China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving 335 SLE patients who received either telitacicept (160 mg) or placebo subcutaneously once a week, in addition to standard treatment, over a period of 52 weeks. The study successfully met its predetermined clinical endpoint, with the SRI-4 response rate in the telitacicept group significantly outperforming the placebo group, demonstrating the drug’s efficacy and safety.
Telitacicept’s Mechanism of Action and Market Impact
Telitacicept is a novel recombinant fusion protein that targets both the B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). It was conditionally approved in China for SLE treatment in March 2021, marking the first domestic SLE drug in the country. The drug’s inclusion in the National Reimbursement Drug List (NRDL) at the end of 2021 further solidified its market position. Telitacicept is also undergoing Phase II/III clinical studies for myasthenia gravis (MG) and rheumatoid arthritis (RA), with the latter’s marketing approval review currently underway in China.- Flcube.com
