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以色列口服胰岛素研发获新突破 牵动资本神经

2013-12-26 上海证券报 上海证券报

在美上市的以色列医药公司Oramed医药上20日宣布,该公司的独家新药,口服胰岛素ORMD-0801二期临床测试成功,在欧洲获得了专利获批,将被允许在欧洲以及承认欧洲药监局条例的主要国家作为一型糖尿病的治疗药物使用。公司股价随即脉冲式上涨,在过去五个交易日累计涨幅115.83%,阶段涨幅在美股所有股票中名列第一。 众所周知,胰岛素的使用主要通过注射给药,给广大糖尿病患者带来很多不便,亟待开发出新

在美上市的以色列医药公司Oramed医药上20日宣布,该公司的独家新药,口服胰岛素ORMD-0801二期临床测试成功,在欧洲获得了专利获批,将被允许在欧洲以及承认欧洲药监局条例的主要国家作为一型糖尿病的治疗药物使用。公司股价随即脉冲式上涨,在过去五个交易日累计涨幅115.83%,阶段涨幅在美股所有股票中名列第一。

众所周知,胰岛素的使用主要通过注射给药,给广大糖尿病患者带来很多不便,亟待开发出新的给药途径。受制于胰岛素自身易被胃酸降解,难以发挥疗效等因素影响,口服胰岛素的研发一直是这一领域公认的难题。口服胰岛素一旦研发成功将极大地改善胰岛素依赖型糖尿病患者的生活质量,因此其巨大的市场应用前景一直牵动着资本市场的神经。

在今年1月,Oramed曾向美国食品药品监督管理局提交了关于ORMD-0801二期临床的新药研究申请。根据临床测试的要求,一型糖尿病病人被要求在不同研究阶段摄入不同剂量的口服胰岛素,通过对病人的血葡萄糖指标与摄入剂量的对比,研究人员证实ORMD-0801的摄入剂量与药效存在正相关联系。在获得欧盟批准之前,口服胰岛素ORMD-0801已在新西兰、南非等全球27个国家获得专利保护。今年九月,公司就曾宣布获得了中国国家知识产权局向其颁发的关于其口服药物核心技术专利。Oramed的CEONadavKidron在接受采访时表示,临床测试的良好结果让公司振幅,公司将继续推进口服胰岛素在二型糖尿病领域的研究。

一型糖尿病原名胰岛素依赖型糖尿病,患者体内的胰岛素生成细胞因病被破坏,导致体内胰岛素不足,容易发生酮症酸中毒,必须用胰岛素治疗才能获得满意疗效,否则将危及生命。据统计,全球目前有3600万一型糖尿病患者,并且正以每年3%的速度增长。

全球胰岛素市场目前规模大约为140亿美元,中国已是世界上糖尿病第二大高发国,患者超过1亿人,且呈继续增长态势;因此口服胰岛素在我国同样拥有巨大市场空间,亚宝药业涉及相关研发。而国内多家A股上市公司涉及胰岛素的生产。

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    2014-08-11 zxxiang
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    2014-05-21 baoya
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    2014-06-05 kord1993
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    2013-12-28 lqvr
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诺和诺德向FDA及EMA提交liraglutide监管文件

诺和诺德(Novo Nordisk)12月20日宣布,已分别向美国食品和药物管理局(FDA)和欧洲药品管理局(EMA)提交了高剂量利拉鲁肽(liraglutide,3mg)的新药申请(NDA)和上市许可申请(MAA)。 liraglutide是一种每日一次的人胰高糖素样肽-1(GLP-1)类似物,作为低热量饮食和增加体力活动的辅助药物,用于肥胖症或超重合并症成人患者的体重管理。 lirag

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