FUJIFILM Biotechnologies Expands Partnership with argenx to Include U.S. Manufacturing

FUJIFILM Biotechnologies, a leading contract development and manufacturing organization (CDMO), announced a major expansion of its global partnership with immunology company argenx SE. As part of the agreement, FUJIFILM will begin manufacturing the drug substance for argenx’s autoimmune treatment efgartigimod at its Holly Springs, North Carolina facility starting in 2028.

argenx will be the first tenant in FUJIFILM’s Phase II expansion at Holly Springs, which will double the site’s capacity by adding eight 20,000-liter mammalian cell culture bioreactors to the existing eight.

Efgartigimod, marketed globally as VYVGART and VYVGART Hytrulo, is a monoclonal antibody fragment targeting the neonatal Fc receptor (FcRn). It is approved for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), two severe autoimmune neuromuscular diseases characterized by muscle weakness.

This expanded collaboration leverages FUJIFILM Biotechnologies’ kojoX modular network, which offers flexible, local manufacturing capabilities across the U.S., Europe, and Japan, enabling a “local-for-local” supply approach that aims to enhance supply chain resilience and ensure timely delivery of therapies to patients worldwide.

“By expanding manufacturing in the United States, we will help meet argenx’s global supply chain needs for efgartigimod,” said Lars Petersen, President and CEO of FUJIFILM Biotechnologies. “We are honored to support the manufacturing of this life-impacting therapy.”

Filip Borgions, Chief Technology Innovation Officer at argenx, emphasized the strategic value of the partnership, stating, “The kojoX concept enables consistent capabilities across the U.S. and Europe, allowing us to manufacture medicines locally for American patients while supporting our broader global reach.”

The partnership underscores both companies’ commitment to advancing access to innovative therapies for autoimmune diseases while building a resilient global manufacturing infrastructure.