Nanjing IASO Biotechnology signed an agreement with Korea’s GC Cell to introduce the CAR-T therapy Fucaso (Equecabtagene Autoleucel) to the South Korean market for the treatment of multiple myeloma.
The partnership aims to provide a new therapeutic option for Korean patients with multiple myeloma, and GC Cell plans to sequentially pursue domestic regulatory approval and commercialization of Fucaso.
Multiple myeloma is an incurable form of blood cancer with a high risk of relapse, most commonly affecting older adults. In South Korea, the number of multiple myeloma patients has been increasing annually due to an aging population. Many patients eventually develop resistance or refractoriness to existing treatments, limiting their effective options. While some combination therapies have recently become reimbursable — improving the initial treatment landscape — patients in fourth-line and later stages still face a critical lack of viable treatments, as advanced options like CAR-T therapies or bispecific antibodies are often prohibitively expensive and out of reach.
Fucaso is a BCMA (B Cell Maturation Antigen)-targeted CAR-T cell therapy developed by IASO Bio. It received approval in China in June 2023 and is currently being prescribed to patients there. By securing a competitive price point, the therapy is expected to greatly improve accessibility for patients who need it.
To facilitate Fucaso’s introduction in Korea, GC Cell obtained Orphan Drug Designation for the therapy from the Ministry of Food and Drug Safety (MFDS) in July. In August, Fucaso was also selected as a fast-track Advanced Therapy Medicinal Product by Korean regulators, expediting its review and development process. Through a stable supply chain, GC Cell aims to ensure that patients can access this treatment in a timely and cost-effective manner.
“This contract marks a meaningful first step for GC Cell, as Korea’s leading cell therapy company, to lay the groundwork for CAR-T commercialization,” said Sungyong Won, co-CEO of GC Cell.
“We will work to stabilize the supply chain so that patients can have the opportunity to receive treatment at a more reasonable cost.”
“This partnership is a significant milestone in our global strategy,” said Jinhua Zhang, founder, chairwoman and CEO of IASO Bio.
“It not only validates the international potential of Fucaso but also enables us to leverage our strengths with GC Cell’s regulatory and commercial expertise in Korea. Together, we are committed to making this innovative therapy accessible to more patients in need.”
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.