4 月 3 日,CDE 官网显示,阿斯利康本瑞利珠单抗注射液新适应症上市申请获受理。此前 2024 年 8 月,该产品已在国内获批用于成人和12岁及以上青少年重度嗜酸粒细胞性哮喘(SEA)的维持治疗,今年 3 月又斩获新适应症。根据临床试验和国内外注册进展,Insight 数据库推测此次申报适应症为6 至 11 岁患者 SEA 或嗜酸性肉芽肿病伴多血管炎。来源:CDE 官网本瑞利珠单抗(...
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