中國生物製藥(01177.HK):TQB3122“PARP1抑制劑”臨牀試驗申請獲NMPA受理
格隆匯8月11日丨中國生物製藥(01177.HK)公告,集團自主研發的創新藥TQB3122「PARP1抑制劑」的新藥臨牀試驗申請(IND)已獲得中國國家藥品監督管理局(NMPA)受理,擬用於治療晚期惡性腫瘤。
TQB3122是一款具有高選擇性和血腦屏障穿透能力的PARP1抑制劑,通過雙重機制發揮抗腫瘤作用:一方面,競爭性抑制PARP1酶的催化活性,阻斷DNA單鏈斷裂修復;另一方面,通過「捕獲」機制穩定DNA-PARP複合物,阻礙複製叉進展。基於「合成致死」原理,TQB3122可選擇性殺傷BRCA突變或同源重組缺陷的腫瘤細胞。研究顯示,TQB3122在多個腫瘤模型中療效顯著,且腦組織分佈能力突出,是顱內腫瘤治療的潛在新選擇。
目前,全球尚無同靶點藥物獲批上市。集團將探索TQB3122在晚期實體瘤中的安全性與療效,有望爲全球患者提供新的治療選擇。
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