诺华抗体新药布西珠单抗注射液新适应症在华申报上市
我爱霍启刚掖
发表于 2024-10-12 11:45:05
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公开资料显示,布西珠单抗(brolucizumab)是靶向抑制VEGF的新一代眼底病治疗药物,此前已在国际范围内获批用于治疗湿性年龄相关性黄斑变性(wAMD,又称nAMD)和糖尿病黄斑水肿(DME)。在中国,该产品的首个上市申请于去年8月获受理,本次为该产品在中国的第二项上市申请。
布西珠单抗此前已在全球数十个国家获批用于治疗nAMD和DME,在中国,布西珠单抗尚未获得国家药监局的正式批准。但诺华公开信息显示,此前它已通过“港澳药械通”政策获批在大湾区指定医疗机构进行临床急需使用。根据中国药物临床试验登记与信息公示平台官网,诺华已经在中国完成布西珠单抗至少3项3期临床研究。
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Disclaimer: The views expressed in this article are those of the author only, this article does not represent the position of CandyLake.com, and does not constitute advice, please treat with caution.
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