IASO Bio's Registration Application for FUCASO® (equecabtagene autoleucel) Accepted by Australia's TGA

Nanjing, China, August 20, 2026 — IASO Bio (the "Company") today announced that Australia's Therapeutic Goods Administration (TGA) has accepted for evaluation the Company's biological registration application to include its CAR-T cell therapy, FUCASO® (equecabtagene autoleucel), in the Australian Register of Therapeutic Goods (ARTG), for the treatment of adult patients with relapsed/refractory multiple myeloma (r/r MM) who have progressed after at least three prior lines of therapy.

Equecabtagene autoleucel, marketed in mainland China under the trade name FUCASO^®, received marketing approval from China's National Medical Products Administration (NMPA) on June 30, 2023, for the treatment of adult patients with relapsed/refractory multiple myeloma (r/r MM) who have progressed after at least three prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent.

As the world's first commercially available fully human CAR-T product, FUCASO® has won recognition from clinical experts and patients in China for its compelling efficacy and favorable safety profile since its approval and has attracted patients from more than ten countries and regions to travel to China to receive the therapy. Since June 2023, ten patients from the Australia–New Zealand (ANZ) region have traveled to China for treatment.

IASO Bio has initiated drug registration in multiple countries and regions to accelerate its internationalization. The acceptance of its Australian registration application by the TGA not only marks a further expansion of FUCASO^®'s global footprint into the Oceania market, but also exemplifies the " In China For Global" model—leveraging China as a global CAR-T manufacturing and supply base to bring innovative China-developed therapies to more patients worldwide.