SHANGHAI, NANJING, China and SAN FRANCISCO, May 9, 2025 — IASO Biotherapeutics (“IASO Bio”), a biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of innovative cell and biological therapies, announced today that the Saudi Food and Drug Authority (SFDA) has granted Orphan Drug Designation (ODD) to its independently developed BCMA-targeted CAR-T cell therapy, Equecabtagene Autoleucel (FUCASO). This designation is for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have previously undergone at least three lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

The Saudi SFDA established the ODD as a special regulatory measure to promote the development of treatments for rare diseases. Drugs with this designation may benefit from accelerated regulatory review and support during product development. With the ODD granted, Equecabtagene Autoleucel can now directly file a New Drug Application (NDA) in Saudi Arabia, potentially expediting the approval process and providing earlier access for patients in the Middle East.

Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Biotherapeutics, commented: “We are very pleased that equecabtagene autoleucel has received Orphan Drug Designation from the SFDA. This further confirms international regulatory recognition of the clinical value of this innovative treatment. Saudi Arabia is a critical starting point for our expansion into the Middle East market and marks a significant step in our ongoing “Go Global” strategy. We will collaborate closely with local regulatory bodies, medical facilities, and partners to advance the approval of Equecabtagene Autoleucel in Saudi Arabia, aiming to deliver clinical benefits to patients in these regions.”

About Multiple Myeloma（MM)

Multiple myeloma (MM) is the second most prevalent hematological cancer worldwide. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 individuals, with a 5-year prevalence of 6.8 per 100,000. Despite advances in current treatments, MM is often incurable, with frequent relapses and the development of resistance to various drug classes, posing a significant therapeutic challenge. Consequently, there is an unmet need for novel treatment options beyond the current anti-myeloma therapies for relapsed or refractory MM that can achieve significant and lasting responses.

About Equecabtagene Autoleucel 

Equecabtagene Autoleucel is an innovative, fully human anti-BCMA CAR-T cell therapy that utilizes a lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane domain, and 4-1BB co-stimulatory molecule and CD3ζactivation domains. Based on extensive molecular structure screening and thorough in vitro and in vivo functional assessments, FUCASO exhibits rapid and strong efficacy, along with exceptional long-term persistence in vivo. This allows patients to achieve significant and sustained remission, offering ongoing protection and care for those with multiple myeloma.

About IASO Bio

IASO Bio is a biopharmaceutical company that focuses on discovering and developing innovative cell therapies and biologics for oncology and autoimmune conditions. IASO Bio has comprehensive capabilities covering the entire drug development spectrum, from early discovery to clinical development, regulatory approval, and commercialization.

Its pipeline features a diverse portfolio of more than 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China’s National Medical Products Administration (NMPA) in June 2023 and U.S. FDA IND approval for the treatment of R/RMM in December 2022.

With its strong management team, innovative product pipeline, and integrated, high-quality manufacturing and clinical capabilities, IASO aims to provide transformative, curable, and affordable therapies that address unmet medical needs for patients in China and globally. For more information, please visit or .

SOURCE IASO Bio

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