China grants first global approval for felzartamab

Chinese biotechnology company TJ Biopharma and US-based Biogen Inc announced on Thursday that felzartamab for injection had received marketing approval from China's National Medical Products Administration.

The drug was approved for use alongside lenalidomide, an immunomodulatory medicine, and dexamethasone, a corticosteroid, in adults with multiple myeloma who have received at least one prior line of therapy, according to the NMPA.

Felzartamab is a human monoclonal antibody targeting CD38. Its approval for multiple myeloma, a type of blood cancer, marks the drug's first approval anywhere in the world, said a joint statement by TJ Biopharma and Biogen.

CD38 is a protein found mainly on plasma cells, plasmablasts and natural killer cells. Clinical studies have shown that felzartamab can selectively deplete CD38-positive plasma cells, the companies said.

In April, Biogen acquired exclusive rights from TJ Biopharma to develop and commercialize the drug in China, consolidating the US company's worldwide rights to felzartamab.

Under the agreement, Biogen will be responsible for commercialization, while TJ Biopharma will manufacture and supply the drug from its facility in Hangzhou, Zhejiang province.