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健康元(600380.SH):“注射用重組腫瘤酶特異性干擾素α-2bFc融合蛋白”臨牀試驗申請獲受理
格隆匯 02-21 18:11

格隆匯2月21日丨健康元(600380.SH)公佈,近日,公司控股子公司珠海市麗珠單抗生物技術有限公司(麗珠單抗)申報的“注射用重組腫瘤酶特異性干擾素α-2bFc融合蛋白”(A-01)臨牀試驗申請獲國家藥品監督管理局(藥監局)受理。

藥物名稱:注射用重組腫瘤酶特異性干擾素α-2bFc融合蛋白;劑型:注射劑規格:2mg/瓶;註冊分類:治療用生物製品1類;受理號:CXSL2000035國;結論:根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。

A-01為全球創新藥物,旨在開發一種長效靶向性細胞因子前體藥物,該藥物進入人體後在人體的外周循環系統和正常組織中主要以前體藥物形式存在,當該前體藥物進入到腫瘤組織後,暴露藥物活性成分,從而在特定腫瘤部位發揮特異性抗腫瘤效應。另外,通過與抗體IgGFc融合,延長了該前體藥物在人體內的半衰期。

細胞因子活性成分抗腫瘤的作用機制是通過與特定的膜受體結合來發揮其生物學活性。既可以通過直接抑制腫瘤細胞增殖和轉移、誘導腫瘤細胞凋亡等途徑發揮直接的抗腫瘤作用,也可通過調節免疫系統發揮間接抗腫瘤作用。

A-01獨特的前體藥物設計,可改善傳統細胞因子藥物的安全性問題,並提高腫瘤組織附近的藥物有效濃度,從而達到更好的抗腫瘤效果。同時藥物半衰期的延長,可以極大的拓展細胞因子藥物在腫瘤免疫治療的應用。該品擬用於晚期實體瘤治療,並可聯合現有療法和/或腫瘤免疫療法進一步提升其抗腫瘤作用。

截至公告披露日,麗珠單抗在A-01研發項目上已累計投入人民幣3225.64萬元。

該品臨牀試驗申請獲受理後,自受理繳費之日起60日內,如未收到國家藥品監督管理局藥品審評中心否定或質疑的,即可按照提交的方案開展臨牀試驗。待臨牀試驗完成並報藥監局審批通過後方可生產上市。

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