泽璟制药(688266.SH):注射用ZG006与PD-1/PD-L1免疫检查点抑制剂及化疗(依托泊苷/卡铂)联用获得药物临床试验批准

智通财经
Nov 18

智通财经APP讯,泽璟制药(688266.SH)发布公告,公司于近日收到国家药品监督管理局(以下简称“国家药监局”)核准签发的《药物临床试验批准通知书》,注射用ZG006与PD-1/PD-L1免疫检查点抑制剂及化疗(依托泊苷/卡铂)联合用于小细胞肺癌的临床试验获得批准。

ZG006(INN 名:alveltamig)是公司通过其双/多特异性抗体研发平台开发的一个三特异性抗体药物,已获得美国FDA和中国NMPA临床试验许可,并已分别被国家药品监督管理局药品审评中心纳入突破性治疗品种,和被美国FDA 授予孤儿药资格认定(Orphan-drugDesignation)。ZG006 是一种针对两个不同 DLL3 表位及CD3的三特异性T细胞衔接器。经查询,ZG006是全球第一个针对 DLL3 靶点的三特异性抗体(DLL3/DLL3/CD3),是全球同类首创(First-in-Class)分子形式,具有成为同类最佳(Best-in-Class)分子的潜力。

ZG006的抗DLL3端与肿瘤细胞表面不同DLL3表位相结合,抗CD3端结合T细胞。ZG006衔接肿瘤细胞和T细胞,将T细胞拉近肿瘤细胞,从而利用 T 细胞特异性杀伤肿瘤细胞。临床前研究结果显示,ZG006在小鼠肿瘤模型上具有显著的肿瘤抑制作用,可以导致显著比例的小鼠肿瘤完全消退,说明ZG006 具有强效的肿瘤杀伤作用。

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