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三生國健(688336.SH):重組抗IL-4Rα人源化單克隆抗體注射液獲得藥物臨牀試驗批准通知書
格隆匯 09-19 15:40

格隆匯9月19日丨三生國健(688336.SH)公佈,近日,公司重組抗IL-4Rα人源化單克隆抗體注射液(研發代號:SSGJ-611)收到國家藥品監督管理局核准簽發的中度至重度慢性阻塞性肺疾病臨牀試驗《藥物臨牀試驗批准通知書》,目前SSGJ-611在中國中重度特應性皮炎受試者中開展的一項II期臨牀研究已達到主要終點,在慢性鼻竇炎伴鼻息肉受試者中開展的一項II期臨牀研究正在招募中,並將於近期開展慢性阻塞性肺疾病適應症的II期臨牀試驗。

SSGJ-611產品是公司創新研發,擁有自主知識產權的人源化抗IL-4Rα單克隆抗體,具有全新的氨基酸序列。SSGJ-611能夠通過特異性的結合IL-4Rα,阻斷IL-4和IL-13的信號傳導,實現對免疫功能的調節,達到緩解特應性皮炎、慢性鼻竇炎伴鼻息肉、慢性阻塞性肺疾病等疾病的作用。

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