Immunoglobulins Building on CSL’s long heritage of providing patients with immunoglobulin products, CSL continues to optimise the patient experience by developing more convenient and flexible ways to dose and administer immunoglobulin products. CSL’s focus is on serving patients with serious immunologic and neurologic diseases, including primary and secondary immunodeficiencies (PID/SID) and chronic inflammatory demyelinating polyneuropathy (CIDP). CSL’s commitment to innovation is reflected in its exploration of inhaled immunoglobulin as a potential treatment for patients with bronchiectasis, complementing the established ZEMAIRA®/RESPREEZA® product for Alpha-1 Antitrypsin deficiency. Guided by the needs and experiences of patients, CSL is advancing an integrated, patient-centric approach that offers greater convenience and improved patient outcomes. Transplant and Immunology In Transplant and Immunology, CSL is leveraging its deep scientific expertise in immunomodulatory mechanisms to unlock synergies between alloimmune and autoimmune diseases. The goal is to bring life-changing solutions to patients in both transplant and immunology. In Immunology, CSL continues to build on its 40-year legacy in hereditary angioedema (HAE) by expanding our portfolio of therapies to provide optimal treatments for the full range of HAE patients. This includes the recent regulatory approval of ANDEMBRY®, a first-in-class, home-grown recombinant monoclonal antibody, in major markets including the United States, European Union, United Kingdom, Japan, Switzerland, Australia and the United Arab Emirates. Looking ahead, CSL is focused on advancing its leadership in immunology with innovative treatments for select autoimmune diseases of high unmet need, reinforcing its commitment to improving patient outcomes across chronic, complex immune-mediated conditions. Despite advances in transplantation improving short‑term survival, long-term survival remains suboptimal. Therefore, CSL is committed to developing therapies to address conditions that may lead to transplant failure. In haematopoietic stem cell transplantation, acute graft‑versus‑host disease (GvHD) is a life-threatening type of rejection and a leading cause of post-transplant morbidity and mortality. There remains a significant unmet need for more effective, less toxic GvHD therapies and CSL is investigating ZEMAIRA® (Alpha-1 Antitrypsin, AAT) for the prevention and treatment of acute GvHD. For solid organ transplant recipients, CSL is advancing therapies to address immune responses that may lead to transplant organ failure, ideally with less toxic treatment regimens and addressing ischemia reperfusion injury (IRI) which can damage the allograft when blood flow is re-introduced. Haematology Improving and extending the lives of patients with rare bleeding disorders is the focus of CSL’s haematology therapeutic area. Significant progress has been achieved in recent years in the treatment of haemophilia A and B through the introduction of innovative recombinant coagulation factor medicines and HEMGENIX® (etranacogene dezaparvovec), an AAV5 (adeno‑associated virus) gene therapy for the treatment of haemophilia B. CSL’s efforts in haematology focus on addressing the high unmet needs of patients with sickle cell disease, with a dual focus on acute treatment of vaso-occlusive crises and effective prophylaxis to reduce the frequency of sickle cell related events. Additionally, CSL is advancing innovative therapies targeting benign haematological conditions, particularly in haemostasis and thrombosis where there is a high unmet need. With a suite of therapies, CSL is also focused on patient blood management (PBM), aiming to reduce reliance on allogeneic blood product transfusions with the use of coagulation factor concentrates wherever available. CSL’s R&D studies include fibrinogen and prothrombin factor concentrates for use in surgical settings with high risk of major bleeding, as well as intravenous iron therapies to support pre- and post-operative anaemia management. Cardiovascular and Renal Extending the lives of patients affected by cardiovascular and renal diseases continues to be a strategic area of focus. Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in patients with chronic kidney disease (CKD), particularly those with advanced stages (4–5), where the risk of CVD is significantly elevated. To address this critical need, Clazakizumab, an anti‑interleukin‑6 (anti‑IL‑6) monoclonal antibody is currently in Phase III development for the prevention of cardiovascular morbidity and mortality in patients with end stage kidney disease (ESKD). CSL’s R&D efforts also target acute cardiovascular conditions. CSL301, a first-in-class monoclonal antibody for the treatment of intermediate–high risk pulmonary embolism, is currently in Phase II development. CSL301 inhibits Alpha-2 antiplasmin ( 2AP), preserving plasmin activity and enhancing fibrinolysis to support the breakdown of blood clots. Most rare renal diseases, such as IgA nephropathy and anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), have limited treatment options and often lead to kidney failure at a younger age compared to most CKD patients. CSL is focused on developing novel therapies to preserve kidney function and delay or avoid dialysis. These efforts complement CSL’s existing therapies, TAVNEOS® and FILSPARI®, which support patients living with rare renal diseases. Vaccines Building on CSL’s foundation of success in developing and marketing a broad range of seasonal and pandemic influenza vaccines, CSL continues to grow with expanded patient age indications and markets for FLUCELVAX® and FLUAD®. Additionally, CSL seeks to advance influenza prevention with the development of aTIVc (adjuvanted trivalent influenza vaccine), which combines the well described benefits of cell-based manufacturing, a higher antigen dose and our MF59® adjuvant. Developing new and advanced vaccines is a strategic priority for CSL with a focus on expanding beyond influenza with approval of the first marketing authorisations in Japan and Europe of its sa‑mRNA COVID‑19 vaccine. As a trusted partner to more than 30 countries throughout the world, CSL Seqirus is the leader in preparedness for pandemic influenza, and strives to meet the evolving global pandemic preparedness needs of governments and health authorities, addressing emerging pandemic threats by building capabilities to provide protection beyond influenza. 21 CSL Limited Annual Report 2024/25
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