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中国生物制药(01177.HK)“盐酸安罗替尼胶囊”获批第三个适应症
格隆汇 09-04 20:30

格隆汇9月4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),获中国国家药品监督管理局颁发药品注册批件,批准新增适应症“三线治疗小细胞肺癌”。这是盐酸安罗替尼胶囊继去年获批用于治疗晚期非小细胞肺癌、今年六月获批用于治疗软组织肉瘤后,获批准的第三个适应症。

对于临床治疗小细胞肺癌,目前标准一线治疗方案是依托泊苷╱铂类联合化疗,二十多年来疗效止步不前;二线治疗方案是托泊替康化疗,效果亦不理想。小细胞肺癌迫切需要新的治疗药物。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,用于三线治疗小细胞肺癌的疗效已得到临床证实。其临床有效性分析显示,与安慰剂组比较,使用盐酸安罗替尼治疗的小细胞肺癌患者的无病进展生存期获得显著延长。

一直以来,本集团积极响应国家号召,为切实降低国内肿瘤患者的用药负担而努力。福可维定价仅为同类进口药物的50%-60%,而且具有剂量小、用药方便等特点。自去年上市以来,福可维为无数肿瘤患者减轻病痛、延缓生命流逝、改善生命质量,同时为临床医生提供了更多的药物选择,具有积极的社会意义和广阔的市场前景。

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