智通财经APP获悉，中国抗体-B(03681)涨超18%，截至发稿，17.48%，报2.42港元，成交额5080.39万港元。
消息面上，中国抗体宣布，经近期与国家药监局药品审评中心（CDE）沟通后，本公司已自愿撤回舒西利单抗在中国用于治疗类风湿关节炎(RA)的BLA申请。该决定乃经内部评估后作出，该评估确定需要补充早期疗效的证据以支持BLA的审批。公司对舒西利单抗获批准于中国上市仍具信心，已开始规划舒西利单抗用于治疗系统性红斑狼疮的新临床开发计划。
值得注意的是，公司近期宣布，其全球首创新药SM03(舒西利单抗)针对系统性红斑狼疮(SLE)的临床前研究In-vivo取得突破性结果。SM03作为靶向CD22靶点的单克隆抗体，凭借“通过 B 细胞相互作用调节自身免疫网络+器官损伤保护获益”的独特优势，有望填补SLE治疗中“长期用药安全风险“与”无实际器官损伤保护性获益”的未满足需求，为全球患者提供疗效更佳更安全的全新治疗方案。
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