Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the Center for Drug Evaluation (CDE) has accepted a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab), for review. The application is intended for the treatment of recurrent glioblastoma (GBM).
Drug Profile
HanBeiTai was first approved in China in November 2022 for the treatment of advanced, metastatic, or recurrent non-small cell lung cancer and metastatic colorectal cancer. Avastin, developed by Roche, was first approved in the US in February 2004 and entered the Chinese market in February 2010. It was included in the National Reimbursement Drug List (NRDL) in 2017.
Market Context
In addition to Henlius Biotech, a total of eight other companies, including Qilu Pharma, Innovent Bio, Hengrui Medicine, Bio-Thera Solutions, Betta Pharma, and Tot Bio, have biosimilar versions of Avastin on the Chinese market.-Fineline Info & Tech
