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

20 July 2023
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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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