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Innovent and IASO Bio Gain NMPA Approval for FUCASO®, a Breakthrough BCMA CAR-T Therapy for Multiple Myeloma

Innovent Biologics, Inc. (HKEX: 01801) and IASO Biotechnology have jointly announced the approval of FUCASO® by the National Medical Products Administration (NMPA) in China. FUCASO® is the first fully-human BCMA-directed CAR T-cell therapy approved for the treatment of relapsed or refractory multiple myeloma (RRMM) in adult patients who have undergone at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

FUCASO® (Equecabtagene Autoleucel) utilizes lentivirus as a gene vector to introduce BCMA-directed CAR into autologous T cells. It features a fully-human scFv, CD8a hinge and transmembrane, as well as 4-1BB-mediated co-stimulation and CD3ζ activation domains. Through extensive evaluation, FUCASO® has demonstrated rapid and potent efficacy, long-lasting persistence, and significant clinical benefits for RRMM patients.

The therapy has received multiple regulatory designations and approvals in the United States, including Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) and Investigational New Drug (IND) approval. It has also been granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations by the FDA in February 2023. Furthermore, an IND application for the potential use of FUCASO® in Neuromyelitis Optica Spectrum Disorder (NMOSD) has been accepted by the NMPA.

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