智通财经网·2025-08-27 10:45Group 1 - The company Rongchang Biologics (09995) announced that its self-developed innovative drug Tai'aisip (泰爱®), a first-in-class BLyS/APRIL dual-target fusion protein, has met the primary endpoint in the Phase III clinical trial for treating IgA nephropathy (IgAN) 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] - Results from the A stage analysis showed that patients in 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, including recurrent microscopic or macroscopic hematuria and varying degrees of proteinuria, and is a major cause of chronic kidney disease and end-stage renal disease in China [2] - Up to 40% of IgAN patients may reach end-stage renal disease within 20 years of diagnosis, indicating a pressing unmet medical need for new therapies [2] - The company’s Tai'aisip targets the underlying mechanisms of IgAN by inhibiting the production of Gd-IgA1 and its antibodies through the dual inhibition of BLyS and APRIL, which are key cytokines in the disease process [2]