Chinese biopharmaceutical company IASO Biotherapeutics (IASO Bio) announced on Friday that it has received approval from the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) for its New Drug Application (NDA) for equecabtagene autoleucel.

The treatment is indicated for adults with relapsed or refractory multiple myeloma (R/R MM) who have received three or more lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent.

Equecabtagene autoleucel (trade name: FUCASO) was approved by China's National Medical Products Administration (NMPA) in June 2023 for treating adults with R/R MM who have received three or more lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent. The NDA for this product for the above indications has also been accepted by the Health Sciences Authority of Singapore and the Department of Health of Hong Kong.

The NDA approval in Macau is based on data from the pivotal FUMANBA-1 trial, a China-based, multi-site, Phase I/II registrational study evaluating the efficacy and safety of equecabtagene autoleucel in patients with R/R MM.