南京一药企产品获欧盟罕见病药物资格认定

金台资讯02-01

近日，南京江北新区生物医药谷企业维立志博宣布，其核心产品维利信已获欧盟委员会授予的罕见病药物资格认定，用于治疗肺外神经内分泌癌。罕见病药物，又称孤儿药。根据欧盟委员会的定义，孤儿药是指用于诊断、预防或治疗有生命危险或导致慢性衰弱疾病的药物，并且患者比例不超过欧盟人口总数的万分之五。维利信是一种靶向PD-L1与 4-1BB的双特异性抗体，是已处于单臂关键性临床阶段的靶向共刺激受体4-1BB的分子。...

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