Expanding the reach and impact of CSL’s life-changing medicines around the world In 2024/25, CSL continued to expand its global reach and impact of its medicines for rare and specialty diseases. This year, CSL achieved a total of 56 regulatory approvals comprising 43 new product registrations and 13 new indications across all five therapeutic areas. A key milestone was the approval of CSL’s first-in-class, internally developed monoclonal antibody, ANDEMBRY®, for the treatment of hereditary angioedema. Approvals began in January in Australia – where ANDEMBRY® was discovered – with the most recent approval received in June in the largest market, the United States. For a complete overview of approvals, please refer to the Product Registrations and Indications 2024/25* chart. Immunoglobulins Focus on improved patient convenience, plasma yield improvements, expanded labels, new formulation science and recombinant technology PRODUCT TYPE COUNTRY/REGION PRIVIGEN® Immune Globulin Intravenous (Human) 10% Liquid NR Bahrain, Oman PRIVIGEN® Immune Globulin Intravenous (Human) 10% Liquid NI Argentina, Dominican Republic (SID & MMN) Haematology Maximise the value and performance of CSL’s existing coagulation therapies and develop new protein and gene-based therapies for bleeding disorders and other benign haematologic conditions PRODUCT TYPE COUNTRY/REGION ALBUMEX® Human Albumin NR Hong Kong AFSTYLA® Coagulation Factor VIII (Recombinant) NR Bahrain, Azerbaijan, Kazakhstan (500, 1000, 2000, 3000 IU) HAEMO- COMPLETTAN® P Fibrinogen Concentrate (Human) NR Saudi Arabia, Colombia HEMGENIX® Recombinant adeno-associated viral vector with codon-optimised Padua derivative of Human FIX cDNA NR Korea, Saudi Arabia, Hong Kong, Taiwan, Singapore IDELVION® Coagulation Factor IX (Recombinant) Albumin Fusion Protein NR Bahrain, South Africa Transplant & Immunology Develop optimal therapies for HAE patients and therapies for select autoimmune and transplant indications of high unmet need PRODUCT TYPE COUNTRY/REGION ANDEMBRY® Anti-FXIIa mAb (HAE) NR United States, European Union, Japan, United Kingdom, Switzerland, Australia, United Arab Emirates BERINERT® C1 Esterase Inhibitor (Human) Intravenous or Subcutaneous1 NR Kuwait (2000, 3000 IU) AAV Antineutrophilic Cytoplasmic Antibody (ANCA) Associated Vasculitis AT Angiotensin CKD Chronic Kidney Disease ET Endothelin IgAN Immunoglobulin A Neuropathy HAE Hereditary Angioedema HK Hyperkalaemia IU International Unit MMN Multifocal Motor Neuropathy NDA New Drug Application NI New Indication NR New Registration sa-mRNA Self-Amplifying Messenger Ribonucleic Acid SID Secondary Immunodeficiency Platforms, Therapeutic Areas and Product Portfolio * First-time registrations or indications for CSL products in the listed countries/ regions over the reporting period. 1. In some markets, subcutaneous C1-esterase inhibitor is marketed as HAEGARDA®. 22 Performance
RkJQdWJsaXNoZXIy MjE2NDg3