Pharma Focus Asia

RemeGen Obtains Positive Phase III Results for New Drug Telitacicept(RC18)

Wednesday, September 27, 2023

RemeGen announced the positive results in a phase III clinical study of Telitacicept (RC18) for the treatment of rheumatoid arthritis (RA) in China. 

This new drug application was based on a rigorous randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial that enrolled a total of 479 patients with rheumatoid arthritis.

Telitacicept is a proprietary fusion protein designed to target autoimmune diseases. It consists of the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor, combined with the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). 

Telitacicept targets two crucial cell-signaling molecules that play pivotal roles in B-lymphocyte development: B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). By doing so, it effectively reduces B-cell mediated autoimmune responses, which are implicated in numerous autoimmune diseases.

Rheumatoid arthritis (RA) is a chronic autoimmune condition characterized primarily by erosive arthritis and affects a substantial number of individuals worldwide. The positive outcomes of Telitacicept's phase III clinical trial offer a promising new therapeutic option for RA patients globally. This innovative treatment has the potential to alleviate the burden of RA and enhance the quality of life for those living with this condition.

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