Zhi Tong Cai Jing·2025-08-27 10:42Group 1 - The company Rongchang Biologics (09995) announced that its self-developed innovative drug Tai'aisip (泰它西普) for treating IgA nephropathy (IgAN) has achieved the primary research endpoint in the Phase III clinical trial in China [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study involving 318 adult patients with IgAN who had received standard treatment, with a dosage of 240mg administered subcutaneously once a week [1] - The A stage analysis showed that the Tai'aisip group had a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the control group at 39 weeks (P<0.0001), demonstrating good tolerability and safety [1] Group 2 - IgAN is a common primary glomerular disease, with diverse clinical manifestations, and is a major cause of chronic kidney disease and end-stage renal disease in China, with up to 40% of patients reaching end-stage renal disease within 20 years of diagnosis [2] - The academic community believes that the excessive secretion of galactose-deficient IgA1 (Gd-IgA1) is a core factor in the pathogenesis of IgAN [2] - The drug Tai'aisip is a recombinant BLyS/APRIL dual-target fusion protein that inhibits the binding of BLyS and APRIL to B cell surface receptors, effectively reducing pathological immune responses [2]