About AstraZeneca PLC

AstraZeneca PLC (AstraZeneca) operates as a biopharmaceutical company worldwide. The company’s pharmaceuticals business consists of the discovery and development of new products, which are then manufactured, marketed and sold. The company is committed to excellence in the research, development and commercialisation of prescription medicines. The company uses its distinctive scientific capabilities to deliver a pipeline of life-changing medicines. The company focuses on areas where it can make the most meaningful difference to patients. With a focus on patients, the company has a global reach and a diversified portfolio of medicines across primary care, specialty care and rare diseases. The company’s priorities reflect how it is working to deliver its growth through innovation strategy and achieve its purpose of pushing the boundaries of science to deliver life-changing medicines. The company has an active presence in 85 countries and sells its products in more than 125 countries. Strategy The company’s growth through innovation strategy is built on the fact that AstraZeneca is science and innovation led; is focused on its chosen therapy areas: Oncology; BioPharmaceuticals (comprising Cardiovascular, Renal & Metabolism (CVRM), Respiratory & Immunology (R&I) and Vaccines & Immune Therapies (V&I)), and Rare Disease; is focused on patients and a diversified portfolio that spans across primary care, specialty care and rare disease; has global strength with a balanced presence across regions. The key elements of the company’s strategy include creating the next generation of therapeutics using an array of drug modalities, for example, advanced biologics, genomic medicines and nucleotide-based and cell therapies; leading in convergence of science, data and technology; advancing its pipeline; advancing its understanding of disease biology to help uncover novel drivers of disease, through multi-omics, functional genomics and innovations in AI and machine learning; progressing an early pipeline consisting of numerous new drug modalities, including ADCs, antibodies (e.g. bispecific, inhaled fragment and cell depleting monoclonal), cell therapies, genomic medicines, PROteolysis TArgeting Chimeras (PROTACs), oligonucleotides and T-cell engagers; creating cutting-edge models to generate data that are more relevant to patients, to better predict the success of its molecules in the clinic; pioneering clinical innovation to design and deliver patient-centric clinical trials that improve the patient and site team experience while optimizing the use of data, digital and AI to improve patient outcomes; embedding AI across R&D, from target identification to clinical development, to deliver medicine to patients faster than ever before; delivering industry-leading growth across its therapy areas and regions; embracing digital technologies and data to transform the patient journey, putting them at the heart of everything it does; continuing with the next phase of its Operations 2025 programme, including implementing next-generation manufacturing technologies and smart factory capabilities: Operations 2030; fostering a patient-focused approach and embedding patient insights across its organisation, building integrated therapy area ecosystem models; engaging with policymakers to support improvements in sustainable access, coverage, care delivery and patient care outcomes; 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 patent strategy that builds robust patent estates to protect its pipeline and products while defending and enforcing patent rights; and harnessing the power of digital throughout its end-to-end supply chain through digital drug development to accelerate development lead times. Therapy Area Review Oncology The company is leading a revolution in oncology to redefine cancer care. The company strives to push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer through Scientific platforms to attack cancer from multiple angles, including targeting cancer cells directly and activating the immune system. The company uses monotherapy and combination approaches to drive deeper, more durable, responses: treating cancer earlier where the greatest opportunity for cure exists and building expertise and leadership in key tumour types; collaborating to harness transformational technologies, including computational pathology, circulating tumour DNA (ctDNA) testing, digital health and data science/AI; and leveraging its global footprint – to make cancer therapies available to every eligible and appropriate patient. Key Marketed Products Tagrisso (Osimertinib): Approved in 101 countries for the adjuvant treatment of patients with early-stage EGFRm NSCLC and in 99 countries for both the 1st- and 2nd-line treatment of advanced EGFRm NSCLC. Imfinzi (durvalumab): Approved in 87 countries in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiotherapy (CRT) and in extensive-stage small cell lung cancer (SCLC) in 85 countries. Also approved in combination with gemcitabine and cisplatin as treatment for patients with locally advanced or metastatic biliary tract cancer (BTC) in 59 countries, and in unresectable hepatocellular carcinoma (uHCC) in combination with Imjudo in 41 countries (Imfinzi monotherapy also approved in certain countries). Also approved in combination with Imjudo and platinum-based chemotherapy for NSCLC in 27 countries, and for previously treated advanced bladder cancer in some countries. Lynparza (olaparib): Approved in 97 countries as maintenance therapy for platinum-sensitive relapsed ovarian cancer and 1st-line BRCAm ovarian cancer, and in 94 countries with bevacizumab for homologous recombination repair deficient (HRD)-positive advanced ovarian cancer. Approved in 97 countries for gBRCAm, HER2-negative early breast cancer (approved in the metastatic setting in 80 countries). Approved in 94 countries for gBRCAm metastatic pancreatic cancer. Approved in 96 countries for homologous recombination repair (HRR) gene-mutated mCRPC BRCAm only in certain countries) and in 59 countries with abiraterone for 1st-line mCRPC. Calquence (acalabrutinib): Approved in 89 countries for the treatment of CLL and in 46 countries for the treatment of adult patients with relapsed or refractory MCL who have received at least one prior therapy. Enhertu (trastuzumab deruxtecan): Approved in more than 55 countries for HER2-positive metastatic breast cancer following one or more prior anti-HER2-based regimen. Also approved in more than 40 countries for HER2-low metastatic breast cancer following chemotherapy. Approved in more than 30 countries for previously treated HER2-mutant metastatic NSCLC and HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. Orpathys (savolitinib): Approved in China and Macau for the treatment of locally advanced or metastatic NSCLC with MET gene alterations. Truqap (capivasertib): Approved in the US in combination with Faslodex (fulvestrant) for the treatment of patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA, AKT1 or PTEN gene alterations following disease progression or recurrence. Other Products Zoladex (goserelin acetate implant): Indicated for Prostate and Breast cancers. Faslodex (fulvestrant): Indicated for Breast cancer. The company’s comprehensive portfolio includes leading medicines Tagrisso, Imfinzi, Imjudo, Enhertu and Orpathys, along with a promising pipeline of potential new medicines and combinations across diverse mechanisms of action. The company’s comprehensive portfolio of approved medicines, including Truqap, Enhertu, Lynparza, Faslodex and Zoladex, and promising breast cancer medicines in development, including Imfinzi, Dato-DXd and camizestrant, leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. In gynaecological (GYN) cancers, the company will continue to redefine survival expectations, introducing new medicines beyond ovarian cancer across multiple GYN tumours, expanding into endometrial with Imfinzi and into cervical cancer. The company reported positive results from the TROPION-Lung01 Phase III trial, which showed that Dato-DXd demonstrated a statistically significant PFS benefit versus docetaxel in patients with previously treated locally advanced or metastatic NSCLC, and a clinically meaningful benefit in those with non-squamous tumours. The company also reported results from TROPION-Lung02 and TROPION-Lung04 Phase Ib trials which showed Dato-DXd in combination with immunotherapy (pembrolizumab or Imfinzi, respectively), with or without chemotherapy, demonstrated encouraging responses and no new safety signals in the 1st-line advanced NSCLC setting. Dato-DXd is jointly developed and commercialised with Daiichi Sankyo. The company’s novel immuno-oncology bispecific development programme continued to advance with the initiation of the eVOLVELung02 Phase III trial investigating volrustomig, which simultaneously targets PD-1 and CTLA-4, as a 1st-line treatment in combination with chemotherapy in metastatic NSCLC. The company’s comprehensive portfolio of approved medicines, including Truqap, Enhertu, Lynparza, Faslodex and Zoladex, and p omising breast cancer medicines in development, including Imfinzi, Dato-DXd and camizestrant, leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. The company’s newest Oncology medicine, Truqap, was approved in the US in combination with Faslodex as the first AKT-inhibitor for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with certain gene alterations following disease progression or recurrence, based on the CAPItello-291 Phase III trial. The US regulatory submission was granted Priority Review in June 2023. Enhertu was approved in the EU and China as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer based on the DESTINY-Breast04 Phase III trial. Two Phase III trials (CAMBRIA-1 and CAMBRIA-2) were initiated to investigate camizestrant, the company’s potential next-generation selective estrogen receptor (ER) degrader, as an adjuvant therapy for patients with ER-positive, HER2-negative early breast cancer. Lynparza plus abiraterone and prednisone was approved in the US and Japan for the treatment of BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer, based on the Phase III PROpel trial. The company’s next wave of potential new medicines includes saruparib, a PARP1 selective agent being investigated in combination with novel hormonal agents in metastatic castrate-sensitive prostate cancer (EvoPAR-Prostate01 Phase III trial), and volrustomig, a potential new treatment being tested in advanced cervical cancer (eVOLVE-Cervical Phase III trial). Through its A.Catalyst Network, AstraZeneca partnered with AI solution provider Qure.ai to use their AI platform qXR for detecting incidental lung nodules in routine chest x-rays. The solution is integrated with medical imaging systems, providing real-time malignancy risk score indicating risk of lung cancer that can be referred for further diagnostics. The technology, which has been implemented in 29 countries across 335 sites and has analysed more than 1.5 million chest x-rays (as of December 2023). As part of its partnership with the World Economic Forum’s EDISON Alliance, the company has committed to screening five million patients for lung cancer risk using AI technology. The company has a broad and robust development programme for the treatment of gastrointestinal cancers in many stages and disease types, including several positive results, as well as approvals across multiple medicines. In haematology, the company is using its six scientific platforms to develop and test novel investigational agents designed to target underlying drivers. Calquence, the company’s next generation BTK inhibitor, has treated 50,000 patients globally with approvals in 89 countries across multiple haematological diseases. The company reported positive high-level results for the EMERALD-1 Phase III trial which showed Imfinzi, in combination with transarterial chemoembolisation (TACE) and bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS versus TACE alone in liver cancer patients eligible for embolisation. Imfinzi was approved in China for the 1st-line treatment of adult patients with unresectable or metastatic BTC in combination with chemotherapy, based on the TOPAZ-1 Phase III trial, and in the EU in combination with Imjudo for the treatment of patients with advanced or uHCC, based on the Phase III HIMALAYA trial. The company accelerated its ADC development programme, entering an exclusive global licence agreement with KYM Biosciences to develop AZD0901, a potentially first-inclass ADC targeting Claudin 18.2, with interim results showing promising early clinical efficacy. For its novel bispecific programme, the company initiated the ARTEMIDE-Biliary01 Phase III trial, assessing its novel anti-PD-1/anti-TIGIT bispecific antibody rilvegostomig, in combination with chemotherapy, in patients with biliary tract cancer. In haematology, the company is using its six scientific platforms to develop and test novel investigational agents designed to target underlying drivers. Calquence, the company’s nextgeneration BTK inhibitor, has treated 50,000 patients globally with approvals in 89 countries across multiple haematological diseases. Calquence was approved for the first time in China for the treatment of CLL or SLL, based on the ASCEND global Phase III trial and a Phase I/II trial in China. The company initiated an exclusive global licence with LaNova Medicines for AZD0305 (LM305), a GPRC5D ADC, with the aim to accelerate its entry into multiple myeloma. Together with Daiichi Sankyo, the company is exploring the potential role of HER2-directed therapies in treating multiple solid tumour types. Positive results from the DESTINYPanTumour02 Phase II trial showed Enhertu demonstrated clinically meaningful survival across multiple HER2-expressing advanced solid tumours, including either biliary tract, bladder, cervical, endometrial, ovarian or pancreatic cancers or other tumours. In January 2024, Enhertu was granted Priority Review in the US for patients with a range of metastatic HER2-positive solid tumours. BioPharmaceuticals The company is working to intervene earlier to protect vital organs, slow or reverse disease progression, and achieve remission for often degenerative, debilitating and life-threatening conditions, so many more people can live better, healthier lives. Cardiovascular, Renal & Metabolism Key Marketed Products Farxiga/Forxiga (dapagliflozin): Forxiga is the number one prescribed SGLT2i worldwide by volume. In August, Forxiga received a 1st-line recommendation from the 2023 European Society of Cardiology Treatment Guidelines for Heart failure (HF) across the range of ejection fractions. Brilinta/Brilique (ticagrelor): Brilinta plus aspirin is currently approved in more than 115 countries for the prevention of atherothrombotic events in adult patients with ACS and in 80 countries for the secondary prevention of CV events among high-risk patients who have experienced a heart attack. Lokelma (Sodium Zirconium Cyclosilicate): Lokelma is now approved in 56 markets and is market leader by value and days-of-therapy volume in branded HK. The company offers Roxadustat for Anaemia of CKD. Andexxa/Ondexxya (andexanet alfa): In June 2023, the Andexxa Phase IV (Annexa-I) trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care. Other Products Crestor (rosuvastatin calcium) is used for Dyslipidaemia Hypercholesterolaemia disease. Seloken/Toprol-XL (metoprolol succinate) is used for Hypertension, HF, and Angina. The company also offers Onglyza family, (exenatide, Qtern, Symlin, Atacand and other established brands). It offes Bydureon (exenatide XR injectable suspension) for T2D. Wainua (eplontersen): On 21 December in the USA, Wainua (eplontersen) was granted its first-ever regulatory approval for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis. The impact of CVRM diseases on people, society and the company’s planet is immense and growing, yet these diseases remain underdiagnosed, undertreated, and their interconnections under-recognised. By understanding their interconnections and targeting the mechanisms that drive CVRM diseases, the company will be able to detect, diagnose and treat people earlier and more effectively, stop disease progression and ultimately pave the way to a cure. AstraZeneca is uniquely positioned to improve the outcomes of patients living with CVRM diseases with its strong and expanding portfolio and a broad, deep and innovative pipeline delivered by a talented, passionate and diverse team. The company is building the leading CVRM business. The company’s CVRM strategy is focused on four key areas: CV, renal, HF, and metabolic diseases. The company continues to make a difference for patients with Brilinta, now approved in more than 124 countries for atherosclerosis and in 82 countries for high-risk patients with history of heart attack. Andexxa is designed to bind to FXa inhibitors and rapidly reverse their anticoagulant effect in patients with major bleeds. In June, the Andexxa Phase IV (Annexa-I) trial stopped early after achieving pre-specified efficacy criteria versus usual care. The results of the trial have been presented at the World Stroke Congress and submitted for publication. In February 2023, AstraZeneca completed the acquisition of CinCor, focused on developing baxdrostat, an investigational once-daily medication, for the treatment of hard-to-treat hypertension. AZD0780 is an oral inhibitor (oPCSK9) being developed for greater ease of use and enhanced convenience, aiming to drive reduction in LDL-C levels not achievable by statins alone. Forxiga is approved in over 120 markets for the treatment of CKD. In November, results from the real-world ZORA observational multicountry study showed that treating HK with the potassium binder Lokelma can allow patients with CKD or HF to maintain their lifesaving ren-inangiotensin-aldosterone system inhibitor (RAASi) therapy which can prevent risk of progression to end-stage kidney disease. In September 2023, the Global Patient Alliance for Kidney Health, a community-led alliance of 17 patient advocacy organisations, was launched with financial sponsorship from AstraZeneca. The company has an innovative early pipeline in renal, with AZD2373 under investigation as a precision medicine with the aim of preventing progression to kidney failure for people genetically at risk of kidney disease due to two apolipoprotein L1 (APOL1) alleles. Forxiga is approved for HF across all LVEF in 91 markets, including the EU, US, China and Japan. In August 2023, Forxiga received a 1st-line recommendation in the 2023 European Society of Cardiology Treatment Guidelines for HF across the LVEF spectrum. Together with the company’s partner Ionis Pharmaceuticals, it received the first regulatory approval for Wainua (eplontersen) for the treatment of ATTRv-PN in the U.S. in December 2023 with the EU and others expected to follow in 2024. Wainua is also being evaluated in the Phase III CARDIO-TTRansform trial for ATTR-CM. The company’s early pipeline is aimed at targeting key mechanisms in HF, including widespread inflammation, fibrosis, hypertrophy and microvascular dysfunction, as a major priority. Mitiperstat (AZD4831) is an investigational, oral myeloperoxidase (MPO) inhibitor intended to be complementary to SoC for patients diagnosed with HF with preserved ejection fraction. The company remains committed to treat beyond haemoglobin A1C in T2D. Forxiga continues to help patients with T2D worldwide with approvals in more than 100 countries. In June 2023, Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) was approved in China and in July 2023, Sidapvia (dapagliflozin and sitagliptin) was approved in Korea, both for the treatment of adults with T2D. With one of the broadest clinical pipelines in MASH and cirrhosis, the company is investigating new therapeutic modalities and precision medicine to target genetic drivers of disease in MASH to stop or slow disease progression. In November, AstraZeneca and Eccogene entered into an exclusive licence agreement for AZD5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) in a US Phase I clinical trial for the treatment of obesity, T2D and other cardiometabolic conditions. In the U.K., the company partnered with NHS Greater Glasgow and Clyde, the West of Scotland Innovation Hub and the University of Glasgow on PROJECT OPERA, an initiative designed to enhance digital diagnostic pathways for HF. Respiratory & Immunology Key Marketed Products Symbicort (budesonide/formoterol): Retained global market leadership. Only ICS/LABA approved as an anti-inflammatory reliever in 47 countries, with regulatory reviews anticipated in additional countries. Fasenra (benralizumab): Approved as an add-on maintenance treatment for severe eosinophilic asthma in 80 countries including the U.S., EU and Japan. Breztri/Trixeo (budesonide/glycopyrrolate/formoterol): The fastest-growing global triple therapy1; approved in more than 73 countries, including the US, EU, Japan and China. More prominent role of fixed-dose triple therapies for early treatment, including mortality reduction benefits, reflected in 2023 GOLD report Tezspire (tezepelumab): Approved in more than 45 countries including the U.S., EU and Japan for the treatment of severe asthma without biomarker or phenotypic limitations. Regulatory reviews are ongoing in additional countries. Saphnelo (anifrolumab): Approved in 61 countries, including the U.S., EU and Japan. Included in 2023 European Alliance of Associations for Rheumatology (EULAR) recommendations for the management of SLE. Other Products Pulmicort (budesonide): Approved in more than 115 countries. Bevespi (glycopyrrolate/formoterol): Approved in 46 countries, including the U.S., EU, Japan and China. Daliresp/Daxas (roflumilast): Approved in more than 50 countries, including the U.S. and EU. The company is working to eliminate COPD as a leading cause of death by transforming care through its broad portfolio. The company’s strategy is to drive earlier diagnosis and prompt intervention with the most effective therapies to reduce mortality by preventing exacerbations and reducing cardiopulmonary risk; and advance innovative biology and novel therapeutic platforms including nextgeneration biologics and orals that will enable it to slow disease progression, drive disease modification, and reverse the structural damage caused by the disease. The company’s strategy is to establish its anti-inflammatory reliever inhaled portfolio as the backbone of care; drive towards clinical remission with systemic biologics, and with pre-biologics for those patients not controlled on current therapies; and introduce new modality therapies and bring forward precision medicine opportunities. The company’s strategy is to Lead in lupus; disrupt in established diseases with suboptimal treatment outcomes through precision medicine and novel mechanisms with a combination of its mid-stage internal pipeline and external collaborations, targeting diseases such as inflammatory bowel disease (IBD) and rheumatoid arthritis; and invest in future transformative technologies with curative potential, such as complex biologics and cell therapy. The company is also moving beyond asthma and COPD to address other respiratory diseases with significant unmet medical need, including severe viral lung infection, interstitial lung disease and idiopathic pulmonary fibrosis (IPF). Breztri, the company’s triple inhaled therapy continues to gain market share, demonstrating strong volume growth within the growing fixed-dose combination triple class across major markets. In October 2023, patients received their first dose in the ATHLOS Phase III trial exploring Breztri’s ability to improve parameters that indicate cardiopulmonary function in COPD. Breztri is also being studied in asthma in two Phase III pivotal trials, KALOS and LOGOS. The OBERON and TITANIA Phase III trials of tozorakimab (anti-IL-33 mAb) are ongoing. In October 2023, patients received their first dose in the MIRANDA Phase III trial of tozorakimab. Compounds in early-stage clinical development include Mitiperstat, a selective MPO inhibitor in Phase II. A 10-fold increase in MPO (an enzyme associated with oxidative stress) concentration is associated with a 40% increase of risk of a COPD exacerbation. AZD6793, an oral IRAK4 inhibitor that targets many of the key pathways triggered by bacterial and viral infections, smoke and other environmental factors in COPD patients In January 2024, Airsupra launched in the U.S. 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 FDA approved anti-inflammatory rescue therapy to treat airway obstruction and inflammation concomitantly. AstraZeneca entered into a codevelopment agreement with Bond Avillion 2 Development in March 2018 for the development of the then drug candidate PT027 for asthma in the U.S. Fasenra, the company’s first respiratory biologic has reached more than 119,000 patients with severe eosinophilic asthma. In April, the company announced positive results from the MIRACLE Phase III trial, an efficacy and safety study of Fasenra in patients in Asia with a history of uncontrolled severe eosinophilic asthma. A Phase III trial in COPD, RESOLUTE, is also ongoing. Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label. Tezspire’s strong performance continues following approval, gaining market share and achieving broad labels and reimbursement globally. Compounds in early-stage clinical development for asthma include AZD8630, an inhaled fragment antibody (inhaled biologic) in co-development with Amgen, that targets thymic stromal lymphopoietin. Atuliflapon (AZD5718), a precision medicine approach in asthma with an oral 5-lipoxygenase-activating protein (FLAP) inhibitor that blocks the 5-lipoxygenase pathway, a clinically validated target which could offer an alternative for uncontrolled patients before becoming eligible for systemic biologics. AZD4604, an inhaled JAK1 inhibitor that has the potential to block the effects of T2-high pro-inflammatory pathways (IL4/13, TSLP) and T2-lower pathways (IL6, IL17), many of which are poorly responsive to ICS in patients with asthma. The TILIA Phase III trial of tozorakimab in severe viral lower respiratory tract disease is ongoing. Other compounds in early-stage clinical development include AZD0292, an anti-pseudomonas aeruginosa mAb for the treatment of bronchiectasis. Saphnelo continues to grow rapidly during its launch phase and in June 2023, was included in the 2023 EULAR recommendations for the management of SLE, less than two years after first launch. Fasenra’s life-cycle management programme includes multiple clinical trials in eosinophilic diseases beyond the current severe asthma indication. In September 2023, the company announced positive high-level results from the MANDARA Phase III trial which showed that Fasenra met the primary endpoint and demonstrated non-inferior rates of remission compared to mepolizumab in patients with EGPA who were receiving oral corticosteroids with or without stable immunosuppressive therapy. MANDARA is the first head-to-head trial of biologics in EGPA, comparing a single injection of Fasenra to three injections of mepolizumab, every four weeks. Compounds in 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 Crohn’s disease. In June 2023, the company announced an agreement with Quell Therapeutics to develop, manufacture and commercialise engineered T-regulator (Treg) cell therapies for autoimmune diseases in order to reset immune tolerance and drive durable responses for patients. In 2023, the company also announced the proposed acquisition of Gracell Biotechnologies. In June 2023, the clinical development programme for brazikumab, an anti-IL-23 mAb, in IBD was discontinued. Vaccines & Immune Therapies COVID-19 mAbs (tixagevimab and cilgavimab): Authorized for pre-exposure prophylaxis (prevention) of COVID-19 (emergency use) in 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 U.S. is =90%. Beyfortus (nirsevimab): Approved in the EU, the U.S., the U.K., China and Canada. In collaboration with Sanofi. Sanofi has full commercial control of Beyfortus in the U.S. Vaxzevria (ChAdOx1-S [Recombinant]): More than three billion vaccine doses have been released for supply to over 180 countries. Synagis (palivizumab): Available in more than 100 countries outside the U.S. Sobi holds the U.S rights. Fluenz Tetra/FluMist Quadrivalent (live attenuated influenza vaccine): Approved in the U.S., EU and other countries. Daiichi Sankyo holds rights to FluMist Quadrivalent in Japan. The company has a portfolio of medicines that includes vaccines for COVID-19 and influenza, long-acting antibodies for COVID-19 and RSV, and a pipeline of next-generation therapeutics and scientific platforms. The company is optimizing the potential of both vaccines and antibodies, providing long-lasting immunity and supporting sustainable and resilient healthcare systems worldwide by reducing the burden of frequent infectious diseases. The company is engineering next-generation vaccines that have the potential to generate potent and long-lasting immune responses. Advancing the company’s ambition in vaccines, in January 2024, the company entered a collaboration agreement with US-based biotechnology company Omniose to research vaccines for serious bacterial diseases, and the company will have exclusive rights to Omniose’s proprietary bioconjugation platform for up to three years. The company is pioneering novel approaches to develop highly targeted, long-acting antibodies, using its half-life extension technology. The company has significantly accelerated the speed at which the company is able to identify potent antibody candidates, screening billions of antibody candidates in a matter of months. This complementary approach, with vaccines providing potential protection for those able to mount their own immune response, and antibody therapies for those who cannot, aims to ensure quality care for all. The company’s Vaccines & Immune Therapies strategy focuses on reducing the burden of respiratory infections, including RSV, hMPV, COVID-19 and influenza. Beyfortus is a single dose long-acting antibody (LAAB), developed and commercialised from an alliance between AstraZeneca and Sanofi, using AstraZeneca’s proprietary YTE half-life extension technology. In April 2023, AstraZeneca, Sobi and Sanofi updated and simplified their contractual arrangements relating to the development and commercialisation of Beyfortus in the U.S. In July 2023, Beyfortus was approved in the U.S. for the prevention of RSV LRTD in newborns and infants born during or entering 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. In the US, Beyfortus is the first approved and recommended immunisation to prevent severe RSV disease in all infants under eight months by the CDC Advisory Committee on Immunization Practices. In January 2024, Beyfortus was approved in China for the prevention of RSV LRTI in neonates and infants entering or during their first RSV season and is anticipated to be available during the upcoming 2024 to 2025 RSV season. Regulatory applications are under review in Japan and other countries. The company’s agreement with Sobi for the rights to Synagis in the US remains ongoing. In December 2023, AstraZeneca announced an agreement to acquire Icosavax, to bolster the Vaccines & Immune Therapies pipeline with a potential first-in-class, Phase III-ready, combination vaccine against RSV and hMPV, using an innovative, protein virus-like particle platform. AZD3152 is an investigational next-generation LAAB being developed to potentially protect vulnerable patients, such as the immunocompromised from COVID-19, given that they may not have any other non-vaccine option. In July 2023, AstraZeneca shared positive high-level results from the Phase I safety cohort of the ongoing SUPERNOVA Phase I/III COVID-19 prevention trial, which showed that AZD3152 was generally well-tolerated and displayed pharmacokinetics consistent with Evusheld through to day 29. AstraZeneca licensed AZD3152 from RQ Biotechnology in May 2022. AstraZeneca is helping to lead the way with innovative immunobridging trials to accelerate access to next-generation monoclonal antibodies for COVID-19, where alternatives to running large efficacy trials are especially important given the rapid pace of viral evolution and the need to potentially protect those at highest risk for severe disease. In October 2023, AstraZeneca announced new data from two extensive real-world evidence studies, which highlighted that immunocompromised people continue to face significant and disproportionate burdens from COVID-19, with substantially higher rates of severe COVID-19 outcomes compared to the general population. The INFORM and EPOCH studies were published in Lancet Regional Health Europe and Current Medical Research and Opinion, respectively. Data from INFORM were presented at the 12th Annual IDWeek Conference. Evusheld is a LAAB combination for the pre-exposure prophylaxis (prevention) and treatment of COVID-19. All Product Sales in 2023 were derived from sales of Evusheld in the first quarter. Vaxzevria was co-invented by the University of Oxford. Through a landmark agreement in 2020, Vaxzevria was developed and distributed by AstraZeneca at cost during the pandemic. Total Revenue for COVID-19 medicines (Vaxzevria and COVID-19 mAbs) declined significantly in 2023, due to the fulfilment of Vaxzevria contracts. Emergency Use Authorisation, based on positive results from the SUPERNOVA sub-study, was submitted in the US for the investigational LAAB sipavibart for preexposure prophylaxis of COVID-19 in an immunocompromised patient population. Fluenz Tetra/FluMist Quadrivalent is a live quadrivalent vaccine, given as an intranasal spray. It is the first and only commercial intranasal flu vaccine that offers a needle-free alternative to traditional flu vaccinations. This year marked the 20th anniversary since the first regulatory approval of FluMist/Fluenz. In February 2023, AstraZeneca entered into an agreement with the US Government’s Department of Defense via the Medical Chemical, Biological, Radiological and Nuclear Defense Consortium to develop a ribonucleic acid (RNA)-based universal pandemic influenza vaccine. As part of this agreement, AstraZeneca will receive up to approximately $80 million over three years to develop the vaccine from preclinical research through a Phase I/II clinical study. In March 2023, Japan’s Ministry of Health, Labour and Welfare approved FluMist Quadrivalent for children aged two to 18 years. Daiichi Sankyo holds rights to FluMist Quadrivalent in Japan. In October 2023, the FDA accepted for review the Supplemental Biologics Licence Application (sBLA) for a self- or caregiveradministration option for FluMist Quadrivalent. Rare Disease After more than two full years as Alexion, AstraZeneca Rare Disease, the company’s medicines are helping patients in 70 countries. As the company expands the reach of its medicines, the company’s growing pipeline of investigational molecules represents continued innovation on behalf of rare disease patients. The company is dedicated to improving the lives of those living with rare diseases, and the people who support them, through advancing its leadership in complement therapies, while also building on its pioneering legacy of innovation to diversify its portfolio. Collaborating with partners to leverage promising new modalities, platforms and technologies. Enhancing science-led innovation across the enterprise to accelerate drug development and delivery. Creating smart and efficient strategies that bring transformative medicines to new markets, reaching more patients in a sustainable and equitable way. Key Marketed Products Soliris (eculizumab): Approved in more than 50 countries for the treatment of patients with PNH, including the U.S., EU, Japan and China. Approved in more than 50 countries for the treatment of patients with aHUS, including the U.S., EU, Japan and China. Approved in more than 40 countries for the treatment of patients with gMG who are anti-acetylcholine receptor antibody-positive (AChR Ab+) including the US, EU, Japan and China. Approved in more than 45 countries for the treatment of adult patients with NMOSD who are anti-aquaporin-4 antibody-positive (AQP4 Ab+), including the U.S., EU, Japan and China. Ultomiris (ravulizumab): Approved in 60 countries for the treatment of patients with PNH, including the U.S., EU and Japan. Approved in 60 countries for the treatment of patients with aHUS, including the U.S., EU and Japan. Approved in more than 55 countries for the treatment of adult patients with gMG who are AChR Ab+, including the US, EU and Japan. Approved in more than 40 countries for the treatment of adult patients with NMOSD who are AQP4 Ab+, including the EU and Japan. Strensiq (asfotase alfa): Approved in more than 50 countries for the treatment of certain patients with HPP, including the U.S., EU, Japan and Canada. Koselugo (selumetinib): Approved in more than 55 countries, including the U.S., EU and Japan. Kanuma (sebelipase alfa): Approved in more than 45 countries, including the U.S., EU and Japan. Alexion was the first company to translate the complement system into transformative medicines. The company is continuing that legacy of leadership across multiple disease areas, leveraging AstraZeneca’s established footprint and expanding its global presence through Centres of Excellence to reach patients with high unmet medical need. The EU and Japan approved its long-acting C5 inhibitor Ultomiris for the treatment of adults with NMOSD, a progressive autoimmune disease that impacts the central nervous system. With no relapses observed in the pivotal CHAMPION-NMOSD trial, Ultomiris marks a significant advance for NMOSD patients, offering dosing every eight weeks and the potential to live relapse-free. Regulatory reviews for Ultomiris for thetreatment of NMOSD are ongoing in additional countries, including the U.S. The company has further expanded access to its first-in-class C5 inhibitor Soliris for patients with rare neurological diseases; Soliris has the potential to improve outcomes and quality of life for these patients and their families. Soliris has been approved in the EU and Japan for certain paediatric patients with refractory gMG, and was approved in China for the treatment of certain adults with gMG and certain adults with NMOSD. The company is developing a broad portfolio of potential medicines that target various components of the complement system, with opportunities to pursue indications across a wide range of therapeutic areas of interest, including haematology, nephrology, neurology and ophthalmology. The company is exploring the ability to treat earlier-line and broader gMG patient populations in a Phase III trial with gefurulimab (ALXN1720), a next-generation C5 inhibitor that is selfadministered subcutaneously. The company is also evaluating potential treatments for certain rare nephrology conditions, including ALXN2030, an investigational small interfering RNA targeting the complement C3 protein. The company has a robust portfolio of investigational medicines that inhibit the complement protein Factor D, including small molecule oral assets with potential broad application across several disease areas. Voydeya (danicopan) received the first-ever regulatory approval in Japan for the treatment of a subset of adults with PNH to be used in combination with C5 inhibitor therapy. The approval of Voydeya, a first-in-class, oral, Factor D inhibitor, was based on the positive results from the pivotal ALPHA Phase III trial; results from the 12-week primary evaluation period of the trial were published in The Lancet Haematology. Voydeya was developed as add-on to proven SoC Ultomiris or Soliris to address the needs of the subset of patients (approximately 10-20%) with PNH who experience clinically significant extravascular haemolysis (EVH) while treated with a C5 inhibitor. Regulatory submissions for Voydeya are under review with multiple global health authorities. Alexion is also evaluating Voydeya in an ongoing Phase II trial as a potential monotherapy for geographic atrophy, a chronic and progressive eye disease. Additional investigational, oral Factor D inhibitors in clinical development are Vemircopan (ALXN 2050) in ongoing Phase II clinical trials in a number of rare diseases; and ALXN2080 in an ongoing Phase I trial. The company has continued to expand its rare disease focus with novel assets for non-complement mediated diseases. Amyloidosis is a group of complex rare diseases, with varying types and severities. Alexion and AstraZeneca are advancing the industry’s largest amyloidosis pipeline, across a broad range of modalities, to address the spectrum of patient need across multiple disease subtypes. In Amyloid light chain(AL) amyloidosis, misfolded abnormal proteins build up and form toxic amyloid deposits in organs throughout the body (including the heart and kidneys), causing significant organ damage and failure that may ultimately be fatal. Anselamimab (CAEL-101), a potentially first-in-class fibril-reactive mAb for the treatment of AL amyloidosis, is being evaluated in the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme in combination with SoC therapy in AL amyloidosis. Two parallel Phase III trials in patients with Mayo Stage IIIa and Stage IIIb disease, respectively, are ongoing. ATTR (Transthyretin amyloidosis) cardiomyopathy (ATTR-CM) is a systemic, progressive and fatal condition that leads to HF and a high rate of fatality within four years from diagnosis. Alexion holds an exclusive licence from Neurimmune to develop and commercialise ALXN2220 (NI006), an investigational mAb that specifically targets misfolded transthyretin. ALXN2220 is designed to directly address the pathology of ATTR-CM by enabling removal of amyloid fibril deposits in the heart, with the potential to treat patients with advanced ATTR-CM. Alexion holds an exclusive licence from BridgeBio’s subsidiary, Eidos Therapeutics, Inc., to develop and commercialise acoramidis in Japan; this trial in Japan was conducted to support local registration. The company completed a Phase I trial in adult patients with HPP for efzimfotase alfa (ALXN1850), its next-generation alkaline phosphatase enzyme replacement therapy. In May 2023, Koselugo was approved in China for paediatric patients with Neurofibromatosis T ype 1(NF1) and Plexiform Neurofibromas (PNs). The company announced the difficult decision to terminate the ALXN1840 programme in Wilson disease based on review of results from Phase II mechanistic trials and discussions with regulatory authorities. The company is partnering with colleagues across AstraZeneca to follow the science and identify opportunities where it can leverage its expertise and infrastructure to deliver transformative outcomes for patients. Acquisitions On 16 January 2023, AstraZeneca completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). Research and Development (R&D) In 2023, the company’s R&D expenditure was $10,935 million, including Core R&D costs of $10,267 million. History The company was incorporated in England and Wales in 1992 under the Companies Act 1985. The company was formerly known as Zeneca Group PLC and changed its name to AstraZeneca PLC in 1999.