SHANGHAI, NANJING, and SAN JOSE, CA., March 28, 2025 – IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) has approved the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for adult patients with relapsed or refractory multiple myeloma (R/RMM) who have received three or more lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent.
This is the first NDA approval for Equecabtagene Autoleucel outside Mainland China. Equecabtagene Autoleucel (trade name: FUCASO) was approved by China’s National Medical Products Administration (NMPA) on June 30, 2023, for treating adult patients with relapsed or refractory multiple myeloma (R/RMM) who have received three or more lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent. On January 29 and February 14, 2025, the NDA for this product for the above indications was formally accepted by the Health Sciences Authority of Singapore and the Department of Health of Hong Kong, China, respectively.
The Macau NDA approval is based on data from the pivotal FUMANBA-1 trial (CTR20192510, NCT05066646), a China-based, multi-site, Phase I/II registrational study evaluating the efficacy and safety of equecabtagene autoleucel in patients with relapsed/refractory multiple myeloma (R/R MM). The results demonstrated that equecabtagene autoleucel achieves outstanding efficacy and a favorable safety profile.
Ms. Zhang Jinhua, Founder, Chairperson, and CEO of IASO Biotherapeutics, stated:
"We are delighted that the New Drug Application (NDA) for equecabtagene autoleucel has been approved by the Macau Drug Administration—the product’s first NDA approval outside Mainland China, marking a significant milestone. Through our innovative 'Manufactured in Nanjing, Supplied Globally' model, we will ensure timely access to this CAR-T therapy for multiple myeloma patients in Macau.
In December last year, we successfully delivered our Nanjing-manufactured CAR-T therapy to patients in Hong Kong through the Named Patient Program (NPP). Subsequently, in January and February of this year, the NDAs for equecabtagene autoleucel were officially accepted by the Singapore Health Sciences Authority and the Hong Kong Department of Health, respectively. 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 multiple myeloma patients worldwide."
About Multiple Myeloma（MM)
Multiple myeloma (MM) is the second most common hematological malignancy globally. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 per 100,000. Despite progress in current anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there is an unmet need for new treatment options beyond these current anti-myeloma therapies for the treatment of relapsed or refractory MM, capable of achieving deep and durable responses.
About Equecabtagene Autoleucel
Equecabtagene Autoleucel is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, FUCASO demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper responses, providing continuous protection and care for patients with multiple myeloma.
