安科生物(300009.SZ):AK2024注射液獲得藥物臨牀試驗批準
格隆匯7月1日丨安科生物(300009.SZ)公佈,近日,安徽安科生物工程(集團)股份有限公司(以下簡稱"公司")收到國家藥品監督管理局下發的關於"AK2024 注射液"的《藥物臨牀試驗批準通知書》,現將相關情況公告如下:
藥品名稱:AK2024 注射液
受理號:CXSL2500318
申請人:安徽安科生物工程(集團)股份有限公司
結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2025 年4 月 17 日受理的 AK2024 注射液臨牀試驗申請符合藥品註冊的有關要求,同意本品單藥在 HER2 陽性晚期實體瘤中開展臨牀試驗。
據悉,AK2024 是通過採用以曲妥珠單抗爲基礎的功能檢測方法篩選出的具有曲妥珠單抗協同抗腫瘤活性的抗 HER2 抗體,選擇性地作用於人表皮生長因子受體-2(HER2)的細胞外部位,其抗原識別表位不同於曲妥珠單抗或帕妥珠單抗結合的表位。臨牀前研究表明,AK2024 可抑制 HER2 陽性腫瘤細胞的增殖,與曲妥珠單抗有協同藥效,且優於帕妥珠單抗的促進曲妥珠單抗的抗腫瘤協同藥效。本次爲 AK2024 注射液全球範圍內首次獲批臨牀,註冊分類爲治療用生物製品 1 類:創新型生物製品。
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