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正大天晴重磅抗肿瘤1类新药安罗替尼获批上市!

2018-05-11 正大天晴药业集团官微 正大天晴药业集团官微

5月9日,正大天晴药业集团自主研发的1.1类新药盐酸安罗替尼胶囊(福可维)获得国家药品监督管理局批准的注册批件。这标志着备受关注的中国肿瘤领域的原研创新药——安罗替尼正式上市。正大天晴药业集团总裁王善春表示:“我们期待这一民族新药上市后,可以惠及更多中国患者、乃至全球患者。”安罗替尼 剑指晚期非小细胞肺癌正大天晴研发团队历经10余年的努力,终于在肿瘤药物的开发上有了突破,1.1类新药盐酸安罗替尼胶

5月9日,正大天晴药业集团自主研发的1.1类新药盐酸安罗替尼胶囊(福可维)获得国家药品监督管理局批准的注册批件。这标志着备受关注的中国肿瘤领域的原研创新药——安罗替尼正式上市。正大天晴药业集团总裁王善春表示:“我们期待这一民族新药上市后,可以惠及更多中国患者、乃至全球患者。”

安罗替尼 剑指晚期非小细胞肺癌


正大天晴研发团队历经10余年的努力,终于在肿瘤药物的开发上有了突破,1.1类新药盐酸安罗替尼胶囊获批上市。这一产品是新型小分子多靶点酪氨酸激酶抑制剂,能有效抑制VEGFR、PDGFR、FGFR、c-Kit等激酶,具有抗肿瘤血管生成和抑制肿瘤生长的双重功效。经临床试验证实,福可维是目前晚期非小细胞肺癌血管生成靶向药物中仅有的单药有效的口服制剂,而且不良反应较轻,患者耐受性良好。业内专家分析,安罗替尼有望成为晚期非小细胞肺癌患者三线治疗的标准用药。

“安罗替尼的上市,还得益于眼下国家药监局正在进行的药品审评审批改革举措。由于临床研究显示安罗替尼相比现有的治疗手段有明显的临床优势,申报后即被药品审评中心纳入优先审评序列,正是由于药品审评部门的重视,审评专家加班加点,使得安罗替尼在很短的时间内完成了上市审评并获得批准,这样才使得广大患者能够尽快用上安全、有效的抗肿瘤创新药。”王善春认为,该药审评期间,适逢国家药品审评审批政策改革期,国家鼓励研发创新的导向越来越明显,像安罗替尼这类临床价值突出的创新药的审批,得到了保障和激励。药审中心通过优先审评程序,为满足临床用药需求、降低用药费用、促进公众健康提供了有效保障。

临床研究结果显示,福可维不仅对非小细胞肺癌,而且对软组织肉瘤、卵巢癌等多个癌种均有很好的治疗效果,正大天晴正在积极开展包括美国在内的多中心临床研究。安罗替尼治疗软组织肉瘤2b期临床研究结果在今年ASCO获得口头报告,治疗非小细胞肺癌3期临床研究病理亚组结果在今年ASCO获得壁报展示,并被写入《2018版CSCO肺癌指南》。王善春表示:“中国原研创新药上市前就已获得如此殊荣,实属不易,这表明国际对中国创新药的认可。”

恶性肿瘤 生命不可承受之重

中国现在每年新发肿瘤患者有400余万人,平均每天有超过一万人被确诊为新发病人,且发病率呈逐年上升趋势。尤其是肺癌,在男性中的发病率和死亡率均排在第一位,在女性中发病率第二位、死亡率也排在第一位。肿瘤患者的五年生存期,远低于发达国家平均水平。

一位普通民众,一旦被确诊为患有恶性肿瘤疾病,不仅患者本人将遭受身体和精神的双重折磨,失去生存的希望,丧失生命的尊严,而且一个家庭可能因此被击垮,并从此背负上沉重的、难以承受的精神和经济包袱。作为一个有社会良知的企业,正大天晴也在竭力努力着,期望有一天能通过科技创新来征服恶性肿瘤这个顽疾。

近年来,随着传统化疗的发展,靶向治疗和免疫治疗陆续进入一线、二线治疗,晚期非小细胞肺癌的治疗获得了很大改善。然而,对于一线、二线治疗失败的中国患者,现有的三线治疗手段较为缺乏且选择混乱,患者往往处于无药可用的困境。在这种情况下,正大天晴自主研发的新型小分子多靶点酪氨酸激酶抑制剂安罗替尼终于获得了成功,为中国晚期非小细胞肺癌患者三线治疗提供了一种有效的全新治疗手段。

正大天晴 抗肿瘤领域产品线丰富

安罗替尼的上市,可以说是正大天晴发展史上一个里程碑式的事件。该药是正大天晴第一个按照国际研发流程和标准进行的创新小分子药,也是该公司迄今为止研发投入最多的抗癌药。安罗替尼的成功上市,标志着正大天晴从“仿创结合”向“创仿结合”战略转型迈出坚实一步,也是企业在“聚焦肝病”战略基础上,向肿瘤领域进军取得重大突破。

正大天晴药业集团是集科研、生产和销售为一体的创新型医药集团企业,是国内知名的肝健康药物研发和生产基地,为国家重点高新技术企业、国家火炬计划连云港新医药产业基地重点骨干企业,位列中国医药工业百强企业榜第16位。正大天晴药业目前每年研发投入超过销售收入的10%,拥有研发人员1000余名,在研品种180余个,其中创新药超过40个,生物药20余个。

据悉,除强势肝病领域,正大天晴抗肿瘤领域也形成了独特的产品线,血液肿瘤产品地西他滨、伊马替尼、达沙替尼为国内首仿上市。未来三年,正大天晴肿瘤领域将上市更多的产品,如硼替佐米、苯达莫司汀、来那度胺、阿扎胞苷等,为肿瘤患者提高药品可及性和生命质量。

安罗替尼相关的拓展阅读:

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    2018-05-13 xxxx1054
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    2018-05-18 weiz
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    2018-05-11 12296478m17暂无昵称

    期待胃癌用药能有突破!加油!

    0

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    2018-05-11 九天.

    第一批沙发

    0

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    2018-05-11 lietome2

    感谢小编为我们精心准备了如此精辟的精神大餐.小编辛苦了.点个赞吧!

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