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Overview of CSL Ltd (CSLLY)
CSL Ltd is a global biotechnology company with a heritage dating back to 1916. The company has built a reputation for innovation and excellence in the development and manufacture of lifesaving medicines across diverse therapeutic areas including immune deficiencies, hemophilia, and iron deficiency. With its three principal business segments—CSL Behring, CSL Seqirus, and CSL Vifor—the company consistently leverages advanced research and development and cutting-edge manufacturing technologies to address critical healthcare challenges worldwide. Keywords such as biotechnology, vaccine manufacturing, and biopharmaceuticals underline its technical expertise and industry acumen from day one.
Core Business Areas and Operations
CSL Ltd operates through a multi-faceted business model that pairs robust R&D with commercial strength. CSL Behring focuses on plasma-derived therapies and advanced biologics for rare and serious conditions, while CSL Seqirus is internationally recognized as a major contributor to influenza vaccine production and pandemic preparedness. In addition, CSL Vifor develops innovative solutions in nephrology and treatments for iron deficiency, further broadening its portfolio with a commitment to precision healthcare.
Global Footprint and Manufacturing Excellence
Operating in more than 100 countries and employing thousands of professionals globally, CSL’s extensive manufacturing network integrates state-of-the-art production facilities in regions such as the U.S., the U.K., Australia, and beyond. This global reach not only supports high-quality vaccine manufacturing and therapeutic production, but also ensures compliance with diverse international regulatory standards. CSL’s strategic collaborations with government entities and public health partners underscore its reliable role in bolstering public health initiatives, particularly in influenza prevention and pandemic response.
Research, Development and Technological Advancements
Innovation is the cornerstone of CSL’s operational philosophy. The company invests heavily in research and development, nurturing a culture that maximizes technological advancements in vaccine technology and biotechnology. Through its dedicated R&D focus, CSL consistently develops next-generation vaccine technologies—including cell-based influenza vaccines and self-amplifying mRNA platforms—demonstrating its role as an authoritative figure in biotechnological innovation. By addressing complex scientific challenges with precision and expertise, CSL reinforces its market significance as a trusted pioneer within the biotechnology and pharmaceutical industries.
Market Position and Industry Significance
CSL Ltd stands apart as a key player in the global healthcare industry. Its dynamic portfolio, deep industry knowledge, and commitment to operational excellence allow it to provide diverse, life-improving solutions. The company’s dedication to public health, demonstrated through strategic collaborations and advanced R&D, solidifies its reputation as an accountable and authoritative participant in the biotechnology space. The integration of innovative technology with measurable outcomes helps CSL maintain a competitive edge in an ever-evolving market, making it a pivotal contributor to worldwide health advancements.
Commitment to Public Health and Future-Ready Operations
As public health remains a priority, CSL continues to focus on producing high-quality products that meet stringent regulatory standards. Its proactive role in pandemic preparedness, particularly in influenza vaccine production and advanced therapeutic formulations, ensures that it is always ready to respond to global health needs. This ongoing commitment to quality, innovation, and strategic partnerships positions CSL as a reliable partner for medical professionals and healthcare providers globally.
CSL Behring has received approval from Japan's MHLW for ANDEMBRY® (garadacimab), a first-in-class monoclonal antibody treatment for preventing hereditary angioedema (HAE) attacks. The treatment, administered via pre-filled pen for once-monthly subcutaneous injection, works by inhibiting activated Factor XII, the initiating factor in the HAE pathway.
The approval follows successful results from the international Phase 3 VANGUARD trial, with the detailed results published in The Lancet (April 2023) and Allergy (October 2024). ANDEMBRY has already received approvals in Australia, the United Kingdom, and the European Union.
HAE is a rare genetic disorder affecting approximately 430 diagnosed patients in Japan, with an estimated total patient population of 2,500 based on global prevalence rates of 1 in 50,000 people. The condition causes recurrent and unpredictable attacks of angioedema in multiple body sites.
CSL (CSLLY) and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. The approval follows a positive CHMP opinion from December 12, 2024, and is valid across all EU member states and EEA countries.
KOSTAIVE, already marketed in Japan, demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on positive data from multiple studies, including an integrated phase 1/2/3 study and Phase 3 booster trials, which showed higher immunogenicity results versus a conventional mRNA COVID-19 vaccine comparator.
CSL and Arcturus Therapeutics (ARCT) have received European Commission marketing authorization for KOSTAIVE®, the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for individuals 18 and older. The approval follows a positive CHMP opinion from the European Medicines Agency on December 12, 2024.
KOSTAIVE demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on data from multiple studies, including an integrated phase 1/2/3 study showing efficacy and tolerability, and Phase 3 booster trials.
The vaccine is already marketed in Japan and will be valid across all EU member states and EEA countries. CSL is working to optimize KOSTAIVE's formulation to better serve healthcare professionals and patients in Europe.
CSL (CSLLY) has received European Commission approval for ANDEMBRY® (garadacimab), the first and only once-monthly treatment targeting factor XIIa for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older. This marks the third regulatory approval for ANDEMBRY, following recent approvals in Australia and the UK.
The treatment comes with a patient-centric pre-filled pen for subcutaneous self-injection and works by inhibiting plasma protein factor XIIa. The approval is based on the Phase 3 VANGUARD trial and its open-label extension study, with results published in The Lancet (April 2023) and Allergy (October 2024).
HAE is a rare genetic disorder affecting approximately 1 in 50,000 people, characterized by recurrent and unpredictable attacks of angioedema. The treatment will be available following access and reimbursement negotiations, and is currently under review in the US, Japan, Switzerland, and Canada.
CSL Behring announced four-year results from the pivotal HOPE-B study of HEMGENIX, their gene therapy for hemophilia B. The data demonstrates sustained efficacy and safety through four years post-treatment. Key findings include:
- 94% of patients remained free of continuous factor IX prophylaxis
- Mean factor IX activity levels maintained at 37% through four years
- Approximately 90% reduction in mean adjusted annualized bleeding rate from lead-in to year four
- Joint bleeds reduced from 2.34 to 0.09 mean ABR
The Phase III HOPE-B trial involved 54 adult male participants with severe or moderately severe hemophilia B. No serious adverse events related to HEMGENIX were reported, with 96% of treatment-related adverse events occurring in the first six months. HEMGENIX, approved by FDA in 2022, is the first gene therapy for hemophilia B that can treat patients with and without AAV5 neutralizing antibodies.
CSL (ASX:CSL; USOTC:CSLLY) received a positive CHMP opinion recommending marketing authorization for garadacimab, a first-of-its-kind once-monthly treatment for hereditary angioedema (HAE) prevention in patients aged 12 and older. The treatment, which targets factor XIIa to prevent HAE attacks, demonstrated impressive results in the Phase 3 VANGUARD trial, with 62% of patients achieving attack-free status and an 86.5% reduction in mean monthly HAE attacks compared to placebo.
The European Commission's final decision is expected in Q1 2025. The recommendation is supported by favorable long-term safety data from an ongoing open-label extension study, with median exposure of 13.8 months. If approved, garadacimab would be available across all EU member states.
CSL Behring, a global leader in biotherapeutics, has significantly scaled its healthcare professional (HCP) engagement program using the ON24 platform. Leveraging ON24's intelligent engagement solutions, CSL Behring has enhanced its digital engagement, resulting in new potential customers and better insights into customer content engagement. The integration with Veeva CRM allows real-time data capture and analysis, informing follow-up strategies and deepening customer relationships. Before partnering with ON24, CSL Behring faced challenges with disjointed digital tools and manual processes that hindered scalability. Now, the company offers consistent, meaningful content to HCPs globally through live and on-demand webinars, reaching thousands of HCPs and increasing engagement. This transformation has enabled CSL Behring to expand its reach without adding headcount, repurposing content across 40 countries. The life sciences industry saw a 13% year-over-year increase in digital experiences in 2023, emphasizing the sector's shift towards omnichannel strategies.
CSL Vifor and Travere Therapeutics announced that Swissmedic has granted temporary marketing authorization for FILSPARI (sparsentan) to treat adults with primary IgA nephropathy (IgAN) with specific urine protein levels. The approval is based on the phase-III PROTECT trial results. This follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.
Emmanuelle Lecomte Brisset of CSL highlighted the high unmet medical need for targeted IgAN therapy. Eric Dube of Travere Therapeutics emphasized FILSPARI's benefits as a non-immunosuppressive, once-daily oral treatment that can provide superior results compared to maximally dosed irbesartan.
CSL Seqirus presented five studies at IDWeek 2024, emphasizing the need to increase influenza vaccination rates and showcasing the benefits of cell-based influenza vaccines. Key findings include:
1. A dynamic model showed that increasing vaccination rates to at least 45% is necessary to avoid hospital system resource saturation, especially in ICUs.
2. Multiple real-world evidence studies demonstrated improved relative vaccine effectiveness of cell-based vaccines compared to egg-based vaccines across different age groups, including children as young as 6 months.
3. A model based on the 2022-23 flu season estimated that cell-based vaccines would have averted a significant burden of influenza-related illnesses compared to egg-based vaccines.
4. Cell-based vaccines were found to be cost-saving compared to recombinant influenza vaccines for adults aged 18-64.
CSL Seqirus, a global leader in pandemic preparedness, has received a $34 million award from the Biomedical Advanced Research and Development Authority (BARDA) to complete the fill and finish process for additional pre-pandemic vaccines. This marks the sixth avian influenza pandemic preparedness award from BARDA to CSL Seqirus. The company will deliver approximately 3 million finished doses of MF59®-adjuvanted H5N1 pre-pandemic vaccine and manufacture an additional lot of H5N8 antigen.
CSL Seqirus' manufacturing facility in Holly Springs, North Carolina, is the largest cell-based influenza vaccine producer in the world. It can deliver 150 million influenza vaccine doses within six months of a pandemic declaration. This project is supported by federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA.