三生国健(688336.SH)重组抗IL-4Rα人源化单克隆抗体注射液获得药物临床试验批准通知书

智通财经
14 Apr 2023

智通财经APP讯,三生国健(688336.SH)公告,公司重组抗IL-4Rα人源化单克隆抗体注射液(研发代号:SSGJ-611)收到国家药品监督管理局(“国家药监局”)核准签发的慢性鼻窦炎伴鼻息肉临床试验《药物临床试验批准通知书》,目前SSGJ-611在中国中重度特应性皮炎受试者中开展的一项II期临床研究已完成全部患者入组,并将于近期开展慢性鼻窦炎伴鼻息肉适应症的II期临床试验。

据悉,SSGJ-611产品是公司创新研发,拥有自主知识产权的人源化抗IL-4Rα单克隆抗体,具有全新的氨基酸序列。SSGJ-611能够通过特异性的结合IL-4Rα,阻断IL-4和IL-13的信号传导,实现对免疫功能的调节,达到缓解特应性皮炎、慢性鼻窦炎伴鼻息肉等疾病的作用。

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