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Henlius Biotech Reports US Accepts Herceptin Biosimilar BLA for Review

publication date: Feb 16, 2023

Shanghai Henlius Biotech reported the US FDA has accepted its BLA for trastuzumab, a biosimilar to Roche’s Herceptin. Henlius, together with its US affiliate, Accord, is seeking approval of the biosimilar in three HER2-overexpressing conditions: breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. To acquire the rights in 2020, Accord paid $27 million upfront, up to $13 million in regulatory milestones, sales milestones and a tiered double-digit royalty of up to 50% of future net profits. More details....

Stock Symbol: (HK: 2696)

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