汤森路透2015全球新药光荣榜

2016-01-06 佚名汤森路透

汤森路透数据显示，2015年(截至2015年12月15日，下同)，全球共有49个新分子实体(NME)和生物药首次获批并推向市场。另外，全球范围内，已上市药物里有29个重要的产品线延伸首次获得批准，包括新适应症、新剂型或者新复方；21个新分子实体在全球首次获批，但还未上市。虽然这些数字表明制药和生物技术行业整体上运行良好，但与去年全球59个上市新药相比，数量明显下降。不过，质量远比数量重要，20

汤森路透数据显示，2015年(截至2015年12月15日，下同)，全球共有49个新分子实体(NME)和生物药首次获批并推向市场。另外，全球范围内，已上市药物里有29个重要的产品线延伸首次获得批准，包括新适应症、新剂型或者新复方；21个新分子实体在全球首次获批，但还未上市。

虽然这些数字表明制药和生物技术行业整体上运行良好，但与去年全球59个上市新药相比，数量明显下降。不过，质量远比数量重要，2015年上市新药中有一些非常杰出的成员。

癌症新药十年来最多

对于癌症患者来说，今年非常值得庆贺，因为2015年是近十年来上市新癌症药数量最多的一年。总体来说，全球范围内共有14个新的癌症药物首次推向市场。

其中，多发性骨髓瘤是个最明显的领域。2015年，有4个多发性骨髓瘤新药获批并上市。在此之前，已有十年没有多发性骨髓瘤新药上市了，市场上仅有屈指可数的几个治疗药物。借用多发性骨髓瘤研究基金会主席Walter Capone的话说，2015年，对于美国9万这种罕见血液癌症患者来说，是个“分水岭”。

首个疾病治疗/预防新药

一些无药可治的疾病在2015年有新药上市，其中一部分用于常见病，另一些则用于极为罕见的疾病。

Shire的Vyvanse(甲磺酸赖氨酸安非他命)是首个用于成人中度至重度暴食症(BED)的药物。估计在美国有280万成人患有暴食症，是最常见的饮食失调疾病。

Addyi(氟班色林)是首个治疗女性性欲减退疾病的药物。在两次拒绝NDA后，2015年FDA最终批准了这个产品。不过因为潜在的严重副作用，在使用上加以严格限制。这个药物的批准引发争议，最近FDA在《新英格兰医学杂志》上阐述了该机构作出批准决定的原因。

罕见出血性疾病遗传性凝血因子X缺陷症在美国仅有400～600名患者，对于这些患者来说，2015年将是值得铭记的一年，用于这一疾病的治疗药物——BPL公司的Coagadex(人源化凝血因子X)终于面世。

此外，用于极罕见致命疾病低磷酸酯酶症的首个治疗药物——Alexion的asfotase alfa(Strensiq)在一些国家获得批准并上市。

另一个有史以来的第一次是，赛诺菲巴斯德的四价登革热疫苗于12月中旬在墨西哥首次获得批准。为了开发这个疫苗，赛诺菲花了20年时间。墨西哥监管机构批准了这个名为Dengvaxia的疫苗，用于疾病流行地区的少年、青少年和成年人预防全部4重血清型的登革热病毒感染。Denvaxia将在2016年上市。

新一批First-in-Class

2015年，有11个作用机制为首创的创新药推向市场，其中包括2个用于高胆固醇血症的创新药。大约十年前，对于那些对标准治疗他汀无效的患者，抑制循环蛋白前蛋白转化酶枯草杆菌蛋白酶Kevin9型(PCSK9)被认为是一个有前途的降低低密度脂蛋白(LDL)胆固醇的新策略。PCSK9通过促进LDL受体降解造成高胆固醇血症。2015年夏天，在开发PCSK9抑制剂的赛跑中，2个抗PCSK9单抗几乎同时获得批准，分别是evolocumab(Repatha，安进)和alirocumab(Praluent，Regeneron/赛诺菲)。

2015年上市的其他首创新药包括：抗IL-5单抗mepolizumab(Nucala；葛兰素史克)，已上市用于哮喘；抗IL-17A单抗secukinumab(Cosentyx；诺华)，已上市用于银屑病和银屑病关节炎，已批准用于强制性脊柱炎；抗SLAMF7单抗elotuzumab(Empliciti；艾伯维/百时美施贵宝)，已上市用于多发性骨髓瘤；细胞周期蛋白依赖性激酶(CDK)4/6抑制剂palbociclib(Ibrance；辉瑞)，已上市用于乳腺癌。

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2016-01-13 medsic

哦，

130 0
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2016-01-13 medsic

哦，

125 0
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2016-01-13 medsic

了解，

171 0
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2016-01-13 medsic

了解，

103 0
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2016-01-13 medsic

感谢分享～～

112 0
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2016-01-13 medsic

感谢分享～～

48 0
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2016-01-08 1249894fm77暂无昵称

#汤森路透#

0 0
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2016-01-06 wzf990214

牛

125 0
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2016-01-06 wzf990214

赞

54 0
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2016-01-06 鲜花飞鸟

抗癌药物比较好

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