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康宁杰瑞(09966.HK)治疗实体瘤生物制品上市许可申请获受理
阿思达克 12-22 04:49
康宁杰瑞制药-B(09966.HK)公布,中国国家药监局已受理KN035(一种重组人源化抗程序性死亡配体1单域抗体,用於治疗微卫星高度不稳定性/错配修复功能缺陷晚期实体瘤的生物制品上市许可申请。

KN035由公司自主研发,2016年起与思路迪医药共同开发,在中国、美国和日本针对多个肿瘤适应症开展临床试验,结果显示出可控安全性及前景良好的临床效果。

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