RemeGen Co. Ltd. ("RemeGen"), a prominent biotechnology company, has recently secured Fast Track Designation (FTD) from the United States Food and Drug Administration (FDA) for its innovative drug Telitacicept (RC18). Telitacicept, a novel BLyS/APRIL dual-target fusion protein, has been developed independently by RemeGen to address the needs of patients suffering from primary Sjögren's syndrome (pSS), a severe autoimmune condition characterized by dry eyes and mouth due to glandular dysfunction.

This designation from the FDA aims to expedite the development and review process of Telitacicept, recognizing its potential to treat life-threatening conditions and fulfill unmet medical needs in pSS patients. The drug targets B-cells, pivotal immune cells implicated in the pathogenesis of pSS. By inhibiting the overexpression of two cytokines, BLyS and APRIL, Telitacicept effectively prevents abnormal differentiation and maturation of B-cells, thereby mitigating autoimmune responses.

Dr. Jianmin Fang, CEO of RemeGen, expressed satisfaction with the FDA's acknowledgment of Telitacicept's significance, highlighting its success in clinical studies across various indications in China. Telitacicept has already obtained Investigational New Drug (IND) status from the FDA for treating active pSS in adults, and a phase III clinical trial is underway in China for this indication.

Telitacicept represents a milestone as the first fusion protein drug developed by RemeGen, demonstrating its potential to revolutionize treatment approaches for autoimmune diseases. With multiple Phase III clinical trials progressing smoothly both domestically and internationally, RemeGen is committed to advancing the global development of Telitacicept across various indications. The company aims to establish itself as a leader in B-cell-mediated autoimmunity drugs, leveraging Telitacicept's efficacy and innovative mechanism of action.

Telitacicept (RC18) is a proprietary fusion protein developed by RemeGen for treating autoimmune diseases. Comprising the extracellular domain of the TACI receptor and the Fc domain of human immunoglobulin G(IgG), Telitacicept effectively targets BLyS and APRIL, key signaling molecules in B-lymphocyte development. This dual-target approach enables Telitacicept to alleviate B-cell-mediated autoimmune responses implicated in various autoimmune diseases. The drug has already received marketing approval from China's National Medical Products Administration (NMPA) for treating systemic lupus erythematosus (SLE) in November 2023.

 

Source: prnewswire.com

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