冰洲石生物自主研发的创新雌激素受体嵌合降解剂AC0682临床申请获国家药监局批准

2022-04-06 网络网络

专注于人工智能药物研发的临床阶段生物技术公司Accutar Biotechnology, Inc.今天宣布，国家药品监督管理局（NMPA）已批准该公司在研药物AC0682用于治疗雌激素受体阳性乳腺癌患

专注于人工智能药物研发的临床阶段生物技术公司Accutar Biotechnology, Inc.今天宣布，国家药品监督管理局（NMPA）已批准该公司在研药物AC0682用于治疗雌激素受体阳性乳腺癌患者的试验用新药申请（IND）。AC0682是一种口服嵌合降解剂分子，可高效选择性地靶向降解雌激素受体蛋白。AC0682也成为全球范围内第一个获得FDA以及NMPA许可，进入临床试验的口服雌激素受体嵌合降解剂。

“乳腺癌是中国女性中最常见的癌症。我们很高兴AC0682 在中国IND获批，这是该药在去年底获得美国IND批准并启动美国1期临床研究之后的又一个里程碑。” 冰洲石生物首席执行官范捷博士说，“我们期待加速AC0682的临床研发，并进一步履行我们为全球癌症患者带来创新药物的承诺。”

中国1期临床研究将评估AC0682治疗中国雌激素受体阳性乳腺癌患者的安全性、耐受性、药代动力学和初步抗肿瘤活性。冰洲石生物预计将于今年下半年在中国启动1期临床试验。

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2022-11-17 xlwang2700

#自主研发#

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2022-04-08 lilianxiang

#创新#

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2022-04-08 lqvr

#研发#

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2022-04-08 xuyu

#药监局#

90 0
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2022-04-08 pyaili

#国家药监局#

96 0
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2022-04-08 surilei

#雌激素受体#

107 0
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2022-04-06 1212ba38m22暂无昵称

学习了

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冰洲石生物自主研发的创新雌激素受体嵌合降解剂AC0682临床申请获国家药监局批准

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