The green light from the National Medical Products Administration of China (formerly the China Food and Drug Administration) is for use of the oral VEGF inhibitor in patients with metastatic CRC who have failed at least two prior systemic rounds of therapy.
Elunate (fruquintinib) will be sold in China by Chi-Med’s commercial partner Eli Lilly, although there’s no word yet on whether the two companies are inclined to develop the drug for use in the US or Europe, particularly as the third-line CRC category is more competitive in those markets. China looks set to be a big market for the drug in its own right, however, as CRC is the second-most common form of cancer with an estimated 380,000 new cases every year.
Elunate will have to go up against well-established oral drugs like Bayer’s multikinase inhibitor Stivarga (regorafenib) and Taiho Oncology’s Lonsurf (trifluridine/tipiracil) in the third-line setting.
The approval has sparked a $13.6m milestone payment from Lilly to Chi-Med, and is a major achievement for the Chinese biopharma company, particularly as other companies have struggled to bring oral VEGF inhibitors to market for CRC…