Globenewswireยท2025-11-08 16:45Core Insights - Telitacicept achieved a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared to placebo, demonstrating significant clinical benefits in treating IgA nephropathy (IgAN) [1][3] - The Phase 3 clinical study in China met its primary endpoint and showed statistically significant improvements across all key secondary endpoints, indicating telitacicept's potential as a foundational therapy for B-cell mediated diseases [2][4] Group 1: Clinical Study Results - The Phase 3 study was a multicenter, randomized, double-blind, placebo-controlled trial involving 318 adult patients with IgAN at high risk of progression [2][5] - Telitacicept demonstrated a significant reduction in 24h-UPCR (-58.9% vs. -8.8%, p<0.0001) and stabilized kidney function, with a change in estimated glomerular filtration rate (eGFR) showing a decline in the placebo group (-0.77) compared to stabilization in the telitacicept group (-0.10) [3][5] - 61% of patients on telitacicept achieved 24h-UPCR <0.8 g/g compared to 19.5% on placebo, indicating a lower risk of disease progression [5] Group 2: Safety Profile - Telitacicept exhibited a favorable safety profile, with treatment-emergent adverse events occurring in 89.3% of patients compared to 78.6% in the placebo group; however, serious adverse events were less frequent with telitacicept (2.5% vs. 8.2%) [6] Group 3: Regulatory and Market Potential - RemeGen has submitted a Biologics License Application (BLA) to the National Medical Products Administration (NMPA) in China for telitacicept in treating IgAN, which could mark its fifth approved indication in the country [7][10] - Vor Bio is focused on advancing telitacicept through Phase 3 clinical development to address serious autoantibody-driven conditions globally [8][9]