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

Expansion of partnership broadens argenx’ manufacturing capabilities in the U.S., supporting its strategy of local-for-local supply of medicines

HOLLY SPRINGS, N.C.--(BUSINESS WIRE)--FUJIFILM Biotechnologies, a world-leading contract development and manufacturing organization for biologics, vaccines, and advanced therapies, today announced a significant expansion of its global partnership with argenx SE, a global immunology company. As part of the expanded agreement, FUJIFILM Biotechnologies will initiate manufacturing of argenx’ drug substance for efgartigimod at the Holly Springs, North Carolina, site in 2028.

argenx is the first announced tenant in FUJIFILM Biotechnologies’ Phase II expansion in Holly Springs, which will add 8 x 20,000-liter (L) mammalian cell culture bioreactors to the site’s existing 8 x 20,000 reactors.

Efgartigimod is a monoclonal antibody (mAb) fragment that targets the neonatal Fc receptor (FcRn) in patients with severe autoimmune disease. It is approved globally (as VYVGART^® and VYVGART^® Hytrulo) for the treatment of adults with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) – both chronic autoimmune neuromuscular diseases characterized by significant muscle weakness.

With the expanded global manufacturing agreement, argenx will benefit from FUJIFILM Biotechnologies’ global kojoX™ network, which provides local-for-local supply, manufacturing in close proximity to patients. Through kojoX, the industry’s largest interconnected modular network, FUJIFILM Biotechnologies offers flexible capacity at clinical and commercial scales from its manufacturing sites in United States, United Kingdom, Denmark, and FUJIFILM Group’s site in Japan.

“This partnership with argenx marks our first global end-to-end program in support of a customer utilizing our kojoX modular network of facilities. By expanding manufacturing in the United States, we will help to meet argenx’ global supply chain needs for efgartigimod,” said Lars Petersen, president and chief executive officer, FUJIFILM Biotechnologies. “We are honored to support the manufacturing of this life-impacting therapy to supply to patients in need.”

“Our expanded partnership with FUJIFILM Biotechnologies at its Holly Springs site adds to our existing U.S. manufacturing footprint and further strengthens our global supply chain,” said Filip Borgions, chief technology innovation officer, argenx. “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.”

“Our kojoX manufacturing approach provides our global biopharmaceutical partners with the flexibility and agility to strengthen supply chain resilience, supporting a seamless delivery of critical therapies to patients worldwide,” added Petersen.

About FUJIFILM Biotechnologies
FUJIFILM Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. With over 30 years of experience, the Company specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian, and host/virus systems. With nearly 5,000 employees, FUJIFILM Biotechnologies operates a fully integrated, kojoX™ global network with major facilities in the United States, the United Kingdom, and Denmark, with a planned new site in Holly Springs, North Carolina, USA. The Company's kojoX manufacturing network ensures supply chain agility for its customers through modular facilities and standardized processes for seamless scaling and technology transfers. FUJIFILM Biotechnologies offers comprehensive services, ranging from proprietary cell line development, to process and analytical development, and through to clinical and commercial manufacturing. For more information, go to: fujifilmbiotechnologies.fujifilm.com

About FUJIFILM Holdings Corporation
FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. For more information, please visit: www.fujifilmholdings.com. For further details about our commitment to sustainability and Fujifilm’s Sustainable Value Plan 2030, click here.