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    中国药企自主研发肿瘤新药上市

    时间:2021-11-10 02:15:21 来源:昆山尚驰机电设备工程有限公司 作者:大渡口区
    原标题:中国药企自主研发肿瘤新药上市历经14年不断努力,中国药企自主研发的创新肿瘤药苏泰达?(索凡替尼胶囊)23日正式上市。据了解,苏泰达?是一种新型的口服酪氨酸激酶抑制剂,已获国家药品监督管理局批准用于治疗非胰腺神经内分泌瘤。与传统抗肿瘤药物不同,苏泰达?兼有“抗血管生成”和“免疫调节”双重抗肿瘤机制,既抑制肿瘤血管生成,又可激活机体免疫功能。中国科学院院士陈凯先23日接受记者采访时表示,苏泰达?的上市不仅为中国非胰腺神经内分泌瘤靶向治疗提供药物解决方案,而且也表明中国创新药正以前沿创新的研究理念、规范严谨的研发流程等加速惠及中国患者,走向世界。”陈凯先说,在过去很长的一段时间里,中国的新药自主研发能力薄弱,无法摆脱对进口药物的依赖。最近一、二十年,中国新药研发的能力和成果产出有了非常快速的进步,从2018年到2020年,中国不断有自主研发的新药获批上市。这意味着,中国药物研发创新能力快速提升。神经内分泌瘤(NET)是一类起源于神经内分泌细胞的肿瘤,以胃、肠、胰腺和肺部最为常见。其中,非胰腺NET约占比90%。上海交通大学医学院附属仁济医院肿瘤科王理伟教授当日表示:“此前,NET患者的治疗选择十分有限,临床亟待更创新的疗法,以满足患者未尽之需。”采访中,记者了解到,相关临床研究现实,苏泰达?治疗组患者的中位无进展生存期(PFS)明显延长,安全性良好。在王理伟教授看来,苏泰达?有望带动中国NET临床实践指南的变革,对中国创新药的蓬勃发展起到了推动作用。采访中,记者了解到,未来索凡替尼作为中国创新药有望迈向全球,为大量海外患者带去更多选择和福音。2020年12月,索凡替尼在中国获批上市,同月也开始向美国FDA滚动提交新药上市申请,并有望在2021年在美国获批上市。据了解,企业还将面向欧洲提交新药上市申请。(白嘉懿)

    (责任编辑:伊犁哈萨克自治州)

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