智通财经APP讯,石药集团(01093)发布公告,集团开发的SYS6045(抗体药物偶联物)(该产品)已获中国国家药品监督管理局批准,可以在中国开展临床试验。
该产品为一款单克隆抗体药物偶联物,可与肿瘤表面的特异性受体结合,通过内吞作用进入细胞并释放毒素,达到杀伤肿瘤细胞的作用。该产品按照治疗用生物制品1类申报,本次获批的适应症为晚期实体瘤,预计适用于治疗乳腺癌、胃癌、子宫内膜癌、宫颈癌、结直肠癌等。临床前研究显示该产品对多种癌症均有较好的抗肿瘤作用,具备较高的临床开发价值。该产品已在国内外提交多项专利申请。
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