<SEC-DOCUMENT>0001654954-25-013981.txt : 20251216
<SEC-HEADER>0001654954-25-013981.hdr.sgml : 20251216
<ACCEPTANCE-DATETIME>20251216085147
ACCESSION NUMBER:		0001654954-25-013981
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20251216
FILED AS OF DATE:		20251216
DATE AS OF CHANGE:		20251216

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:		251573483

	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>a6711l.htm
<DESCRIPTION>EXDENSUR (DEPEMOKIMAB) UK MHRA APPROVAL
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REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
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UNDER THE SECURITIES EXCHANGE ACT OF 1934</font></div>
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&#xA0;</font></div>
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Issued: 15 December 2025, London UK</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="font-weight: bold; font-style: italic; color: #000000; font-size: 24px">
Exdensur</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000; font-size: 24px">(depemokimab)
approved in the UK for</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000; font-size: 24px">treatment
of asthma with type 2 inflammation and chronic rhinosinusitis with
nasal polyps</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">First and only ultra-long-acting biologic with
twice-yearly dosing to treat respiratory
diseases</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 16px">&#x25CF;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;
&#xA0;</font><font style="color: #000000; font-size: 16px">UK
approval based on data from the SWIFT and ANCHOR phase III
trials</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 16px">&#x25CF;</font><font style="font-style: italic; color: #000000; font-size: 16px">&#xA0;
&#xA0;Exdensur</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 16px">has
shown sustained efficacy to reduce exacerbations, with fewer
hospitalisations</font></font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><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">&#xA0;
First global approval for&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 16px">Exdensur</font><font style="color: #000000; font-size: 16px">,
with upcoming regulatory decisions
expected&#xA0;</font></font><font style="color: #000000; font-family: Times New Roman; font-size: 16px">in
the US, Japan, EU and China</font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">
GSK plc (LSE/NYSE: GSK) today</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">announced
the marketing authorisation of&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Exdensur</font><font style="color: #000000; font-size: 13px">&#xA0;(depemokimab)&#xA0;by
the UK's Medicines and Healthcare products Regulatory Agency
(MHRA). In the UK,&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Exdensur</font><font style="color: #000000; font-size: 13px">&#xA0;is
now approved in</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">two
indications:</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">&#x25CF;&#xA0;&#xA0;</font><font style="color: #000000">&#xA0; as an add-on maintenance treatment of
asthma in adult and adolescent patients aged 12 years and older
with type 2 inflammation characterised by an eosinophilic phenotype
who are inadequately controlled on maximum moderate-dose or
high-dose inhaled corticosteroids (ICS) plus another asthma
controller;</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">&#x25CF;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;
&#xA0;</font><font style="color: #000000; font-size: 13px">as an
add-on therapy with intranasal corticosteroids for the treatment of
adult patients with severe chronic rhinosinusitis with nasal polyps
(CRSwNP) for whom therapy with systemic corticosteroids and/or
surgery do not provide adequate control.</font></font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">
The approval is based on data from the SWIFT and ANCHOR phase III
trials which showed</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">sustained
efficacy with a twice-yearly dosing regimen for
depemokimab.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Each
of the four trials met their primary or co-primary endpoints with
statistically significant and clinically meaningful results,
comparing the addition of depemokimab to standard of care versus
standard of care alone.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font></font></div>
<div style="text-align: justify"><font style="font-family: Times New Roman; font-size: 10">&#xA0;</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: 16px"><font style="font-weight: bold; color: #000000; font-size: 13px">
Kaivan Khavandi, SVP &amp; Global Head, Respiratory, Immunology
&amp; Inflammation R&amp;D, GSK said:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">"Today's
UK approval of&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Exdensur</font><font style="color: #000000; font-size: 13px">,
the first in the world, has the potential to redefine care for
millions of patients. This ultra-long-acting biologic delivers
sustained efficacy to reduce asthma exacerbations, keep patients
out of hospital and help prevent cumulative lung damage in just two
doses a year. This is a step change in respiratory treatment, and
we look forward to additional regulatory decisions expected in the
US, Japan, EU and China."</font></font></div>
<div style="text-align: justify; 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: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">
Asthma affects more than 260 million people
globally</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">and</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">about
7 million people in the UK,</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font><font style="color: #000000; font-size: 13px">&#xA0;a
portion of whom have type 2 inflammation characterised by an
eosinophilic phenotype.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000; font-size: 13px">&#xA0;Approximately</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">half
continue to experience symptoms and exacerbations despite
treatment.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Asthma
exacerbations place a significant resource burden on healthcare
systems due to emergency department visits and hospitalisations,
with an estimated 22% increase in NHS costs by
2031.</font><font style="font-size: 70%; vertical-align: top; color: #000000">7</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">With
the potential to reduce asthma exacerbations, including those
leading to hospitalisations, and alleviate the debilitating
symptoms associated with CRSwNP,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Exdensur</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">could
improve patient outcomes while contributing to a reduction in
health system burden.</font></font></div>
<div style="text-align: justify"><font style="font-family: Times New Roman; font-size: 10">&#xA0;</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: 16px"><font style="color: #000000; font-size: 13px">
The pooled results from the SWIFT trials showed a 54% reduction in
clinically significant exacerbations (asthma attacks) over 52 weeks
[rate ratio 0.46, 95% confidence interval (0.36, 0.59), nominal
p&lt;0.001] (AER depemokimab = 0.51 exacerbations per year versus
placebo = 1.11).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1
&#xA0;</font><font style="color: #000000; font-size: 13px">Additionally, this pooled
analysis</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">showed
a 72% reduction [RR 0.28, 95% CI (0.13, 0.61), nominal p=0.002]
(AER: depemokimab = 0.02 versus placebo = 0.09) in the secondary
endpoint of clinically significant exacerbations requiring
hospitalisation or emergency department visit compared to
placebo.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">In
AGILE, an open-label 12-month extension study, depemokimab
maintained the results seen in SWIFT-1 and SWIFT-2, confirming the
sustained safety and efficacy of a twice-yearly dose of depemokimab
over the course of two years.</font></font></div>
<div style="text-align: justify"><font style="font-family: Times New Roman; font-size: 10">&#xA0;</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: 16px"><font style="color: #000000; font-size: 13px">
Pooled results from the ANCHOR trials showed an improvement
(reduction) from baseline in nasal polyp score (scale: 0-8) at 52
weeks [treatment difference -0.7, 95% CI (-0.9, -0.4), nominal
p&lt;0.001]</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">and
in nasal obstruction verbal response scale (scale: 0-3) over weeks
49-52 [treatment difference -0.24, 95% CI (-0.39, -0.08), nominal
p=0.003].</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-size: 70%; vertical-align: top; color: #000000; font-family: Times New Roman">
&#xA0;</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"><font style="color: #000000">
Across these trials, depemokimab was well-tolerated, with patients
experiencing a similar rate and severity of side effects as those
receiving placebo.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font></font></div>
<div style="text-align: justify; 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: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Depemokimab recently received a positive CHMP opinion in the EU and
it is currently under regulatory review in other countries,
including in the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">US</font><font style="color: #000000">, Japan and China. Decisions on these approvals
are expected starting in December 2025 and continuing through H1
2026.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 16px">
About asthma with type 2 inflammation</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: 16px">Asthma
affects more than 260 million people globally, many of whom
continue to experience symptoms and exacerbations despite
treatment.<font style="font-size: 70%; vertical-align: top">8,9</font>&#xA0;Severe asthma
is defined as asthma that requires treatment with medium- to
high-dose inhaled corticosteroids plus a second therapy (i.e.,
systemic corticosteroid or biologic) to prevent it from becoming
uncontrolled, or which remains uncontrolled despite
therapy.<font style="font-size: 70%; vertical-align: top">10</font>Type 2 inflammation
is the underlying cause of pathology in more than 80% of patients
with severe asthma, in which patients exhibit elevated levels of
eosinophils (a type of white blood cell).<font style="font-size: 70%; vertical-align: top">11</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: 16px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 16px">
About CRSwNP</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"><font style="color: #000000">
CRSwNP is caused by inflammation of the nasal lining that can lead
to soft tissue growths, known as nasal polyps.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12,13</font><font style="color: #000000">&#xA0;People
with CRSwNP experience debilitating symptoms such as nasal
obstruction, loss of smell, facial pain, sleep disturbance,
infections and nasal discharge that can significantly affect their
emotional and physical well-being.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12,13</font><font style="color: #000000">&#xA0;Similar
to asthma, the majority of cases of CRSwNP (85%) are driven by
chronic type 2 inflammation, which is strongly associated with
comorbidities, more severe disease, recurring symptoms and tissue
remodelling.</font><font style="font-size: 70%; vertical-align: top; color: #000000">14</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<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">Exdensur</font><font style="color: #000000">&#xA0;(depemokimab)</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: 16px"><font style="color: #000000; font-size: 13px">
Exdensur is the first ultra-long-acting biologic being evaluated
for certain respiratory diseases with underlying type 2
inflammation, such as severe asthma.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">It
combines high interleukin-5 (IL-5) binding affinity and high
potency with an extended half-life to enable twice-yearly
dosing.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000; font-size: 13px">&#xA0;IL-5
is a key cytokine in type 2 inflammation.</font></font></div>
<div style="text-align: justify; 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: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
More information can be found in the&#xA0;</font><font style="font-style: italic; color: #000000">Exdensur</font><font style="color: #000000">&#xA0;Summary of Product Characteristics and
Patient Information leaflets which will be published on the MHRA
Products&#xA0;</font><font style="text-decoration: underline; color: #0000FF">website</font><font style="color: #000000">&#xA0;within
7 days of approval.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About the SWIFT phase III trials</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"><font style="color: #000000">
Results from the SWIFT trials were presented at the 2024 European
Respiratory Society International Conference and published in
the&#xA0;</font><font style="font-style: italic; color: #000000">New England Journal of
Medicine</font><font style="color: #000000">.</font></font></div>
<div style="text-align: justify; 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: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and
safety of depemokimab adjunctive therapy in 382 and 380
participants with severe asthma who were randomised to receive
depemokimab or a placebo respectively, in addition to their
standard of care (SOC) treatment with medium to high-dose inhaled
corticosteroids plus at least one additional controller. The full
analysis set in SWIFT-1 included 250 patients in the depemokimab
plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252
patients were included in the depemokimab plus SOC arm and 128 in
the placebo plus SOC arm.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About the ANCHOR phase III trials</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"><font style="color: #000000">
Results from the ANCHOR trials were presented at the 2025 American
Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy
Organization (WAO) Joint Congress and published
in&#xA0;</font><font style="font-style: italic; color: #000000">The
Lancet</font><font style="color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</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"><font style="color: #000000">
ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and
128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were
included in the depemokimab plus SOC arm and 128 in the placebo
plus SOC arm. All 528 patients had inadequately controlled CRSwNP,
including nasal polyps in both nasal cavities (an endoscopic
bilateral NPS &#x2265;5), and had either undergone previous surgery
for CRSwNP, had received previous treatment with SCS or were
intolerant to SCS. Patients received depemokimab or placebo at
six-monthly intervals (26 weeks) in addition to SOC (maintenance
intranasal corticosteroids).</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font></font></div>
<div style="text-align: justify; 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: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About the depemokimab development programme</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Depemokimab is currently being evaluated in phase III trials for
the treatment of other diseases with underlying type 2
inflammation, including OCEAN for eosinophilic granulomatosis with
polyangiitis (EGPA) and DESTINY for hyper eosinophilic syndrome
(HES). GSK has also initiated the ENDURA-1, ENDURA-2 and VIGILANT
phase III trials assessing the efficacy and safety of depemokimab
as an add-on therapy in patients with uncontrolled moderate to
severe COPD with type 2 inflammation.</font></div>
<div style="text-align: justify; 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; color: #000000; font-family: Times New Roman; font-size: 13px">
About GSK in respiratory</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
GSK continues to build on decades of pioneering work to deliver
more ambitious treatment goals, develop the next generation
standard of care, and redefine the future of respiratory medicine
for hundreds of millions of people with respiratory diseases. With
an industry-leading respiratory portfolio and pipeline of vaccines,
targeted biologics, and inhaled medicines, GSK is focused on
improving outcomes and the lives of people living with all types of
asthma and COPD along with less understood refractory chronic cough
or rarer conditions like systemic sclerosis with interstitial lung
disease. GSK is harnessing the latest science and technology with
the aim of modifying the underlying disease dysfunction and
preventing progression.</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>
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<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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Cautionary statement regarding forward-looking
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include, but are not limited to, those described in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q3 Results for 2025.</font></div>
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Registered in England &amp; Wales:</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">No.
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References</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">1.&#xA0;&#xA0;&#xA0;&#xA0;
Jackson D., et al. Twice-Yearly Depemokimab in Severe Asthma with
an Eosinophilic Phenotype.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">NEJM</font><font style="color: #000000; font-size: 13px">.
September 2024. Vol. 391 No. 24.DOI:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">10.1056/NEJMoa2406673.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">2.&#xA0;&#xA0;&#xA0;&#xA0;
Gevaert, Philippe et al. Efficacy and safety of twice per year
depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1
and ANCHOR-2): phase 3, randomised, double-blind, parallel trials.
The Lancet, Volume 405, Issue 10482, 911 - 926.
DOI:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">10.1016/S0140-6736(25)00197-7.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">3.&#xA0;&#xA0;&#xA0;&#xA0;
World Health Organisation. Asthma Key Facts. Available at:
https://www.who.int/news-room/fact-sheets/detail/asthma. Accessed
December 2025.</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">4.&#xA0;&#xA0;&#xA0;&#xA0;
Office for Health Improvement &amp; Disparities. Respiratory
disease profile: statistical commentary, June 2025. Available at:
https://www.gov.uk/government/statistics/update-of-indicators-in-the-respiratory-disease-profile-june-2025/respiratory-disease-profile-statistical-commentary-june-2025.
Accessed December 2025.&#xA0;&#xA0;</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">5.&#xA0;&#xA0;&#xA0;&#xA0; "What
Is Type 2 Inflammation?" Allergy &amp; Asthma Network, 22 May
2025,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://allergyasthmanetwork.org/health-a-z/type-2-inflammation-resources/</font><font style="text-decoration: underline; color: #000000; font-family: Times New Roman; font-size: 13px">.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Accessed
December 2025.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">6.&#xA0;&#xA0;&#xA0;&#xA0;
Menzies-Gow, Andrew et al. "A Renewed Charter: Key Principles to
Improve Patient Care in Severe Asthma." Advances in therapy vol.
39,12 (2022): 5307-5326. doi:10.1007/s12325-022-02340</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">7.&#xA0;&#xA0;&#xA0;&#xA0;
Orlovic M, Tzelis D, Guerra I, Bar-Katz V, Woolley N, Bray H,
Hanslot M, Usmani O, Madoni A. Environmental, healthcare and
societal impacts of asthma: a UK model-based assessment. ERJ Open
Res. 2024 Jul 22;10(4):00577-2023. doi:
10.1183/23120541.00577-2023. PMID: 39040585; PMCID:
PMC11261382.</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">8.&#xA0;&#xA0;&#xA0;&#xA0;
Global Initiative for Asthma. Global Strategy for Asthma Management
and Prevention,2024. Updated May 2024. Available at:
https://ginasthma.org/. Accessed December 2025.</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">9.&#xA0;&#xA0;&#xA0;&#xA0; World
Health Organisation. Asthma Key Facts. Available
at:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.who.int/news-room/fact-sheets/detail/asthma</font><font style="color: #000000; font-size: 13px">.
Accessed December 2025</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">10.&#xA0;&#xA0;&#xA0;
Wang E, et al. Characterization of Severe Asthma Worldwide: Data
From the International Severe Asthma Registry. CHEST, Volume 157,
Issue 4, 790 - 804.
https://doi.org/10.1016/j.chest.2019.10.053.</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">11.&#xA0;&#xA0;&#xA0;
Heaney L, et al. Eosinophilic and Noneosinophilic Asthma: An Expert
Consensus Framework to Characterize Phenotypes in a Global
Real-Life Severe Asthma Cohort. Chest.
2021;160(3):814-830.</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">12.&#xA0;&#xA0;&#xA0;
Bachert C, et al. Burden of Disease in Chronic Rhinosinusitis with
Nasal Polyps. J Asthma Allergy. 2021;b 11;14:127-134. doi:
10.2147/JAA.S290424. PMID: 33603409; PMCID:
PMC7886239.</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">13.&#xA0;&#xA0;&#xA0;
Bachert C, et al. EUFOREA expert board meeting on uncontrolled
severe chronic rhinosinusitis with nasal polyps (CRSwNP) and
biologics: Definitions and management. J Allergy Clin Immunol.
2021;147(1):29-36.</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">14.&#xA0;&#xA0;&#xA0;
Bernstein JA. Use of patient-reported outcome measures and
inflammatory biomarkers to differentiate chronic rhinosinusitis
with nasal polyp endotypes: Is it feasible? Ann Allergy Asthma
Immunol. 2023 Apr;130(4):409-410. doi: 10.1016/j.anai.2023.01.004.
PMID: 37005049.</font></div>
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