The Macau Special Administrative Region (ISAF) Pharmaceutical Administration Bureau has approved IASO Biotherapeutics’ new drug application (NDA) for equecabtagene autoleucel to treat adults with relapsed or refractory multiple myeloma (R/RMM).
This is the first NDA approval for the fully human anti-B-cell maturation antigen (BCMA) CAR-T cell therapy outside Mainland China, offering new hope for R/RMM sufferers who have received three or more previous therapy lines including a minimum of a proteasome blocker and an immunomodulatory agent.
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Commercially known as Fucaso, the therapy was previously approved by China’s National Medical Products Administration (NMPA) in June 2023.
The Health Sciences Authority of Singapore and the Department of Health of Hong Kong, China, accepted the therapy’s NDA for the given indication in January and February 2025 respectively.
The latest application is supported by data from the multi-site Phase I/II FUMANBA-1 registrational trial conducted in China, which assessed the therapy’s efficacy and safety in R/RMM subjects.
Findings showed that the therapy exhibited a favourable safety profile.
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By GlobalDataIASO Biotherapeutics CEO, founder and chairperson Zhang Jinhua stated: “In December 2024, we successfully delivered our Nanjing-manufactured CAR-T therapy to patients in Hong Kong through the Named Patient Program (NPP).
“We are actively collaborating with regulatory authorities to advance the approval processes and look forward to delivering clinical benefits to patients in these regions at the earliest opportunity. Meanwhile, IASO Bio remains committed to expanding the global footprint of our CAR-T therapies, dedicated to providing more treatment options for MM patients worldwide.”
IASO Bio entered a research agreement with Umoja Biopharma in November 2022, aiming to develop off-the-shelf therapies for haematological malignancies.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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