百奧泰(688177.SH):注射用BAT8009獲得臨牀試驗批准通知書
格隆匯4月15日丨百奧泰(688177.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於公司在研藥品注射用BAT8009的《臨牀試驗批准通知書》。
根據《Clinical Development Success Rates2006-2015》公佈的數據,通常情況下對於抗腫瘤藥物,一般I/II期臨牀研究階段持續約2年時間,I期完成進入II期的比率約62.8%,II期完成進入III期的比率約24.6%。
BAT8009是百奧泰開發的靶向B7H3的抗體藥物偶聯物(ADC),擬開發用於實體腫瘤治療。B7H3(又稱為CD276)是免疫調節蛋白B7家族的膜蛋白成員,在多種實體腫瘤中高表達,在腫瘤發生發展、免疫逃逸等多個過程中發揮作用,與腫瘤的不良預後相關。而B7H3在正常人體組織中表達水平較低。腫瘤組織和正常組織中表達水平的差異使得B7H3成為ADC治療B7H3表達腫瘤的一個有吸引力的靶點。
BAT8009由重組人源化抗B7H3抗體與毒性小分子拓撲異構酶I抑制劑,通過自主研發的可剪切連接子連接而成。BAT8009具有高效的抗腫瘤活性,毒素小分子有很強的細胞膜滲透能力,在ADC殺傷癌細胞後能釋放並殺死附近的癌細胞,產生旁觀者效應,有效克服腫瘤細胞的異質性。
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