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康哲藥業(00867.HK):替拉珠單抗注射液獲藥物臨試批准通知書
格隆匯 08-19 20:05

格隆匯 8 月 19日丨康哲藥業(00867.HK)發佈公告,關於與Sun Pharmaceutical Industries Ltd.就用於治療銀屑病及銀屑病性關節炎的替拉珠單抗注射液(Tildrakizumab)簽訂許可協議。該產品是一種人源化的lgG1/k單克隆抗體,旨在選擇性地與白細胞介素-23(IL-23)的p19亞基結合,並抑制其與IL-23受體相互作用,從而抑制促炎症細胞因子和趨化因子的釋放。該產品已在美國、歐洲、澳大利亞和日本獲批上市,用於治療符合系統治療或光療指徵的中度至重度斑塊狀銀屑病的成年患者。

公告表示,該產品獲得國家藥品監督管理局於2020年8月18日簽發的藥物臨牀試驗批准通知書,同意開展在中國人羣中評價Tildrakizumab治療中度至重度斑塊型銀屑病患者的療效及安全性的隨機、雙盲、安慰劑對照、多中心臨牀研究。集團正積極準備開展產品的驗證性臨牀試驗。

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