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中国首款个性化肿瘤新生抗原疫苗获NMPA批准进入临床阶段

2023-03-16


中国首款个性化肿瘤新生抗原疫苗获NMPA批准进入临床阶段

2023年3月15日,国家药品监督管理局药品审评中心(CDE)网站临床试验默示许可栏更新数据,北京立康生命科技有限公司旗下的个性化肿瘤新生抗原疫苗产品——LK101 注射液获临床试验默示许可,适应症是晚期实体瘤。

LK101 注射液是立康完全自主研发的首条核心管线,这是一款个性化肿瘤新生抗原疫苗,采用 mRNA-DC 疫苗形式,通过将编码数十个基于患者自体肿瘤突变信息设计的个性化肿瘤抗原靶点的 mRNA 转导入树突状细胞,从而兼具 mRNA 疫苗和 DC 疫苗的优势。


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