奇耶西全球罕见病公司申请重新审查欧洲药品管理局CHMP对Elfabrio 2 mg/kg每4周给药方案的负面意见

投资观察
Nov 04, 2025

11月3日(路透社) - 奇耶西全球罕见病公司请求重新审查欧洲药品管理局(EMA)药品人用委员会(CHMP)对Elfabrio(PEGUNIGALSIDASE ALFA)每4周2 mg/kg给药方案的负面意见,同时与Protalix BioTherapeutics共同寻求对此持否定态度的重新审查。现有的Elfabrio市场授权依然生效。

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