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安科生物(300009.SZ)參股公司靶向CD19自體嵌合抗原受體T細胞輸注劑獲批臨牀試驗
格隆匯 12-06 20:35

格隆匯12月6日丨安科生物(300009.SZ)公佈,2019年12月6日,公司參股公司博生吉安科細胞技術有限公司(“博生吉安科”)收到國家藥品監督管理局的《臨牀試驗通知書》。

藥品名稱為靶向CD19自體嵌合抗原受體T細胞輸注劑;適應症為18-70歲復發或難治性B細胞急性淋巴細胞白血病。

嵌合抗原受體T細胞(英文簡稱:CAR-T)是代表腫瘤治療最新發展趨勢的新型免疫療法。這種技術是將靶向識別腫瘤抗原的單鏈抗體基因以及激活T細胞活性和促進T細胞生存的信號分子,通過基因修飾的策略表達在患者的外周T巴細胞上,從而將患者的T淋巴細胞改造成為特異性殺傷腫瘤的藥物。在國際和國內的相關臨牀試驗中,已表現出對特定腫瘤類型的巨大殺傷力和臨牀療效。

博生吉安科本次獲批臨牀CAR-T藥品,是靶向CD19分子的針對B細胞急性淋巴細胞白血病(英文簡稱:B-ALL)的療法,同時也是國內首個按照全自動工藝生產要求申報的CAR-T藥品,在前期的臨牀驗證研究中,表現出優越的臨牀緩解率。

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