智通财经APP讯，迈威生物(688062.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，9MW5211注射液用于1型糖尿病(T1DM)适应症的临床试验申请获得批准，此前，其用于炎症性肠病(IBD)适应症的临床试验申请已分别获得国家药品监督管理局批准和FDA许可，用于多发性硬化(MS)适应症的临床试验申请已获得国家药品监督管理局批准。
9MW5211是公司自主研发的一种高度特异性的清除型创新抗体，针对自身免疫性疾病中由异常免疫细胞介导的关键病理机制进行精准干预。免疫细胞的异常活化及组织浸润是多种自身免疫疾病发生发展的核心驱动因素。9MW5211所靶向的分子在致病性免疫细胞表面特异性表达，是这些细胞异常活化的重要生物学标志。通过选择性识别并清除这群致病性细胞，9MW5211可有效阻断免疫级联反应，进而缓解疾病进展并改善临床症状。
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