Telitacicept: First Approval

Telitacicept (Tai'ai(R)) is fusion protein comprising a recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept is being developed by Yantai Rongchang Pharmaceutical through its subsidiary RemeGen for the treatment of B cell-mediated autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and multiple sclerosis (MS). Telitacicept binds to and neutralizes the activity of two cell-signalling molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing the development and survival of plasma cells and mature B cells. In March 2021, telitacicept received its first approval in China for the treatment of patients with active SLE. Clinical studies of telitacicept in several other indications, including IgA nephropathy, MS, myasthenia gravis, neuromyelitis optica spectrum disorders, RA and Sjogren's syndrome are underway in China. This article summarizes the milestones in the development of telitacicept leading to this first approval for SLE.

Automated summary

Telitacicept is a fusion protein developed for the treatment of B cell-mediated autoimmune diseases by binding and neutralizing specific cell-signalling molecules. It has received its first approval in China for the treatment of active SLE and is undergoing clinical studies for several other indications.