Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments

Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s Herceptin (trastuzumab), under the trade name Adheroza. Hanquyou is indicated for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer, with both dosages of 150mg/bottle and 420mg/bottle being authorized.

Herceptin, the reference product, initially gained approval in China in 2002 for the treatment of HER2 positive early/metastatic breast cancer and HER2 positive metastatic gastric cancer. It was later included in China’s National Reimbursement Drug List (NRDL) in 2017. Henlius Biotech’s Hanquyou quickly followed suit, earning market approvals in both the EU and China in July and August 2020, respectively. Since then, the biosimilar has garnered marketing approvals across a wide range of countries, including the UK, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and over 40 nations globally. The most recent addition to this list came with the drug’s approval in the US in April 2024.- Flcube.com

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