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麗珠醫藥(01513.HK):託珠單抗注射液獲得註冊批准
格隆匯 01-19 08:01

格隆匯1月19日丨麗珠醫藥(01513.HK)發佈公吿,近日,公司從國家藥品監督管理局網站查詢獲悉,公司控股子公司珠海市麗珠單抗生物技術有限公司提交的託珠單抗注射液(安維泰®)的藥品上市許可申請已獲批准。

安維泰®是以羅氏公司的託珠單抗(雅美羅®)作為參照藥,按照生物類似藥研發的託珠單抗注射液。上市申報註冊的受理時間為2021年12月(受理號:CXSS2101056國),該品適應症為類風濕關節炎。

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