中国生物制药(01177.HK):抗肿瘤药"盐酸安罗替尼胶囊"新增适应症“软组织肉瘤”
格隆汇7月5日丨中国生物制药(01177.HK)公布,由公司附属公司正大天晴药业集团股份有限公司自主研发的抗肿瘤药"盐酸安罗替尼胶囊"(商品名称(福可维®)),继去年获批上市后,刚获国家药品监督管理局颁发药品注册批件,批准新增适应症“软组织肉瘤”。
公告显示,目前临床治疗晚期软组织肉瘤的药物主要为细胞毒类抗肿瘤药物,其不良反应相对较大,而靶向治疗药物则较为缺乏,因此对靶向治疗药物的开发具有重要的临床意义和价值。盐酸安罗替尼属于多靶点受体酪氨酸激酶抑制剂,具有抗肿瘤血管生成和抑制肿瘤生长的作用,用于治疗晚期软组织肉瘤的疗效已得到临床证实。相比国内外同类药物,盐酸安罗替尼具有疗效更好、剂量小、毒副作用低等特点,有着广阔的市场前景。
此外,集团研发的盐酸安罗替尼胶囊是目前国内唯一获批软组织肉瘤适应症的靶向药,已被中国临床肿瘤学会纳入软组织肉瘤诊疗指南。
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