石藥集團(01093.HK):高選擇性MAT2A抑制劑(SYH2039)獲美國臨牀試驗批准
格隆匯4月26日丨石藥集團(01093.HK)公佈,集團開發的化藥1類新藥高選擇性MAT2A抑制劑(SYH2039)已獲得美國食品藥品監督管理局(FDA)批准,可以在美國開展臨牀試驗。此前,該產品已於2024年3月獲得中國國家藥品監督管理局批准,可以在中國開展臨牀試驗。
SYH2039是一種高活性甲硫氨酸腺甘轉移酶2A(MAT2A)抑制劑,可選擇性殺傷MTAP缺失型腫瘤細胞,同時對正常細胞的影響較小。該產品既可單用,也可與PRMT5二代抑制劑等聯用協同增效。本次獲批的臨牀適應症為晚期惡性腫瘤。臨牀前研究顯示,該產品可有效抑制非小細胞肺癌、膠質瘤、胃食管癌、胰腺癌和膀胱癌等多種MTAP缺失型腫瘤細胞的生長,具有優異的體內外活性,同時也具有良好的PK特性和安全性,有潛力成為一款同類最優(best-in-class)的抗腫瘤藥物,目前已在國內外提交多項專利申請。MTAP缺失腫瘤缺乏有效的靶向療法,臨牀需求大,該產品極具臨牀開發價值。
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