This is the first NDA approval for FUCASO outside mainland China. FUCASO was approved by China NMPA in 2023 for adult patients with R/R MM who have received 3+ lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent. The Macau NDA approval is based on data from the pivotal FUMANBA-1 trial, a China-based, multi-site, Ph I/II registrational study evaluating the efficacy and safety of equecabtagene autoleucel in patients with R/R MM. The NDAs for FUCASO was formally accepted by the pharmaceutical authorities in Singapore and Hong Kong in Jan and Feb 2025, respectively.