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三生制药(01530.HK)重组人源化抗白介素-17A单克隆抗体获国家药监局临床试验批准
格隆汇 08-01 23:00

格隆汇8月1日丨三生制药(01530.HK)公告,集团的重组人源化抗白介素-17A(IL-17A)单克隆抗体注射液临床试验申请于2019年7月31日获得国家药品监督管理局批准,集团正积极准备开展该产品的临床试验。

608是一种重组人源化抗白介素-17A单克隆抗体,采用DNA重组技术在中国仓鼠卵巢细胞(CHO细胞)中表达,用于治疗中重度斑块状银屑病。银屑病是一种常见的免疫相关的慢性复发性炎症性皮肤病,是一种多基因遗传和环境相互作用下,主要由细胞免疫异常介导的慢性炎症性增殖性皮肤病。

流行病学调查显示,1984年中国银屑病的患病率为0.123%,而2008年的患病率则为0.47%,显示中国银屑病的患病率有升高趋势。

此外,近30%的银屑病患者可能发生银屑病关节炎。PsA的关节受累会引起疼痛、僵硬等不适症状,部分患者甚至可能出现不可逆的关节损伤,致使关节变形和残废。银屑病也经常伴随其他疾病出现,例如糖尿病、心脏病和抑郁等,严重影响患者的身心健康和生活质量。

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