CSL Ltd Annual Report 2021

New products to market CSL Behring continues to broaden the geography and use of our medicines for rare and specialty diseases across the globe within our immunology, haematology and respiratory therapeutic areas. Within the immunology portfolio, regulatory indication expansion and new registrations are primarily focused on our subcutaneous immunoglobulin HIZENTRA ® and our intravenous immunoglobulin PRIVIGEN ® . In 2020/21, indication expansion was sought for HIZENTRA ® for chronic inflammatory demyelinating polyneuropathy (CIDP) and for PRIVIGEN ® for multifocal motor neuropathy (MMN) in select markets. CIDP is a chronically progressive, rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. The myelin sheath, or the protective covering of the nerves, is damaged, which may result in numbness or tingling, muscle weakness, fatigue and other symptoms, which worsen over time. MMN is a rare, progressive neuropathy that presents as muscle weakness asymmetrically in the extremities. Additionally, three new product registrations were achieved for ALBUREX ® , two each for RHOPHYLAC ® 300 and BERINERT ® and one for each of HIZENTRA ® , PRIVIGEN ® , TETAGAM ® and Hepatitis-B- Immunoglobulin P Behring ® . In our haematology therapeutic area, the focus in 2020/21 was expansion of the current portfolio. Notably, IDELVION ® , our coagulation factor IX (recombinant), albumin fusion protein (rFIX-FP) which is used to control and prevent bleeding episodes in people with haemophilia B, was approved in Mexico as IDELVIAN. In October 2020, the line extension for IDELVION ® 3500 IU was approved by the TGA. Additionally, new product registrations were achieved for our recombinant factor VIII product AFSTYLA ® , our human coagulation factor VIII product BERIATE ® , and for our human prothrombin complex concentrate BERIPLEX ® . In our respiratory therapeutic area, we achieved a new product registration for ZEMAIRA ® , our human alpha-1 proteinase inhibitor (A1-PI), which is indicated to raise the plasma levels of A1-PI in patients with A1-PI deficiency and related emphysema. For Seqirus, 2020/21 brought significant progress in broadening our influenza vaccine portfolio. In 2020, Seqirus achieved new product registrations for FLUCELVAX ® QUADRIVALENT in Argentina and Switzerland and approval for expanded age indications, down to two years of age in the US, Europe and Canada and down to nine years of age in Australia. In addition, the cell-based quadrivalent vaccine is under review with other global health authorities to support expanding the indicated age to include infants down to six months of age in other countries. In addition, FLUCELVAX ® TETRA was approved in the UK. FLUAD ® QUAD, our four-strain adjuvanted influenza vaccine, was officially launched in New Zealand for adults 65 years and above, and granted approval in Europe and UK, as FLUAD ® TETRA. AFLURIA ® QUAD was approved for expanded age indications, down to three years of age, in Argentina and AFLURIA ® QUAD JUNIOR was approved for use in Argentina in children from six months to less than three years. As we continue to expand our pandemic portfolio, FOCLIVIA ® , our adjuvanted, egg-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic, was approved in Canada. In Australia and New Zealand, Seqirus’ in-licensing business continues to provide greater access to a broad portfolio of vaccines and medicines. REAGILA ® (cariprazine) was approved for the treatment of schizophrenia in adult patients, as well as IKERVIS ® (ciclosporin eye drops) for severe keratitis in adult patients. 28 product registrations or new indications for serious diseases 7 Powered by Innovation CSL Limited Annual Report 2020/21 34