Chinese regulatory approval for Elunate to treat colorectal cancer.- Hutchison China MediTech .

Hutchison China MediTech Limited (�Chi-Med�) 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. In the FRESCO trial led by Dr. Jin Li and Dr. Shukui Qin, Elunate was shown to provide a statistically significant and clinically meaningful improvement in overall survival (�OS�) versus placebo, with median OS of 9.3 (95% CI 8.2, 10.5) vs. 6.6 (95% CI 5.9, 8.1) months, respectively (HR=0.65, 95% CI 0.51-0.83; p<0.001), and a manageable safety profile. in addition to the significant efficacy, fruquintinib�s good kinase selectivity has been shown to limit off-target toxicity and deliver what chi-med assesses to be best-in-class tolerability. this allows it to be evaluated in combination with other agents such as chemotherapies, targeted therapies and immunotherapies, thereby maximizing the number of potential patients who may benefit from this novel cancer treatment.>

CRC is the second most common cancer type in China, with about 380,000 new cases per year. There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.The most common adverse reactions included hypertension, hand-foot syndrome and proteinuria. Clinically effective management of these adverse effects is feasible.

See- "Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial"-Jin Li, MD; Shukui Qin, MD; Rui-Hua Xu, MD, PhD; Lin Shen, MD, PhD; et.al. JAMA. 2018; 319(24):2486-2496. doi: 10.1001/jama.2018.7855.

Comment: In October 2013, Chi-Med entered into a licensing, co-development and commercialization agreement in China with Eli Lilly for fruquintinib. Under the terms of the agreement, the costs of development of fruquintinib, carried out by Chi-Med, are shared; Chi-Med has received upfront payments and development and regulatory approval milestone payments; and upon commercialization in China, Chi-Med would receive royalties. Chi-Med and Lilly agreed to develop fruquintinib in three initial solid tumor indications, CRC, non-small cell lung cancer (�NSCLC�) and gastric cancer..