RemeGen (HKG: 9995), a China-based pharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another market filing for its drug telitacicept with priority review status. The filing seeks approval for the treatment of generalized myasthenia gravis (gMG), a serious neurological condition.
Telitacicept is an innovative recombinant fusion protein that targets both B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). It was conditionally approved in China for the treatment of systemic lupus erythematosus (SLE) in March 2021, and this conditional approval was converted to a full approval in November 2023. Additionally, in July this year, the NMPA granted full approval for telitacicept combined with methotrexate for the treatment of moderate to severe rheumatoid arthritis (RA) patients who have shown a poor response to methotrexate.
The acceptance of the market filing for telitacicept for gMG and the priority review status underscore RemeGen’s commitment to expanding the drug’s therapeutic applications and addressing unmet medical needs in the field of autoimmune diseases.- Flcube.com
