Grifols' Subsidiary Biotest Receives FDA Approval For Yimmugo, An Intravenous Immunoglobulin Therapeutic, To Treat Primary Immunodeficiencies, With US Launch Expected In Second Part Of 2024
Grifols' Subsidiary Biotest Receives FDA Approval For Yimmugo, An Intravenous Immunoglobulin Therapeutic, To Treat Primary Immunodeficiencies, With US Launch Expected In Second Part Of 2024
基立福子公司Biotest獲得FDA批准，推出治療原發性免疫缺陷病的靜脈免疫球蛋白治療藥物Yimmugo，預計於2024年下半年在美國上市。
- With Biotest-developed Yimmugo, Grifols adds to its remarkable franchise of intravenous and subcutaneous immunoglobulins to meet strong demand
- Yimmugo, already approved for production and marketing in Europe, is the first U.S.-approved medicine in Biotest's portfolio and is manufactured with an innovative process at Biotest's new FDA-certified 'Next Level' facility
- U.S. approval of Yimmugo paves the way for other Biotest proteins in late-stage development, including fibrinogen and trimodulin
- Launching Yimmugo in the U.S. will over time significantly add to Grifols Group sales and underpins its future growth strategy
- 通過Biotest開發的Yimmugo，Grifols增加了其IVIG和SCIG的銷售。以滿足大量的需求。
- Yimmugo已在歐洲獲得生產和營銷批准，是Biotest組合中首個獲得美國批准的藥品。是在Biotest的新的FDA認證的“Next Level”工廠中使用創新的工藝製造的。
- Yimmugo獲得美國批准將爲正在進行晚期開發的其他Biotest蛋白質，包括纖維蛋白原和三聯模聯蛋白提供方便。
- 在美國推出Yimmugo將隨着時間的推移顯着增加Grifols集團的銷售額，並支撐其未來的增長策略。
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