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Innovent Biologics, Inc. and IASO Biotechnology have announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel). FUCASO is the first fully-human BCMA-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. FUCASO (Equecabtagene Autoleucel) is a BCMA-directed CAR T cell therapy, using lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on selection and screening of the molecular structures, and in vivo and in vitro evaluation, FUCASO has demonstrated rapid and potent efficacy as well as prolonged persistency in RRMM patients, providing higher and deeper responses and long-term clinical benefit. Innovent and IASO Bio are responsible for the joint development and commercialization of FUCASO for treatment of RRMM in China. The NDA approval was based on the results from the FUMANBA-1 clinical study, a multi-center phase I/II registrational clinical trial conducted in China to evaluate the efficacy of Equecabtagene Autoleucel in patients with RRMM. Clinical study A total of 103 subjects received a dose of 1.0×106 CAR-T cells/kg, with a median follow-up time of 13.8 months. Among the 101 evaluable patients, the overall response rate (ORR) was 96%, and the stringent complete response/complete response (sCR/CR) rate was 74.3%. Median time to response (mTTR) was 16 days, and the 12-month PFS rate was 78.8%. 95% of the patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Of the 12 patients with prior CAR-T therapy, nine achieved CR, and five achieved sCR (including 4 patients that sustained sCR for over 18 months post-infusion). In 89 patients without prior CAR-T therapy, 7% reached sCR/CR. Of the 103 patients, only one experienced grade ≥3 cytokine release syndrome (CRS), and two experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS). All patients with CRS or ICANS recovered after the treatment. Equecabtagene Autoleucel was still detectable in 50% and 40% respectively of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% of the patients were anti-drug antibody (ADA)-positive after Equecabtagene Autoleucel infusion. 'Novel breakthrough option' The principal investigators of FUMANBA-1 study, Lugui Qiu, Chinese Academy of Medical Science Hematology Hospital, and Chunrui Li, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, said: “There’s a significant unmet clinical need for the treatment of multiple myeloma (MM) in China. As a fully-human BCMA CAR-T therapy, FUCASO has demonstrated remarkable efficacy, with evidence of deep and durable response for high-quality survival for MM patients. We believe that FUCASO’s approval offers clinicians a novel breakthrough option benefiting patients with later-line RRMM.” Hui Zhou, senior vice president of Innovent Biologics, said: "Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are almost inevitable after current treatments. There’s an urgent unmet need of a treatment with well-tolerated and long persistence for RRMM patients in China. FUCASO, as an innovative fully-human BCMA-directed T cell therapy, has demonstrated robust and long-lasting efficacy and outstanding safety in long-term follow-up data from the registrational clinical study, which underscores its potential to be a pioneering treatment option for patients with RRMM. We are very pleased with the approval of FUCASO and hope it could benefit RRMM patients as the first approved BCMA CAR-T therapy in China." Jinhua Zhang, chairman and chief executive officer of IASO Bio, added: "We are excited that FUCASO was approved as a new drug, which is a significant milestone for our team. FUCASO is not only IASO Bio’s first commercialized product but is also the world's first commercially available fully-human CAR-T therapy. Furthermore, FUCASO is the first self-developed and independently manufactured CAR-T cell therapy in China as well as China’s first approved BCMA CAR-T product and first approved cell therapy for the treatment of MM in China. The NMPA’s NDA approval of FUCASO will help us in achieving our strategic goal of bringing groundbreaking treatment options, as well as new hope for a potential cure, to MM patients in need."

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