China-based pharmaceutical firm RemeGen (HKG: 9995) has announced the first patient dosing in a global multi-center Phase III clinical study for its fusion protein drug telitacicept, targeting moderate to severe active systemic lupus erythematosus (SLE). The study will be conducted across more than 100 centers in North America, Central/South America, Europe, Asia, and other regions.
Drug Background and Mechanism
Telitacicept is a novel recombinant fusion protein that targets both B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). It received approval in China for the treatment of SLE in March of last year, becoming the country’s first domestically developed SLE drug. The drug was officially launched into the market on March 31, with a standard retail price of RMB 2,586 (USD 395) per shot. Telitacicept was included in China’s National Reimbursement Drug List (NRDL) at the end of 2021.
Clinical Trial Progress
A Phase III study for telitacicept in SLE is currently undergoing data cleansing in China. Additionally, Phase II/III trials for the drug in rheumatoid arthritis, IgA nephritis, Sjögren’s syndrome, neuromyelitis optica, myasthenia gravis, and other autoimmune diseases are ongoing in China. A Phase II clinical study in IgA nephropathy is also advancing in the US.-Fineline Info & Tech
