Chi-Med Gets OK on Capsules for Colorectal Cancer in China

– Fruquintinib capsules provide a new oral treatment option for patients with metastatic colorectal cancer and will be marketed as Elunate^® –

– Elunate^® data published in JAMA demonstrated increased overall survival versus placebo –

– First ever approval of an innovative medicine by Chi-Med –

– The first China-discovered and developed treatment for CRC approved in China –

Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that fruquintinib capsules have been granted approval for drug registration by the National Medical Products Administration of China (“NMPA”, formerly the China Food and Drug Administration) for the treatment of metastatic colorectal cancer (“CRC”) 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 (“VEGF”) or anti-epidermal growth factor receptor (“EGFR”) therapies. 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.”

“We are particularly grateful to the patients, their families, investigators, nurses, caregivers and study team members who participated in the clinical development of Elunate^® and now look forward to making this world-class new therapy available as quickly as possible to patients with CRC in China.”

https://www.biospace.com/article/chi-med-announces-the-approval-of-fruquintinib-capsules-for-previously-treated-colorectal-cancer-in-china/