澤璟製藥(688266.SH):注射用ZGGS18用於治療晚期實體瘤的臨牀試驗獲批
格隆匯8月16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核准簽發的《藥物臨牀試驗批准通知書》,注射用ZGGS18用於治療晚期實體瘤的臨牀試驗獲得批准。
ZGGS18是公司及子公司Gensun Biopharma Inc.通過其雙/多特異性抗體研發平台開發的一個雙功能抗體融合蛋白藥物,也是公司遞交臨牀試驗申請的第二個雙特異性抗體類藥物。ZGGS18的註冊分類為治療用生物製品1類,有望成為治療實體瘤的創新型生物製品。
ZGGS18是一種重組人源化抗VEGF/TGF-β的雙功能抗體融合蛋白,可以特異性地結合血管內皮生長因子(VEGF)和“捕獲”轉化生長因子-β(TGFβ),起到抑制腫瘤新生血管形成和降低腫瘤轉移發生等協同抑制腫瘤生長的多重作用。另外,ZGGS18也可以改善和調節腫瘤微環境,從而可以和抗PD-1/L1抗體、公司正在開展臨牀研究的抗PD-1/TIGIT雙特異性抗體ZG005等腫瘤免疫治療藥物聯合增強腫瘤殺傷作用。
臨牀前研究結果顯示,ZGGS18在人非小細胞肺癌、結直腸癌等模型上具有顯著的腫瘤抑制作用,且在和抗PD-1抗體聯合治療後,可以導致顯著比例的小鼠腫瘤完全消退,説明ZGGS18具有強效的腫瘤殺傷作用和增強腫瘤免疫治療藥物療效的潛力。ZGGS18在非人靈長類動物中顯示出長半衰期等優良的藥代動力學特徵及良好的安全性特徵。
根據公開數據查詢,目前暫無相同作用機制的藥品在國內外獲批上市或進入臨牀研究。
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