阿斯利康(AZN.US)自免双抗“戈鲁利单抗”在华申报上市

Core Viewpoint - AstraZeneca has submitted an application for the approval of gefurulimab in China, targeting generalized myasthenia gravis (gMG) as its indication, based on clinical trial progress [1] Group 1: Product Information - Gefurulimab is a mini bispecific antibody (25kD) that includes a variable region of the antibody heavy chain targeting C5 and an antibody fragment that specifically binds to albumin [1] - The smaller molecular weight of gefurulimab allows for better permeability, and its binding to albumin extends its half-life [1] Group 2: Disease Context - Generalized myasthenia gravis (gMG) is a rare, debilitating, chronic autoimmune neuromuscular disease that leads to muscle function loss and severe weakness [2] - Initial symptoms of gMG may include slurred speech, diplopia, ptosis, and weakness, with progression leading to more severe symptoms such as extreme fatigue, difficulty swallowing, choking, and respiratory failure [2]