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復宏漢霖(02696.HK):HLX02(曲妥珠單抗)獲美國FDA批准用於乳腺癌輔助治療、轉移性乳腺癌及轉移性胃癌治療
格隆匯 04-26 12:46

格隆匯4月26日丨復宏漢霖(02696.HK)宣佈,近日,Accord收到FDA的批准函,150mg/瓶規格HLX02(注射用曲妥珠單抗)獲FDA批准用yu (1)輔助治療HER2過表達乳腺癌;(2)治療HER2過表達轉移性乳腺癌;及(3)治療HER2過表達轉移性胃腺癌或胃食管交界腺癌,其yu 美國獲批的商品名為HERCESSITM。據此,HLX02(注射用曲妥珠單抗)成為公司首個獲FDA批准於美國上市的產品。

此次FDA批准主要是基於對於中國大陸境內被稱為漢曲優®的HLX02(注射用曲妥珠單抗)對比其參照藥(Herceptin®)一系列研究數據的審查,包括分析相似性研究及臨牀研究等,這些數據都證明了HLX02(注射用曲妥珠單抗)與其參照藥(Herceptin®)在質量、安全性和有效性方面的高度相似。同時,集團HLX02(注射用曲妥珠單抗)的相關生產場地和設施亦接受了FDA的批准前檢查(Pre-License Inspection, PLI),該等生產場地和設施均能夠滿足FDA的cGMP。

公吿稱,HLX02(注射用曲妥珠單抗)是公司首個獲FDA批准於美國上市的產品。本次獲批,將進一步推進公司國際化佈局的進程,提升公司產品的國際影響力。

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