华海药业(600521.SH)子公司获注射用HB0043新增皮下注射给药途径临床试验许可

智通财经07-24 17:38

智通财经APP讯，华海药业(600521.SH)发布公告，近日，公司下属子公司上海华奥泰生物药业股份有限公司(简称“华奥泰”)和华博生物医药技术(上海)有限公司(系华奥泰下属全资子公司)收到国家药品监督管理局核准签发的注射用HB0043项目新增皮下注射给药途径的《药物临床试验批准通知书》。

据悉，HB0043为全球首款双抗药物，同时靶向白细胞介素-17A(IL-17A)和白细胞介素-36受体(IL-36R)，具有高结合和阻断活性，开发用于治疗多种难以治疗的自身免疫性疾病，有望突破现有单靶点治疗的局限。当前IL-17A抑制剂(司库奇尤单抗)、IL-17A/F双重抑制剂(比美吉珠单抗)及抗IL-36R单抗(佩索利单抗)等虽已在多个适应症中取得积极疗效，但其对炎症单一维度干预在部分患者中仍存在不足。HB0043创新性地融合IL-17A与IL-36R双重靶点，有望广泛应用于多种Th17/IL-36相关的免疫介导疾病，展现出机制领先、潜力广泛的同类首创(FIC)优势。

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