China-based pharma firm RemeGen (HKG: 9995) has announced receiving approvals from authorities in the European Union (EU) and China to conduct a global multi-center Phase III clinical study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE). This marks a significant step forward in the development of innovative treatments for SLE.
Telitacicept: Drug Profile and Development
Telitacicept is a novel recombinant fusion protein targeting both the B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). The drug was conditionally approved in China to treat SLE in March 2021, becoming the first domestically developed SLE drug in the country. RemeGen set a standard retail price of RMB 2,586 (USD 359) per shot for telitacicept on March 31, the day it was officially launched onto the market. The drug was included in the National Reimbursement Drug List (NRDL) at the end of 2021.
Clinical Study Results and Future Outlook
A Phase III confirmatory study for telitacicept in SLE in China was completed last month, with preliminary results showing that the drug produced a significantly higher SRI-4 response rate than placebo (P < 0.001). This indicates the drug’s potential to provide substantial benefits to patients with SLE. In addition to SLE, telitacicept is undergoing Phase II/III clinical studies in other indications, including Sjogren’s syndrome, IgA nephropathy, neuromyelitis optica, multiple sclerosis, myasthenia gravis (MG), and more.-Fineline Info & Tech
