Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi.
Originally approved in China in 2002 for treating HER2 positive early and metastatic breast cancer, as well as HER2 positive metastatic gastric cancer, Herceptin was added to China’s National Reimbursement Drug List (NRDL) in 2017. Hanquyou has since expanded its reach, gaining approvals in both the European Union and China in July and August 2020, respectively. The biosimilar has now received marketing approvals in over 40 countries, including the UK, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and more.- Flcube.com
