前沿生物:FB7013注射液临床试验申请获得受理

Core Viewpoint - Frontier Biotech (688221.SH) has submitted a clinical trial application for FB7013, a siRNA drug targeting the MASP-2 protein, aimed at treating primary immunoglobulin A nephropathy (IgA nephropathy), marking it as the first-in-class drug in this category [1] Group 1 - The clinical trial application was submitted to the National Medical Products Administration on December 22, 2025, and the acceptance notice was received on December 31, 2025 [1] - FB7013 demonstrates strong and sustained inhibition of the target protein in healthy crab-eating macaques and shows clear efficacy in a crab-eating macaque model of IgA nephropathy, with good safety profile [1] - This drug represents a significant advancement as it is the first globally to target the MASP-2 protein with siRNA technology [1]