telitacicept + methotrexate

Telitacicept (RC18) is a first-in-class recombinant fusion protein developed by RemeGen Co., Ltd. for the treatment of various autoimmune diseases. It is constructed by fusing the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept dual-targets and neutralizes two critical cell-signaling molecules: B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing B-cell mediated autoimmune responses. In the treatment of rheumatoid arthritis (RA), telitacicept is evaluated in combination with methotrexate (MTX), a folate antimetabolite that inhibits dihydrofolate reductase. This combination is specifically intended for patients with moderate to severe RA who have shown an inadequate response to methotrexate monotherapy. A Phase III clinical trial demonstrated that the combination of telitacicept 160 mg and MTX significantly improved ACR20 response rates compared to MTX alone, leading to a New Drug Application submission to China's NMPA in 2023.

Brand names

Tai'ai

Other names

telitacicept plus methotrexateRC18 plus MTXRC-18 plus MTXRC 18 plus MTX