澤璟製藥(688266.SH):ZG005粉針劑用於治療實體瘤患者的臨牀試驗獲得批准
格隆匯12月30日丨澤璟製藥(688266.SH)公佈,公司於近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,ZG005粉針劑用於治療實體瘤患者的臨牀試驗獲得批准。
ZG005是重組人源化抗PD-1/TIGIT雙特異性抗體粉針劑,為創新型腫瘤免疫治療生物製品,註冊分類為1類,有望用於治療多種實體瘤。根據公開查詢,ZG005是全球率先進入臨牀研究的同靶點藥物之一,目前全球範圍內尚未有同類機制藥物獲批上市。
ZG005擁有雙靶向阻斷PD-1和TIGIT的作用,既可以通過有效阻斷PD-1與其配體PD-L1的信號通路,進而促進T細胞的活化和增殖;又可以有效阻斷TIGIT與其配體PVR等的信號通路,促使PVR結合CD226產生共刺激激活信號,進而促進T細胞和NK細胞的活化和增殖,併產生兩個靶點被同時阻斷後的協同增強免疫系統殺傷腫瘤細胞的能力。臨牀前研究結果顯示,ZG005具有顯著且長效的抗腫瘤作用,療效優於單藥(抗PD-1抗體或抗TIGIT抗體)及聯合給藥;ZG005在非人靈長類動物中顯示出藥物半衰期等方面優良的藥代動力學特徵及良好的安全性特徵。ZG005有望成為治療實體瘤的腫瘤免疫創新型生物製品。
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