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中國生物製藥(01177.HK)"TQB3019(BTKPROTAC)"臨牀試驗申請獲NMPA批准
格隆匯 04-09 18:17

格隆匯4月9日丨中國生物製藥(01177.HK)公吿,集團自主研發的"TQB3019 (BTK PROTAC)"已獲得中國國家藥品監督管理局(NMPA)的臨牀試驗批准,擬用於治療血液腫瘤。

TQB3019是基於集團OAPD®技術平台開發的一款口服、靶向BTK的蛋白降解靶向嵌合體(PROTAC)藥物。作為一種異雙功能分子,TQB3019通過結合BTK蛋白和E3泛素連接酶,啟動泛素蛋白酶體途徑,降解靶蛋白。該作用機制可以抑制BTK及下游信號傳導,進而抑制腫瘤生長。與傳統的BTK抑制劑相比,PROTAC藥物在攻克BTK耐藥難題上展現出更大潛力。

臨牀前研究證明,TQB3019療效顯著、機制明確,且安全性良好,具備攻克腫瘤耐藥難題的潛力。體外研究顯示,TQB3019對多種體外培養BTK野生型及不同突變類型的腫瘤細胞均有顯著的增殖抑制作用。在動物模型中,TQB3019可以顯著抑制BTK野生型及不同耐藥突變細胞的小鼠皮下移植瘤的生長,且抑制活性強。

目前全球尚無同靶點PROTAC藥物獲批上市。集團積極佈局BTK和PROTAC藥物,除TQB3019外,TQB3702(二代BTK抑制劑)已啟動Ⅱ期臨牀,TQB3201(ARPROTAC)和TQB3142(BCL-XLPROTAC)已處於pre-IND階段。集團將加速推進該等產品的臨牀開發進程,聚焦全球尚未被滿足的臨牀需求,為患者提供更優的治療選擇。

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