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三生制药(01530.HK)抗PD-1单克隆抗体获得临床试验批准
格隆汇 08-29 23:39

格隆汇8月29日丨三生制药(01530.HK)发布公告,本集团的抗PD-1单克隆抗体(609A)的临床试验申请于近日获得国家药品监督管理局批准。609A此前已于2019年1月获得美国食品药品监督管理局的药物临床试验批准,目前美国1期临床试验病人入组正在顺利进行。公司将尽快开展609A中国临床试验的病人入组。

609A是一种重组人源化单克隆抗体,针对程序性细胞死亡蛋白1(programmedcelldeath-1)(PD-1)靶点,用于治疗多种癌症。PD-1即T细胞抑制受体,是一种重要的免疫抑制分子,其主要表达于激活的T细胞和B细胞中,可作为停止信号在肿瘤中抑制T细胞的活化。抗PD-1抗体通过阻断PD-1,恢复T细胞功能,阻断肿瘤的发生,其单药疗法和组合疗法具有治疗多种类型癌症的潜力。

本公司的主席兼行政总裁娄竞博士评论道:公司很高兴看到抗PD-1抗体的新药临床申请获国家药品监督管理局批准,并已于美国开始临床试验病人入组。同时期望于中美两国加速推进临床试验进程。公司将针对不同实体瘤探索多种联合治疗方案,开展多个临床试验,力图开发出独特的联合治疗方法。三生将继续寻找机会,致力于探寻及开发更安全有效的治疗性生物制剂,以应对迫切的医疗需求,为患者提供重要的治疗选择。

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