Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving a fourth indication approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar, Hanbeitai. The drug is now approved for the treatment of hepatocellular carcinoma (HCC), expanding its therapeutic applications in China.
Previous Approvals and Therapeutic Indications
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. Last week, the drug received approval to treat recurrent glioblastoma (GBM). Bevacizumab, the reference drug, has been approved to treat advanced HCC in multiple countries and regions worldwide and is widely recommended as a first-line treatment for HCC.
Market Landscape and Competitors
In addition to Henlius Biotech, a total of eight other companies have biosimilar versions of bevacizumab on the local market. These include Roche (approved in 2010), Qilu Pharma (2019), Innovent Bio (2020), Hengrui Medicine (2021), Bio-Thera Solutions (2021), Betta Pharma (2021), and Tot Bio (2021). The approval for Hanbeitai in HCC further strengthens Henlius Biotech’s position in the competitive biosimilar market.
Future Outlook
The expanded indications for Hanbeitai highlight Henlius Biotech’s ongoing commitment to bringing accessible and effective treatments to patients with various cancers. With multiple biosimilars already on the market, the company aims to differentiate its product through additional indications and strong clinical performance.-Fineline Info & Tech
