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.”
