Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the initiation of commercial supply of its biosimilar product, Hanquyou (trastuzumab; HLX02), in the US market. This move marks the expansion of the company’s commercial supply network to include China, South Asia, North America, Europe, the Middle East, and Latin America.
Herceptin and Hanquyou: A History of approvals and Reimbursements
Herceptin, the reference product, was first approved in China in 2002 for the treatment of HER2 positive early/metastatic breast cancer and HER2 positive metastatic gastric cancer. It was included in China’s National Reimbursement Drug List (NRDL) in 2017. Hanquyou, Henlius’ biosimilar version, earned market approvals in the EU and China within weeks of each other in July and August 2020. The drug has since obtained marketing approvals in the UK, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and others, totaling over 40 countries worldwide. The latest marketing approval was secured in the US in April 2024.
Partnership with Intas Pharmaceuticals and Accord Healthcare
The commercial supply expansion reflects the partnership between Henlius and India-based Intas Pharmaceuticals Ltd and its subsidiary Accord Healthcare Inc. Accord previously secured exclusive commercialization rights to Hanquyou in Europe, the Middle East, North Africa, and the Commonwealth of Independent States in a June 2018 deal. Later, in 2021, Accord acquired development and commercialization rights to the drug in the United States and Canada.-Fineline Info & Tech
