Legend Biotech, a subsidiary of GenScript Biotech Corporation, a global leader in life sciences research and manufacturing services, has received approval from the China National Medical Products Administration (NMPA) for its cell therapy product, ciltacabtagene autoleucel (cilta-cel).

This groundbreaking treatment is approved for use in adult patients with relapsed or refractory multiple myeloma (MM) who have previously undergone at least three prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent. The approval of cilta-cel provides a novel treatment for patients in China who have not benefit from traditional therapies.

Cilta-cel is a gene-modified autologous chimeric antigen receptor T cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA). It is administered via intravenous infusion. Cilta-cel features a unique CAR structure composed of two BCMA-targeting, heavy-chain, single-domain antibodies. This design allows cilta-cel to bind the BCMA-expressing myeloma cells, and induce activation and proliferation of T cells to eliminate tumour.

Legend Biotech CEO Ying Huang stated, "The approval of cilta-cel in China market marks a key milestone and will bring significant benefits to many patients. Moving forward, we will continue to pursue our goal of curing patients, expand our clinical research, and enhance the accessibility of this innovative product to benefit more patients."