2021年上半年盘点:FDA批准52款新药,6款生物制品

2021-07-04 药智网 药智网

FDA

2021年1月至6月,美国FDA共计批准了52款新药,6款生物制品(CDER批准)。按照企业提交的申请分类包括新分子实体类占比50%,新酯新盐类或其他非共价键的衍生物类5%,新剂型10%,新配方26%

2021年1月至6月,美国FDA共计批准了52款新药,6款生物制品(CDER批准)。按照企业提交的申请分类包括新分子实体类占比50%,新酯新盐类或其他非共价键的衍生物类5%,新剂型10%,新配方26%,其他类(新药物组合等)9%。近半年来,其批准的新药药理主要分布在系统用抗感染药类、神经系统类、血管系统类以及消化道代谢和抗肿瘤药等领域。

其中,FDA批准了共22款抗癌新疗法,包括靶向,免疫检查点抑制剂,过继性细胞免疫疗法等等,覆盖了几乎全部的癌症种类,值得一提的是KRAS和EGFR20ins两大难治性靶点打破了治疗僵局,迎来了首款靶向药物,又有很多幸运的病友们等来了新的希望和治疗选择。详细见:2021年上半年盘点:FDA批准抗肿瘤药物汇总

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其中,商品名称MAVYRET和EPCLUSA这两款新药为美国FDA首次批准,都为新剂型类药物,并已获得了FDA的孤儿药认定。MAVYRET是格卡瑞韦和哌仑他韦的固定剂量组合药物,由艾伯维制药持有并于2021年6月获得FDA的上市批准,主要治疗慢性丙型肝炎病毒。EPCLUSA是一种核苷酸类似物聚合酶抑制剂和泛基因型NS5A抑制剂的固定剂量组合药物(索磷布韦和维帕他韦),由吉利德科学公司持有并于2021年6月获得FDA的上市批准,同样也用于慢性丙型肝炎病毒的治疗。

中国药企在2021年上半年中,有超过20家企业拿到了FDA授予的上市批准,有30个品种(多以注射剂和片剂为主)通过了FDA仿制药上市批准,同比下降16%。复星医药执掌牛耳,共计有9款仿制药在美国获批上市。

以下为2021年上半年FDA批准新药和部分生物制品的数据(参考)。

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数据来源:药智美国上市药品数据库、Drugs@FDA

 

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    2021-07-05 weigq

    👏👏👏

    0

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    2021-11-08 bugit
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    2021-07-04 小小医者

    #FDA#批准#创新药#记录

    0

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    2021-07-04 李燕

    学习了

    0

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