China 'Breakthrough' status for Hutchmed's fruquintinib-sintilimab combo

20 July 2023

The Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) for the combination of fruquintinib and sintilimab (a PD-1 antibody), which is being developed by Hong Kong-based Hutchmed (HKEX:13; AIM: HCM)), whose London listed shares dipped 2.6% to 192.48 pence this morning.

The combo therapy is intended for the treatment of patients with advanced endometrial cancer (EMC) with pMMR tumors that have failed at least one line of platinum-based therapy.

A study for potential registration of this combination in patients with previously treated advanced EMC in China has recently completed enrollment.

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