Argenx Expands Partnership with Fujifilm Biotechnologies to Manufacture Efgartigimod in the U.S.
核心洞察
Argenx has expanded its strategic partnership with Fujifilm Biotechnologies (搜索) to initiate manufacturing of efgartigimod drug substance at the Holly Springs, North Carolina site beginning in 2028.
The collaboration marks Fujifilm Biotechnologies (搜索)' first global end-to-end program utilizing its kojoX modular network, providing local-for-local supply across the U.S., U.K., Denmark, and Japan.
Efgartigimod is a monoclonal antibody fragment targeting the neonatal Fc receptor (搜索), approved globally for treating generalized myasthenia gravis (搜索) and chronic inflammatory demyelinating polyneuropathy (搜索).
Argenx SE, a global immunology company, has significantly expanded its strategic partnership with Fujifilm Biotechnologies (搜索) to enhance local medicine supply through U.S.-based manufacturing of its autoimmune therapy efgartigimod. The expanded agreement will see Fujifilm Biotechnologies initiate drug substance manufacturing at its Holly Springs, North Carolina facility beginning in 2028.
The collaboration represents a milestone for both companies, marking Fujifilm Biotechnologies (搜索)' first global end-to-end program utilizing its kojoX modular network of facilities. This network provides flexible capacity at clinical and commercial scales across manufacturing sites in the United States, United Kingdom, Denmark, and Japan.
Efgartigimod Manufacturing Expansion
Argenx becomes the first announced tenant in Fujifilm Biotechnologies (搜索)' Phase II expansion at Holly Springs, which will add 8 x 20,000-liter mammalian cell culture bioreactors to the site's existing 8 x 20,000 reactors. This expansion will support the manufacturing of efgartigimod, a monoclonal antibody fragment that targets the neonatal Fc receptor (搜索) (FcRn (搜索)) in patients with severe autoimmune diseases (搜索).
Efgartigimod is approved globally under the brand names VYVGART and VYVGART Hytrulo for treating adults with generalized myasthenia gravis (搜索) (gMG) and chronic inflammatory demyelinating polyneuropathy (搜索) (CIDP). Both conditions are chronic autoimmune neuromuscular diseases characterized by significant muscle weakness.
Strategic Benefits of Global Network
The partnership leverages Fujifilm Biotechnologies (搜索)' kojoX network, described as the industry's largest interconnected modular network, to provide local-for-local supply by manufacturing in close proximity to patients. This approach aims to strengthen supply chain resilience and support seamless delivery of critical therapies worldwide.
"This partnership with argenx marks our first global end-to-end program in support of a customer utilizing our kojoX modular network of facilities," said Lars Petersen, president and chief executive officer of Fujifilm Biotechnologies (搜索). "By expanding manufacturing in the United States, we will help to meet argenx' global supply chain needs for efgartigimod. We are honored to support the manufacturing of this life-impacting therapy to supply to patients in need."
Enhanced Supply Chain Capabilities
The expanded partnership will allow Argenx to manufacture medicines in the U.S. for American patients while supporting its broader global reach. Filip Borgions, chief technology innovation officer at Argenx, emphasized the strategic value of the collaboration.
"Our expanded partnership with FUJIFILM Biotechnologies (搜索) at its Holly Springs site adds to our existing U.S. manufacturing footprint and further strengthens our global supply chain," Borgions stated. "The kojoX concept enables consistent capabilities across the U.S. and Europe, allowing us to manufacture medicines in the U.S. for American patients while supporting our broader global reach. We're excited to partner with the FUJIFILM Biotechnologies team to unlock the full potential of the kojoX platform."
The strategic move underscores both companies' commitment to enhancing supply chain agility and ensuring timely delivery of critical medicines to patients in need. Fujifilm Biotechnologies (搜索), as a leading contract development and manufacturing organization for biologics, vaccines, and advanced therapies, will provide the manufacturing expertise to support Argenx's mission of delivering life-impacting therapies to patients worldwide.