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夏帆宁获得中国国家药品监督管理局批准用于治疗1-6型慢性丙型肝炎

2018-12-04 美通社 美通社

吉利德科学1-6型慢性丙型肝炎病毒(HCV)感染
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吉利德科学（纳斯达克上市代码:GILD）今日宣布中国国家药品监督管理局批准夏帆宁® （来迪派韦90mg/索磷布韦400mg）在中国用于治疗1-6型慢性丙型肝炎病毒(HCV)感染的成人和12至18岁青少年患者。 来迪派韦索磷布韦片（夏帆宁） 慢性丙型肝炎是全球范围内的重大的公共卫生挑战。在中国，有将近1000万人感染HCV病毒[1]，其中，大约58%是HCV基因1型患者。[2] 吉利德科学今日宣布

吉利德科学（纳斯达克上市代码:GILD）今日宣布中国国家药品监督管理局批准夏帆宁® （来迪派韦90mg/索磷布韦400mg）在中国用于治疗1-6型慢性丙型肝炎病毒(HCV)感染的成人和12至18岁青少年患者。

来迪派韦索磷布韦片（夏帆宁）
来迪派韦索磷布韦片（夏帆宁）

慢性丙型肝炎是全球范围内的重大的公共卫生挑战。在中国，有将近1000万人感染HCV病毒[1]，其中，大约58%是HCV基因1型患者。[2]

吉利德科学今日宣布中国国家药品监督管理局批准夏帆宁（来迪派韦90mg/索磷布韦400mg）在中国用于治疗1-6型慢性丙型肝炎病毒(HCV)感染的成人和12至18岁青少年患者。

北京大学人民医院肝病研究所魏来教授表示：“夏帆宁®在中国多中心临床研究中，每日一片治疗方案，基因1型HCV患者可获得100%SVR12（定义为完成治疗后12周检测不出HCV RNA）”。

“吉利德始终致力于研发并提供创新的丙肝治疗方法，希望可以帮助所有丙肝患者获得治愈的机会”，吉利德科学研发负责人、首席科学官、澳大利亚官佐勋章获得者、医学博士John McHutchison表示，“我们很高兴能通过提供这一重要而全新的治疗选择来帮助患者，并进一步支持中国为消除丙肝流行所付出的努力”。

夏帆宁® 此次的获批基于一项开放标签的3b期研究，该研究于2016年5月至2017年7月在中国大陆的18个研究中心进行，评估了夏帆宁® 在206例基因1型丙肝患者（包括未经治疗患者和无肝硬化或者有代偿期肝硬化的经治患者）中进行的12周治疗效果。

在该研究中，100%的入组患者实现了SVR12。患者最常见的不良反应（>/=10%）是病毒性上呼吸道感染和上呼吸道感染。

夏帆宁®及吉利德都是吉利德科学公司或其相关公司的商标。©2018吉利德科学公司版权所有

 

[1] The Polaris Observatory HCV Collaborators. Lancet Gastroenterol Hepatol 2017;2:161-76;

[2] Rao H, et al. J Gastroenterol Hepatol 2014;29:545-53;

 

关于吉利德科学

吉利德科学是一家生物制药公司，在未满足的医疗需求领域发现、研发创新疗法并使之商业化。公司的使命是改善和简化全球重疾患者的治疗方案。吉利德在全世界超过35个国家进行运营，总部位于加利福尼亚州福斯特市。

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    2019-09-04 zxl738

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