Global Research and Development Pipeline for the period between 1 July 2023 to 30 June 2024 Clinical Registration Post-Launch† Immunology HAEGARDA®/BERINERT® (C1 Esterase Inhibitor SC & IV) Hereditary Angioedema HIZENTRA® (20% subcutaneous Ig) Multiple Indications PRIVIGEN® (10% intravenous Ig) Multiple Indications Garadacimab (Anti-FXIIa mAb) Hereditary Angioedema HIZENTRA® (20% subcutaneous Ig) Dermatomyositis Anumigilumab (Anti-G-CSFR mAb) Hidradenitis Suppurativa Haematology AFSTYLA® (Recombinant FVIII) Haemophilia A IDELVION® (Recombinant FIX-FP) Haemophilia B HEMGENIX® (Recombinant adeno-associated viral vector with codon-optimized Padua derivative of Human FIX cDNA) Haemophilia B* KCENTRA® (Prothrombin Complex Concentrate) Trauma Vamifeport (Ferroportin inhibitor) Sickle Cell Disease CSL301 (Anti- 2 Anti-Plasmin mAb) Intermediate-Risk (Sub-massive) Pulmonary Embolism* CSL889 (Hemopexin) Sickle Cell Disease Respiratory ZEMAIRA®/RESPREEZA® (Alpha 1 Antitrypsin) AAT Deficiency Anumigilimab (Anti-G-CSFR mAb) Community Acquired Pneumonia – Acute Respiratory Distress Syndrome Garadacimab (Anti-FXIIa mAb) Interstitial Lung Disease/Idiopathic Pulmonary Fibrosis Trabikibart (Anti-Beta Common mAb) Asthma CSL787 (Nebulised Ig) Non-Cystic Fibrosis Bronchiectasis Cardiovascular and Metabolic INJECTAFER® (Ferric carboxymaltose) Heart Failure in Iron Deficiency HAEGARDA®/BERINERT® (C1 Esterase Inhibitor SC & IV) Acute Ischemic Stroke Clazakizumab (Anti-IL-6 mAb) End Stage Kidney Disease CSL112 Apolipoprotein A-I (human)‡ CSL525 (SNF472; Vascular Calcification Inhibitor) Calcific Uraemic Arteriolopathy in End Stage Kidney Disease Nephrology and Transplant KORSUVA®/KAPRUVIA® (Kappa Opioid Receptor Agonist) Chronic Kidney Disease-associated Pruritus1 RAYALDEE® (Oral ext. release Calcifediol) Secondary Hyperparathyroidism2 TAVNEOS® (Oral C5a Receptor Inhibitor) Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis3 VELPHORO® (Sucroferric Oxyhydroxide) Serum Phosphorous control in Chronic Kidney Disease VELTASSA® (Oral Potassium Binder) Hyperkalemia FILSPARI® (Dual ET A & AT1 antagonist) IgA Nephropathy4 FILSPARI® (Dual ET A & AT1 antagonist) Focal Segmental Glomerulosclerosis4 Clazakizumab (Anti-IL-6 mAb) Chronic Active Antibody-Mediated Rejection CSL964 (Alpha 1 Antitrypsin) Prevention of Acute Graft-versus-Host Disease CSL964 (Alpha 1 Antitrypsin) Treatment of Acute Graft-versus-Host Disease* Vaccines AUDENZ® (adjuvanted cell-based pandemic vaccine) Influenza A (H5N1) FLUAD® (adjuvanted trivalent vaccine) Influenza FLUAD® QUAD (adjuvanted quadrivalent vaccine) Influenza FLUCELVAX® (trivalent cell-based vaccine) Influenza FLUCELVAX® QUAD (quadrivalent cell-based vaccine) Influenza FOCLIVIA®/AFLUNOV® (adjuvanted egg-based pandemic vaccine) Influenza A (H5N1) KOSTAIVE® (sa-mRNA vaccine) COVID-19* CSL400 (sa-mRNA seasonal quadrivalent/trivalent vaccine) Influenza CSL403 (adjuvanted quadrivalent/trivalent cell-based vaccine) Influenza CSL404 (cell-based pandemic vaccine) Influenza A (H5N8) CSL405 (cell-based pandemic vaccine) Influenza CSL406 (sa-mRNA pandemic vaccine) Influenza Outlicensed Programs Eblasakimab (Anti-IL-13R mAb) Atopic Dermatitis Mavrilimumab (Anti-GM-CSFR mAb) Giant Cell Arteritis, Rheumatoid Arthritis5 LASN01 (Anti-IL-11R mAb) Idiopathic Pulmonary Fibrosis, Thyroid Eye Disease † Some products in the Post-Launch phase may have ongoing R&D activities including, but not limited to, clinical trials and regulatory activities. ‡ The Phase III AEGIS-II trial evaluating the efficacy and safety of CSL112 compared to placebo in reducing risk of major adverse cardiovascular events (MACE) in patients following acute myocardial infarction (AMI) did not meet its primary efficacy endpoint of MACE reduction at 90 days. Assessments of other indications beyond post-AMI are ongoing. * Partnered Project. 1. KORSUVA®/KAPRUVIA® is a registered trademark of Cara Therapeutics, Inc. 2. RAYALDEE® is a registered trademark of OPKO Health, Inc. 3. TAVNEOS® is a registered trademark of ChemoCentryx Inc. 4. FILSPARI® is licensed from Travere Therapeutics, Inc. 5. Mavrilimumab Phase II studies in GCA & RA achieved their primary & secondary endpoints with statistical significance; Kiniksa granted Huadong Medicine exclusive rights in Asia Pacific Region, excluding Japan. Kiniksa is evaluating potential partnership opportunities to advance development of mavrilimumab. CSL’s pipeline also includes Life Cycle Management projects that address regulatory post-marketing commitments, pathogen safety, capacity expansions, yield improvements, and new packages and sizes. 23
RkJQdWJsaXNoZXIy MjE2NDg3