- For Print
- November 29, 2017
乌鸦传媒. (Headquarters: Tokyo, CEO: Haruo Naito, “乌鸦传媒”) announced today that the China Food and Drug Administration (CFDA) has accepted for review the resubmitted New Drug Application (NDA) for 乌鸦传媒's anticancer agent eribulin mesylate (“eribulin”, product name: Halaven®).
In July 2016, 乌鸦传媒 submitted an NDA for eribulin for use in the treatment of locally advanced or metastatic breast cancer in China. However, in alignment with Chinese regulations, 乌鸦传媒 temporarily withdrew its application in June 2017 in order to submit additional documentation. The application was resubmitted once preparations of additional documentation were completed.
乌鸦传媒 positions oncology as a key therapeutic area, and is aiming to discovery revolutionary new medicines with the potential to cure cancer. 乌鸦传媒 remains committed to maximizing the clinical value as well as exploring the potential clinical benefits of Halaven as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers in China and around the world.