EMA accepts First "China-Developed" Biosimilar - Henlius HLX02 MAA for Review

Henlius, a leading biotech company in China developing both biosimilar and innovative biologics, on 21 June 2019, announced that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02. The European rights of this product have been out-licensed to its business partner Accord Healthcare. HLX02 is indicated for human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer, HER2+ metastatic breast cancer, and untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer.

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