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.
TJ Biopharma led clinical development and the NMPA registration filing in Greater China. 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 approval follows a randomized Phase III study in Chinese patients with relapsed/refractory multiple myeloma who had received at least one prior line of therapy. The study compared felzartamab plus lenalidomide and dexamethasone with lenalidomide and dexamethasone, with progression-free survival as the primary endpoint. TJ Biopharma previously reported that the registrational study met its prespecified efficacy endpoints, although detailed Phase III results have not been publicly disclosed.
Felzartamab is a fully human IgG1 anti-CD38 monoclonal antibody originally developed by MorphoSys AG, now MorphoSys GmbH under Novartis. It targets CD38, a glycoprotein highly expressed on plasma cells and natural killer cells, depleting CD38-positive malignant cells through antibody-dependent cellular cytotoxicity and other immune effector mechanisms. The company said clinical studies indicate selective depletion of CD38-positive plasma cells, with potential applicability across antibody-driven diseases beyond myeloma.