HCM has announced that National Medical Products Administration of China (NMPA) granted approval for drug registration of fruquintinib capsules for the treatment of metastatic colorectal cancer (“CRC”) patients.
Fruquintinib is a highly selective and potent small molecule oral inhibitor of vascular endothelial growth factor receptors (VEGFR) designed to be a global best in class for many types of solid tumours. Fruquintinib capsules are to be marketed in China under the brand name Elunate®. The approval is based on results from the Phase III FRESCO trial, presented at the American Society of Clinical Oncology 2017 Meeting and published in the JAMA (Journal of the American Medical Association) in 2018. The market launch of Elunate® in China will be through collaboration with Eli Lilly & Company. This approval also triggers an approximately $13.6m milestone payment to HCM from Lilly.
Simon To, Chairman of Chi-MedTech commented:”Today’s approval is a major achievement for Chi-Med. Elunate® is the first home-grown, China-discovered and developed drug we are aware of an oncology indication to be unconditionally approved through a randomized clinical trial in China.”