Commercial-stage, biopharmaceutical company HUTCHMED (China) Limited (Nasdaq:HCM)(AIM:HCM)(HKEX:13) and Innovent Biologics, Inc. (HKEX:1801), a biopharmaceutical company, on Tuesday jointly announce New Drug Application, (NDA) acceptance in China for fruquintinib combination with sintilimab in advanced endometrial cancer, granted Priority Review after Breakthrough Therapy designation in July 2023.

This marks the first regulatory filing for fruquintinib in combination with a leading immune checkpoint inhibitor. The NDA targets patients with advanced endometrial cancer who are not eligible for curative surgery or radiation.

The submission is based on data from FRUSICA-1, a Phase II study evaluating the combination's efficacy and safety. Primary endpoints include objective response rate, with secondary endpoints covering various clinical and pharmacokinetic assessments. Breakthrough Therapy designation was granted due to the combination's potential in addressing an unmet medical need with significant clinical advantages. Fruquintinib, a selective oral VEGFR inhibitor, shows promise in inhibiting tumor angiogenesis with enhanced selectivity and sustained target inhibition, potentially expanding its utility in combination therapies.