石藥集團(01093.HK):高選擇性CDK9抑制劑“SYHX1903”獲中國臨牀試驗批件
格隆匯5月25日丨石藥集團(01093.HK)發佈公吿,集團自主開發的“SYHX1903”已獲得中國國家藥品監督管理局批准,可在中國開展臨牀試驗。該產品在國內外已提交多項專利申請。
根據披露,該產品為一種高選擇性的週期蛋白依賴的蛋白激酶9(CDK9)抑制劑,在以CDK9為靶點的惡性血液瘤和實體瘤治療方面具有巨大的潛力。本次獲批臨牀試驗的適應症為惡性血液腫瘤,後期將繼續申請晚期實體瘤適應症的臨牀試驗。臨牀前研究顯示,該產品通過高選擇性抑制CDK9,對惡性血液瘤和實體瘤有顯着藥效,同時具有良好的安全性和藥代動力學特點,極有希望在臨牀研究中展現出良好的抗腫瘤治療效果。
基於良好的非臨牀研究結果,集團將全力以赴推進該產品的臨牀研究工作,力爭該產品儘快上市。
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