Protalix：歐洲藥品管理局/英國藥品及醫療保健產品管理局核准 Elfabrio E4W 給藥方案用於 Fabry 病

歐洲藥品管理局和英國藥品及醫療保健產品管理局核准 Elfabrio 針對已接受酵素替代療法（ERT）且病情穩定的成年 Fabry 病患者，採用每 4 週 2 mg/kg 的新給藥方案，使其成為歐盟/英國唯一提供 E4W 選項的 ERT。Protalix 從 Chiesi 獲得 2500 萬美元的法規里程碑付款。美國 FDA 核准的給藥方案仍為每 2 週 1 mg/kg。

關鍵事實

申報時間: 2026年5月21日上午11:03
事件: FDA 仿單更新
方向: 正面
公司: PLXProtalix BioTherapeutics
資產: pegunigalsidase alfa
來源: SEC 8-K
可信度: 有出處
里程碑付款: 2500 萬美元

來源摘錄

EX-99.1 2 plx-20260521xex99d1.htm EX-99.1 Exhibit 99.1 1 PROTALIX BIOTHERAPEUTICS C O R P O R A T E P R E S E N T A T I O N J u n e 2024 PROTALIX BIOTHERAPEUTICS Pioneering solutions to transform the treatment of rare diseases C O R P O R A T E P R E S E N T A T I O N M a y 2026 2 Forward-Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management’s current expectations or plans, and projections for future operating and financial performance, based on assumptions currently

SEC 8-K