China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Eisai’s (TYO: 4523) cancer therapy Halaven (eribulin). The approval signifies that BrightGene’s product, trade-named BoLiNing, has passed the generic quality consistency evaluation (GQCE). BoLiNing is now approved for the treatment of locally advanced or metastatic breast cancer in patients who have previously been treated with at least two chemotherapy regimes, including at least one anthracycline and taxane.
Background on Halaven
Halaven, originally derived from Halichondrin B in Kanagawa, Japan, was first approved in the US for the treatment of breast cancer in 2010. A second indication for liposarcoma in inoperable patients was granted in 2016. The compound patent for eribulin expired in China on June 16, 2019, and is set to expire in the US on July 20, 2023. BoLiNing marks the first generic version of the drug in China, where the originator was approved in July 2019 and subsequently included on the National Reimbursement Drug List (NRDL) in 2021.
Market Outlook
The drug has demonstrated significant market potential, generating USD 353 million in global annual sales as of September 30, 2022. In China, BoLiNing is estimated to achieve RMB 90 million (USD 12.97 million) in sales in 2022, highlighting the growing demand for effective cancer therapies in the country. This approval positions BrightGene to capture a share of the market for breast cancer treatments, offering patients a more accessible option for this critical medication.-Fineline Info & Tech
