<SEC-DOCUMENT>0001654954-25-014033.txt : 20251217
<SEC-HEADER>0001654954-25-014033.hdr.sgml : 20251217
<ACCEPTANCE-DATETIME>20251217071051
ACCESSION NUMBER:		0001654954-25-014033
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20251217
FILED AS OF DATE:		20251217
DATE AS OF CHANGE:		20251217

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:		251577242

	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>a8507l.htm
<DESCRIPTION>EXDENSUR (DEPEMOKIMAB ULLA) APPROVED BY US FDA
<TEXT>
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UNDER THE SECURITIES EXCHANGE ACT OF 1934</font></div>
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GSK plc</font></div>
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79 New Oxford Street, London, WC1A 1DG</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Form
20-F . . . .X. . . . Form 40-F . . . . . . . .</font></div>
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&#xA0;</font></div>
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Issued: 16 December 2025, London, UK</font></div>
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&#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: 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 by US FDA for the treatment of severe
asthma</font></font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#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: 16px">&#x25CF;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 16px">&#xA0;
Exdensur</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 16px">is
the first and only ultra-long-acting biologic with twice-yearly
dosing approved for patients with severe asthma with an
eosinophilic phenotype &#xA0;</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">&#x25CF;</font><font style="color: #000000">&#xA0;
&#xA0;Approval based on SWIFT trials showing significantly lower
rate of annualised asthma exacerbations in patients receiving
depemokimab versus placebo</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-size: 16px">&#xA0; &#xA0;SWIFT data included
reduction in</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 16px">exacerbations
requiring hospitalisation and/or emergency department visits
with</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 16px">depemokimab</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">An
estimated 2 million Americans live with severe asthma and 50%
continue to experience frequent exacerbations and hospitalisations
requiring novel solutions</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved&#xA0;</font><font style="font-style: italic; color: #000000">Exdensur</font><font style="color: #000000">&#xA0;(depemokimab-ulaa) as an add-on maintenance
treatment of severe asthma characterised by an eosinophilic
phenotype in adult and paediatric patients aged 12 years and
older.</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; font-size: 13px">
The FDA approval of&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Exdensur</font><font style="color: #000000; font-size: 13px">&#xA0;is
based on data from the SWIFT-1 and SWIFT-2 phase III trials. In
these studies, depemokimab</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">demonstrated
sustained exacerbation reduction with two doses per year versus
placebo, both plus standard of care.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Treatment
with depemokimab resulted in a significant 58% and 48% reduction in
the rate of annualised asthma exacerbations (asthma attacks) over
52 weeks from SWIFT-1 and SWIFT-2, respectively [rate ratio (95%
confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p&lt;0.001
and SWIFT-2 0.52 (0.36, 0.73) p&lt;0.001] (AER depemokimab versus
placebo: SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08
exacerbations per year).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></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: 13px"><font style="color: #000000">
In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated
with depemokimab experienced numerically fewer exacerbations
requiring hospitalisation and/or emergency department visits (1%
and 4%) compared with placebo (8% and 10%), respectively. A
pre-specified pooled analysis of the two trials showed there was a
72% reduction in the annualised rate of clinically significant
exacerbations requiring hospitalisation and/or ED visits over 52
weeks for depemokimab compared with placebo [rate ratio 0.28, 95%
CI (0.13, 0.61), nominal p=0.002] (AER depemokimab 0.02 versus
placebo 0.09). 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</font></font></div>
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&#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: 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">"Physicians
in the US now have the option to provide sustained protection from
exacerbations for patients living with severe asthma with an
eosinophilic phenotype in just two doses a
year.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Exdensur</font><font style="color: #000000; font-size: 13px">&#xA0;could
redefine patient care and further establish the use of biologics
for those who continue to experience exacerbations despite
treatment."</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; 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: 16px"><font style="color: #000000; font-size: 13px">
Depemokimab is a novel therapy that</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">has
been developed</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">with
an extended half-life,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">enabling
the sustained suppression of disease-driving type 2 inflammation
with twice-yearly dosing.</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">These
distinct properties could potentially improve patient outcomes
while reducing health system burden.</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: 16px"><font style="color: #000000; font-size: 13px">
An estimated 2 million Americans live with severe asthma and half
continue to experience frequent exacerbations that may lead to
hospitalisations, emergency department visits and corresponding
increased health system costs.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3,4</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">While
biologics have demonstrated benefit in controlling severe asthma,
only 20% of eligible patients in the US currently receive one,
increasing their risk of exacerbations and worsening
disease.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Longer
dosing intervals have been associated with an increased likelihood
that patients would consider a biologic and 73% of physicians
believe it would be beneficial.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6,7</font></font></div>
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<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="font-weight: bold; color: #000000">
Geoffrey Chupp, MD, Professor of Medicine, Pulmonary, Critical Care
and Sleep Medicine, Yale University said</font><font style="color: #000000">: "Current biologic treatments for asthma are
often underutilised and frequent injections can be inconvenient for
many patients and lead to inconsistent use</font><font style="font-weight: bold; color: #000000">.</font><font style="color: #000000">&#xA0;There is clearly an opportunity to provide a
longer duration of protection from exacerbations between injections
for severe asthma patients that reduces the frequency of doses and
may improve overall health care
utilisation.&#xA0;</font><font style="font-style: italic; color: #000000">Exdensur</font><font style="color: #000000">&#xA0;could empower physicians and patients to
potentially achieve their treatment goals with fewer
injections."</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="font-weight: bold; color: #000000">
Tonya Winders, President and CEO, Global Allergy &amp; Airways
Patient Platform said</font><font style="color: #000000">: "The
struggle for people living with severe asthma is immense, with many
silently enduring continued symptom recurrence and exacerbations.
An innovative treatment option like&#xA0;</font><font style="font-style: italic; color: #000000">Exdensur</font><font style="color: #000000">&#xA0;that offers the long-acting protection from
exacerbations that severe asthma patients with an eosinophilic
phenotype deserve, with the benefit of fewer doses, is truly
welcome."</font></font></div>
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<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="color: #000000; font-family: Times New Roman; font-size: 13px">
Depemokimab recently received marketing authorisation from the UK's
Medicines and Healthcare products Regulatory Agency (MHRA) and a
positive CHMP opinion in Europe, with an approval decision expected
in Q1 2026. Regulatory submissions are also under review across the
globe, including in China and Japan.</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 severe asthma</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: 16px">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">8</font><font style="color: #000000">&#xA0;</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">9</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-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-ulaa)</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: 16px"><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">is
the first ultra-long-acting biologic being evaluated for certain
respiratory diseases with underlying type 2 inflammation, such as
severe asthma. It has been developed with an extended half-life to
enable twice-yearly dosing.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
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Please see accompanying&#xA0;US Prescribing
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About the SWIFT phase III trials</font></div>
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Results from the SWIFT trials were presented at
the</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">2024</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">European
Respiratory Society International Conference</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">and
published in the</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF; font-size: 13px">New
England Journal of Medicine</font><font style="color: #151515; font-size: 13px">.</font><font style="font-size: 70%; vertical-align: top; color: #151515">1</font></font></div>
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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>
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About the</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000; font-size: 13px">depemokimab</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #151515; font-size: 13px">development
programme</font></font></div>
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The phase III programme consists of SWIFT-1 and SWIFT-2 in severe
asthma, with an open label extension study (AGILE), and the
ANCHOR-1 and ANCHOR-2 trials in chronic rhinosinusitis with nasal
polyps (CRSwNP).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,10,11</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; 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 EGPA and DESTINY for HES.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12,13</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">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><font style="color: #000000; font-family: Times New Roman">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">14</font></font></div>
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About GSK in respiratory</font></div>
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<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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About GSK</font></div>
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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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<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">1.&#xA0;&#xA0;&#xA0;&#xA0; Jackson, David J., et
al. "Twice-yearly Depemokimab in severe asthma with an eosinophilic
phenotype."&#xA0;</font><font style="font-style: italic; color: #000000">New England Journal of
Medicine</font><font style="color: #000000">, vol. 391, no. 24, 19
Dec. 2024, pp. 2337-2349,
https://doi.org/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">2.&#xA0;&#xA0;&#xA0;&#xA0; Wang, Eileen, et al.
"Characterization of severe asthma
worldwide."&#xA0;</font><font style="font-style: italic; color: #000000">CHEST</font><font style="color: #000000">, vol. 157, no. 4, Apr. 2020, pp. 790-804,
https://doi.org/10.1016/j.chest.2019.10.053.</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="font-size: 13px">3.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="font-size: 13px">Menzies-Gow, Andrew, et al. "A renewed charter:
Key principles to improve patient care in severe
asthma."&#xA0;</font><font style="font-style: italic; font-size: 13px">Advances in
Therapy</font><font style="font-size: 13px">, vol. 39, no. 12, 17
Oct. 2022, pp. 5307-5326,
https://doi.org/10.1007/s12325-022-02340-w.</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">4.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="font-size: 13px">"Cost
of Asthma on Society."&#xA0;</font><font style="font-style: italic; font-size: 13px">Cost of Asthma on
Society</font><font style="font-size: 13px">, Asthma &amp; Allergy
Foundation of America, 31 Jan. 2025,</font><font style="color: #000000">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.aafa.org/advocacy/key-issues/access-to-health-care/cost-of-asthma-on-society.</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">5.&#xA0;&#xA0;&#xA0;&#xA0; Park, Jihye, et al.
"Unmet treatment needs in asthma patients with eosinophilic
phenotype: A US claims-based study on asthma exacerbations and
Healthcare Resource Utilization."&#xA0;</font><font style="font-style: italic; color: #000000">CHEST</font><font style="color: #000000">, vol. 166, no. 4, Oct. 2024,
https://doi.org/10.1016/j.chest.2024.06.2816.</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">6.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Tal-Singer,
Ruth, et al.</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">"Disease impact and perception of
biologics in adults with type 2 inflammation respiratory disease:
International survey results."&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Patient
Preference and Adherence</font><font style="color: #000000; font-size: 13px">, Volume 19, Apr. 2025, pp.
1159-1170, https://doi.org/10.2147/ppa.s517466.</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">7.&#xA0;&#xA0;&#xA0;&#xA0;
Research Partnership Quant uptake Market Research, 200 HCPs Top two
box on a seven-point scale where seven equaled "highly
beneficial".</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">8.&#xA0;&#xA0;&#xA0;&#xA0; Brussino, Luisa, et al.
"Is it severe asthma or asthma with severe
comorbidities?"&#xA0;</font><font style="font-style: italic; color: #000000">Journal of Asthma and
Allergy</font><font style="color: #000000">, Volume 10, Nov. 2017,
pp. 303-305,
https://doi.org/10.2147/jaa.s150462.</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">9.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Heaney,
Liam G., et al. "Eosinophilic and noneosinophilic
asthma."&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">CHEST</font><font style="color: #000000; font-size: 13px">,
vol. 160, no. 3, Sept. 2021, pp. 814-830,
https://doi.org/10.1016/j.chest.2021.04.013.</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;
"An Open-Label Extension Study of GSK3511294 (Depemokimab) in
Participants Who Were Previously Enrolled in 206713 (NCT04719832)
or 213744 (NCT04718103) (AGILE)." ClinicalTrials.gov,
GlaxoSmithKline, clinicaltrials.gov/study/NCT05243680. Accessed 8
Dec. 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: 13px"><font style="color: #000000">11.&#xA0;&#xA0;&#xA0; Gevaert P, Desrosiers M,
Cornet M, Mullol J, De Corso E, Keles Turel N, Maspero J, Fujieda
S, Zhang L, Sousa AR, Woods SJ, Davis AM, Schalkwijk S, Edwards D,
Ranganathan P, Follows R, Marshall C, Han JK; ANCHOR-1 and ANCHOR-2
trial investigators. 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.&#xA0;</font><font style="font-style: italic; color: #000000">Lancet.</font><font style="color: #000000">&#xA0;2025 Mar 15;405(10482):911-926. doi:
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">12.&#xA0;&#xA0;&#xA0;
"Efficacy and Safety of Depemokimab Compared With Mepolizumab in
Adults With Relapsing or Refractory Eosinophilic Granulomatosis
With Polyangiitis (EGPA) (OCEAN)." ClinicalTrials.gov,
GlaxoSmithKline, clinicaltrials.gov/study/NCT05263934. Accessed 8
Dec. 2025.</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;
"Depemokimab in Participants With Hypereosinophilic Syndrome,
Efficacy, and Safety Trial (DESTINY)." ClinicalTrials.gov,
GlaxoSmithKline, clinicaltrials.gov/study/NCT05334368. Accessed 8
Dec. 2025.</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;
"Depemokimab as an Extended treatmeNt Duration Biologic in Adults
With Chronic Obstructive Pulmonary Disease (COPD) and Type 2
Inflammation (ENDURA -1) (ENDURA -1)." ClinicalTrials.Gov,
GlaxoSmithKline, clinicaltrials.gov/study/NCT06959095. Accessed 8
Dec. 2025.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
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