#Nanjing #South Korea #CAR-T therapy #IASO Bio #GC Cell

Introduction

On October 29, 2025, Nanjing IASO Biotechnology, commonly known as IASO Bio, made headlines with a crucial partnership agreement with South Korea’s GC Cell. This collaboration aims to introduce the CAR-T therapy known as "Fucaso" (Equecabtagene Autoleucel) to the South Korean healthcare market. This innovative treatment is intended for patients suffering from multiple myeloma, a notoriously challenging form of blood cancer that currently lacks curative options.

The Need for New Treatments

Multiple myeloma predominantly affects older adults, and its occurrence in South Korea has seen a significant rise due to the aging population. Current treatments often lead to resistance over time, leaving patients with limited alternatives, particularly in the later stages of their treatment journey. While recent advancements have made some combination therapies available on reimbursement, those in advanced stages still face an acute shortage of effective therapies. The overwhelming cost of existing advanced treatments often puts them out of reach for many.

Fucaso: A Promising Solution

Fucaso, developed by IASO Bio, is designed to target B Cell Maturation Antigen (BCMA) and operates as a CAR-T cell therapy. The therapy received market approval in China back in June 2023 and has already been administered to patients there. Through this partnership, IASO aims to offer Fucaso in South Korea at a competitive price point, which could significantly lower barriers to access for patients who need this kind of treatment the most.

Steps Toward Regulatory Approval

To pave the way for Fucaso’s introduction in Korea, GC Cell secured Orphan Drug Designation for the therapy from the Ministry of Food and Drug Safety (MFDS) in July. This designation is crucial as it facilitates a quicker pathway for approvals, which is crucial for getting patients started on potentially life-saving therapies. In August, the therapy was classified as a fast-track Advanced Therapy Medicinal Product by Korean regulators, further accelerating the review process necessary for bringing Fucaso to market.

Commitment to Accessibility

GC Cell is steadfast in its commitment to ensuring timely and affordable access to Fucaso for patients. They highlighted the importance of establishing a stable supply chain to uphold the promise of reasonable pricing. Sungyong Won, Co-CEO of GC Cell, emphasized the significance of this agreement as a foundational step toward CAR-T therapy commercialization in Korea, noting their aim to stabilize the supply chain for this purpose.

A Mutual Benefit

Jinhua Zhang, the Founder, Chairwoman, and CEO of IASO Bio, expressed that this partnership marks a pivotal achievement in their global strategy. The partnership not only highlights the international potential of Fucaso but also enables the leveraging of GC Cell's deep regulatory and commercial expertise within the Korean market.

Conclusion

The collaboration between IASO Bio and GC Cell represents a significant stride toward improving access to cutting-edge CAR-T therapies in South Korea. With Fucaso’s introduction, patients suffering from multiple myeloma may soon have a new, effective treatment option that is more affordable and accessible. As the partnership progresses, its impact on patients’ lives and the overall healthcare landscape in Korea will be closely monitored, showcasing the potential of international collaborations in advancing medical therapy accessibility.