RemeGen has submitted a new drug application (NDA) in its China homeland for BLyS/APRIL dual-target fusion protein telitacicept in primary immunoglobulin A (IgA) nephropathy after Phase III data demonstrated 55% reduction in urinary protein creatinine ratio versus placebo at 39 weeks. The subcutaneous biologic met the primary endpoint in a 318-patient randomised double-blind study showing significant proteinuria reduction with a favourable tolerability profile. The indication has received priority review designation from China's Centre for Drug Evaluation (CDE), addressing an unmet need in progressive kidney disease where 30% to 40% patients advance to end-stage renal disease.

Telitacicept simultaneously inhibits the BlyS and APRIL cytokines driving pathogenic IgA production and immune complex deposition in glomeruli. The candidate holds three existing approvals for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and myasthenia gravis, with a primary Sjogren's syndrome application submitted in September 2025. The global IgA nephropathy patient population is projected to reach 10.16 million by 2030 including 2.37 million cases in China, representing a significant market opportunity for a first-in-class disease-modifying therapy.

According to PharmCube's NextBiopharm® database, RemeGen licensed telitacicept ex-China rights to Vor Biopharma. Click here to request a free trial for NextBiopharm®.