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药明生物祝贺Amicus新一代庞贝氏症疗法获FDA突破性疗法认定

2019-02-28 不详 美通社

全球领先的开放式生物制药技术平台公司药明生物(WuXi Biologics, 2269.HK)的合作伙伴Amicus(纳斯达克股票代码:FOLD)近日宣布,公司用于治疗晚发型庞贝氏症的新一代疗法AT-GAA(ATB200/AT2221)获美国FDA授予突破性疗法认定。药明生物对此表示热烈祝贺。庞贝氏症是由酸性α-葡萄糖苷酶(GAA)缺乏而引起的一种遗传性溶酶体贮积症(LSD)。AT-GAA是首个获

全球领先的开放式生物制药技术平台公司药明生物(WuXi Biologics, 2269.HK)的合作伙伴Amicus(纳斯达克股票代码:FOLD)近日宣布,公司用于治疗晚发型庞贝氏症的新一代疗法AT-GAA(ATB200/AT2221)获美国FDA授予突破性疗法认定。药明生物对此表示热烈祝贺。

庞贝氏症是由酸性α-葡萄糖苷酶(GAA)缺乏而引起的一种遗传性溶酶体贮积症(LSD)。AT-GAA是首个获得突破性疗法认定的庞贝氏症在研疗法。

药明生物(WuXi Biologics, 2269.HK)的 合作伙伴Amicus(纳斯达克股票代码:FOLD)近日宣布,公司用于治疗晚发型庞贝氏症的新一代疗法AT-GAA (ATB200/AT2221)获美国FDA授予突破性疗法认定。药明生物对此表示热烈祝贺 。

AT-GAA项目于2012年在药明生物平台上从一个“主意”诞生,在公司全球领先生物制药技术及强劲产能实力的支持下,目前已顺利进入三期临床试验阶段。不久前,药明生物与Amicus达成独家商业化生产战略合作,成为ATB200项目商业化阶段的独家原液生产合作伙伴和主要制剂供应合作伙伴,通过全球双重供应策略为其提供高质量生产服务。

“我们对Amicus取得这项激动人心的里程碑表示祝贺,”药明生物CEO陈智胜博士表示,“我们很荣幸通过药明生物世界一流技术能力和强劲产能实力赋能Amicus这样的创新合作伙伴。公司对确保ATB200在全球市场的供应充满信心,衷心祝愿此项目尽早获批上市,造福全球病患。”


值得一提的是,这是药明生物赋能合作伙伴开发的第二个收获突破性疗法认定的产品。艾滋病治疗抗体TrogarzoTM是药明生物赋能合作伙伴开发的首个获得突破性疗法认定的产品,于2018年3月获美国FDA批准上市,也是药明生物首个商业化生产项目。

关于AT-GAA

AT-GAA由一种碳水化合物结构优化的独特重组人酸α-葡糖苷酶(rhGAA)ATB200和药物伴侣AT2221组成。临床前研究显示,ATB200与组织酶水平升高,肌肉糖原水平降低以及肌肉力量增强相关。一项全球临床Ⅱ/Ⅲ期研究(ATB200-02)正在评估AT-GAA的安全性、耐受性及药代动力学和药效学情况。

Amicus在晚发型庞贝氏症成人患者中开展的另一项为期52周、双盲、随机全球Ⅲ期临床研究PROPEL(ATB200-03)旨在对比AT-GAA与目前标准疗法酶替代疗法(ERT)阿葡糖苷酶的疗效、安全性和耐受性。

关于Amicus

Amicus Therapeutics(纳斯达克股票代码:FOLD)是一家致力于为罕见代谢疾病患者发现、开发和提供高质量创新药的全球性生物技术公司。公司立足于“以患者为中心”,针对罕见代谢疾病打造了强大的先进在研产品线。

关于药明生物

药明生物(股票代码:2269.HK)作为一家香港上市公司,是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务,帮助任何人、任何公司发现、开发及生产生物药,实现从概念到商业化生产的全过程,加速全球生物药研发进程,降低研发成本,造福病患。截至2018年6月30日,在药明生物平台上研发的综合项目达187个,包括98个处于临床前研究阶段,78个在临床早期(I期,II期)阶段,10个在后期临床(III期)以及1个在商业化生产阶段。预计到2021年,公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能约22万升,这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药

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    2019-12-24 yhy100200
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    2019-03-01 1ddf0692m34(暂无匿称)

    学习了,长知识

    0

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    2019-02-28 坚强007

    向科研人员致敬!!!

    0

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