Pharma Focus Asia

Innovent Bio and IASO Biotechnology Announced National Medical Products Administration Approval for FUCASO®

Monday, July 03, 2023

Innovent Biologics and IASO Biotechnology announced that the China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO®, the first fully-human BCMA CAR-T Therapy, for the treatment of relapsed or refractory multiple myeloma.

The approval of FUCASO® is based on the positive results from the FUMANBA-1 clinical study (CTR20192510, NCT05066646), a Phase I/II registrational clinical trial conducted in China. This study evaluated the efficacy of Equecabtagene Autoleucel in patients with RRMM. The results demonstrated remarkable efficacy, with evidence of deep and durable responses, leading to high-quality survival for patients with RRMM.

FUCASO® (Equecabtagene Autoleucel) is indeed an innovative fully-human anti-BCMA CAR-T cell therapy. It utilises lentivirus as a gene vector to introduce genetic modifications into a patient's own T cells (autologous T cells).

The CAR (chimeric antigen receptor) in FUCASO® consists of several important components. It includes a fully-human single-chain variable fragment (scFv), which is responsible for recognising and binding to BCMA (B-cell maturation antigen) on multiple myeloma cells. The scFv allows the CAR T cells to specifically target and attack BCMA-expressing cancer cells. 

Multiple myeloma is a type of blood cancer that has a significant unmet clinical need in China. The approval of FUCASO® provides a novel breakthrough treatment option for clinicians and offers hope to patients with later-line RRMM.

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