color: #000000">Shingrix</font><font style="color: #000000">&#xA0;(Recombinant Zoster Vaccine or
RZV)</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-style: italic; color: #000000; font-size: 13px">
Shingrix</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">combines
an antigen, glycoprotein E, with an adjuvant system,
AS01</font><font style="font-size: 70%; vertical-align: bottom; color: #000000">B</font><font style="color: #000000; font-size: 13px">,
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.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3</font><font style="color: #000000; font-size: 13px">&#xA0;RZV
is not indicated to prevent primary varicella infection
(chickenpox). The use of RZV should be in accordance with official
recommendations and local product label.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Please refer to the Product Information (PI) for important dosage,
administration, and safety information in Europe available at this
link:
https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; 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="color: #000000; 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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<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="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Pinchinat
et al. Similar herpes zoster incidence across Europe: results from
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[3]</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">The
GSK proprietary AS01 adjuvant system contains QS-21 Stimulon&#xAE;
adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of
Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.</font></font></div>
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Last Accessed: October 2025.</font></font></div>
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R.W., et al. Herpes zoster epidemiology, management, and disease
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perspective.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Therapeutic
advances in vaccines</font><font style="color: #000000; font-size: 13px">.
2015;3(4):109-20.</font></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">
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et al. Risk factors for herpes zoster infections: a systematic
review and meta-analysis unveiling common trends and heterogeneity
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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">
[13]</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Kawai,
K., et al. Systematic review of incidence and complications of
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2014;4(6).</font></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">
[14]</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Ultsch
B, Koster I, Reinhold T, et al.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Epidemiology
and cost of herpes zoster and postherpetic neuralgia in Germany.
Eur J Health Econ. 2013;14(6):1015-26.</font></font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
GSK plc</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;October
21, 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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<font style="font-family: Times New Roman; font-size: 13px">Authorised
Signatory for and on</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">behalf
of GSK plc</font></div>
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