China's National Medical Products Administration (NMPA) has approved felzartamab, an anti-CD38 monoclonal antibody, in combination with lenalidomide and dexamethasone for adults with relapsed/refractory multiple myeloma who have received at least one prior line of therapy.
The approval, granted to China-based TJ Biopharma and Biogen (Nasdaq:
BIIB), marks the first regulatory clearance for felzartamab anywhere in the world.
Under a deal struck in April 2026, Biogen acquired exclusive Greater China commercialization rights for felzartamab, consolidating global rights to the asset.
Biogen will handle commercial launch; TJ Biopharma will supply the product from its GMP manufacturing facility in Hangzhou.
The China decision is felzartamab's first approval globally and comes four months after Biogen acquired TJ Biopharma's Greater China rights, consolidating worldwide control of the asset.
Sources:
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