凡舒卓 在华获批新适应症，用于治疗成人嗜酸性肉芽肿性多血管炎

Core Viewpoint - Fasenra (benralizumab) has received approval from the NMPA for the treatment of adult eosinophilic granulomatosis with polyangiitis (EGPA), marking a significant advancement in the treatment options available for this rare autoimmune disease [1][4]. Group 1: Clinical Research and Approval - The approval is based on the results of the MANDARA global Phase III clinical trial, which is the first head-to-head study comparing the efficacy and safety of benralizumab with mepolizumab in patients with refractory EGPA [1][5]. - In the benralizumab treatment group, nearly 60% of patients achieved remission, consistent with the mepolizumab group, while 41% of patients could completely discontinue oral corticosteroids (OCS), compared to 26% in the mepolizumab group [1][5]. - The open-label extension study of the MANDARA trial showed that patients switching from mepolizumab to benralizumab had an OCS discontinuation rate of up to 43.5% [1]. Group 2: Disease Background and Treatment Challenges - EGPA is a rare autoimmune disease characterized by eosinophil infiltration and necrotizing granulomatous inflammation, primarily affecting the respiratory system and leading to severe complications if untreated [2][4]. - Current treatment options are limited, with many patients requiring high-dose OCS and experiencing frequent relapses, as approximately 75% of patients have not achieved remission despite multiple therapies [2][4]. Group 3: Expert Opinions and Future Directions - Experts highlight that benralizumab's approval represents a milestone in providing targeted therapy for EGPA, potentially improving patient outcomes and reducing reliance on corticosteroids [3][4]. - The subcutaneous administration of benralizumab every four weeks enhances treatment convenience for patients, addressing a significant need for effective and safe treatment options [3][4]. - AstraZeneca plans to continue exploring the potential of benralizumab in other eosinophil-related diseases, aiming to innovate treatment strategies in this area [3][6].