On February 28, 2023, the National Medical Products Administration (NMAP) accepted Xiling Lab's initial application for the production license of eribulin mesylate Injection (Acceptance No.: CYHS2300657). This marks a significant milestone in Xiling Lab's product development, entering a stage of commercialization.
Eribulin mesylate Injection, originally developed by Eisai, is designed for patients with locally advanced or metastatic breast cancer who have undergone at least two prior chemotherapy regimens. We anticipate the approval of our ANDA application for eribulin mesylate injection by the end of 2024. Additionally, the API and key intermediates of eribulin have been successfully registered as DMF both in China and the United States, providing accessibility to domestic and international partners. We are actively collaborating with partners to expand the global sales of the API and FDF.
