Fruquintinib filed for approval in China for advanced colorectal cancer

Chinese biopharmaceutical company Hutchison China MediTech (AIM: HCM), also known as Chi-Med, says that the China Food and Drug Administration (CFDA) has acknowledged acceptance of the New Drug Application for fruquintinib for the treatment of patients with advanced colorectal cancer.

The development triggers a milestone payment of 30.8 million renminbi ($4.5 million) from partner Eli Lilly (NYSE: LLY) to Chi-Med. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with locally-advanced or metastatic colorectal cancer (CRC) in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 5, 2017. The company also expects to begin US clinical studies in 2017.

CRC is the second most common cancer type in China, with about 380,000 new cases per year, according to National Central Cancer Registry of China. There were around 1.5 million new CRC cases globally in 2015 which are expected to increase to about 1.7 million new cases per year by 2020, according to Frost & Sullivan.