IASO Bio's Equecabtagene Autoleucel Gains First Approval Outside Mainland China

Macau approves IASO Bio’s Equecabtagene Autoleucel, expanding treatment options for multiple myeloma patients.

IASO Biotherapeutics has reached a significant milestone as Macau’s Pharmaceutical Administration Bureau granted approval for Equecabtagene Autoleucel (FUCASO), marking its first regulatory nod outside Mainland China. This innovative cell therapy is designed for adults with relapsed or refractory multiple myeloma (R/RMM) who have undergone at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent. The approval is backed by data from the pivotal FUMANBA-1 trial, which demonstrated remarkable efficacy and a favorable safety profile in patients battling this aggressive blood cancer.

The approval in Macau follows China’s National Medical Products Administration (NMPA) approval in 2023 and aligns with IASO Bio’s ongoing regulatory efforts in Singapore and Hong Kong, where applications were recently submitted. This expansion signals growing global confidence in Equecabtagene Autoleucel’s potential to transform multiple myeloma treatment. As IASO Bio continues its mission to bring cutting-edge cell therapies to more patients worldwide, this latest approval represents a major step forward in the fight against relapsed and refractory multiple myeloma.