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Henlius is First to have China-Developed Biosimilar Accepted for EU Review

publication date: Jun 21, 2019

Shanghai Henlius, a biosimilar/innovative biologics subsidiary of Fosun Pharma, reported the European Medicines Agency (EMA) has accepted its Marketing Authorization Application of a Herceptin (trastuzumab) biosimilar for review. The company says HLX02 is the first China-developed biosimilar to achieve this milestone, as well as the first China-developed trastuzumab biosimilar accepted in China. The candidate is indicated for HER2+ breast cancer and untreated HER2+ metastatic gastric/gastroesophageal junction (GEJ) cancer. Henlius has out-licensed European rights for HLX02 to Accord Healthcare. More details....

Stock Symbol: (SHA: 600196; HK: 02196)

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