GreenGene F在美治疗A型血友病进入3期临床试验

2012-04-16 环球医学环球医学

2012年2月28日，美国FDA批准韩国生物制药公司绿十字公司的IND申请，该IND申请是关于启动一项重组VIII因子产品GreenGene F(Berotocog alfa)在美国治疗A型血友病的3期临床试验。 GreenGene F是一种重组人B区缺失凝血因子VIII，目前正由绿十字公司开发。理化分析显示，GreenGene F的同质性得到了改善且杂质水平较低。此外，制造过程中采用无血清和白

2012年2月28日，美国FDA批准韩国生物制药公司绿十字公司的IND申请，该IND申请是关于启动一项重组VIII因子产品GreenGene F(Berotocog alfa)在美国治疗A型血友病的3期临床试验。

GreenGene F是一种重组人B区缺失凝血因子VIII，目前正由绿十字公司开发。理化分析显示，GreenGene F的同质性得到了改善且杂质水平较低。此外，制造过程中采用无血清和白蛋白培养方式，再加上两道病原体灭活工序，并用一种专利的氨基酸组成替代白蛋白来稳定最终的结构。

绿十字说：“GreenGene F是第三代重组凝血因子VIII，其所携带的感染风险极小，并已于2010年获韩国食品和药物管理局(KFDA)批准后在韩国上市。有了这项临床研究，我们就有望将GreenGene F的市场扩大到其他国家，我们预计，随着其安全性得到改善，GreenGene F将为A型血友病患者提供更多的选择。”（生物谷 Bioon.com）

>>延伸阅读：Science：基因研究证明“皇家病”是B型血友病

>>延伸阅读：NEJM：基因疗法治疗血友病获初步成功

>>延伸阅读：Blood：血管性血友病因子(VWF)功能的新调控机制

>>延伸阅读：E．Eng．Jou．：基因治疗可用于B型血友病

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2012-09-02 仁者大医

#A型血#

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2012-08-02 cy0324

#Gene#

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2013-03-18 andy2087

#3期临床#

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2012-12-25 spoonycyy

#Eng#

29 0
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2012-04-18 changfy

#A型血友病#

28 0
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2012-04-18 仁医06

#3期临床试验#

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