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Additional Information What science can do AstraZeneca Annual Report and Form 20-F Information 2019 Additional Information Development Pipeline 238 Patent Expiries of Key Marketed Products 243 Risk 246 Shareholder Information 258 Directors’ Report 263 Sustainability: supplementary information 266 Trade Marks 267 Glossary 268 Cautionary statement regarding forward-looking statements 272 Additional Information AstraZeneca Annual Report & Form 20-F Information 2019 / Additional Information 237 Development Pipeline as at 31 December 2019 AstraZeneca-sponsored or -directed trial PP Partnered product New Molecular Entities (NMEs) and significant indications Regulatory submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by the business need to maintain condentiality, information in relation to some compounds listed here has not been disclosed at this time. Phase I Compound Mechanism Area Under Investigation Oncology AZD0466 BCL2/xL haematological and solid tumours AZD1390 ATM inhibitor glioblastoma AZD4573 CDK9 inhibitor haematological malignancies AZD5153 BRD4 inhibitor solid tumours, haematological malignancies AZD5991 MCL1 inhibitor haematological malignancies AZD9496 selective oestrogen receptor degrader oestrogen receptor +ve breast cancer Calquence + ceralasertib BTK inhibitor + ATR inhibitor haematological malignancies Calquence + danvatirsen BTK inhibitor + STAT3 inhibitor haematological malignancies Imfinzi + adavosertib PD-L1 mAb + Wee1 inhibitor PP solid tumours Imfinzi + RT (platform) locally-advanced head and neck squamous cell carcinoma, non-small PD-L1 mAb + RT PP CLOVER cell lung cancer (NSCLC), small cell lung cancer Imfinzi + selumetinib PD-L1 + MEK inhibitor PP solid tumours Imfinzi + tremelimumab PD-L1 mAb + CTLA-4 mAb PP solid tumours 1st-line pancreatic ductal adenocarcinoma, oesophageal and small cell Imfinzi + tremelimumab + CTx PD-L1 mAb + CTLA-4 mAb + CTx PP lung cancer MEDI1191 IL-12 mRNA solid tumours MEDI2228 BCMA antibody drug conjugate multiple myeloma MEDI5083 CD40 ligand fusion protein solid tumours MEDI5395 rNDV GMCSF solid tumours oleclumab + Tagrisso CD73 mAb + EGFR inhibitor EGFRm NSCLC CVRM AZD2693 NASH resolution NASH AZD6615 hypercholesterolemia CV disease AZD8233 hypercholesterolemia CV disease AZD9977 MCR CV disease MEDI6570 LOX-1 mAb CV disease MEDI7219 anti-diabetic type-2 diabetes Respiratory AZD0449 inhaled JAK inhibitor asthma AZD1402 inhaled IL-4Ra PP asthma AZD5634 inhaled ENaC cystic brosis AZD8154 inhaled PI3Kgd asthma Other AZD0284 RORg psoriasis/respiratory AZD4041 orexin 1 receptor antagonist PP opioid use disorder MEDI0618 PAR2 antagonist mAb osteoarthritis pain MEDI1341 alpha synuclein mAb PP Parkinson’s disease MEDI1814 amyloid beta mAb PP Alzheimer’s disease MEDI5117 China IL-6 mAb-YTE PP rheumatoid arthritis Phase II Compound Mechanism Area Under Investigation Oncology (oleclumab + CTx) or (Imfinzi + oleclumab + CTx) (CD73 mAb + CTx) or (PD-L1 mAb + CD73 mAb + CTx) metastatic pancreatic cancer adavosertib Wee1 inhibitor PP ovarian cancer, solid tumours AZD2811 Aurora B inhibitor solid tumours, haematological malignancies AZD4635 A2aR inhibitor prostate cancer AZD9833 selective oestrogen receptor degrader oestrogen receptor +ve breast cancer capivasertib AKT inhibitor PP breast cancer capivasertib AKT inhibitor PP prostate cancer Enhertu HER2 targeting antibody drug conjugate PP HER2-expressing advanced colorectal cancer HER2-over-expressing or -mutated, unresectable and/or metastatic Enhertu HER2 targeting antibody drug conjugate PP NSCLC Imfinzi (platform) PP COAST PD-L1 mAb + multiple novel oncology therapies NSCLC Imfinzi (platform) PP NeoCOAST PD-L1 mAb + multiple novel oncology therapies NSCLC Imfinzi + AZD4635 PD-L1 mAb + A2aR inhibitor prostate cancer 238 AstraZeneca Annual Report & Form 20-F Information 2019 / Additional Information Phase II continued Compound Mechanism Area Under Investigation Imfinzi + AZD5069 or PD-L1 mAb + CXCR2 antagonist or PP Imfinzi + danvatirsen PD-L1 mAb + STAT3 inhibitor head and neck squamous cell carcinoma, bladder and NSCLC Imfinzi + FOLFOX + bevacizumab (COLUMBIA 1) PD-L1 mAb + CTx + VEGF 1st-line metastatic microsatellite-stable colorectal cancer Imfinzi + Lynparza (BAYOU) PD-L1 mAb + PARP inhibitor PP 1st-line unresectable stage IV bladder cancer Imfinzi + Lynparza (ORION) PD-L1 mAb + PARP inhibitor PP 1st-line metastatic NSCLC Imfinzi + MEDI0457 PD-L1 mAb + DNA HPV vaccine PP head and neck squamous cell carcinoma Imfinzi + monalizumab PD-L1 mAb + NKG2a mAb PP solid tumours Imfinzi + oleclumab PD-L1 mAb + CD73 mAb PP solid tumours Imfinzi + tremelimumab PD-L1 mAb + CTLA-4 mAb PP biliary tract, oesophageal Imfinzi + tremelimumab PD-L1 mAb + CTLA-4 mAb PP gastric cancer Lynparza + adavosertib PARP inhibitor + Wee1 inhibitor PP solid tumours Lynparza + ceralasertib (AZD6738) PP (VIOLETTE) PARP inhibitor + ATR inhibitor breast cancer Lynparza + Imfinzi PP (MEDIOLA) PARP inhibitor + PD-L1 mAb ovarian cancer, breast cancer, gastric cancer and small cell lung cancer MEDI5752 PD-1/CTLA-4 bispecic mAb solid tumours oleclumab + AZD4635 CD73 mAb + A2aR inhibitor prostate cancer Tagrisso + selumetinib or savolitinib PP advanced EGFRm NSCLC (TATTON) EGFR inhibitor + (MEK inhibitor or MET inhibitor) Tagrisso + savolitinib (SAVANNAH) EGFR inhibitor + MET inhibitor PP advanced EGFRm NSCLC CVRM AZD4831 myeloperoxidase heart failure with a preserved ejection fraction AZD5718 FLAP coronary artery disease AZD8601 VEGF-A CV disease cotadutide GLP-1/glucagon dual agonist type-2 diabetes, obesity and NASH MEDI3506 IL-33 mAb diabetic kidney disease MEDI5884 cholesterol modulation CV disease MEDI6012 LCAT CV disease roxadustat hypoxia-inducible factor prolyl hydroxylase inhibitor chemotherapy induced anaemia verinurad URAT1 inhibitor chronic kidney disease (CKD) Respiratory abediterol LABA PP asthma/chronic obstructive pulmonary disease (COPD) AZD7594 inhaled SGRM asthma/COPD AZD7986 DPP1 PP COPD AZD8871 MABA PP COPD AZD9567 oral SGRM rheumatoid arthritis/respiratory MEDI3506 IL-33 mAb COPD and atopic dermatitis tezepelumab TSLP mAb PP atopic dermatitis tezepelumab TSLP mAb PP COPD Other anifrolumab Type I IFN receptor mAb PP lupus nephritis anifrolumab Type I IFN receptor mAb PP systemic lupus erythematosus (subcutaneous) MEDI39021 Psl/PcrV bispecic mAb prevention of nosocomial Pseudomonas aeruginosa pneumonia MEDI7352 NGF/TNF bispecic mAb osteoarthritis pain and painful diabetic neuropathy suvratoxumab1 mAb binding to S. aureus toxin prevention of nosocomial Staphylococcus aureus pneumonia Additional Information Phase III/Pivotal Phase II/Registration (listed until launched in all applicable major regions) Estimated Filing Acceptance Compound Mechanism Area Under Investigation US EU Japan China Oncology capivasertib + CTx AKT inhibitor + PP 2021+ 2021+ 2021+ 2021+ CAPItello-290 CTx 1st-line metastatic triple negative breast cancer Enhertu HER2 targeting (trastuzumab HER2-Positive, unresectable and/or metastatic breast PP deruxtecan) antibody drug cancer subjects previously treated with T-DM1 Approved H2 2020 (DESTINY-Breast01)2 conjugate Enhertu HER2 targeting (trastuzumab HER2-low, unresectable and/or metastatic breast cancer PP deruxtecan) antibody drug subjects 2021+ (DESTINY-Breast04) conjugate Enhertu HER2 targeting HER2-positive, unresectable and/or metastatic breast (trastuzumab PP deruxtecan) antibody drug cancer pretreated with prior standard of care HER2 2021 (DESTINY-Breast02) conjugate therapies, including T-DM1 AstraZeneca Annual Report & Form 20-F Information 2019 / Development Pipeline 239 Development Pipeline continued Phase III/Pivotal Phase II/Registration (listed until launched in all applicable major regions) continued Estimated Filing Acceptance Compound Mechanism Area Under Investigation US EU Japan China Enhertu (trastuzumab HER2 targeting HER2-overexpressing advanced gastric or gastro- deruxtecan) antibody drug esophageal junction adenocarcinoma patients who have PP N/A N/A N/A (DESTINY-Gastric01)2 conjugate progressed on two prior treatment regimens Enhertu HER2 targeting HER2-positive, unresectable and/or metastatic breast (trastuzumab PP deruxtecan) antibody drug cancer subjects previously treated with trastuzumab and 2021+ (DESTINY-Breast03) conjugate taxane Imfinzi + PL-L1 mAb + tremelimumab + PP SoC CTLA-4 mAb + 1st-line urothelial cancer 2021+ 2021+ 2021+ (NILE) SoC Imfinzi + PD-L1 mAb + tremelimumab 1st-line bladder cancer PP H1 2020 H1 2020 H1 2020 H2 2020 (DANUBE) CTLA-4 mAb Imfinzi + 2021 PD-L1 mAb + PP tremelimumab CTLA-4 mAb 1st-line hepatocellular carcinoma (Orphan Drug 2021 2021 2021+ (HIMALAYA) Designation) Imfinzi + PD-L1 mAb + tremelimumab 1st-line head and neck squamous cell carcinoma PP H1 2020 H1 2020 H1 2020 (KESTREL) CTLA-4 mAb Imfinzi +/- PD-L1 mAb tremelimumab + PP CRT +/- CTLA-4 1st-line limited-stage small cell lung cancer 2021+ 2021+ 2021+ 2021+ (ADRIATIC) mAb + CRT Imfinzi +/- PD-L1 mAb tremelimumab + PP CTx +/- CTLA-4 1st-line NSCLC 2021 2021 2021 (POSEIDON) mAb + CTx Imfinzi +/- PD-L1 mAb Accepted tremelimumab + PP SoC +/- CTLA-4 1st-line extensive-stage small cell lung cancer (Orphan Drug Accepted Accepted H2 2020 (CASPIAN) mAb + SoC Designation) anti-CD22 Launched (Orphan Accepted Lumoxiti recombinant 3rd-line hairy cell leukaemia PP (Orphan immunotoxin Drug, Priority Review) designation) Lynparza + Imfinzi + PARP inhibitor + bevacizumab PD-L1 mAb + 1st-line ovarian cancer PP 2021+ 2021+ 2021+ (DUO-O) VEGF inhibitor Accepted H1 2020 (Orphan Drug, (Orphan selumetinib PP Breakthrough (SPRINT)3
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