Cai Jing Wang·2025-10-15 03:29Core Insights - Rongchang Biologics announced that its self-developed dual-target fusion protein innovative drug, Tai'axi, has received acceptance for its marketing application for the treatment of primary immunoglobulin A (IgA) nephropathy by the National Medical Products Administration (NMPA) and is included in the priority review process [1] - The application is based on positive results from the Phase III clinical study (Stage A) of Tai'axi for treating IgA nephropathy, which involved 318 adult patients receiving standard treatment [1] Group 1 - The Phase III clinical trial was a multi-center, randomized, double-blind, placebo-controlled study, where patients received a dosage of 240mg of Tai'axi via subcutaneous injection once a week [1] - The primary endpoint was achieved, showing that the Tai'axi group had a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment (P<0.0001) [1] - The drug demonstrated good tolerability and safety, with detailed data to be presented at an upcoming major international academic conference [1] Group 2 - IgA nephropathy is one of the most common primary glomerular diseases globally, with an estimated 10.16 million patients by 2030, including 2.37 million in China [2] - In China, IgA nephropathy patients account for approximately 54.3% of all renal biopsy cases, with 30% to 40% of these patients progressing to end-stage renal disease (ESRD), severely impacting their quality of life [2] - There is a significant unmet clinical need for effective treatments for IgA nephropathy, as current therapeutic options are very limited [2] - Besides IgA nephropathy, Tai'axi is also undergoing Phase II/III clinical studies for lupus nephritis and membranous nephropathy in China [2]