赛诺菲(SNY.US)纳米双抗1类新药在中国获批临床

智通财经
03 Jan

智通财经APP获悉,中国国家药监局药品审评中心(CDE)官网近日公示,赛诺菲(SNY.US)申报的1类新药SAR442970注射液获得临床试验默示许可,拟用于治疗成人和16岁及以上青少年原发性局灶节段性肾小球硬化(FSGS)或原发性微小病变肾病(MCD)。公开资料显示,SAR442970是一款靶向TNFα和OX40L的双特异性纳米抗体(VHH),目前正在国际范围内处于2期临床阶段。本次是该产品首次在中国获批IND。

截图来源:CDE官网

SAR442970注射液是一款基于Nanobody技术开发而成的双特异性抗体,靶向TNFα和OX40L。TNFα和OX40L在炎症和自身免疫性疾病中的应用潜力已经得到一系列临床验证。

局灶节段性肾小球硬化(FSGS)是APOL1介导的慢性肾病的一种类型。遗传性功能增益性(gain of function)APOL1基因突变产生的蛋白会导致足细胞损伤。这种损伤破坏了肾脏正常的过滤功能,导致蛋白尿和快速进展的肾脏疾病。足细胞损伤与多种肾小球疾病密切相关,包括FSGS以及微小病变型肾病(MCD)等。

本次SAR442970注射液在中国获批临床,意味着该产品即将在中国进入临床研究阶段。

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