三生國健(688336.SH)：重組抗IL-17A人源化單抗治療中重度斑塊狀銀屑病II期臨試完成首例受試者入組
格隆匯4月21日丨三生國健(688336.SH)公佈，公司自主研發的重組抗IL-17A人源化單克隆抗體(藥物代碼：608)，目前正在開展治療中重度斑塊狀銀屑病的臨牀研究，“重組抗IL-17A人源化單克隆抗體注射液皮下注射治療中國中重度斑塊狀銀屑病患者的隨機、雙盲、安慰劑對照、多劑量遞增及劑量探索的安全耐受性、藥代動力學及療效II期臨牀試驗”已於近日完成首例受試者入組。
608是公司自主研發的瞄準IL-17A靶點的藥物，針對斑塊狀銀屑病，目前尚無此類國產藥物上市，目前國內市場上已有兩個同靶點藥物,分別為諾華製藥的Secukinumab(COSENTYX®；Novartis)和禮來製藥的ixekizumab(TALTZ；Eli Lilly)，可通過抑制IL-17A而達到治療中至重度斑塊狀銀屑病的目的，2020年Secukinumab全球銷售額為39.95億美元，ixekizumab的全球銷售額為17.88億美元。
銀屑病，是一種免疫介導的多基因遺傳性皮膚病，因其反覆發作，難以治癒，民間俗稱“牛皮癬”；其發病機制主要是通過細胞免疫異常介導的，皮膚組織發生慢性炎症性增殖的過程；典型臨牀表現為軀體皮膚出現鱗屑性紅斑或斑塊，呈侷限或廣泛分佈，多數患者夏季緩解，冬季復發或加重。
608與諾華製藥Secukinumab(Cosentyx)和美國禮來公司的Ixekizumab(Taltz)為相同靶點的同類藥物，但為全新的氨基酸序列，在體外和體內動物模型中顯示出和同靶點抗體Cosentyx和Taltz相當的生物活性：能顯著改善人IL-17轉基因小鼠經咪喹莫特誘導的銀屑病模型的症狀，其治療作用與蘇金單抗相當；在猴關節炎模型中，與Ixekizumab在臨牀評分、近側指間關節(Proximal Interpha langeal Point，PIP)腫脹程度、PIP關節發病率等多個指標上治療效果相似。
“重組抗IL-17A人源化單克隆抗體注射液皮下注射治療中國中重度斑塊狀銀屑病患者的隨機、雙盲、安慰劑對照、多劑量遞增及劑量探索的安全耐受性、藥代動力學及療效II期臨牀試驗”已於近日完成首例受試者入組。在已經完成的健康成年志願者單次給藥、劑量遞增的I期臨牀試驗中，608顯示出良好的耐受性和安全性。
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