RemeGen's Telitacicept shows positive results in IgA nephropathy trial

RemeGen Co., Ltd. announced that its global first-in-class BLyS/APRIL dual-target fusion protein, Telitacicept, met the primary endpoint in Stage A of its Phase III clinical trial for IgA Nephropathy (IgAN) in China. The company plans to submit a Biologics License Application (BLA) to the CDE of the NMPA for this indication.

The multi-center, randomized, double-blind, placebo-controlled trial involved 318 adult IgAN patients. Results showed that the Telitacicept group, receiving 240mg once weekly, achieved a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) after 39 weeks of treatment, compared to the control group. The drug also demonstrated a favorable tolerability and safety profile.

Telitacicept is currently approved in China for myasthenia gravis, systemic lupus erythematosus, and rheumatoid arthritis. IgAN is a leading cause of chronic kidney disease and end-stage renal disease in China, with up to 40% of patients progressing to ESRD within 20 years.