The world’s first approved fully human BCMA-targeted CAR-T/FUCASO
BCMA CAR-T FUCASO
On June 30, 2023，China National Medical Products Administration(NMPA) has approved the New Drug Application (NDA) for FUCASO(Equecabtagene Autoleucel, co-developed and co-commercialized by IASO Bio and Innovent, IASO Bio R&D code: CT103A, Innovent R&Dcode: IBI326) the world’s first fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM)who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent.
FUCASO (Equecabtagene Autoleucel Injection)
FUCASO (Equecabtagene Autoleucel) is an autologous BCMA CAR-T cell injection, transduced by a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3 activation domains. FUCASO® was given as a one-time treatment with a recommended dose of 1.0×106 CAR-T cells/kg. Based on strict selection and screening of the molecular structures, using a proprietary in-house optimization platform and integrated in-house manufacturing process, FUCASO is potent and shows prolonged persistency inpatients. It will bring new treatment options to R/R MM patients with higher and more profound responses.
About IASO Bio
IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel 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 commercial production.
The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China’s National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM.
Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world.
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