RemeGen (HKG: 9995), a China-based pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to proceed with a global multi-center Phase III clinical study for its fusion protein drug telitacicept in the treatment of active primary Sjogren’s syndrome (pSS). This 48-week, multi-center, randomized, double-blinded, placebo-controlled Phase III study aims to evaluate the efficacy and safety of 160mg telitacicept in adult patients with active pSS, as well as its pharmacokinetic properties, pharmacodynamics, and immunogenicity. Prior non-clinical studies and preliminary clinical trials have demonstrated significant efficacy and a favorable safety profile for the drug in adult pSS patients.
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, marking the first domestic SLE drug in China. The drug was included in the National Reimbursement Drug List (NRDL) at the end of 2021. Furthermore, telitacicept is in Phase II/III clinical studies for myasthenia gravis (MG), rheumatoid arthritis (RA), and other conditions, with the RA indication under marketing approval review in China. The drug has also gained clinical approval for use in MG in the US.- Fineline.com
