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石藥集團(01093.HK):SYH2051(選擇性ATM抑制劑)獲美國臨牀試驗批准
格隆匯 03-13 18:03

格隆匯3月13日丨石藥集團(01093.HK)公吿,集團開發的SYH2051("該產品")已獲得美國FDA批准可以在美國開展臨牀研究。該產品亦已於2023年6月獲得中華人民共和國國家藥品監督管理局批准在中國開展臨牀試驗。

該產品為集團自主研發的化藥1類新藥。作為ATM抑制劑,該產品選擇性靶向抑制ATM蛋白激酶及其下游信號蛋白CHK2和KAP1的磷酸化,延遲DNA雙鏈斷裂修復,導致持續的DNA雙鏈斷裂和ATM介導的細胞週期阻滯,從而抑制腫瘤細胞增殖。本次獲批適應症為晚期實體瘤。臨牀前研究顯示,該產品對ATM靶點選擇性好,並表現出較優的體內外活性,具有較高的臨牀開發價值。該產品在國內已經完成單藥在晚期實體瘤的Ia期爬坡試驗,獲得了單藥的安全性及人體藥代動力學數據,目前正在積極開展聯合放療、聯合抗體偶聯藥物(ADC)及聯合化療等一系列臨牀試驗。

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