IASO Bio Receives Orphan Drug Designation from the Saudi Food and Drug Authority for Equecabtagene Autoleucel

SHANGHAI, NANJING, China and SAN FRANCISCO, May 9, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, today announced that its self-developed BCMA-targeted CAR-T cell therapy product, Equecabtagene Autoleucel (FUCASO), has been granted Orphan Drug Designation (ODD) by the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

The ODD is a special regulatory incentive established by the Saudi SFDA to encourage the development of therapies for rare diseases. Drugs receiving this designation are eligible for expedited regulatory review and assistance with product development. With the ODD approval, Equecabtagene Autoleucel can now directly submit a New Drug Application (NDA) in Saudi Arabia, which is expected to shorten the approval process and enable earlier access for patients in the Middle East region.

Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Biotherapeutics, stated: "We are delighted that equecabtagene autoleucel has been grated the Orphan Drug Designation by the SFDA. This once again demonstrates international regulatory recognition of the clinical value of this innovative therapy. Saudi Arabia serves not only as a crucial starting point for our extension into the Middle East market, but also represents a significant step in our steady strategy of "Go Global". We will work closely with local regulatory authorities, medical institutions and partners to advance the approval processes of Equecabtagene Autoleucel in Saudi Arabia, with the goal of delivering clinical benefits to patients in these regions."

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 domain, and 4-1BB co-stimulatory molecule 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 deep and durable remission,providing continuous protection and care for patients with multiple myeloma.

About IASO Bio

IASO Bio is a biopharmaceutical company focused on the discovery and development of innovative cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization.

Its pipeline includes a diversified portfolio of over 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 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022.

Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.

View original content:https://www.prnewswire.com/news-releases/iaso-bio-receives-orphan-drug-designation-from-the-saudi-food-and-drug-authority-for-equecabtagene-autoleucel-302450954.html

SOURCE IASO Bio