Hutchison China MediTech Ltd. said the National Medical Products Administration of China approved the company's drug fruquintinib for treating certain patients with colorectal cancer.
The Chinese regulator approved the therapy for patients with colorectal cancer whose disease has spread across the body and who have failed at least two previous antineoplastic therapies such as fluoropyrimidine, oxaliplatin and irinotecan. The approval covers patients regardless of whether they received anti-vascular endothelial growth factor or anti-epidermal growth factor receptor therapies in the past.
The regulator's nod is based on the results of the phase 3 Fresco trial, which showed that fruquintinib improved the survival of colorectal cancer patients.
Hong Kong-based Chi-Med said fruquintinib capsules will be sold under the brand name Elunate in China through a collaboration with Eli Lilly and Co.
Colorectal cancer affects the colon and rectum and is the second most common cancer type in China. About 380,000 new cases of the disease are recorded per year in the Asian country.
Fruquintinib is also being studied as a potential treatment of lung cancer and gastric cancer in China, while the therapy is undergoing early-stage clinical studies in the U.S.