Shanghai Henlius Biotech Inc., (HKG: 2696) a leading China-based biotech firm, has announced that its biosimilar version of Roche’s Herceptin, known as Hanquyou (trastuzumab; HLX02), has been granted marketing authorization in both Thailand and the Philippines. The drug, which is marketed under the trade names TRAZHER and Hertumab in these countries respectively, is now approved for the treatment of HER2-positive breast cancer and gastric cancer. This follows previous marketing approvals in Singapore, Cambodia, and other Southeast Asian nations.
Developed in accordance with both Chinese and EU biosimilar guidelines, Hanquyou received marketing 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 a total of over 40 countries worldwide. Henlius is also expecting a marketing approval in the United States in the coming year. Trastuzumab, the originator medicine, was included in China’s National Reimbursement Drug List (NRDL) in 2017, enhancing its accessibility for patients.- Flcube.com
