SHANGHAI, NANJING, and SAN JOSE, CA., February 14, 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 Hong Kong Department of Health (DOH) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapies.
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. As the world's first commercialized fully human CAR-T product, FUCASO has gained recognition from healthcare professionals and patients in China for its remarkable efficacy and safety since its launch. Furthermore, it has also attracted patients from over ten regions/countries to China to receive this innovative therapy.
Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, stated:
"We are delighted that the New Drug Application for Equecabtagene Autoleucel has been officially accepted by the Hong Kong Department of Health. Hong Kong occupies a 'frontline position' for biopharmaceutical companies in mainland China to expand into global markets, making it a key step in IASO Bio's journey to 'go global.' Thanks to the latest '1+' Mechanism introduced by the Hong Kong Department of Health, we swiftly submitted the NDA. This not only demonstrated our regulatory team's in-depth understanding of and swift response to drug regulatory policies in different regions and countries, but also marks our first successful practice in adopting a flexible and localized registration strategy. We will actively collaborate with the DOH throughout the regulatory process and strive to expedite the launch of this CAR-T therapy in Hong Kong.
Fully believing in the outstanding clinical value of Equecabtagene Autoleucel, we have also submitted NDAs in other regions and countries. We remain committed to accelerating access to advanced CAR-T therapies for patients around the world."
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（FUCASO）
FUCASO (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 CD3ζ activation 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.
