Therapy Areas: Inflammatory Diseases
RemeGen's Telitacicept receives US FDA Fast Track Designation
3 April 2024 -

RemeGen Co Ltd (9995.HK, 688331.SH), a China-based commercial-stage biotechnology company, announced on Tuesday that it has received Fast Track Designation (FTD) from the United States Food and Drug Administration (FDA) for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18), intended for the treatment of patients with primary Sjögren's syndrome (pSS).

Telitacicept has been independently developed by RemeGen and is an innovative BLyS/APRIL dual-target fusion protein drug that simultaneously inhibits the overexpression of two cytokines, B-cell lymphocyte stimulator (Blys) and a proliferation-inducing ligand (APRIL). It prevents abnormal differentiation and maturation of B-cells via a two-pronged approach, thereby treating various autoimmune diseases mediated by B-cells.

Dr Jianmin Fang, RemeGen CEO, said: "As the first fusion protein drug of its kind independently developed by RemeGen, we are delighted the FDA has recognised Telitacicept for fast-track designation. It has performed well in clinical studies for multiple indications that have been marketed in China, including primary Sjögren's syndrome (pSS) and systemic lupus erythematosus (SLE) with rheumatoid arthritis, igA nephritis, and myasthenia gravis (MG) in the pipeline. Multiple Phase III clinical trials are progressing smoothly both domestically and abroad and we are accelerating global development of multiple indications of Telitacicept, and we are confident of cementing a leadership position in B-cell-mediated autoimmunity drugs."