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1、What science can doAstraZeneca Annual Report and Form 20-F Information 2022Science can.Front cover and inside front cover images:Unlocking the potential of the complement system.The dysregulation of the complement system,an essential part of the immune system,is a key driver of many devastating dise
2、ases.Targeting and inhibiting the complement system before it can trigger tissue damage or destruction can help restore balance.We are committed to continue unlocking the potential of the complement system,to discover new life-changing therapies for even more patients.Use of terms:In this Annual Rep
3、ort,unless the context otherwise requires,AstraZeneca,the Group,we,us and our refer to AstraZeneca PLC and its consolidated entities.We are a global,science-led,patient-focused pharmaceutical company.From the beginning,science has been at the front and centre of everything we do,taking us to places
4、we never thought possible.This is the adventure of what science can do See what science can do on page 00Key For more information within this Annual Report For more information,see BV Denotes sustainability information independently assured by Bureau VeritasOur SupplementsDetailed information on our
5、 Development Pipeline,Patent Expiries and Key Marketed Products and Risk.See our website, Science can.We are a global,science-led,patient-focused pharmaceutical company.We are dedicated to transforming the future of healthcare by unlocking the power of what science can do for people,society and the
6、planet.See what science can do on page 2Our SupplementsDetailed information on our Development Pipeline,Patent Expiries and Key Marketed Products and Risk.See our website, For more information within this Annual Report.For more information,see .BV Denotes sustainability information independently ass
7、ured by Bureau Veritas.Front cover image:Next-generation therapeutics.Advancements in biotechnology have expanded our toolkit of drug modalities.This provides an opportunity to design therapeutics for disease mechanisms previously considered difficult,if not impossible,to target and enables our scie
8、ntists to pioneer new approaches to drug discovery.Use of terms:In this Annual Report,unless the context otherwise requires,AstraZeneca,the Group,we,us and our refer to AstraZeneca PLC and its consolidated entities.zDenotes a scale break.Throughout this Annual Report,all bar chart scales start from
9、zero.We use a scale break where charts of a different magnitude,but the same unit of measurement,are presented alongside each other.For more information in relation to the inclusion of Reported performance,Core financial measures and constant exchange rate(CER)growth rates as used in this Annual Rep
10、ort,see the Financial Review from page 52 and for more information on the reconciliation between Reported and Core performance,see the Reconciliation of Reported to Core results in the Financial Review on page 56.Denotes a scale break.Throughout this Annual Report,all bar chart scales start from zer
11、o.We use a scale break where charts of a different magnitude,but the same unit of measurement,are presented alongside each other.For more information in relation to the inclusion of Reported performance,Core financial measures and constant exchange rate(CER)growth rates as used in this Annual Report
12、,see the Financial Review from page 60 and for more information on the reconciliation between Reported and Core performance,see the Reconciliation of Reported results to Core results in the Financial Review on page 64.Corporate GovernanceChairs Introduction 78Corporate Governance Overview 79Board of
13、 Directors 80Senior Executive Team(SET)82Corporate Governance Report 83Nomination and Governance Committee Report 92 Science Committee Report 94Sustainability Committee Report 95Audit Committee Report 96Directors Remuneration Report 104Financial highlightsTotal Revenue1Up 19%at actual rate of exchan
14、ge to$44,351 million(up 25%at CER),comprising Product Sales of$42,998 million(up 18%;24%at CER)and Collaboration Revenue of$1,353 million(up 54%;56%at CER)Net cash flow from operating activitiesUp 64%at actual rate of exchange to$9,808 million 202220212020$37,417m$26,617m$44,351m$44.4bn$9,808m$5,963
15、m$4,799m202220212020$9.8bnReported operating profitUp 256%at actual rate of exchange to$3,757 million(up 298%at CER)Core operating profitUp 34%at actual rate of exchange to$13,350m(up 42%at CER)202220212020$3,757m$1,056m$5,162m$3.8bn$13,350m$9,928m$7,340m202220212020$13.4bnReported EPS2Increase in R
16、eported EPS to$2.12(2021:$0.082)Core EPSUp 26%at actual rate of exchange to$6.66(up 33%at CER)202220212020$2.12$0.08$2.44$2.020$6.66$5.29$4.02$6.661 As detailed from page 142,Total Revenue consists of Product Sales and Collaboration Revenue.2 Reported EPS is up 2,581%at actual rate of exc
17、hange to$2.12(up 4,903%at CER).Financial StatementsPreparation of the Financial Statements and Directors Responsibilities 130Directors Annual Report on Internal Controls over Financial Reporting 130Auditors Report 131Consolidated Statements 138Group Accounting Policies 142Notes to the Group Financia
18、l Statements 149Group Subsidiaries and Holdings 199Company Statements 204Company Accounting Policies 206Notes to the Company Financial Statements 208Group Financial Record 211Additional InformationShareholder information 213Directors Report 215Sustainability supplementary information 218Trade Marks
19、219Glossary 220Cautionary statement regarding forward-looking statements 224Strategic ReportScience can 2 AstraZeneca at a Glance 4 Chairs Statement 6 Chief Executive Officers Review 7Healthcare in a Changing World 9Our Purpose,Values and Business Model 12Our Strategy and Key Performance Indicators
20、14Therapy Area Review 18 Oncology 18 BioPharmaceuticals 22 Cardiovascular,Renal&Metabolism 24 Respiratory&Immunology 26 Vaccines&Immune Therapies 28 Rare Disease 30Business Review 34EU Taxonomy Disclosure 52Task Force on Climate-related Financial Disclosures Summary Statement 53Risk Overview 56Finan
21、cial Review 60Contents1AstraZeneca Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportContentsChange the way we see the worldChange how we live our lives.Make us pioneers.See the full story at the beginning,science has been at the fr
22、ont and centre of everything we do,taking us to places we never thought possible.This is the limitless adventure of what science can do.It can.Science canBring people together to achieve the impossibleImpel us to take risks,share and collaborate.Harness data,technology and AI toaccelerate change.See
23、 the full story at Annual Report&Form 20-F Information 2022Strategic ReportWhat science can doCreate novel therapies and vaccines Help people with chronic diseases livebetter,healthier lives.Redefine cancer care.Pioneer treatments for rare diseases.Make patients partners in their owntreatment.See th
24、e full story at people,societies and the planet healthierMake healthcare systems more sustainable and resilient.Lead the way to a low-carbon world.See the full story at the lives of billions of peopleGive more and more of us access tohealthcare.Inspire us to do incredible things.See the full story a
25、t the QR code to see our film,Science can3AstraZeneca Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportScience can1.Science and Innovation2.Growth and Therapy Area Leadership3.People and SustainabilityWe are transforming the future
26、 of healthcare by unlocking the power of what science can do for people,society and the planet.Our strategic prioritiesOur priorities reflect how we are working to deliver our growth through innovation strategy and achieve our Purpose of pushing the boundaries of science to deliver life-changing med
27、icines.Science and innovation-ledWe use our distinctive scientific capabilities to deliver a pipeline of life-changing medicines.Distinctive R&D capabilities 179projects in our development pipeline1 15NMEs in our late-stage pipeline121NME or major LCM projects in Phase II and Phase III179177171 2022
28、20212020 Phase I Phase II Late-stage development Life-cycle management projects1 Includes NME and major LCM projects up to launch in all applicable major markets.Leading in our Therapy AreasFocused on areas where we can make the most meaningful difference to patients.Therapy AreasOncologyBioPharmace
29、uticalsRare Disease Total Revenue2$44.4bn$44.4bn$37.4bn$26.6bn202220212020Broad-based,diverse source of business Diversified portfolio across primary,specialty care andraredisease with a global reach.Total Revenue by Therapy AreaOncology 35%BioPharmaceuticals 45%Rare Disease 16%Other Medicines 4%Tot
30、al Revenue by reporting region3US 40%Emerging Markets 26%Europe 20%Established Rest of World 13%2 Total Revenue includes revenues from Other Medicines.See page 33.3 Due to rounding,the sum of percentages above does not equal 100%.4AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportA
31、straZeneca at a Glance49Commitment to our peopleWe are empowering our people toreach their full potential in adynamic,inclusive andhigh-performing working environment.For more information,see from page 44.83,500employees2021:83,1002020:76,10049.5%of our senior roles are filled by womenEmp
32、loyees by reporting regionEurope 38%Emerging Markets 35%US 20%Established Rest of World 7%Commitment to societyWe are harnessing the power ofScience and Innovation to deliver a positive impact to society,healthcare systems andthe environment.For more information,see from page 48.Priority1Access to h
33、ealthcareIncreasing access to life-saving treatments,promoting prevention,and strengthening global health system resilience and sustainability.Priority2Environmental protectionAccelerating the delivery of net-zero healthcare,managing our environmental impact,and investing in nature and biodiversity.
34、Priority3Ethics and transparencyEnsuring ethical,open,and inclusive behaviour across our organisation and value chain.3rd overall and#1 for Product DeliveryDouble A List for Climate Change and Water Security World and Europe constituentBloomberg Gender-Equality Index listingGlobal reach and presence
35、Our R&D organisation has more than 13,000 employees across our global sites.We have four strategic R&D centres:Cambridge,UK;Boston,MA,US;Gaithersburg,MD,US;and Gothenburg,Sweden,as well as seven other R&D centres and offices.Global R&D centres1.Cambridge,UK(HQ)2.Boston,MA,US3.Gaithersburg,MD,US4.Got
36、henburg,Sweden 28 manufacturing sitesin16 countries Other R&D centres and offices5.San Francisco,CA,US6.New York,NY,US 7.New Haven,CT,US8.Alderley Park,UK9.Macclesfield,UK10.Shanghai,China11.Osaka,Japan Oncology.See from page 18.Rare Disease.See from page 30.BioPharmaceuticals.See from page 22.5Astr
37、aZeneca Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportAstraZeneca at a GlanceAs we look ahead,confidence in the years to come builds on our track record of success that is demonstrated most clearly in shareholder returns.In the
38、last decade,AstraZeneca has delivered a Total Shareholder Return of 467%,compared with 85%for the FTSE100 and 366%for our pharma peers.Scientific leadershipUnderpinning confidence in the future is our scientific leadership that continues to deliver life-changing and innovative medicines to patients.
39、In the last 10 years,we have launched a remarkable total of 20 new medicines,including three in 2022 alone.In 2022,we also had 14 blockbuster medicines(with annual revenues in excess of$1 billion)and a record 34 approvals of our medicines in major markets.Over and above this,I am incredibly proud of
40、 AstraZenecas leading role in fighting the COVID-19 pandemic where we have made,and continue to make,a real difference.A great place to workCentral to AstraZenecas success has been its talented,collaborative team and its efforts to ensure we remain a great place to work an inclusive and diverse work
41、place where everyone has the potential to develop and grow.I am grateful for everything they have achieved and the inspiring relationships I have established over the years.I am also grateful for the contribution made by my fellow Directors,past and present,in their important role of overseeing the
42、governance of the Company and delivery of its strategy.AstraZeneca has also contributed more broadly to the wellbeing of society.Earlier this year,I was proud to lead AstraZenecas delegation to the World Economic Forum at Davos,making the case for health as the foundation of strong and resilient soc
43、ieties.Our ground-breaking Ambition Zero Carbon strategy provides an example of how we are also contributing to the health of the planet.Our Chief Executive OfficerFinally,I would like to take this opportunity to pay tribute to Pascal Soriot,our exceptional Chief Executive Officer.His leadership of
44、our science,entrepreneurial skills,ability to identify and recruit great people and sheer hard work have underpinned our return to growth and achievements of the past decade.It has been a privilege to work with him and it was only fitting that his contribution to UK life sciences and leadership in t
45、he global response to the COVID-19 pandemic was recognised with the award of a knighthood.I look forward to seeing AstraZeneca continue to thrive and grow under his leadership.Leif JohanssonChairApril 2022 marked my tenth anniversary as a Director of AstraZeneca and I have served as Chair since June
46、 2012.In April this year,I will be standing down from the Board at the conclusion of our AGM and handing over the role of Chair to Michel Demar.It has been a privilege to chair AstraZeneca in what has been a remarkable decade for the Group under the inspiring leadership of our Chief Executive Office
47、r,Pascal Soriot,in which we have more than delivered our strategic goals of achieving scientific leadership and returning AstraZeneca to growth,all the while being a great place to work.A growing businessSince AstraZeneca returned to growth in the years after 2018,Total Revenue has doubled to more t
48、han$44 billion in 2022.Reflecting this financial performance,the Board intends to declare a second interim dividend of$1.97 per share,making a total dividend declared for the full year of$2.90.$2.90Full-year dividend of$2.90 per share(2021:$2.87)6AstraZeneca Annual Report&Form 20-F Information 2022S
49、trategic Report“Underpinning confidence in the future is our scientific leadership that continues to deliver life-changing and innovative medicines to patients.”ChairsStatementA remarkable decade in which to have chaired AstraZeneca,working with excellent Board colleagues and a great management team
50、.$44.4bnTotal Revenue(2021:$37.4bn)72Regulatory events submissions or approvals in major markets“Our R&D success and revenue increase in 2022 demonstrate that we are on track to deliver industry-leading revenue growth through 2025 and beyond,and have set AstraZeneca on a path to deliver at least 15
51、new medicines before the end of the decade.”for the treatment of PNH(a rare and life-threatening blood disorder)in patients who experience clinically significant extravascular haemolysis.In a year of many achievements,no one in the room at the American Society of Clinical Oncology annual meeting las
52、t June will forget the standing ovation that greeted the positive Phase III results for Enhertu in advanced HER2-low breast cancer.This was followed by its swift approval in the US as the first ever HER2-directed therapy in this indication and represents a major advance for patients with HER2-low me
53、tastatic breast cancer.Our commitment to science was further demonstrated during the year by our announcement in April of plans for a new strategic R&D centre and Alexion headquarters in Kendall Square,Cambridge,MA,US.This move will bring together colleagues from across AstraZeneca and Alexion in a
54、world-leading life sciences hub.Of course,pushing boundaries sometimes means setbacks and we had some life-cycle management trials during the year that did not meet their primary objectives.However,2022 was predominantly a year of scientific success,including the approval of three new medicines:Imju
55、do for liver cancer and non-small cell lung cancer(NSCLC);Beyfortus for the prevention of RSV,respiratory syncytial virus in infants;and Airsupra for asthma.We are also initiating new late-stage trials for high-potential medicines such as camizestrant,datopotamab deruxtecan and volrustomig.Our R&D s
56、uccess and revenue increase in 2022 demonstrate that we are on track to deliver industry-leading revenue growth through 2025 and beyond,and have set AstraZeneca on a path to deliver at least 15 new medicines before the end of the decade.2022 was a year of continued strong performance and execution o
57、f our long-term growth strategy.Total Revenue increased by 19%(25%at CER)to$44.4 billion,with$7.1 billion coming from our Rare Disease portfolio that was incorporated into the Groups results from 21 July 2021.In our therapy areas,Total Revenue for Oncology increased by 15%(20%at CER);Cardiovascular,
58、Renal&Metabolism by 13%(19%at CER);Respiratory&Immunology fell by 1%but rose 3%at CER;and Rare Disease rose by 4%(10%at CER).In the US,Total Revenue was up 47%in 2022 and in Europe it grew by 9%(21%at CER).While Total Revenue in Emerging Markets fell by 4%(growth of 1%at CER),largely the result of t
59、he anticipated decline in growth in China,it grew in Established Rest of World during the year by 22%(40%at CER).Pioneers in scienceOur success is built on relentlessly pushing the boundaries of science to deliver life-changing medicines.In that regard,we made excellent progress in 2022 with a remar
60、kable 72 regulatory events,either submissions or approvals for our medicines in major markets,and 29 pipeline progression events.During the year,our pioneering science was evident across all therapy areas.For example,in BioPharmaceuticals,the DELIVER Phase III trial established Forxiga as the first
61、heart failure(HF)medicine to demonstrate mortality benefit across the full ejection fraction range.This represents a population of patients,many of whom had previously had no treatment options.Building on Alexions 30-year history in Rare Disease,in 2022 we announced the positive high-level results o
62、f the ALPHA Phase III trial of danicopan,an investigational oral Factor D inhibitor,as an add-on to Ultomiris or Soliris The success of AstraZeneca is built on being true to our Purpose and living our Values to deliver for people,society and the planet.7AstraZeneca Annual Report&Form 20-F Informatio
63、n 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportChief Executive Officers ReviewChief ExecutiveOfficers ReviewPatientsAs well as requiring us to follow the science,AstraZenecas Values put patients first.In this regard,our industry-leading growth means more patients
64、 around the world are benefiting from our medicines and our continued commitment to innovate for patients and improve health outcomes including the use of data,digital technologies and AI.I am particularly proud of what we were able to achieve for patients in Japan in 2022,with a record-breaking fiv
65、e approvals for our cancer treatments in one day,and a remarkable total of 12 medicine approvals for the year.Also in 2022,cancer patients around the world benefited,not only from Enhertu and Imjudo,but also from Imfinzi and Lynparza which,taken together,saw eight new indication launches and 21 majo
66、r market approvals.Following last years acquisition of Alexion,by combining resources,we have been able to bring treatments for rare diseases to patients in 10 more countries around the world,including the availability of Alexions first medicine in China,Soliris.We have also remained at the frontlin
67、e in the fight against COVID-19,with independent analysis showing that our vaccine,Vaxzevria,saved more than six million lives in its first year.Our long-acting antibody combination,Evusheld,continues to play an important role helping to protect those most vulnerable to COVID-19.However,as the COVID
68、-19 virus continues to evolve,so too must our response,and we have commenced a late-stage trial for our next-generation COVID-19 long-acting antibody.We were honoured when TIME magazine announced that Evusheld had been named on its annual list of the Best Inventions,which features 200 extraordinary
69、innovations changing our lives.Additionally,our top-three ranking in the 2022 Access to Medicine Index is external recognition of our focus on increasing equitable and affordable access to our life-changing treatments.AstraZenecas role in societyIn addition to helping patients and in line with our v
70、alue of doing the right thing,we work to create healthier societies,collaborating with partners to tackle major health challenges.We are working to identify barriers and give more people equitable access to healthcare.For example,our Healthy Heart Africa programme is committed to reducing hypertensi
71、on and the burden of cardiovascular disease.We work with partners to raise awareness and offer training,screening and reduced cost treatment,where applicable.By the end of 2022,the programme had launched in nine countries and conducted more than 32 million screenings for high blood pressure since la
72、unch,with plans for further expansion.Our Young Health Programme,which helps young people make informed choices about their health,provides a further example.So far,we have reached more than nine million young people with health information in 39 countries.Given the multiple challenges facing the wo
73、rld today,we continue to do all we can to ensure healthcare systems are more resilient,effective and sustainable.We used the opportunities provided by a pandemic-delayed EXPO 2020 in Dubai to collaborate across the health,private and academic sectors to launch multiple initiatives in support of our
74、science,therapy areas and a sustainable healthcare network across the Middle East and Africa.Our Partnership for Health System Sustainability and Resilience is a collaboration with the London School of Economics and the World Economic Forum(WEF)and continues its work to strengthen global health syst
75、ems.It is now active in more than 30 countries.At the WEF annual meeting in January 2023,our Chair,Leif Johansson,led AstraZenecas advocacy for the continued prioritisation of health as the foundation for strong societies and economies,as well as the need to encourage a fundamental re-evaluation of
76、health as a long-term investment for the future.Looking after the planetWe continue to make important progress with our own science-led Ambition Zero Carbon strategy.By the end of December 2022,we had achieved a 59%reduction in our Scope 1 and 2 greenhouse gas emissions compared to our 2015 baseline
77、.Our efforts include a partnership with Honeywell to develop a next-generation respiratory inhaler which will have a near-zero global warming potential.We are also playing a leading role in accelerating change across the health sector,including through the Sustainable Markets Initiative(SMI)which wa
78、s launched by HM King Charles III in 2021.Ahead of COP27 in 2022,the SMI Health Systems Task Force,which I am honoured to champion,announced shared commitments and actions to reduce emissions in line with the pathway to limit global warming to 1.5C and deliver the transition to net-zero health syste
79、ms.My thanks to all AstraZeneca colleaguesIn January 2023,after almost 25 years with AstraZeneca,Katarina Ageborg,our Executive Vice-President Global Sustainability,Chief Compliance Officer and President,AstraZeneca AB in Sweden,retired.I am grateful to her for the integral role she played in AstraZ
80、eneca becoming a global leader in sustainability and in our re-emergence as one of the worlds most innovative biopharmaceutical companies.I would like to extend my thanks to all our 84,000 employees for the part they played in achieving our strong results in 2022.I would especially like to recognise
81、 the efforts of those who ensured that our medicines reached patients across the world and contributed to our support for humanitarian relief.Our ChairMy particular thanks must go,of course,to Leif Johansson who has chaired our Board for the decade in which I have been leading AstraZeneca.I am grate
82、ful to him,not only for his skilled leadership of the Board but also for all he has done for AstraZeneca as Chair.More than that,he has been a great colleague and friend.I will miss Leif when he steps down after this years AGM.The last 10 years has shown what AstraZeneca and its people can achieve.I
83、 am energised at the prospect of working more closely with Michel Demar,our new Chair,and by what more we can do for people,society and the planet,thereby earning further returns for shareholders who have entrusted their funds to us.Pascal Soriot Chief Executive OfficerThe Terra Carta Seal recognise
84、s global corporations that are demonstrating their commitment to,and momentum towards,thecreation of genuinely sustainable markets.For more information on our strategy,see Our Strategy and Key Performance Indicators from page 14.8AstraZeneca Annual Report&Form 20-F Information 2022Strategic Report20
85、22202120201,1201,0361,214World($bn)1,214bn(8.4%)202220206Established RoW($bn)$106bn(+5.7%)2022202605US($bn)$605bn(+8.8%)2022202290Emerging Markets($bn)$290bn(+8.4%)2022202213Europe($bn)$213bn(+8.6%)The external environment presents us with both challenges
86、and opportunities that require us to adapt,innovate and build trust.Healthcare in a Changing WorldThe pharmaceutical sector continues to grow against a backdrop of increasing demand for healthcare.Global pharmaceutical sales grew by 8.4%in 2022.Global healthcare spending is projected to increase at
87、an annual rate of 5.7%from 2021 to 2026.A growing pharmaceutical sectorGlobal pharmaceutical salesIn 2022,Established Markets saw an average revenue increase of 8.4%and Emerging Markets revenue also grew at 8.4%.The US,Japan,China,Germany and France are the worlds top five pharmaceutical markets by
88、2021 sales.In 2022,the US had 49.8%of globalsales(2021:49.7%).Data based on world market sales using AstraZeneca Market definitions on page 220.Changes in data subscriptions,exchange rates and subscription coverage,as well as restated IQVIA data,have led to the restatement of total market values for
89、 prior years.Source:IQVIA,IQVIA Midas Quantum Q3 2022(including US data).Reported values and growth are based on CER.Value figures are rounded to the nearest billion and growth percentages are rounded to the nearest tenth.We expect developing markets,including Africa,the Commonwealth of Independent
90、States(CIS),the Indian subcontinent and Latin America,to fuel pharmaceutical growth.Market growth in China is expected to remain below historical levels at a compound annual growth rate of 2.6%.This is due to the continued slowdown of the major hospital sector.1 Includes Armenia,Azerbaijan,Belarus,G
91、eorgia,Kazakhstan,Kyrgyzstan,Moldova,Russia,Tajikistan,Turkmenistan,Uzbekistan and excludes Ukraine.2 Non-EU countries;including the UK.$1,214bn(+8.4%)Estimated pharmaceutical sales 2026.Data is based on ex-manufacturer prices at CER.Source:IQVIA.Estimated pharmaceutical market growth.Data is based
92、on the compound annual growth rate from 2021 to 2026.Source:IQVIA Market Prognosis Global 20222026.Other Europe2$82bn9.9%Japan$74bn0.2%China$189bn2.6%Oceania$19bn4.4%Southeast Asia and East Asia$267bn3.8%Middle East$29bn5.3%Africa$34bn6.2%Indian subcontinent$52bn9.4%CIS$40bn8.3%EU$295bn5.4%North Ame
93、rica$774bn4.5%Latin America$170bn17.2%Estimated pharmaceutical sales and market growth to 20269AstraZeneca Annual Report&Form 20-F Information 2022Additional InformationFinancial StatementsCorporate GovernanceStrategic ReportHealthcare in a Changing World Global trends are influencing and shaping th
94、e pharmaceutical sector.Changes can be observed at many levels,for example,in industry regulations and policies,pricing reforms in the US and China,the use of digital and artificial intelligence,and changes in the workplace.Impact of global trendsOver the next two decades,the geopolitical environmen
95、t is expected to become more contested,potentially reaching levels of intensity not seen since the Cold War.The slowdown of the global economy will continue to affect businesses across the globe.Together with national and regional healthcare services,pharmaceutical companies play a key role in preve
96、ntion,diagnosis and treatment for patients with chronic diseases.It is expected that,over the next two decades,the geopolitical environment will become more contested,potentially reaching levels of intensity not seen since the Cold War.Additionally,global geopolitical volatility has fundamentally al
97、tered the relationships and norms that have governed international economic partnerships and frameworks since the Second World War.For example,when Russia invaded Ukraine in early 2022,it did not take long for the geopolitical consequences to be felt around the globe.Responses to other global issues
98、,such as climate change or the COVID-19 pandemic,are at risk of being derailed or undermined as a result.Geopolitical tensions also place increased pressure on supply chains and distribution networks.(Source:Global Trends 2040,March 2021)Since 2021,the global economy has experienced a slower recover
99、y than expected,particularly in major economies such as the US,Europe,China and Russia.High governmental debt loads,a slowdown in global trade,increasing energy prices and labour shortages have all contributed to suppressing growth a trend that can be observed across the globe.In January 2023,the In
100、ternational Monetary Fund(IMF)upgraded its growth forecast for 2023 to 2.9%.This is an increase from its previous forecast of 2.7%but still below the historical annual average of 3.8%between 2000 and 2019.In addition,inflationary pressures from the risein energy prices,consequences of thepandemic an
101、d conflict in Ukraine have led tohigher inflation and,with that,higher nominalinterest rates that are expected to continue.(Source:IMF)NCDs,also known as chronic diseases,are the result of a combination of genetic,physiological,environmental and behavioural factors.Cardiovascular diseases account fo
102、r most NCD deaths annually(17.9 million people),followed by cancers(9.3 million),respiratory diseases(4.1 million),and diabetes(1.5 million).(Source:WHO)Increasing demand for healthcare is putting pressure on healthcare budgets which,exacerbated by the impact of the COVID-19 pandemic,is leading to d
103、ownward pressure on pricing.66%Two thirds of respondents said geopolitical changes are pushing their organisation to re-evaluate strategy.(Source:Control Risks Global Risk Survey 2022)2.9%Global GDP growth is forecast to slow from 6.2%in 2021 to 3.4%in 2022 and 2.9%in 2023.(Source:IMF)80%By 2040,non
104、-communicable diseases(NCDs)could account for 80%of deaths in low-income countries,up from 25%in 1990.(Source:Global Trends 2040,March 2021)EconomicGlobal economic downturnSocietalGrowing burden of chronic diseasesHealthcare in a Changing World continuedPoliticalGreater geopolitical conflict10AstraZ
105、eneca Annual Report&Form 20-F Information 2022Strategic ReportArtificial intelligence is transformational and its broad use has significant potential to reshape societies,economies and industries.Climate change,caused by growing human-produced concentrations of greenhouse gases in the atmosphere,is
106、intensifying.AI will improve productivity in the workplace and challenge existing business models.At the same time,it will disrupt the labour force by creating new job fields while eliminating others.To harness the advantages of AI,countries and companies will need to focus on educating and upskilli
107、ng their workforce.(Sources:Global Trends 2040,March 2021 and United Nations)The impact of climate change via rising temperatures and other extreme weather conditions,rising sea levels and declining biodiversity will be felt across the globe,with the cost and related challenges disproportionately af
108、fecting developing economies.When converging with environmental degradation,the risks to food security,access to water,public health,and energy supply will intensify.To avoid the worst impacts,the global temperature needs to be kept to no more than 1.5C above pre-industrial levels.This means GHG emi
109、ssions need to be reduced by 45%by 2030,compared to 2010,and to net-zero by 2050.(Source:Intergovernmental Panel on Climate Change(IPCC)Summary for Policymakers of Special Report on Global Warming of 1.5C)While demand for healthcare is increasing and science is driving improvements in healthcare,ris
110、ks remain for the sector.At the same time as demographic and other changes are driving an increased demand for healthcare,continued advances in science and digital technologies are driving innovation and improvements in healthcare.However,risks remain.In addition to the downward pressure on pricing,
111、the sector also faces regulatory challenges and the loss of exclusivity and genericisation.More generally,to be successful,pharmaceutical companies will need to be able to respond to the pressures and demands made on them by patients and caregivers,health authorities,payers,policymakers and others,w
112、hile earning their trust.They will also need to develop strategies for protecting themselves against harmful misinformation,which will require collaboration between businesses,policymakers and other stakeholders to tackle at scale.$5.2bnInvestment in AI-enabled drug discovery more than doubled in th
113、e past five years,exceeding$5.2 billion at the end of 2021.(Source:BCG)14%Human-produced emissions are projected to increase 14%by 2030 from 2010 levels,short of the 45%target reduction.(Source:Global Trends 2040,March 2021 and Net-zero Coalition,October 2022)31%During the pandemic,public trust in p
114、harma rose to 31%in 2022,from 25%in 2018.But there is still room to improve.(Source:Ipsos Global Trustworthiness Monitor:Is Trust in Crisis?)TechnologicalArtificial intelligence becoming mainstreamEnvironmentalClimate change acceleratingOutlookOpportunities and challenges for the sector These risks
115、are explored further in the Risk Overview from page 56 and Pricing and value of our medicines from page 39.AstraZenecas response to the trends we face is explored further in Our Strategy and Key Performance Indicators from page 14.11AstraZeneca Annual Report&Form 20-F Information 2022Corporate Gover
116、nanceAdditional InformationFinancial StatementsStrategic ReportHealthcare in a Changing WorldOur business modelInspired by our Values and what science can do,we are focused on accelerating the delivery of life-changing medicines that create enduring value for patients,society and our shareholders.Wh
117、at our business model requires to be successfulHow we add valueImproved healthContinuous scientific innovation is vital to achieving sustainable healthcare,which creates value by:Improving health outcomes and transforming the lives of patients who use our medicines.Enabling healthcare systems to red
118、uce costs and increase efficiency.Improving access to healthcare and healthcare infrastructure.Helping develop the communities in which we operate through local employment and partnering.Financial valueRevenue from our Product Sales and collaboration activities generates cash flow,which helps us:Fun
119、d our investment in science and the business to drive long-term value.Follow our progressive dividend policy.Meet our debt service obligations.105mOur main therapy area medicines impact more than 105 million patient lives annually.In addition,AstraZeneca and our global partners have released for sup
120、ply more than three billion Vaxzevria/Covishield COVID-19 vaccine doses to more than 180 countries.Ability to acquire,retain and develop a talented and diverse workforce.Global commercial presence and skills that ensure our medicines are available to patients when needed.130countries where we sell o
121、ur products49.5%of our senior middle management roles and above are filled bywomenA leadership position in science thatenables us to deliver life-changing medicines.$9.8bninvested in our science in 2022Patent protection for our intellectual property for a reasonable period of time to prevent our new
122、 medicines being copied.90countries where we obtained patent protectionUnderstanding the issues that are mostimportant to our many and variedstakeholders.199,000healthcare practitioner enquiriesresponded toA supply of high-quality medicines,whether from our own operations or fromsuppliers.$25.1bnspe
123、nt with suppliersEffective collaborations that supplement and strengthen our pipeline and our efforts to achieve scientific leadership.1,000collaborations worldwideFinancial strength,including access tofinancing and ability to bear the financial risk of investing in the life-cycleof a medicine.$9.8b
124、nnet cash flow from operating activitiesWe are a global pharmaceutical business with a science-led and patient-focused value proposition committed to excellence in the research,development,manufacturing and commercialisation of prescription medicines.We are committed to operating sustainably,in a wa
125、y that recognises the interconnection between business growth,the needs of society and the limitations of our planet.We invest resources to create financial and non-financial value that benefit patients,society and our business.Our Values determine how we work together and the behaviours that drive
126、our success.They guide our decision making and define our beliefs.We follow the science.We put patients first.We play to win.We do the right thing.We are entrepreneurial.Business Review,see from page 34.Our PurposeWe push the boundaries of science to deliver life-changing medicines.Our ValuesOur Pur
127、pose,Values and Business Model 12AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportThis is a high-level overview of a medicines life-cycle and is illustrative only.It is neither intended to,nor does it,represent the life-cycle of any particular medicine or of every medicine discove
128、red and/or developed by AstraZeneca,or the probability of success or approval of any AstraZeneca medicine.Investment in discovery,development,manufacturing and commercialisation of patent-protected medicines Revenue generation Reinvestment of returnsInputs Applying our resources to address unmet med
129、ical need Outputs Improved health Returns to shareholdersOur PurposeResearch and development phases 515 years Launch phase 515 yearsPost-exclusivity20+years1 2 34 5 6 789Life-cycle of a medicineWe create financial value throughout the life-cycle of a medicine.InvestmentWe invest in the discovery,dev
130、elopment,manufacturing and commercialisation of our pipeline of innovative prescription medicines.Revenue generationWe generate revenue from Product Sales of our existing medicines and new medicine launches,as well as from our collaboration activities.Our focus is on creating medicines that facilita
131、te profitable future revenue generation,while bringing benefits to patients.ReinvestmentWe reinvest in developing the next generation of innovative medicines andin our business to provide the platform for future sources of revenue in the face of losses of key patents.We also assess opportunities to
132、investin value-enhancing additions toour portfolio.1.Undertake scientific research to identify potential new medicines.2.Pre-clinical studies in laboratory and animals to understand if the potential medicine is safe to introduce into humans.3.Phase I trials with small groups of healthy human volunte
133、ers(small molecules)or patients(biologics)to understand how the potential medicine is absorbed into the body,distributed and excreted.Launch phase duration:515 years 7.Launch new medicine while continuously monitoring,recording and analysing reportedside effects.8.Post-launch research and developmen
134、t to further understandthe benefit/risk profile ofthe medicine and life-cycle management activities to understand itsfull potential.Post-exclusivity duration:20+years 9.Patent expiry and generic medicine entry.4.Phase II trials on small-to medium-sized groups of patients to test effectiveness and to
135、lerability of the medicine and determine optimal dose.5.Phase III trials in a largergroup of patients togather information abouteffectiveness and safety of the medicine andevaluate the overall benefit/risk profile.6.Seek regulatory approvals for manufacturing,marketing and selling themedicine.Resear
136、ch and development phases duration:515 years13AstraZeneca Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportOur Purpose,Values and Business Model Effective delivery of our strategic priorities will help us achieve our financial targ
137、ets.Our capital allocation priorities include investing in the business and pipeline,including potentially value-enhancing business development opportunities;maintaining a strong,investment-grade credit rating;and supporting a progressive dividend policy,balancing opportunities for growth and mainta
138、ining a strong balance sheet.Our strategy is straightforward.We:are science and innovation led are focused on our chosen therapy areas:Oncology;BioPharmaceuticals(comprising Cardiovascular,Renal&Metabolism(CVRM),Respiratory&Immunology(R&I)and Vaccines&Immune Therapies(V&I);and Rare Disease have a di
139、versified portfolio with broad coverage across primary care,specialty care and rare disease have global strength with balanced presence across regions have a commitment to people,society and the planet.We have three priorities designed to deliver our strategy and achieve our financial targets:KPI ke
140、y Used for remuneration of Executive DirectorsOur Key Performance Indicators and remuneration Our KPIs are aligned to our strategic priorities and are the indicators against which we measure our productivity and success.Several KPIs used in this section are used to measure the remuneration of Execut
141、ive Directors and allow us to disclose aggregated targets without disclosing sensitive commercial information at the individual KPI level.Any variances between the KPI and values used in determining remuneration are explained in the Directors Remuneration Report from page 104.Other indicators used a
142、re now included in the Business Review from page 34.Since 2021,a metric focusing on the delivery of our Ambition Zero Carbon commitments has been included in our executive incentive arrangements.This underlines the importance we place on reducing GHG emissions from our global operations and fleet(Sc
143、ope 1 and 2)by 98%by 2026(from a 2015 baseline).Achieve Group Financial TargetsKey Performance IndicatorsCash generation is a key driver of long-term shareholder returns and facilitates reinvestment in our pipeline,which is critical for delivering new medicines and future value.Earnings per share(EP
144、S)is an important profitability metric and a key driver of shareholder value.For more information on our Core measures,see the Financial Review from page 60.For details of how Achieve Group Financial Targets are considered when calculating the annual bonus,see page 114.Actual growth2022 n/m2021-97%2
145、020+137%CER growth2022 n/m2021-84%2020+142%Actual growth2022+26%2021+32%2020+15%CER growth2022+33%2021+37%2020+18%Actual growth2022+64%2021+24%2020+62%Our ambition is to launch 15 new medicines by 2030.2.Growth and Therapy Area Leadership1.Science and Innovation3.People and SustainabilityAchieve Gro
146、up Financial Targets202220212020$2.12$0.08$2.44$2.12Reported EPS202220212020$6.66$5.29$4.02$6.66Core EPS202220212020$9,808m$5,963m$4,799m$9,808mNet cash flow from operating activities14AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportOur Strategy and Key Performance Indicators1 25
147、 against our Group scorecard for determining annual bonus.2 26 against our Group scorecard for determining annual bonus.3 25 against our Group scorecard for determining annual bonus.1 50 against our Group scorecard for determining annual bonus.2 37 against our Group scorecard for determining annual
148、bonus.3 43 against our Group scorecard for determining annual bonus.Science&Innovation Key Performance IndicatorsOur science measures incentivise the development of NMEs and the maximisation of the potential of existing medicines.Pipeline progression events(Phase II NME starts/progressions and Phase
149、 III investment decisions)measure innovation and sustainability.Regulatory events(regulatory submissions and approvals)demonstrate the advancement of this innovation to patients and the value to the Group.For more information on performance against the Group scorecard,see page 114.“Our approach to R
150、&D and innovation aims to deliver the quickest and greatest impact possible on disease prevention and treatment.”Our focus areas Creating the next generation of therapeutics using an array of drug modalities,for example,advanced biologics,nucleotide-based and cell therapies.Leading in convergence of
151、 science,data and technology.Advancing our pipeline.How our strategy responds toglobaltrendsTo ensure we are able to respond to the increasing burden of disease and incorporate advances in science and digital technologies,we are:Advancing our understanding of disease biology to help uncover novel dr
152、ivers of disease,through genomics,functional genomics and knowledge graphs.Progressing an early pipeline consisting of numerous new drug modalities,including ADCs,cell therapy,epigenetics,gene therapy,oligonucleotides,radio-immuno conjugates(RICs)and self-amplifying RNA(saRNA).Creating humanised mod
153、els to better predict the success of our molecules in the clinic.Pioneering new approaches to engagement in the clinic and beyond,incorporating patient insights to improve experiences and outcomes.Embedding AI across our R&D activities,from target identification to clinical trials,to understand wher
154、e we can harness new technologies and further automate processes.How we progressed in 2022 Achieved 72 regulatory events:38 NME and major LCM submissions and 34 approvals in major markets(US,EU,China and Japan).Secured 29 pipeline progression events:six NME Phase II starts/progressions and 23 NME an
155、d major LCM Phase III investment decisions.Our pipeline includes 179 projects,of which 155 are in the clinical phase of development.At the end of the year,we had 15 NME projects in pivotal trials or under regulatory review covering 28 indications(2021:16).27 projects were discontinued.Focus for 2023
156、 Drive innovation opportunities across our global R&D sites.Continue transforming the way we discover and develop new medicines using AI and machine learning.Continue attracting the brightest minds tocreate an environment in which science thrives.For more information,see Therapy Area Review from pag
157、e 18 and Business Review from page 34.2022202363291 Pipeline progression events2022202533721 Regulatory events15AstraZeneca Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportOur Strategy and Key Performance Ind
158、icators202220212020$44,351m$37,417m$26,617m$44,351mTotal RevenueOur focus areas Leveraging our innovative science to create a more personalised,precise and accessible healthcare experience.Engaging with the entire healthcare ecosystem and unlocking visionary partnerships that drive positive change a
159、nd outcomes.Creating industry-leading growth across our therapy areas and regions.Continuing to implement our Operations 2025 programme.How our strategy responds to global trendsTo ensure we can respond to the increasing demand for healthcare,downward pressure on prices and increasing control that p
160、eople have over their own healthcare,we are:Fostering a patient-focused approach and embedding patient insights across our organisation,building integrated therapy area ecosystem models.Engaging with policymakers to support improvements in sustainable access,coverage,care delivery and patient care o
161、utcomes.Leveraging technology across prevention and awareness,diagnosis,treatment,post-treatment and wellness to deliver better patient outcomes.Partnering with industry,governments,and others to adopt value-based pricing solutions and bring new medicines to market more quickly.Pursuing a strong pat
162、ent strategy that builds robust patent estates to protect our pipeline and products while defending and enforcing patent rights.Leveraging the power of digital throughout our end-to-end supply chain through digital drug development to accelerate development lead times.How we progressed in 2022 Total
163、 Revenue,comprising Product Sales and Collaboration Revenue,increased by 19%(25%at CER)to$44,351 million.Collaboration Revenue increased by 54%(56%at CER)to$1,353 million.Grew Total Revenue across our Therapy Areas:Oncology 15%(20%at CER)to$15,539 million;CVRM 13%(19%at CER)to$9,211 million;and R&I
164、declined 1%(+3%at CER)to$5,963 million.Our new V&I unit grew by 1%(8%at CER)to$4,836 million and Rare Disease grew by 4%(10%at CER)to$7,053 million.Total Revenue in Emerging Markets declined by 4%(+1%at CER)to$11,745 million.In the US,it grew by 47%to$17,920 million and in Europe grew by 9%(21%at CE
165、R)to$8,738 million.Focus for 2023 Deliver sustainable growth by seizing opportunities open to us in regions,markets and through targeted business development opportunities.Continue transforming how we work.Advance digital approaches to transform the patient experience.“Our belief in the power of sci
166、ence is growing the success of our Company and helping us contribute to transforming the future of healthcare.”Growth and Therapy Area Leadership 1 Growth rates on medicines acquired with Alexion have been calculated on a pro forma basis compared with the corresponding period in the prior year.For m
167、ore information,see Therapy Area Review from page 18 and Business Review from page 34.Actual growth2022+19%2021+41%2020+9%CER growth2022+25%2021+38%2020+10%Key Performance IndicatorsOur Total Revenue measure reflects the importance of incentivising sustainable growth in both the short and longer ter
168、m.For details of how Total Revenue is considered when calculating the annual bonus,see from page 114.16AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportOur Strategy and Key Performance Indicatorscontinued20222021202085%86%89%86%Employee belief that AstraZeneca is a great place to
169、work2022 7/92021 10/122020 13/14Green AmberRed7/9Sustainability scorecard performanceOur focus areas Continuing to make AstraZeneca a great place to work.Making it easier to work across our Group to deliver sustainable growth.Ensuring we operate in the smartest way,increasing the speed of delivery o
170、f medicines to patients through our Future of Work initiative.Harnessing the power of Science and Innovation in ways that positively impact patients,healthcare systems,and the environment.Progressing our Sustainability strategy across three integrated priority pillars:access to healthcare,environmen
171、tal protection,and ethics and transparency.How our strategy responds to global trendsTo ensure we are able to deliver our strategy,build trust in AstraZeneca and contribute to the health of society and the planet,we are:Creating an inclusive and equitable environment where people belong,using our di
172、versity as a competitive advantage.Fostering a culture of lifelong learning,strengthening and evolving our capabilities,and instilling confidence to challenge convention and explore possibilities.Simplifying the way we work,driving productivity,and optimising digital and technology to deliver a bett
173、er experience for our people and better outcomes for patients.Working towards a future where all people have access to affordable,sustainable and innovative healthcare.Playing our part in protecting the planet by reducing GHG emissions from our global operations and fleet by 98%by 2026 and halving o
174、ur entire value chain footprint by 2030.Empowering employees through our Code of Ethics to make decisions in the best interests of the Group and society.How we progressed in 2022 We continued to invest in our people to ensure we recruit,retain and develop a talented workforce.In 2022,we delivered a
175、strong performance across the key priorities of our People and Sustainability strategy pillar.We continued to score highly in our Pulse surveys for questions relating to our Purpose,direction,patient centricity and employee commitment to our success.We demonstrated our continued commitment to workin
176、g in partnership to strengthen health systems worldwide.We maintained a leading role in efforts to address the effects of climate change on our planet and increasingly on public health inequalities and disease prevalence.Our Ambition Zero Carbon strategy delivered further reductions in our GHG emiss
177、ions,and we are on track with our environmental commitments.Focus for 2023 Maintain positive employee engagement.Accelerate digital transformation and activities to drive productivity.Advance our sustainability priorities,particularly health equity and health system resilience,as well as addressing
178、the effects of the climate crisis on health and conserving biodiversity.For more information,see People from page 45 and Sustainability from page 48.People and Sustainability“We continue to make AstraZeneca a great place to work while ensuring we have a positive impact on people,society and the envi
179、ronment.”Key Performance IndicatorsOur People and Sustainability strategy is built around two priorities:Contribution to the enterprise and Contribution to society.Our Contribution to the enterprise KPI is based on our Pulse survey measure of those employees who believe that AstraZeneca is a great p
180、lace to work.Our Contribution to society KPI is based on our sustainability scorecard.Ratings for this KPI reflect our success in achieving our sustainability goals.In 2020,we used 14 priorities and 12 in 2021.Following a materiality assessment,we updated our strategy around nine focus areas as the
181、basis for our 2022 scorecard.These reflect the focus areas,outlined in our Sustainability Report on our website, guide our sustainability strategy and where we can have the most positive impact.2 In 2022,we assessed our performance against nine focus areas,each made up of a number of indicators.For
182、a focus area to be green,at least 70%of the indicators within it need to have achieved its target in 2022.An overall KPI green rating requires at least seven individual indicators rated green;an amber rating shows five or six rated green;a red rating shows four or fewer rated green.1 Source:November
183、 Pulse survey for each year.For more information on our Key Performance Indicators,including definitions,methodology and restatements,see our Sustainability Data Summary at Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportOur Strat
184、egy and Key Performance IndicatorsWe are leading a revolution in oncology to redefine cancer care.Our ambition is to follow the science to discover,develop and deliver life-changing treatments that transform outcomes and increase the potential for cure.Epigenetics:DNA undergoing epigenetic modulatio
185、n OncologyTherapy Area Review 18AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportSmall molecule targeted agents$50.9bnImmune checkpoint inhibitors$36.6bnMonoclonal antibodies(mAbs)$34.3bnChemotherapy$24.5bnHormonal therapies$16.0bnPARP inhibitors$3.1bnOther oncology therapies$0.5b
186、n$165.8bnAnnual worldwide market valueTherapy area world market(MAT Q3-22)2022 overview Performance driven by rapid and broad market penetration of our oncology medicines,with 8 new indication launches and 21 major market approvals across four medicines,including Imfinzi,Enhertu,Lynparza and a new m
187、edicine approved for the first time,Imjudo2.Impressive business performance underpinned by exceptional Total Revenue growth for Calquence and Enhertu and strong double-digit growth for Tagrisso,Lynparza and Imfinzi.1 Total Revenue from Koselugo is included within Rare Disease for 2022 reporting,prev
188、iously reported within Oncology.The comparatives and growth rates shown for each therapy area have been calculated as though these changes had been implemented in 2020.2 Imfinzi Total Revenue includes revenue of Imjudo which commenced in 2022.Total Revenue$15,539mup 15%(20%at CER)2021:$13,555m12020:
189、$11,417m1Unmet medical need and world market20mNearly 20 million people were diagnosed with cancer in 2020 and it remains the second leading cause of death across the globe.27.5mThe global burden of cancer is expected to grow,with an estimated 27.5 million newly diagnosed patients and 16.3 million d
190、eaths annually by 2040.Source:IQVIA.AstraZeneca focuses on specific segments within this overall therapy area market.Oncology Therapy Area submarket totals($165.9bn)do not sum up exactly to the Therapy Area total($165.8bn)due to rounding.ProductDiseaseTotal Revenue CommentaryTagrisso(osimertinib)Lun
191、g cancer$5,444m,up 9%(15%at CER)Approved in 94 countries for the adjuvant treatment of patients with early-stage EGFR mutated(EGFRm)NSCLC and in 99 countries for both the 1st-and 2nd-line treatment of advanced EGFRm NSCLC.Lynparza(olaparib)Ovarian cancerBreast cancerPancreatic cancerProstate cancer$
192、2,993m,up 9%(14%at CER)Approved in 93 countries as maintenance therapy for platinum-sensitive relapsed ovarian cancer and 1st-line BRCA-mutated(BRCAm)ovarian cancer,and in 89 countries with bevacizumab for homologous recombination repair deficient(HRD)-positive advanced ovarian cancer.Approved in 56
193、 countries for germline BRCAm(gBRCAm),HER2-negative early breast cancer(approved in the metastatic setting in 92 countries).Approved in 89 countries for gBRCAm metastatic pancreatic cancer.Approved in 92 countries for homologous recombination repair(HRR)gene-mutated metastatic castration-resistant p
194、rostate cancer(mCRPC)(BRCAm only in certain countries)and in 31 countries in combination with abiraterone for the 1st-line treatment of adult patients with mCRPC.Imfinzi2(durvalumab)Lung cancerBladder cancerLiver cancer$2,784m,up 15%(21%at CER)Approved in the curative-intent setting of unresectable,
195、Stage III NSCLC after chemoradiotherapy in 85 countries and in extensive-stage small cell lung cancer in 81 countries.Also approved in combination with gemcitabine and cisplatin as treatment for adult patients with locally advanced or metastatic biliary tract cancer in three countries,and in unresec
196、table hepatocellular carcinoma in the US in combination with Imjudo.2 Also approved in the US in combination with Imjudo and platinum-based chemotherapy for NSCLC,and for previously treated advanced bladder cancer in 10 countries.Calquence(acalabrutinib)Mantle cell lymphoma(MCL)Chronic lymphocytic l
197、eukaemia(CLL)$2,057m,up 66%(69%at CER)Approved in 85 countries for the treatment of CLL and in 43 countries for the treatment of adult patients with MCL who have received at least one prior therapy.Enhertu(trastuzumab deruxtecan)Breast cancerGastric cancerLung cancer$602m,up 182%(184%at CER)Approved
198、 in more than 40 countries for HER2-positive metastatic breast cancer following a(one or more)prior anti-HER2-based regimen.Also approved in more than 30 countries for HER2-low metastatic breast cancer following chemotherapy and previously treated HER2-positive advanced gastric cancer.Approved in th
199、e US for previously treated HER2-mutant metastatic NSCLC.Orpathys(savolitinib)Lung cancer$33m,up 109%(106%at CER)Approved in China for treatment of NSCLC with MET gene alterations.Other productsZoladex(goserelin acetateimplant)Prostate cancerBreast cancer$957m,down 1%(up 7%at CER)Arimidex (anastrozo
200、le)Breast cancer$99m,down 29%(24%at CER)Faslodex(fulvestrant)Breast cancer$334m,down 22%(14%at CER)Casodex/Cosudex(bicalutamide)Prostate cancer$78m,down 45%(40%at CER)Iressa(gefitinib)Lung cancer$114m,down 38%(34%at CER)Key marketed products See full product information in the Patent Expiries Supple
201、ment on our website, Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportTherapy Area Review/OncologyOur strategy in OncologyWe strive to push the boundaries of science to change the practice of medicine and transform the lives of pat
202、ients living with cancer through:1.Scientific platforms to attack cancer from multiple angles,including targeting cancer cells directly and activating the immune system.We use monotherapy and combination approaches to drive deeper,more durable,responses:a.Tumour drivers and resistance targeting gene
203、tic mutations and resistance mechanisms that enable cancer cells to survive and proliferate.b.DNA damage response targeting the DNA repair process to block cancer cells reproducing.c.Antibody drug conjugates(ADCs)highly potent cancer-killing agents delivered directly to cancer cells via a linker att
204、ached to a targeted antibody.d.Epigenetics targeting changes to genome expression caused by cancer.e.Immuno-oncology activating the bodys own immune system to help fight cancer.f.Cell therapies harnessing living cells to target cancer.2.Treating cancer earlier where the greatest opportunity for cure
205、 exists and building expertise and leadership in key tumour types.3.Collaborating to harness transformational technologies,including computational pathology,circulating tumour DNA(ctDNA)testing,digital health and data science/AI.4.Leveraging our global footprint to make cancer therapies available to
206、 every eligible and appropriate patient.Lung cancerScientific advances are strengthening the potential of our medicines to offer cure and long-term survival in lung cancer with a focus on early detection and precision medicine.Our comprehensive portfolio includes leading medicines Tagrisso,Imfinzi,I
207、mjudo,Enhertu and Orpathys,with a pipeline of potential new medicines and combinations across diverse mechanisms of action.Positive Phase III results from the AEGEAN trial showed Imfinzi plus chemotherapy significantly improved pathologic complete response in resectable NSCLC.The trial continues to
208、assess the additional primary endpoint of event-free survival.Tagrisso approved in Japan for the adjuvant treatment of patients with early-stage EGFRm NSCLC based on the ADAURA Phase III trial.Updated results from ADAURA showed Tagrisso continued to prolong the time these patients can live cancer-fr
209、ee after surgery.Together with Daiichi Sankyo,we are accelerating Phase III trials in lung and breast cancers for our TROP2-directed ADC,datopotamab deruxtecan as monotherapy and in combinations following promising clinical data and strong tolerability profile.We are also driving Phase III trials in
210、 breast,endometrial,gastric,prostate,ovarian and colorectal cancers.Our novel bispecific antibody,volrustomig(MEDI5752),simultaneously targets PD-1 and CTLA-4,which has potential to improve therapeutic benefit and reduce the risk of toxicity typically associated with CTLA-4 inhibitors.Initial data i
211、n late-stage non-squamous NSCLC shows durable responses.Breast cancerWe are aiming to shape clinical practice and transform outcomes across all subtypes and stages of breast cancer and ultimately,to eliminate breast cancer as a cause of death.Our comprehensive portfolio of medicines including Enhert
212、u,Lynparza,Faslodex and Zoladex and promising compounds in development leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.For Enhertu,positive Phase III results in advanced HER2-low metastatic breast cancer led to a rare standing ovation at t
213、he American Society of Clinical Oncology Annual meeting and swift approval in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.Lynparza became the first and only approved medicine targeting BRCAm in early breast cancer following US approval as adjuvant tr
214、eatment for gBRCAm HER2-negative high-risk patients based on the OlympiA Phase III trial.Positive Phase III results for capivasertib plus Faslodex in advanced HR-positive breast cancer reinforced the opportunity with this AKT inhibitor for patients who experience tumour progression on,or resistance
215、to,available endocrine therapies.Promising Phase II data for our next-generation,selective estrogen receptor degrader(SERD),camizestrant,in advanced ER-positive breast cancer,demonstrated the potential for camizestrant to improve on currently available endocrine therapies for patients with early and
216、 metastatic disease.Gynaecological/Genitourinary cancersOur ambition is to establish Lynparza plus abiraterone as the standard of care in 1st-line mCRPC based on its transformational efficacy and best-in-class safety profile.In gynaecological cancers,we aim to maximise progression-free survival and
217、provide hope of cure for women with advanced ovarian cancer.Positive results from PROpel Phase III trial showed Lynparza in combination with abiraterone significantly delayed disease progression in 1st-line mCRPC,now approved in the EU based on these results.US regulatory submission remains under re
218、view following an extension by the FDA in December 2022.Our next-generation PARP1 selective inhibitor,AZD5305,is progressing towards potential registrational trials for prostate cancer in combination with new hormonal agents,with data showing good tolerability at higher doses.AZD5305 is designed to
219、selectively target PARP1,thereby killing cancer cells by targeting tumour cell DNA damage response mechanisms.2ndCancer is the second leading cause of death worldwide.16.3mBy 2040,cancer is expected to account for 16.3 million deaths annually across the globe.20AstraZeneca Annual Report&Form 20-F In
220、formation 2022Strategic ReportTherapy Area Review Oncology continuedGastrointestinal cancersWith positive results across multiple medicines and a robust development programme in many stages and disease types,gastrointestinal cancers are a critical new growth area.Imfinzi in combination with chemothe
221、rapy is the first immunotherapy-based regimen approved in the US,EU and Japan and a new standard of care in advanced biliary tract cancer,a treatment setting with no major global treatment advance in over a decade.Imjudo in combination with Imfinzi is now approved in the US and Japan for patients wi
222、th unresectable liver cancer and recommended for approval in the EU based on the HIMALAYA Phase III trial.Blood cancersIn haematology,we are using our six scientific platforms to develop and test novel investigational agents designed to target underlying drivers,resulting in 25,000 patients treated
223、globally and approvals in 84 countries.A new tablet formulation of Calquence,our next-generation Brutons tyrosine kinase(BTK)inhibitor,is now approved in the US for all current indications which allows for co-administration with gastric acid-reducing agents.Calquence was approved in Japan as a 1st-l
224、ine treatment for patients with CLL(including small lymphocytic lymphoma)based on findings from the ELEVATE-TN trial.Building on the success of Calquence,our acquisition of TeneoTwo and its T-cell engager AZD0486(TNB-486)aims to accelerate and diversify our Oncology pipeline for haematologic maligna
225、ncies.For full details,see the Development Pipeline Supplement on our website, clinical data for AZD0486 shared at the 2022 American Society of Hematology annual meeting showed early signs of activity in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.Were thinking differently about th
226、e underlying genetic causes of cancer,defining new biomarkers and therapeutic targets that span multiple tumour types.21AstraZeneca Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportTherapy Area Review/OncologyWe are transforming ca
227、re for billions of people living with chronic diseases and delivering long-lasting immunity.Our ambition is to intervene earlier to protect vital organs,slow or reverse disease progression,and achieve remission for these often degenerative,debilitating,and life-threatening conditions,so many more pe
228、ople can live better,healthier lives.Severe asthma disease pathways:the role of epithelial cytokines and eosinophils.BioPharmaceuticalsTherapy Area Review 22AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportWe have a relentless focus on developing and delivering innovative,life-cha
229、nging medicines and solutions for the millions of people affected by the complex spectrum of cardiovascular,renal and metabolic diseases.2022 overview DELIVER Phase III trial showed Forxiga significantly reduced the risk of cardiovascular death or worsening of heart failure in patients with mildly r
230、educed or preserved ejection fraction.Lokelma launched in 23 markets and achieved global branded market leadership.Andexxa received the first approved reversal agent specifically for Factor Xa inhibitors in Japan.Eplontersen met co-primary and secondary endpoints in interim analysis of the NEURO-TTR
231、ansform Phase III for ATTRv-PN.Human progenitor cells promote the formation of new heart tissue following a heart attack,in new study.Total Revenue$9,211mup 13%(19%at CER)2021:$8,103m12020:$7,139mCardiovascular,Renal&Metabolism 2022 overview Tezspire approved in the EU and Japan as an add-on mainten
232、ance treatment for severe asthma with no phenotype or biomarker limitations.Saphnelo approved in the EU as an add-on therapy for the treatment of adult patients with moderate to severe systemic lupus erythematosus(SLE).Continued strong growth,across the portfolio,including from Breztri(up 103%at CER
233、)and Fasenra(up 15%at CER).Airsupra(PT027)approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.Total Revenue$5,963mdown 1%(up 3%at CER)2021:$6,049m2020:$5,375mRespiratory&ImmunologyTo
234、tal Revenue$4,836mup 1%(8%at CER)2021:$4,779m2020:$669mVaccines&Immune Therapies Our ambition is to intervene earlier to protect vital organs,slow or reverse disease progression,and achieve remission for these often degenerative,debilitating,and life-threatening conditions.2022 overview Vaxzevria ap
235、proved in the EU as a third dose booster against COVID-19 received full marketing authorisation in the EU.Evusheld long-acting antibody(LAAB)combination approved in the EU and Japan for both pre-exposure prophylaxis and treatment of COVID-19.Beyfortus approved in the EU for the prevention of respira
236、tory syncytial virus(RSV)lower respiratory tract disease in infants.First patient dosed in the SUPERNOVA Phase I/III trial of AZD3152 for pre-exposure prophylaxis of COVID-19.Our ambition is to develop and deliver transformative vaccines and antibodies,providing long-lasting immunity to millions of
237、people,where the burden of disease is greatest.Unmet medical need and world market64mpeople living with heart failure(HF)worldwide.850mpeople living with chronic kidney disease(CKD).230mwill be affected by non-alcoholic steatohepatitis by 2030.Unmet medical need and world marketUp to 26mpeople globa
238、lly have severe asthma,with up to 50%of those treated remaining uncontrolled.3rdChronic obstructive pulmonary disease(COPD)is the worlds third leading cause of death.5mpeople worldwide have a form of lupus.Unmet medical need and world market 630mconfirmed cases of COVID-19 and more than 6.5 million
239、deaths globally.40%of those hospitalised with breakthrough infections after COVID-19 vaccination are immunocompromised,with an increased risk of inpatient mortality compared with the general population.23AstraZeneca Annual Report&Form 20-F Information 20221 Total Revenue from Andexxa is included wit
240、hin BioPharmaceuticals:Cardiovascular,Renal&Metabolism for 2022 reporting,previously reported within Rare Disease.The comparatives and growth rates shown for each therapy area have been calculated as though these changes had been implemented in 2020.Corporate GovernanceAdditional InformationFinancia
241、l StatementsStrategic ReportTherapy Area Review/BioPharmaceuticalsDiabetes$125.2bnHigh blood pressure$35.5bnAbnormal levels of blood cholesterol$17.2bnThrombosis$6.8bnCKD$9.9bnCKD-associated anaemia$6.0bnHyperkalaemia$0.7bn Other CV$50.2bn$244.3bnAnnual worldwide market valueTherapy area world marke
242、t(MAT Q3-22)Key marketed products See full product information in the Patent Expiries Supplement on our website, RevenueCommentaryFarxiga/Forxiga(dapagliflozin)Type-2 diabetes(T2D)Heart failure with reduced ejection fraction(HFrEF)Chronic kidney disease(CKD)$4,386m,up 46%(56%at CER)CKD label and HFr
243、EF label approved in over 100 markets each.SGLT2i recognised as foundational HFrEF treatment by major societies(new AHA/ACC/HFSA 2022&ESC/HFA Guidelines).Brilinta/Brilique(ticagrelor)Acute coronary syndromes(ACS)$1,358m,down 8%(4%at CER)Approved in 123 countries for ACS and in 82 countries for high-
244、risk patients with history of heart attack.Expansion to new patients in Emerging Markets.Lokelma(sodium zirconium cyclosilicate)Hyperkalaemia$289m,up 65%(75%at CER)Launched in 23 markets,with global branded market leadership,US total K+binder market leadership and EU maintaining branded market leade
245、rship.RoxadustatAnaemia of CKD$202m,up 12%(17%at CER)Value and volume market share leadership within China HIF-PHI+ESA market,helping more than 500,000 patients.Andexxa/Ondexxya(andexanet alfa)1Factor Xa inhibitor reversal agent$160m,up 12%(21%at CER)The first approved reversal agent specifically fo
246、r Factor Xa inhibitors.Approved in Japan in 2022.Other productsCrestor(rosuvastatin calcium)Dyslipidaemia Hyper-cholesterolaemia$1,050m,down 4%(up 2%at CER)Seloken/Toprol-XL(metoprolol succinate)Hypertension Heart failure Angina$863m,down 9%(4%at CER)Bydureon(exenatide XR injectable suspension)T2D$2
247、80m,down 27%(26%at CER)Onglyza family,(exenatide,Qtern,Symlin,Atacand and other established brands)n/a$257m,down 28%(25%at CER)1 Growth rates for Andexxa/Ondexxya acquired with Alexion have been calculated on a pro forma basis compared with the corresponding period in the prior year.Cardiovascular,R
248、enal&Metabolism Our strategy in CVRMOur bold ambition is to stop,reverse and cure CVRM diseases by maximising our medicines,delivering innovative solutions and advancing our pipeline.We do this by:unravelling the underlying causes of these diseases by identifying novel targets linked to disease biol
249、ogy to create the next generation of medicines advancing our precision medicine strategy to develop diagnostic strategies and deliver the right therapy for the right patient driving our CVRM Clinical Development of the Future programme to help bring medicines to market quicker by shortening enrolmen
250、t times,promoting diversity in clinical trials,and automating and detecting events earlier through home monitoring devices investing strongly in research to drive data that can be incorporated into clinical practice guidelines to advance patient outcomes supporting our team of over 5,000 people acro
251、ss more than 23 functions including early and late R&D,medical and commercial.Full details are given in the Development Pipeline Supplement on our website, review strategy in actionOur CVRM strategy is focused on four key disease areas:heart failure(HF),chronic kidney disease(CKD),cardiovascular dis
252、ease(CV)and metabolic liver disease.Our focus also extends to several rare disease areas,including transthyretin amyloidosis and factor Xa inhibitor-related bleeds.Chronic kidney diseaseIn CVRM,we remain committed to working towards halting the progression of CKD and eliminating progression to kidne
253、y failure.In 2022,real world evidence data studies REVEAL-CKD and INSIDE-CKD were released,showing alarming prevalence of undiagnosed Stage III CKD and demonstrating that Forxiga can cut 33%of healthcare costs by delaying disease progression and reducing incidence of cardiorenal events,respectively.
254、These findings reinforce an urgent need for early screening of CKD and the benefits of starting treatment earlier.Source:IQVIA.AstraZeneca focuses on specific segments within this overall therapy area market.Some sales for CKD($9.9bn)and CKD-associated anaemia($6.0bn)fall outside the CVRM total mark
255、et.All sales for CKD-associated anaemia($6.0bn)fall within the CKD market and should not be double-counted.Therapy Area Review BioPharmaceuticals continued24AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportAstraZeneca CaReMe CKD,one of the largest real-world studies on the prevale
256、nce,outcomes and cost of CKD in over 2.4 million CKD patients,was published in June.Findings highlighted the high disease burden on patients and healthcare systems and the urgent need to improve early screening,diagnosis and treatment.Hyperkalaemia(HK)remains a key risk for people living with CKD.As
257、 the K+binder market grows globally,CVRM is well positioned with Lokelma as the leading global branded novel K+binder with quarter-over-quarter growth.In September,NLRP3 advanced into Phase I for the treatment of acute kidney injury(AKI),which each year affects approximately 13 million people,result
258、ing in two million deaths.Heart failureOur aim is to eliminate HF as first cause of hospitalisation and to cure HF with reduced ejection fraction.DELIVER Phase III trial results,published in August 2022,showed that Forxiga significantly reduced the risk of CV death or worsening of HF in patients reg
259、ardless of ejection fraction.Importantly,in the pooled analysis of the DAPA-HF and DELIVER Phase III clinical trials,Forxiga demonstrated a reduction in CV death,making Forxiga the first HF treatment to demonstrate mortality benefit across the full ejection fraction range.These findings were simulta
260、neously published in 11 top-tier articles in peer-reviewed journals including New England Journal of Medicine,Nature Medicine and The Lancet.In November,an additional data analysis of DELIVER showed Forxiga improved symptom burden and health-related quality of life in patients with mildly reduced or
261、 preserved ejection fraction.In an encouraging example of our early CVRM R&D pipeline,a preclinical study published in May 2022 in Nature Cell Biology showed human ventricular progenitor cells promote the formation of new heart tissue following a heart attack with improved cardiac function and reduc
262、ed scar tissue in a laboratory setting.Research continues in this area and elsewhere in the HF treatment pipeline.Cardiovascular diseaseWith an ambition to stop progression of atherosclerosis caused by dyslipidaemia,we are making a difference for patients with Brilinta expanding to new patient popul
263、ations in Emerging Markets(excluding China).In September,we decided to discontinue the development of AZD8233 as results from the Phase IIb SOLANO trial did not meet pre-specified criteria to demonstrate benefit significantly above current standard of care for patients with high-risk hypercholestero
264、laemia.In June,our small molecule PCSK9 inhibitor AZD0780 entered Phase I with a focus on high-risk primary prevention and secondary prevention in patients with dyslipidaemia.MetabolismNon-alcoholic steatohepatitis(NASH)prevalence is growing and is a major public health burden.In July,the first pati
265、ent was dosed in the Phase IIb/III PROXYMO-ADVANCE for cotadutide in non-cirrhotic NASH.Our precision medicine portfolio in NASH also advanced with the start of the Phase I trial for our investigational antisense oligonucleotide(ASO)AZD7503 17bHSD.In the fourth quarter of 2022,a Phase I MAD study on
266、 ASO precision medicine AZD2693,completed in NASH patients homozygous for the PNPLA3 I148M risk allele,a gene linked to a significant proportion of NASH cases globally.Transthyretin amyloidosis(ATTR)ATTR cardiomyopathy(ATTR-CM)and polyneuropathy are progressive,systemic diseases caused by aging or g
267、enetic mutations that result in tissue damage leading to poor quality of life,which can be fatal without treatment.In June,eplontersen met co-primary and secondary endpoints in the interim analysis of the NEURO-TTRansform Phase III trial for hereditary transthyretin-mediated amyloid polyneuropathy(A
268、TTRv-PN).See Rare Disease on page 30.Factor Xa-related bleedsAndexxa is the first approved reversal agent for Factor Xa inhibitors,rivaroxaban or apixaban,providing a major advance in the treatment of patients hospitalised with life-threatening bleeding.In March,Ondexxya(Andexxa)was approved in Japa
269、n for reversal of acute major bleeds in patients on Factor Xa inhibitors.17.9mpeople die from cardiovascular diseases every year more than any other chronic disease.25AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportCorporate GovernanceFinancial StatementsAdditional InformationThe
270、rapy Area Review/BioPharmaceuticals/Cardiovascular,Renal&MetabolismAsthma$24.8bnCOPD$19.8bnOther$37.8bn$82.4bnAnnual worldwide market valueTherapy area world market(MAT Q3-22)Key marketed products See full product information in the Patent Expiries Supplement on our website, RevenueCommentarySymbico
271、rt(budesonide/formoterol)Asthma COPD$2,538m,down 7%(2%at CER)Retained global market leadership.Only ICS/LABA approved as mild asthma anti-inflammatory reliever in 46 countries,with regulatory reviews anticipated in additional countries.Fasenra(benralizumab)Severe asthma$1,396m,up 11%(15%at CER)Conso
272、lidated leadership in severe eosinophilic asthma.Currently approved as an add-on maintenance treatment for severe eosinophilic asthma in over 75 countries including the US,EU and Japan.Breztri/Trixeo(budesonide/glycopyrrolate/formoterol)COPD$398m,up 96%(103%at CER)Approved in more than 45 countries,
273、including the US,Japan and China.More prominent role of fixed-dose triple therapies,including mortality reduction benefits included in 2023 GOLD report.Saphnelo(anifrolumab)Systemic lupus erythematosus(SLE)$116m(2021:$8m)Approved in the US,EU,Japan and several other countries.Regulatory reviews are
274、ongoing in additional countries.Tezspire(tezepelumab)Severe asthma$82m Approved in the US,EU,Japan and several other countries for severe asthma.Regulatory reviews are ongoing in additional countries.Included in the 2022 GINA guidelines.Other productsPulmicort(budesonide)Asthma$645m,down 33%(31%at C
275、ER)Approved in more than 115 countries.2022 was first full year of volume-based procurement in China.Daliresp/Daxas(roflumilast)COPD$189m,down 17%(16%at CER)Approved in more than 50 countries,including the US and EU.Loss of exclusivity in the US in October 2022.Bevespi(glycopyrrolate/formoterol)COPD
276、$58m,up 7%(9%at CER)Approved in 44 countries,including the US,EU,Japan and China.Respiratory&Immunology Our strategy in Respiratory&ImmunologyOur ambition is to transform care in respiratory and immune-mediated diseases by moving beyond symptom control to achieve disease modification,remission and,o
277、ne day,cures for millions of patients worldwide.COPD We are working to eliminate COPD as a leading cause of death by modifying the course of the disease.Our strategy is to:drive broad,early diagnosis and 1st-line use of the most effective therapies to improve patient outcomes by preventing exacerbat
278、ions before damage is accrued in the lung invest in therapies and trials that will enable us to demonstrate true disease modification,including stopping lung function decline over time and reversing the structural damage caused by the disease.AsthmaOur ambition in asthma is to eliminate exacerbation
279、s and achieve clinical remission,even in people with the most severe asthma.Our strategy is to:establish our anti-inflammatory reliever inhaled portfolio as the backbone of care across all asthma severities drive towards disease remission through an industry-leading biologics portfolio in patients w
280、ith more severe disease bring forward the next generation of medicines by combining precision medicines with new delivery modalities to achieve clinical remission in patients who remain uncontrolled in spite of current therapeutics.ImmunologyOur ambition is to disrupt immunology by focusing on areas
281、 of high unmet medical need to drive clinical remission and eventually cure.Our strategy is to:build momentum in rheumatology,winning in lupus and further expanding into other indications where type 1 interferon is a disease driver establish a presence in gastroenterology and dermatology through a c
282、ombination of our mid-stage internal pipeline and external collaborations,targeting diseases such as inflammatory bowel disease,atopic dermatitis and chronic spontaneous urticaria invest in future transformative technologies with curative potential such as ADCs and cell therapy.Full details are give
283、n in the Development Pipeline Supplement on our website, review strategy in actionAsthmaSymbicort maintained its position as the leading ICS/LABA globally by volume and value.Performance has been driven by steady growth in Emerging Markets and some key Established RoW markets,offset by generic erosi
284、on in the EU and Japan and continued price erosion in the US.In January 2023,Airsupra(PT027)was approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older,offering the first and only anti-i
285、nflammatory reliever treatment approach in the US.Approval was based on results from the MANDALA and DENALI trials and followed a positive vote in November 2022 from the FDAs Pulmonary-Allergy Drugs Advisory Committee on the benefit risk assessment of PT027 in adults.Breztri,our triple therapy,is be
286、ing studied in asthma in two Phase III pivotal trials,KALOS and LOGOS,in addition to our current indication in COPD.Source:IQVIA.AstraZeneca focuses on specific segments within this overall therapy area market.26Therapy Area Review BioPharmaceuticals continuedAstraZeneca Annual Report&Form 20-F Info
287、rmation 2022Strategic ReportFasenra,our first respiratory biologic is now approved in more than 75 countries and reached more than 100,000 patients with severe eosinophilic asthma.In September 2022,Tezspire was approved in the EU as an add-on maintenance treatment in patients 12 years and older with
288、 severe asthma who are inadequately controlled with high-dose ICS plus another medicinal product.It was also approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid-or high-dose ICS and other long-ter
289、m maintenance therapies.Tezspire is the first and only biologic for severe asthma to be approved without phenotype or biomarker limitations.Approval was based on results from the PATHFINDER clinical trial programme,including positive results from the Phase III NAVIGATOR trial.Compounds in early-stag
290、e clinical development include:elarekibep(AZD1402):an inhaled Anticalin protein being developed in collaboration with Pieris Pharmaceuticals that inhibits the interleukin-4 receptor subunit alpha(IL-4Ra),a clinically validated target in severe asthma AZD8630:an inhaled fragment antibody(inhaled biol
291、ogic)in co-development with Amgen,that targets thymic stromal lymphopoietin atuliflapon(AZD5718):a precision medicine approach in asthma with an oral FLAP inhibitor that blocks the 5-lipoxygenase pathway,a clinically validated target which could offer an alternative for uncontrolled patients before
292、becoming eligible for systemic biologics.COPDIn the first quarter of 2022,the first patients were enrolled in two Phase III trials(OBERON and TITANIA)of tozorakimab(MEDI3506).Other RespiratoryIn the fourth quarter of 2022,the first patients were dosed in the TILIA Phase III trial of tozorakimab in v
293、irally-induced acute respiratory failure.ImmunologyIn February 2022,Saphnelo was approved in the EU as an add-on therapy for the treatment of adult patients with moderate to severe,active autoantibody-positive SLE,despite receiving standard therapy.Saphnelo is the first biologic for SLE approved in
294、Europe with an indication not restricted to patients with a high degree of disease activity.In May 2022,the first patients were enrolled in a Phase III trial(IRIS)of Saphnelo in lupus nephritis.Fasenras life-cycle management programme includes multiple clinical trials in eosinophilic diseases beyond
295、 the current severe asthma indication.High-level results from the MESSINA Phase III trial showed Fasenra did not meet one of two dual-primary endpoints.Fasenra demonstrated a statistically significant improvement in histological disease remission but not a change in dysphagia symptoms,compared with
296、placebo in patients with eosinophilic esophagitis aged 12 years or older.In March 2022,the FDA issued a Complete Response Letter regarding the supplemental Biologics License Application for Fasenra for patients with inadequately controlled chronic rhinosinusitis with nasal polyps.Other compounds in
297、early-stage clinical development include AZD7798,a CCR9-depleting mAb.CCR9 is the main chemokine receptor for trafficking lymphocytes to the small intestine and considered central to the generation of small bowel inflammation in Crohns Disease.Over 600m people worldwide live with chronic respiratory
298、 and immune-mediated diseases.27AstraZeneca Annual Report&Form 20-F Information 2022Corporate GovernanceAdditional InformationFinancial StatementsStrategic ReportCorporate GovernanceAdditional InformationFinancial StatementsStrategic ReportTherapy Area Review/BioPharmaceuticals/Respiratory&Immunolog
299、y$9.8bnAnnual worldwide market valueTherapy area world market(MAT Q3-22)Key marketed products See full product information in the Patent Expiries Supplement on our website, RevenueCommentaryEvusheld(tixagevimab and cilgavimab)COVID-19$2,184m,(2021:$135m)Authorised for pre-exposure prophylaxis(preven
300、tion)of COVID-19 in the US(emergency use),EU,Japan and many other countries.Approved for the treatment of COVID-19 in the EU and Japan.US emergency use authorisation for Evusheld revised in January 2023 to limit its use to when the combined frequency of non-susceptible variants in the US is 90%.Vaxz
301、evria(ChAdOx1-S Recombinant)COVID-19$1,875m,down 53%(51%at CER)More than three billion vaccine doses have been released for supply to over 180 countries.Synagis(palivizumab)RSV$578m,up 41%(59%at CER)Available in more than 100 countries outside the US.Sobi holds the US rights.Fluenz Tetra/FluMist Qua
302、drivalent(live attenuated influenza vaccine)Influenza$175m,down 31%(20%at CER)Approved in the US,EU and other countries.Daiichi Sankyo holds rights to FluMist Quadrivalent in Japan.Beyfortus(nirsevimab)RSV$25m Approved in the EU.In collaboration with Sanofi.Sobi has the right to participate in Astra
303、Zenecas share of the US profits and losses related to Beyfortus.Vaccines&Immune Therapies Our strategy in Vaccines&Immune TherapiesWith an initial focus on some of the most common and debilitating respiratory diseases,we have a portfolio of medicines that includes vaccines for COVID-19 and influenza
304、,long-acting antibodies for COVID-19 and respiratory syncytial virus(RSV),and a pipeline of next-generation therapeutics and scientific platforms.We are optimising the potential of both vaccines and antibodies,with a focus on developing medicines that provide effective and long-lasting immunity.Vacc
305、inesWe are engineering novel,next-generation vaccines that have the potential to generate potent and long-lasting immune responses.AntibodiesWe are pioneering novel approaches to developing highly-targeted,long-acting antibodies,using our half-life extension technology.We have significantly accelera
306、ted the speed at which we are able to identify potent antibody candidates,screening billions of antibody candidates in a matter of months.This complementary approach,with vaccines providing protection for those able to mount their own immune response,and antibody therapies for those who cannot,aims
307、to ensure that no one is left behind.Full details are given in the Development Pipeline Supplement on our website, review strategy in actionVaxzevriaVaxzevria was co-invented by the University of Oxford.Through a landmark agreement in 2020,Vaxzevria was developed and distributed by AstraZeneca at co
308、st during the pandemic.Under a sub-licence agreement with AstraZeneca,the vaccine is manufactured and supplied by the Serum Institute of India under the name Covishield.Vaxzevria has been granted marketing or emergency-use authorisation as both a primary vaccine schedule and as a booster in multiple
309、 countries worldwide.In May 2022,the EU granted conditional marketing approval for the use of Vaxzevria as a third-dose booster in adults in both homologous(same vaccine)or heterologous(mixed vaccine)settings.In November 2022,Vaxzevria was granted full marketing approval in the EU as both a primary
310、vaccination series and a third-dose booster.To date,AstraZeneca and our global partners have released over 3.1 billion doses for supply to over 180 countries.Approximately two thirds of these doses went to low-and middle-income countries,and more than 580 million doses have been delivered to 130 cou
311、ntries through the COVAX Facility.In July 2022,Airfinity reported that Vaxzevria is estimated to have helped save more than six million lives in its first year of use.The majority of vaccine product sales and doses delivered related to pandemic contracts.AstraZeneca will continue to supply the vacci
312、ne around the world as needed,in line with our agreement with the University of Oxford.EvusheldEvusheld is a long-acting antibody(LAAB)combination for the pre-exposure prophylaxis(prevention)and treatment of COVID-19.Evusheld is approved and being supplied in about 50 countries around the world.Evus
313、held is intended to protect those most vulnerable to COVID-19,including those who may not be well protected against the virus from vaccination,such as the immunocompromised,and those at high risk for severe COVID-19 hospitalisation and death if they get infected.In February 2022,AstraZeneca finalise
314、d an agreement with the US Department of Health and Human Services for them to purchase an additional one million units of Evusheld.In March 2022,Evusheld was approved for pre-exposure prophylaxis(prevention)of COVID-19 in the EU in a broad population of adults and adolescents aged 12 years and olde
315、r weighing at least 40kg.The approval was based on a review of Evusheld data,including results from the PROVENT Phase III pre-exposure prophylaxis(prevention)trial published in the New England Journal of Medicine in April.In August 2022,Evusheld was granted Special Approval for Emergency use in Japa
316、n for both pre-exposure prophylaxis(prevention)and treatment of symptomatic disease caused by SARS-CoV-2 infection in adults and adolescents aged 12 years and older weighing at least 40kg.The approvals were based on a review of Evusheld data,including results from PROVENT and the TACKLE Phase III CO
317、VID-19 treatment trial published in The Lancet Respiratory Medicine in June.Source:IQVIA.AstraZeneca focuses on specific segments within this overall therapy area market.Therapy Area Review BioPharmaceuticals continued28AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportThe Japan go
318、vernment also agreed to purchase 300,000 units of Evusheld.In September 2022,Evusheld was approved in the EU for the treatment of adults and adolescents aged 12 years and older weighing at least 40kg with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to
319、 severe COVID-19.In January 2023,the FDA stated that Evusheld is not currently authorised for Emergency Use for pre-exposure prophylaxis(prevention)of COVID-19 in the US until further notice,due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro
320、 neutralisation against.The FDA will make a determination about reinstating authorisation of Evusheld if the national prevalence of resistant variants decreases to 90%or less on a sustained basis.AZD3152AZD3152 is an investigational next-generation long-acting antibody being developed to have broad
321、neutralising activity across SARS-CoV-2 strains.In December 2022,the first participant was dosed in the SUPERNOVA Phase I/III trial evaluating AZD3152 for pre-exposure prophylaxis(prevention)of symptomatic COVID-19.AZD3152 neutralises all tested SARS-CoV-2 variants in in vitro studies to date.Synagi
322、s Since its initial approval in 1998,Synagis has become the global standard of care for RSV prevention and helps protect at-risk babies against RSV.Synagis is available for the prevention of RSV in more than 100 countries outside the US.Our agreement with Sobi for the rights to Synagis in the US rem
323、ains ongoing.BeyfortusFollowing an accelerated assessment procedure,Beyfortus(nirsevimab)was approved in November 2022 in the EU for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season.Following EU approval,Beyfortus became the first and only s
324、ingle-dose RSV preventative option approved for the broad newborn and infant population.Approval was based on positive results from the MELODY Phase III and MEDLEY Phase II/III trials published in The New England Journal of Medicine in March 2022.The Biologics License Application for nirsevimab has
325、been accepted for review by the FDA for the prevention of RSV lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.The FDA has indicated th
326、at it will work to expedite its review.Beyfortus is being jointly developed and commercialised by AstraZeneca and Sanofi.Fluenz Tetra/FluMist QuadrivalentFluenz Tetra/FluMist Quadrivalent is the first and only commercial intranasal influenza vaccine offering a needle-free alternative to traditional
327、vaccines.It is licensed in multiple countries and remains a central part of the UK,Irish,Italian and Finnish paediatric national influenza vaccination programmes,demonstrating positive and cost-effective protection of the health of both children and the wider population.In addition,we are a global p
328、artner to governments in supplying doses for influenza pandemics.Nearly one billionseasonal influenza cases may result in 290,000 to 650,000 deaths annually due to influenza-related respiratory diseases.Source:WHO.29AstraZeneca Annual Report&Form 20-F Information 2022Strategic ReportCorporate Govern
329、anceFinancial StatementsAdditional InformationTherapy Area Review/BioPharmaceuticals/Vaccines&Immune Therapies2022 marked the first full year of Alexion,AstraZeneca Rare Disease,following AstraZenecas acquisition of Alexion Pharmaceuticals,Inc.on 21 July 2021.Our mission is to transform the lives of
330、 people affected by rare diseases through the development and delivery of innovative medicines as well as supportive technologies and healthcare services.For more information,see Science and Innovation from page 35 and Growth and Therapy Area Leadership from page 39.Rare Disease Unlocking the potent
331、ial of the complement system:The dysregulation of the complement system,an essential part of the immune system,is a key driver of many devastating diseases.Targeting and inhibiting the complement system before it can trigger tissue damage or destruction can help restore balance.30AstraZeneca Annual
332、Report&Form 20-F Information 2022Strategic ReportTherapy Area Review$152.3bnAnnual worldwide market valueTherapy area world market(MAT Q3-22)Total Revenue$7,053mup 4%(10%at CER)1 2021:$3,110m2 2020:$38m2Key marketed products See full product information in the Patent Expiries Supplement on our websi
333、te, Revenue CommentarySoliris(eculizumab)PNHaHUSgMGNMOSD$3,762m,down 11%(5%at CER)Approved in 50+countries for treatment of patients with PNH,including the US,EU and Japan.Approved in 50+countries for treatment of aHUS,including the US,EU and Japan.Approved in the US as treatment for gMG in adults who are anti-acetylcholine receptor antibody-positive.Approved in the EU and Japan as treatment for r