安科生物:AK2024注射液获药物临床试验批准

格隆汇
01 Jul

安科生物公告,公司收到国家药品监督管理局下发的关于“AK2024注射液”的《药物临床试验批准通知书》。AK2024注射液为治疗用生物制品1类:创新型生物制品,注册分类为单药在HER2阳性晚期实体瘤中开展临床试验。AK2024是通过采用以曲妥珠单抗为基础的功能检测方法筛选出的具有曲妥珠单抗协同抗肿瘤活性的抗HER2抗体,选择性地作用于人表皮生长因子受体-2(HER2)的细胞外部位,其抗原识别表位不同于曲妥珠单抗或帕妥珠单抗结合的表位。临床前研究表明,AK2024可抑制HER2阳性肿瘤细胞的增殖,与曲妥珠单抗有协同药效,且优于帕妥珠单抗的促进曲妥珠单抗的抗肿瘤协同药效。

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