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東誠藥業(002675.SZ):擬用於治療PSMA陽性表達的晚期前列腺癌的相關藥品獲FDA批准開展臨牀試驗
格隆匯 05-04 11:53

格隆匯5月4日丨東誠藥業(002675.SZ)公佈,2023年4月28日,公司下屬公司藍納成新加坡收到美國食品藥品監督管理局(“FDA”)核准簽發的關於177Lu-LNC1003注射液的藥品臨牀試驗批准通知書(Study May Proceed Letter,“SMP”),將於近期開展I期臨牀試驗。

公司在研產品177Lu-LNC1003注射液是一種靶向前列腺特異性膜抗原(Prostate Specific Membrane Antigen,“PSMA”)的放射性體內治療藥物,擬用於治療PSMA陽性表達的晚期前列腺癌患者。

PSMA是由前列腺上皮細胞分泌的一種II型穀氨酸縮肽酶,特異性高表達於前列腺癌及其轉移灶的細胞中。177Lu-LNC1003注射液在動物體內外試驗及IIT (investigator-initiated trial,研究者發起的臨牀研究)研究中均展現出較高的結合親和力和PSMA靶向特異性,使放射性核素能夠濃聚於腫瘤病灶,實現腫瘤的精準治療。

此外,177Lu-LNC1003注射液前體化學結構中含有伊文思藍(Evans Blue,“EB”),能夠增加腫瘤對藥物的有效攝取,延長治療時間窗並可以在同等或更優的治療效果下降低放射性核素的用量,進而降低患者的治療成本。

目前國內外暫無同產品上市,亦無相關銷售數據。截至目前,177Lu-LNC1003注射液相關項目累計已投入研發費用約3007.69萬元。

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