GE医疗**超声造影剂示卓安(R)在中国上市

2019-04-20 不详 美通社

GE医疗中国今日宣布,该公司旗下首款超声造影剂示卓安®(Sonazoid ®)已通过中国国家药品监督管理局(NMPA)审批,在中国正式上市。作为新一代特异性超声造影剂,示卓安®(Sonazoid ®)由GE医疗挪威奥斯陆研发中心研制而成,主要针对肝内及肝外脏器及病变的显影,可应用于肝脏局灶性病变血管相和枯否相的超声成像,全程监控肿瘤,从而实现早期诊断、策略优化、精准治疗、疗效监测及随访,对于推动肝

GE医疗中国今日宣布,该公司旗下首款超声造影剂示卓安®(Sonazoid ®)已通过中国国家药品监督管理局(NMPA)审批,在中国正式上市。作为新一代特异性超声造影剂,示卓安®(Sonazoid ®)由GE医疗挪威奥斯陆研发中心研制而成,主要针对肝内及肝外脏器及病变的显影,可应用于肝脏局灶性病变血管相和枯否相的超声成像,全程监控肿瘤,从而实现早期诊断、策略优化、精准治疗、疗效监测及随访,对于推动肝脏肿瘤的早诊早治和精准治疗具有重要意义。

示卓安(Sonazoid)新品发布仪式现场嘉宾云集
示卓安(Sonazoid)新品发布仪式现场嘉宾云集

GE医疗中国今日宣布,该公司旗下首款超声造影剂示卓安(Sonazoid)已通过中国国家药品监督管理局(NMPA)审批,在中国正式上市。

示卓安®(Sonazoid ®)的药品通用名称为注射用全氟丁烷微球,是一种高特异性的单核吞噬细胞(MPS)超声造影剂。其外观呈现为白色块状物或粉末,上层填充是可通过肺呼吸代谢的无色全氟丁烷气体,微球外壳则是可通过肝肾代谢的氢化卵磷脂酰丝氨酸钠。使用示卓安®(Sonazoid ®)的增强造影维持时间超过1小时、显影效果清晰,且具有良好的安全性。自2006年在日本率先上市后,示卓安®(Sonazoid ®)已先后在韩国、挪威和中国台湾上市,帮助全球大量的肝脏肿瘤患者获得了更为精准、高效的诊断和治疗。

近年来,亚洲逐渐成为全球癌症高发区。据2018年国际癌症研究机构(International Agency for Research on Cancer)发布的《全球癌症报告2018》显示,中国平均每天有超过1万人被确诊癌症,肝癌的死亡率位居前三,并且80%以上的肝细胞肝癌被诊断时已发展至中晚期,对临床治疗造成极大的困难。超声造影一直是肝脏肿瘤影像诊断和辅助治疗的重要手段之一,传统超声造影剂的显影时间通常只能维持3-7分钟,较难发现隐匿小病灶,更遑论从容实施超声引导的介入手术了。

作为新一代的超声造影剂,示卓安®(Sonazoid ®)的优势在于具有枯否相(即血管后期影像),这一特点使得造影增强效果可持续1至2小时之久,由此医师能够精准早期检出小病灶(<1cm),在早期诊断中准确判断肝癌的分化程度,帮助良恶性病灶区分,并实现术前精准定位病灶范围,优化治疗策略;术中准确界定安全边界、实时引导;术后即刻进行疗效评估,对肝癌的早期诊断和实施超声引导的介入手术极具价值。此外,示卓安®(Sonazoid ®)稳定性好,在不同厂家高低档超声设备中显影效果都表现优异,令超声造影技术可以被更广泛地应用,从而更好地满足民众早期筛查、早诊早治的需要。

中国超声医师学会会长何文教授表示:中国是肝癌大国,目前影像学早期诊断技术敏感性较低,超声造影技术尤其是新一代的造影剂技术在肝癌的早期诊断方面提供了有效的工具,新一代造影剂示卓安®将为肝脏的精准治疗提供有效的治疗方案。”

中国超声医师学会会长何文教授致辞
中国超声医师学会会长何文教授致辞

GE医疗中国诊断药物部总经理戴红东先生表示:“一直以来,GE医疗始终践行‘关爱先行’市场战略,通过实施精准医学为患者实现更早、更优的临床解决方案。作为GE医疗在超声造影剂领域推出的第一款产品,示卓安®(Sonazoid ®)在中国的上市凝聚了GE医疗团队多年来的心血,其枯否相的优势和对微小肿瘤的敏感性将为广大中国肿瘤患者和高危人群带来福音,让病人更早享受更高效的诊断过程、更精准的治疗方案和更好的治疗效果。未来,GE医疗会继续加快诊断药物的研发创新,借助人工智能新技术开发更为完善的诊断解决方案,推动精准医学朝更可及性、更先进的方向发展,造福更多中国患者,这也是我们医疗从业者的伟大使命。”

GE医疗中国诊断药物部总经理戴红东先生致辞
GE医疗中国诊断药物部总经理戴红东先生致辞

关于GE医疗

GE医疗是全球领先的医学成像、监护、生物制造以及细胞和基因治疗技术提供商,通过提供智能设备、数据分析、软件应用和服务,实现从疾病诊断、治疗到监护全方位的精准医疗。GE医疗拥有100多年的悠久历史,在全球拥有5万多名员工,享誉业界。公司致力于帮助医疗服务提供商、科研人员和生命科学企业为全球患者改善临床结果。

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    2019-04-22 sodoo
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    2019-04-20 122b9cbbm13暂无昵称

    有意思 看一下

    0

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