China's RemeGen announced its BLyS/APRIL dual-target fusion protein telitacicept achieved the primary endpoint in the Phase III A-stage trial for IgA nephropathy, reducing proteinuria by 55% versus placebo at 39 weeks. The 318-patient study demonstrated significant reduction in 24-hour urine protein-to-creatinine ratio with weekly 240 mg subcutaneous dosing, supporting planned New Drug Application (NDA) submission to China's Centre for Drug Evaluation (CDE). Telitacicept is the only therapy simultaneously inhibiting both B-cell activating factors implicated in IgA pathogenesis.

IgA nephropathy affects 2.37 million patients in China, representing 54.3% of renal biopsy cases with 30% to 40% progressing to end-stage renal disease. RemeGen's candidate addresses critical unmet needs in this immune-mediated kidney disorder where abnormal BLyS and APRIL levels drive pathogenic immunoglobulin A deposition. The company previously reported Phase III success for telitacicept in Sjögren's syndrome in August 2025, expanding its autoimmune disease portfolio beyond approved indications for lupus and myasthenia gravis.

PharmCube's NextBiopharm® database shows that, apart from RemeGen, seven other companies are actively developing BLyS/APRIL-targeting therapies. Click here to request a free trial for NextBiopharm®.