Therapeutic Areas and Product Portfolio Bringing our life-changing medicines to people around the world In FY2026, CSL continued to expand the global reach and impact of our medicines for rare and specialty diseases. We achieved a total of 83 major regulatory approvals comprising 60 new product registrations and 23 new indications across all five of our therapeutic areas. For a complete overview of approvals, please refer to the Product Registrations and Indications 2025/26*. Clinical trials In FY2026, CSL had 41 clinical trials in operation across all therapeutic areas. Of those, nine trials had a first patient enrolled in the trial during this fiscal year. CSL conducts clinical trials ethically and adheres to high standards of integrity in the formulation, conduct and reporting of scientific research. This is based upon three primary elements: scientific integrity; patient safety; and investigator objectivity. The CSL Clinical Quality Management System allows CSL to monitor and effectively oversee the quality of clinical trials and includes both regulatory authority inspections and internal audits for good clinical practice (GCP), good manufacturing practice (GMP), good laboratory practice (GLP), good clinical laboratory practice (GCLP) and good research laboratory practice (GRLP). Over the reporting period, ten clinical trials were added, and nine clinical trial results were posted, on an International Committee of Medical Journal Editors (ICMJE)-recognised public clinical trial registry. CSL’s disclosure policy reflects international requirements and standards, including requirements from ICMJE, WHO guidance and legislative requirements. In addition, seven Good Clinical Practice (GCP) inspections were undertaken by regulatory agencies, including United States Food and Drug Administration (FDA), Health Canada, South African SHAPRA, Argentinian ANMAT, Serbian ALIMS and German HLfGP (formerly RP Darmstadt). These inspections were all Investigator Sites for CSL interventional clinical studies. All inspections confirmed adherence with GCP requirements, validated the data integrity of CSL clinical trials and had no impact on clinical trial operations. Abbreviations AFD Acquired Fibrinogen Disease AI Autoinjector cDNA Complementary Deoxyribonucleic Acid CKD-aP Chronic Kidney Disease-associated Pruritus HAE Hereditary Angioedema HK Hyperkalemia IgAN Immunoglobulin A Neuropathy IU International Unit KOR Kappa Opioid Receptor MMN Multifocal Motor Neuropathy NI New Indication NR New Registration NSD Needle Safety Device SID Secondary Immunodeficiency vWF von Willebrand Factor Immunoglobulins Focusing on improving patient convenience, increasing plasma yield improvements, expanding product labels, new formulation science and recombinant technology PRODUCT TYPE COUNTRY/REGION HIZENTRA® Immune Globulin Subcutaneous (Human), 20% Liquid NR Panama (1, 2 & 4 g) HIZENTRA® Immune Globulin Subcutaneous (Human), 20% Liquid NI Argentina, Brazil, Kazakhstan (broader SID) PRIVIGEN® Immune Globulin Intravenous (Human) 10% Liquid NI European Union (Measles), Azerbaijan, Brazil, Costa Rica, Ecuador, El Salvador, Iran, Kazakhstan, Malaysia, Moldova, Nicaragua, Paraguay (broader SID and MMN) Immunology Developing optimal therapies for HAE patients and therapies for select autoimmune indications of high unmet need PRODUCT TYPE COUNTRY/REGION ANDEMBRY® Anti-Factor XIIa monoclonal antibody (HAE) NR Brazil, Israel, New Zealand, Puerto Rico, Saudi Arabia (200mg AI), Canada (200mg AI, 200mg NSD) BERINERT® C1 Esterase Inhibitor Human Intravenous or Subcutaneous NR New Zealand (500, 1500, 2000, 3000 IU), Panama (500 IU), South Africa (500, 1500, 2000, 3000 IU) BERINERT® C1 Esterase Inhibitor Human Intravenous NI Brazil (short-term or pre-procedural prophylaxis of Type I and II HAE 16 Performance
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