Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The drug is also awaiting regulatory decisions regarding the treatment of glioblastoma (GBM) and hepatocellular carcinoma (HCC).
Previous Approvals and Market Position
HanBeiTai was first approved in China in November of last year for the treatment of advanced, metastatic, or recurrent non-small cell lung cancer and metastatic colorectal cancer. It is the eighth bevacizumab biosimilar in China, with its sBLAs for GBM and HCC accepted for review in July and August of this year, respectively.
Market Landscape
Roche’s originator drug Avastin was first approved in the United States in February 2004 and entered the Chinese market in February 2010, gaining inclusion on the National Reimbursement Drug List (NRDL) in 2017. In addition to Henlius Pharma, 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 bevacizumab on the local market.
Future Outlook
The acceptance of the sBLA for HanBeiTai by the CDE underscores Henlius Biotech’s commitment to expanding its biosimilar portfolio. By targeting multiple indications, HanBeiTai aims to address significant unmet medical needs and improve patient outcomes in oncology.-Fineline Info & Tech
