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百奧泰(688177.SH):BAT1308注射液獲臨牀試驗通知書
格隆匯 05-27 15:52

格隆匯5月27日丨百奧泰(688177.SH)公佈,公司於2020年5月26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BAT1308注射液的《臨牀試驗通知書》。

BAT1308注射液是百奧泰生物製藥股份有限公司自主研發的一種單抗藥物,其活性成分是一種由中國倉鼠卵巢細胞表達的靶向人程序性細胞死亡蛋白1(PD-1)的抗體,屬於免疫球蛋白IgG4κ亞型,能夠以高親和力特異性地結合人PD-1,從而阻斷PD-1與其配體PD-L1、PD-L2的相互作用。BAT1308能夠與T細胞表面的PD-1結合,解除PD-1通路對T細胞的抑制作用,從而恢復和提高T細胞的免疫殺傷功能,抑制腫瘤生長。

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%,考慮到臨牀研究週期長、投入大,過程中不可預測因素較多,臨牀試驗、審評和審批的結果以及時間都具有一定的不確定性,容易受到一些不確定性因素的影響,敬請廣大投資者謹慎決策,注意防範投資風險。

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