石藥集團(01093.HK)腹水治療藥物獲得美國FDA臨牀試驗批准
格隆匯10月31日丨石藥集團(01093.HK)宣佈,公司附屬友芝友生物自主研發的I類新藥"注射用重組抗EpCAM和CD3人鼠嵌合雙特異性抗體"(M701)獲得美國食品藥品監督管理局(FDA)批准在美國進行臨牀試驗,這也是友芝友生物該年度獲得美國FDA批准開展臨牀的第二個在研項目。
惡性腫瘤腹水是晚期腫瘤患者的常見併發症,會嚴重影響生活質素,並增加死亡率。在中國每年約有40萬的癌症患者會發生癌性腹水,但市場上缺少非常安全有效的通過抗腫瘤機制治療腹水的專用藥物。
M701為在友芝友生物自主開發的YBODY®雙特異性抗體技術平台上研發的在研品種,為國內首個引入免疫和靶向多重機制的癌性腹水治療藥物,可通過CD3招募患者自身免疫T細胞,繼而通過EpCAM引導免疫細胞靶向腫瘤細胞,最後啟動T細胞殺傷腫瘤細胞,從而達到治療腹水的效果。
此前,M701已經獲得中國和美國的發明專利授權,並於2018年獲得國家藥品監督管理局(NMPA)頒發的臨牀批件,正在中國開展的臨牀試驗已初步獲得積極的結果。
此次美國臨牀試驗批准將為友芝友生物開展創新藥物國際合作和進軍國際市場提供有力支持。
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