澤璟製藥(688266.SH):注射用ZG005與注射用ZG006聯用獲得藥物臨牀試驗批准通知書
格隆匯6月17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
ZG005 與注射用 ZG006
聯合用於晚期小細胞肺癌或神經內分泌癌的臨牀試驗獲得批准。
注射用 ZG005 是重組人源化抗 PD-1/TIGIT
雙特異性抗體,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。
注射用 ZG006 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三特異性抗體藥物,已獲得美國FDA 和中國NMPA臨牀試驗許可,並已被美國 FDA
授予孤兒藥資格認定(Orphan-drug Designation)。ZG006 是一種針對兩個不同 DLL3 表位及 CD3 的三特異性T
細胞銜接器。經查詢,ZG006 是全球第一個針對 DLL3
靶點的三特異性抗體(DLL3×DLL3×CD3),是全球同類首創(First-in-Class)分子形式,具有成為同類最佳(Best-in-Class)分子的潛力。
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