BrightGene Bio-Medical Technology Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 688166), has announced the receipt of a First Adequate Letter from the US FDA for the active pharmaceutical ingredients (APIs) of its generic version of Eisai’s Halaven (eribulin), signifying that the drug has successfully passed the technical review process.
Eribulin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have previously undergone at least two chemotherapy treatments. These treatments must have included an anthracycline and a taxane, which are standard components of breast cancer chemotherapy regimens.
As the original microtubule inhibitor, eribulin was the first chemotherapy agent to demonstrate a survival benefit as a monotherapy in patients with metastatic breast cancer. The generic version was first approved in China in March 2023. In April 2020, BrightGene Bio entered into a partnership with an unnamed US firm to supply eribulin APIs for joint development of pharmaceutical preparations. The Abbreviated New Drug Application (ANDA) submitted by the US firm for the product was approved last month.
Eribulin lost its patent protection in the US in July of the previous year. According to the data, the original drug now faces competition from generic versions by Gland Pharma (approved in April 2024), Qingfeng Pharma (June 2024), and Custopharm, Inc. (July 2024), indicating a market shift towards more accessible treatment options for patients.- Flcube.com
