Beyond strengthening our core portfolio, we are expanding into disease-modifying therapies in areas aligned with CSL’s capabilities and long-term strategy. In sickle cell disease, an underserved population with significant unmet need, we are advancing two Phase II programs aimed at improving patient quality of life. We are also exploring disease-modifying approaches in myeloproliferative neoplasms, alongside continued investment in vascular disorders, iron haemostasis and bone marrow conditions. Our strategy reinforces leadership in our core franchises, drives disciplined growth through lifecycle management, and accelerates innovation via focused R&D and strategic partnerships in high-unmet-need areas aligned with our capabilities. Cardiovascular and Renal While many treatments are available to treat the conditions associated with chronic kidney disease, there are few that impact the underlying cause and rate of progression, particularly in rare kidney diseases. This leads to a slow progressive march towards renal failure. Unfortunately, many patients progress to kidney failure, requiring dialysis or a kidney transplant to survive. Kidney failure also significantly increases the risk of serious cardiovascular events, including heart attack, stroke and sudden cardiac death, often at a younger age and with limited treatment options. CSL has made notable progress in expanding its presence across the kidney disease spectrum. FILSPARI® has enhanced CSL’s portfolio in this therapeutic area. CSL’s efforts reflect a comprehensive approach to chronic kidney disease (CKD), offering solutions that span from slowing kidney disease progression in rare kidney disease, to treatment of complications of CKD and dialysis. Most rare renal diseases, such as IgA nephropathy and antineutrophil 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 or the need for a kidney transplant. These efforts complement CSL’s existing therapies, such as FILSPARI®, which support patients living with rare renal diseases. Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in patients with 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). Additionally, we have entered into an exclusive licensing agreement with Eli Lilly, a major American multinational pharmaceutical company, to expand access to clazakizumab for other indications. 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, preserving plasmin activity and enhancing fibrinolysis to support the breakdown of blood clots. Looking ahead, CSL continues to expand its position in renal disease. Strategic partnerships have remained a cornerstone of CSL’s growth model. Internal and external innovation also continue to play a pivotal role in addressing patient needs. Vaccines Building on CSL’s foundation of leadership in developing and marketing differentiated seasonal and pandemic influenza vaccines, CSL continues to grow and raise the standard of care with expanded patient indications and markets for FLUCELVAX®, FLUAD® and pandemic vaccines. As a trusted partner to more than 30 countries throughout the world, CSL Seqirus’ leadership expands beyond our products. Working with governments and health authorities, we shape and improve pandemic vaccine programs, raise the standards for response, and foster capabilities to drive better health outcomes against emerging pandemic threats. 15 CSL Limited Annual Report 2025/26
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