Sirtex Medical和China Grand Pharmaceutical宣布SIR-Spheres Y-90树脂微球获得NMPA认可

2020-11-29 Allan MedSci原创

SIR-Spheres®Y-90树脂微球的新药申请(NDA)已获得中国NMPA的批准。

Sirtex Medical是针对性肝癌治疗的领先制造商,近日宣布,Sirtex在其股东China Grand Pharmaceutical(CGP)的支持下,SIR-Spheres®Y-90树脂微球的新药申请(NDA)已获得中国NMPA的批准。

Sirtex预计将在2021年第四季度收到批准SIR-Spheres®在中国商业化的决定。程序和最终批准取决于各种因素。NDA中包含的适应症是与氟尿苷辅助化疗联合治疗不可切除的转移性结直肠癌(mCRC)。

根据2015年中国的癌症统计数据,中国大肠癌新病例数为376,300,其中一半以上的患者(约188,000)可能患有肝转移。此外,肝癌(HCC)治疗市场甚至更大,根据世界卫生组织2018年的统计数据,全世界有841,000新的HCC病例,其中40万在中国发生,占总数的47.6%。

 

原始出处:

https://www.firstwordpharma.com/node/1777618?tsid=4

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  5. 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    2021-03-30 zz12341245
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    2021-05-02 shanyongle
  7. 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    2021-11-15 jj000001
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    2020-12-01 海豹
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    2020-12-01 lfyang
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