Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that the National Medical Products Administration (NMPA) has approved a supplementary Biologic License Application (sBLA) for its biosimilar Hanbeitai (bevacizumab). The approval expands the indications for which Hanbeitai can be used, now including cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
Previous Approvals and Market Position
Hanbeitai was first approved in China in November 2021 for the treatment of advanced, metastatic, or recurrent non – small cell lung cancer and metastatic colorectal cancer. In October of last year, the drug received additional approvals for the treatment of recurrent glioblastoma (GBM) and hepatocellular carcinoma (HCC). Bevacizumab, the reference drug, has been widely approved globally for the treatment of advanced HCC and is recommended as a first – line treatment in multiple countries and regions.
Competitive Landscape
With the latest approval, Henlius joins a competitive market for bevacizumab biosimilars. In addition to Roche’s original Avastin, a total of eight other companies, including Qilu Pharma, Innovent Bio, Boan Bio, Hengrui Pharma, Bio-Thera Solutions, Betta Pharma, and Tot Bio, already have biosimilar versions of bevacizumab on the local market. The expanded indications for Hanbeitai further strengthen Henlius’ position in this growing therapeutic area.-Fineline Info & Tech
