前沿生物FB7013临床试验申请获受理 全球首款靶向MASP-2靶点siRNA新药进入临床申请审批通道

Core Viewpoint - Frontier Biotech's siRNA drug FB7013 has received clinical trial approval from the National Medical Products Administration, marking a significant milestone in the treatment of IgA nephropathy [1][2] Company Summary - FB7013 is the world's first siRNA drug targeting the key protein MASP-2 in the complement lectin pathway, developed independently by Frontier Biotech [1] - The drug aims to treat primary immunoglobulin A nephropathy (IgA nephropathy) by specifically inhibiting MASP-2, thereby reducing complement-mediated kidney tissue damage [1] - Clinical pre-research indicates that a single subcutaneous injection in healthy monkeys resulted in over 95% reduction of serum MASP-2 protein, with effects lasting over 105 days [1] - The drug shows significant dose-dependent efficacy in IgA nephropathy models, with improvements in urinary protein levels and kidney function [1] - The clinical trial approval is a crucial step for Frontier Biotech in establishing itself as a competitive player in the global siRNA innovation market [2] Industry Summary - The global IgA nephropathy patient population is projected to reach 10.2 million by 2030, with the treatment market expected to grow from $567 million in 2020 to $1.196 billion by 2025, reflecting a compound annual growth rate of 16.1% [2] - Current treatments primarily involve corticosteroids and immunosuppressants, which have limited efficacy and significant side effects [2] - If successful, FB7013 could provide a new treatment option for IgA nephropathy and potentially expand to other diseases related to complement pathway abnormalities, such as membranous nephropathy and diabetic nephropathy [2]