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復宏漢霖(02696.HK):漢貝泰®(貝伐珠單抗注射液)的上市註冊申請(NDA)獲國藥監局批准
格隆匯 12-03 18:26

格隆匯12月3日丨復宏漢霖(02696.HK)宣佈,近日,公司自主開發的漢貝泰®(貝伐珠單抗注射液)的上市註冊申請(NDA)獲國家藥品監督管理局("NMPA")批准,用於治療:1)轉移性結直腸癌;2)晚期、轉移性或複發性非小細胞肺癌。

此次漢貝泰®(貝伐珠單抗注射液)獲NMPA上市註冊申請(NDA)批准主要基於對其與原研貝伐珠單抗進行的多項頭對頭比對研究數據的審查,包括質量對比研究、臨牀前研究及臨牀1期和多中心臨牀3期研究相關數據,研究結果證明漢貝泰®(貝伐珠單抗注射液)在藥代動力學、療效、安全性、耐受性及免疫原性與原研貝伐珠單抗高度相似

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