<SEC-DOCUMENT>0001654954-25-010847.txt : 20250917
<SEC-HEADER>0001654954-25-010847.hdr.sgml : 20250917
<ACCEPTANCE-DATETIME>20250917074620
ACCESSION NUMBER:		0001654954-25-010847
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20250917
FILED AS OF DATE:		20250917
DATE AS OF CHANGE:		20250917

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		251318795

	BUSINESS ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		PROVINCE COUNTRY:   	X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		PROVINCE COUNTRY:   	X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a6053z.htm
<DESCRIPTION>SAPHNELO MET PRIMARY ENDPOINT IN TULIP-SC
<TEXT>
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<font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Saphnelo met primary endpoint in TULIP-SC</font></div>
</div>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">
&#xA0;</font><font style="color: #000000">17 September
2025</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 16px">
<font style="color: #000000">S</font><font style="font-style: italic; color: #000000">aphnelo</font><font style="color: #000000">&#xA0;self-administration TULIP-SC Phase III trial
meets primary endpoint in patients with systemic lupus
erythematosus based on an interim analysis</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: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Subcutaneous administration of first-in-class biologic Saphnelo
demonstrates statistically significant and clinically meaningful
reduction in disease activity</font></div>
<div><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: 13px"><font style="color: #000000">
Positive high-level results from a pre-specified interim analysis
of the Phase III TULIP-SC trial in patients with systemic lupus
erythematosus (SLE) showed that the subcutaneous (SC)
administration of AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;(anifrolumab)&#xA0;demonstrated a
statistically significant and clinically meaningful reduction in
disease activity compared to placebo.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;The
&#xA0;safety profile observed in the interim analysis was
consistent with the known clinical profile
of&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;administered as an intravenous (IV)
infusion.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2-4</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 TULIP-SC trial evaluated the efficacy and safety of the
subcutaneous&#xA0;administration&#xA0;of&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;compared to placebo in participants with
moderately to severely active, autoantibody-positive SLE, with both
treatment groups receiving standard therapy (oral corticosteroids,
antimalarials, and/or immunosuppressants).</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</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">
Affecting over 3.4 million people globally, SLE can impact any
organ, leading many patients to experience debilitating symptoms,
irreversible organ damage and poor health-related quality of
life.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6-11</font><font style="color: #000000">&#xA0;While
oral corticosteroids are often used to provide relief from symptoms
of SLE patients, they are associated with adverse events and
short-term benefits without targeting the underlying drivers of the
disease, preventing patients from experiencing adequate disease
control and achieving remission.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12-14</font><font style="color: #000000">&#xA0;Recent
updates to clinical guidelines elevate the importance of treating
to target remission or low disease activity and minimising the use
of oral corticosteroids.</font><font style="font-size: 70%; vertical-align: top; color: #000000">15,16</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="color: #000000; font-family: Times New Roman; font-size: 13px">
Susan Manzi, MD, MPH,&#xA0;Professor of Medicine and Chair of the
Medicine Institute at Allegheny Health Network, Professor of
Medicine at Drexel University College, Philadelphia&#xA0;and
principal investigator of the TULIP-SC trial,&#xA0;said: "Today's
results for subcutaneous anifrolumab reinforce the efficacy and
safety of this therapy and provide the opportunity for this
important biologic to reach a wider group of patients in a more
flexible and convenient way. Despite guidelines recommending
earlier intervention and biologic treatments, too many people
with&#xA0;systemic lupus erythematosus&#xA0;rely on
oral&#xA0;corticosteroids, which contribute to irreversible organ
damage."</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">
Sharon Barr, Executive Vice President, BioPharmaceuticals R&amp;D,
AstraZeneca, said: "Today's news takes us one step closer in making
the clinically meaningful benefits of&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;accessible for more patients&#xA0;with
systemic lupus erythematosus. The TULIP-SC results are especially
important because approximately half of&#xA0;systemic lupus
erythematosus&#xA0;patients today taking a biologic are already
treated with a self-administered subcutaneous option.
With&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">, we hope to establish remission as an achievable
treatment goal for more patients and we are actively working with
regulatory authorities to bring this new administration option to
patients as soon as possible."</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 reduction in disease activity in TULIP-SC was measured using
the British Isles Lupus Assessment Group based Composite Lupus
Assessment (BICLA) at week 52.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;The
BICLA requires improvement in all organs with disease activity at
baseline with no new flares.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</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="color: #000000; font-family: Times New Roman; font-size: 13px">
The TULIP-SC interim results are under regulatory review and will
be presented during the American College of Rheumatology (ACR)
Convergence 2025 annual meeting, 24-29 October
2025.&#xA0;</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="font-style: italic; color: #000000">
Saphnelo</font><font style="color: #000000">&#xA0;IV infusion is
approved for the treatment of moderate to severe SLE in more than
70 countries worldwide including
the&#xA0;US,&#xA0;EU&#xA0;and&#xA0;Japan with regulatory reviews
ongoing in other countries. To date, more than 38,000 patients
globally have been treated with&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">17</font></font></div>
<div><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="text-decoration: underline; color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Notes</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">
Financial considerations</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">
AstraZeneca acquired global rights to&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;through an exclusive license and
collaboration agreement with Medarex, Inc. in 2004. The option for
Medarex to co-promote the product expired on its acquisition by
Bristol-Myers Squibb (BMS) in 2009. Under the agreement AstraZeneca
will pay BMS a low to mid-teens royalty for sales dependent on
geography.</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">
Systemic lupus erythematosus</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">
SLE is an autoimmune disease in which the immune system attacks
healthy tissue in the body.</font><font style="font-size: 70%; vertical-align: top; color: #000000">18&#xA0;</font><font style="color: #000000">It
is a chronic and complex disease with a variety of clinical
manifestations that can impact many organs and can cause a range of
symptoms, including pain, rashes, fatigue, swelling in joints and
fevers.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</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">
Over 3.4 million people globally are affected by SLE, and it is
among the leading causes of death in young women in the
US.</font><font style="font-size: 70%; vertical-align: top; color: #000000">7,19&#xA0;</font><font style="color: #000000">Living
with SLE can be painful, debilitating, have a profound impact on
patients' mental and financial well-being,&#xA0;and
disproportionately affects women in their prime, and those of
Asian, Black or Hispanic racial/ ethnic
backgrounds.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6,7,11,20,21</font><font style="color: #000000">&#xA0;&#xA0;</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">
An estimated 50% of people with SLE have irreversible organ damage
within five years of diagnosis due to long-term corticosteroid use
and disease activity.</font><font style="font-size: 70%; vertical-align: top; color: #000000">13,21,22</font><font style="color: #000000">&#xA0;Even
a small reduction in daily steroid use (for example 1 mg/day) can
lower the risk of organ damage.</font><font style="font-size: 70%; vertical-align: top; color: #000000">23</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">
TULIP-SC</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">
TULIP-SC is a Phase III, multicentre, randomised, double-blind,
placebo-controlled study to evaluate the efficacy and safety of a
subcutaneous administration of anifrolumab versus placebo in
participants with moderately to severely active,
autoantibody-positive SLE while receiving standard
therapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</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">
Patients recruited were aged 18 to 70 years and must have been
taking either one or any combination of the following: oral
corticosteroids, antimalarial, and/or immunosuppressants. In the
trial, 367 participants on standard therapy were randomised 1:1 to
receive 120mg subcutaneous dose of anifrolumab or placebo
administered once weekly via an accessorised prefilled
syringe.&#xA0;A planned interim analysis was conducted when the
first 220 participants reached week 52. The trial also includes an
open-label extension period of 52 weeks for participants who
completed the 52-week treatment period.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</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">
Saphnelo</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="font-style: italic; color: #000000">
Saphnelo</font><font style="color: #000000">&#xA0;(anifrolumab) is
a first-in-class, fully human monoclonal antibody that binds to
subunit 1 of the type I interferon (IFN) receptor, blocking the
activity of type I IFN.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,22</font><font style="color: #000000">&#xA0;Type
I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines
involved in regulating the inflammatory pathways implicated in
SLE.</font><font style="font-size: 70%; vertical-align: top; color: #000000">24-29</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">
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Saphnelo</font><font style="color: #000000">&#xA0;continues to be
evaluated in diseases where type I IFN plays a key role, including
Phase III trials in cutaneous lupus erythematosus, myositis,
systemic sclerosis and lupus nephritis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">30-33</font><font style="color: #000000">&#xA0;&#xA0;&#xA0;</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">
AstraZeneca in Respiratory &amp; Immunology</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Respiratory &amp; Immunology, part of AstraZeneca
BioPharmaceuticals, is a key disease area and growth driver to the
Company.</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca is an established leader in respiratory care with a
50-year heritage and a growing portfolio of medicines in
immune-mediated diseases. The Company is committed to addressing
the vast unmet needs of these chronic, often debilitating, diseases
with a pipeline and portfolio of inhaled medicines, biologics and
new modalities aimed at previously unreachable biologic targets.
Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma
attacks and achieve clinical remission in immune-mediated
diseases.</font></div>
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AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal &amp; Metabolism, and Respiratory &amp;
Immunology. Based in Cambridge, UK, AstraZeneca's innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
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A Study to Investigate the Efficacy and Safety of Anifrolumab
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Care Compared With Placebo Added to Standard of Care in Adult
Participants With Idiopathic Inflammatory Myopathies (Polymyositis
and Dermatomyositis) (JASMINE). Available
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Determine Effectiveness of Anifrolumab In SYstemic Sclerosis
(DAISY). Available
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accessed:&#xA0;September&#xA0;2025].</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">33.&#xA0;&#xA0;ClinicalTrials.gov.
Phase 3 Study of Anifrolumab in Adult Patients With Active
Proliferative Lupus Nephritis (IRIS). Available
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accessed:&#xA0;September&#xA0;2025].</font></div>
<div style="text-align: left; margin-left: 24px; 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: 24px; 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">
Matthew Bowden</font></div>
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Company Secretary</font></div>
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AstraZeneca PLC</font></div>
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SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
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Date:</font> 17 September 2025</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Matthew Bowden</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Matthew Bowden</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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