原始来源记录
重大FDA 说明书更新
Protalix：欧盟委员会/MHRA批准Elfabrio E4W给药方案用于法布里病
欧盟委员会和MHRA批准了Elfabrio用于成人法布里病患者的新型2 mg/kg每4周给药方案，这些患者在酶替代治疗（ERT）下病情稳定，使其成为欧盟/英国唯一提供E4W选项的ERT。Protalix从Chiesi获得2500万美元的监管里程碑付款。美国FDA批准的给药方案仍为每2周1 mg/kg。
关键事实
- 申报时间
- 2026年5月21日 11:03
- 事件
- FDA 说明书更新
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 里程碑付款
- 2500万美元
来源摘录
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