智通财经APP讯,百利天恒(688506.SH)公告,公司于近日收到国家药品监督管理局(NMPA)正式批准签发的《药物临床试验批准通知书》,公司自主研发的创新生物药注射用BL-M07D1(HER2-ADC)的II/III期临床试验获得批准。
据悉,BL-M07D1是一种靶向HER2的创新ADC,具有best-in-class潜力,已在临床试验中展示出显著的抗肿瘤功效。截至本公告披露日,除本次新获得批准的临床试验外,BL-M07D1正于中国及美国的10项I/II/III期临床试验中作为单药或联用进行评估。各项临床研究包括各种HER2表达/突变的实体瘤(包括非小细胞肺癌、乳腺癌、尿路上皮癌、妇科肿瘤及消化道肿瘤)的患者。
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