Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China.
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. This year, its sBLAs for hepatocellular carcinoma (HCC) and for cervical cancer, epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were accepted for review in August and October, respectively.
Pipeline and Global Trials
Henlius is also developing HLX04-O, an anti-VEGF monoclonal antibody (mAb) based on Hanbeitai, targeting wet age-related macular degeneration (wAMD). The drug completed first patient dosing in a Phase III clinical study in China in November last year and initiated a global multi-center Phase III clinical trial in Latvia and Australia in April this year. HLX04-O has secured Phase III clinical trial approvals in several countries, including Australia, the United States, Singapore, Latvia, Spain, the Czech Republic, and Poland.
Market Landscape
In addition to Henlius Pharma, a total of eight other companies, including Roche, Qilu Pharma, Innovent Bio, Hengrui Medicine, Bio-Thera Solutions, Betta Pharma, and Tot Bio, have biosimilar versions of bevacizumab on the local market. Hanbeitai generated significant sales in China, reaching RMB 6.315 billion (USD 874 million) in 2021 and RMB 3.196 billion (USD 442 million) in the first half of 2022.
Future Outlook
The approval of the sBLA for recurrent glioblastoma underscores Henlius Biotech’s commitment to expanding the therapeutic indications of Hanbeitai. With ongoing global trials and a robust pipeline, Henlius aims to enhance its market position and address significant unmet medical needs in oncology and ophthalmology.-Fineline Info & Tech
