三生國健(688336.SH):重組抗IL-17A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12月19日丨三生國健(688336.SH)公佈,公司重組抗IL-17A人源化單克隆抗體注射液(研發代號:SSGJ-608)收到國家藥品監督管理局核准簽發的強直性脊柱炎和放射學陰性中軸型脊柱關節炎兩個臨牀試驗《藥物臨牀試驗批准通知書》。截至目前,608項目已獲批開展三個適應症的臨牀試驗:其中成人中重度斑塊狀銀屑病的關鍵註冊性Ⅲ期臨牀研究已達到主要療效終點,強直性脊柱炎和放射學陰性中軸型脊柱關節炎適應症將於近期分別開啟臨牀II期試驗。
重組抗IL-17A人源化單克隆抗體注射液(SSGJ-608)產品是公司自主研發設計、篩選的人源化抗IL-17A單克隆抗體,具有全新的氨基酸序列。SSGJ-608可選擇性結合人IL-17A,中和IL-17A的活性,有效抑制炎性因子的釋放,進而發揮抑制IL-17A生物學活性的作用,從而有效的抑制炎症反應,達到治療銀屑病、強制性脊柱炎、放射學陰性中軸型脊柱關節炎的效果。
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