智通财经APP获悉，昭衍新药(06127)涨超3%，截至发稿，涨3.6%，报19.87港元，成交额2574.99万港元。
消息面上，据昭衍新药官微消息，近日，益科思特自主研发的靶向CD19/CD3的创新双特异性抗体YK012.正式获得美国食品药品监督管理局(FDA)的临床试验批准(IND)，用于治疗原发性膜性肾病(pMN)。这是全球首个针对该适应症获批临床的T细胞衔接器(TCE)类双抗药物，标志着中国原研双抗技术在自身免疫病领域实现中美同步突破。昭衍新药作为益科思特的非临床CRO合作伙伴，全面参与了YK012项目的药代动力学服务、毒理试验等非临床试验过程。
据介绍，YK012的研发依托益科思特“北京总部+美国全资子公司Excyte LLC”双中心布局，此次FDA IND获批后，公司将逐步启动国际多中心临床研究，与中国已开展的多中心试验(由北京大学第一医院赵明辉教授牵头)形成数据互补，加速全球研发进程。
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