Chi-Med Announces the Approval of Fruquintinib Capsules for Previously Treated Colorectal Cancer in China

Hutchison China MediTech (AIM/Nasdaq: HCM) today announces that fruquintinib capsules have been granted approval for drug registration by the National Medical Products Administration of China (formerly the China Food and Drug Administration) for the treatment of metastatic colorectal cancer patients, who have failed at least two prior systemic antineoplastic therapies including fluoropyrimidine, oxaliplatin and irinotecan, with or without prior use of anti-vascular endothelial growth factor or anti-epidermal growth factor receptor therapies.

As quoted in the press release:

Fruquintinib is a highly selective and potent small molecule oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3 designed to be a global best-in-class VEGFR inhibitor for many types of solid tumors. 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, which were presented at the American Society of Clinical Oncology 2017 Meeting and published in the JAMA (Journal of the American Medical Association) in 2018.

“Today’s approval is a major achievement for Chi-Med,” said Simon To, Chairman of Chi-Med. “Elunate^® is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomized clinical trial in China,” he added, “This is the result of over a dozen years of steadfast commitment by Chi-Med in research and development in China’s emerging biotech ecosystem.”

Click here to read the full press release.