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阿斯利康(AZN.US)凡舒卓 新适应症在华获批 用于儿童重度嗜酸粒细胞性哮喘的维持治疗
Zhi Tong Cai Jing· 2025-08-07 07:40
Core Insights - AstraZeneca (AZN.US) announced the approval of its first respiratory biologic, Fasenra (benralizumab), for a new indication in China, specifically for the maintenance treatment of severe eosinophilic asthma (SEA) in children aged 6 to under 12 years [1] Group 1: Approval and Clinical Trials - The approval is based on positive results from the global multicenter, open-label TATE Phase III clinical trial [1] - This trial was conducted in the United States and Japan to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and long-term safety of benralizumab in SEA pediatric patients aged 6-11 years [1] Group 2: Sales Performance - Since its initial approval, benralizumab has shown steady sales growth, entering the $1 billion sales club in 2021 [1] - Global sales are projected to reach $1.689 billion in 2024, reflecting an 8.76% year-over-year growth [1] - According to the semi-annual report disclosed for 2025, the drug's sales for the first half of the year reached $920 million, marking an 18% year-over-year increase [1]