BLyS/APRIL双靶点融合蛋白创新药

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荣昌生物(09995):泰它西普(商品名:泰爱®)治疗IgA肾病中国III期临床研究A阶段达到主要终点
Zhi Tong Cai Jing· 2025-08-27 10:47
Group 1 - The core point of the article is that Rongchang Biologics (09995) has achieved the primary endpoint in the Phase III clinical trial of its innovative drug Taitasip (brand name: Tai'ai) for the treatment of IgA nephropathy (IgAN) in China [1] - The Phase III trial was a multicenter, randomized, double-blind, placebo-controlled study involving 318 adult patients with IgAN who had received standard treatment [1] - Taitasip was administered at a dosage of 240mg via subcutaneous injection once a week, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the control group after 39 weeks (P<0.0001) [1] Group 2 - IgAN is a common primary glomerular disease that can lead to severe hypertension or renal dysfunction, with up to 40% of patients reaching end-stage renal disease within 20 years of diagnosis [2] - The pathogenesis of IgAN is believed to be linked to the excessive secretion of galactose-deficient IgA1 (Gd-IgA1), with BLyS and APRIL being key cytokines in promoting Gd-IgA1 and its antibodies [2] - Taitasip is a recombinant dual-target fusion protein that inhibits both BLyS and APRIL, preventing abnormal differentiation and maturation of B cells, thereby alleviating pathological immune responses [2]