智通财经APP讯，宜明昂科-B(01541)发布公告，IMM0306 治 疗IgG4 相关疾病 (IgG4-RD)的II/III期试验顺利完成首例患者给药。IgG4-RD是一种慢性、进行性纤维发炎性疾病，可能影响多个器官系统，包括胰腺、胆管、唾液腺、泪腺及腹膜后组织。在严重情况下，该疾病可能导致器官衰竭。现有免疫抑制治疗仍受限于低反应率及高复发率。Inebilizumab(一种抗CD19单克隆抗体)是目前唯一获批的生物疗法，目前尚存在大量未获满足的临床需求。研究显示，B细胞异常活化及IgG4阳性浆细胞浸润是IgG4-RD的核心病理机制，这与IMM0306的作用机制高度匹配。
II/III期临床试验(登记号：CTR20262001)旨在评估IMM0306在降低IgG4-RD患者疾病复发风险方面的疗效，并以此作为其主要终点。次要终点着重评估该药物的安全性、耐受性、群体药代动力学特征及免疫原性。受试者将连续四周每周接受一次静脉输注，并于第27周重复给药方案。
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