Jinwu Financial News | Cinda Biotech (01801) announced that China's National Drug Administration (“NMPA”) has officially accepted a new drug marketing application (“NDA”) for the combination therapy of cindilimab and furoquintinib and has granted priority review qualifications to treat patients with advanced mismatch repair (“pMMR”) or advanced mismatch repair (“non-MSI-H”) with advanced mismatch repair (“non-MSI-H”) after previous systemic antineoplastic treatment and is unsuitable for radical surgery or radical radiotherapy (“non-MSI-H”) endometrial cancer patients.
The FRUSICA-1 study data supports this NDA. FRUSICA-1 is a multi-center, open-label endometrial cancer registration cohort for phase II clinical trials aimed at evaluating endometrial cancer patients with recurrent disease, disease progression, or intolerable toxicity after treatment with cindilizumab plus fruquintinib in platinum-containing dual-agent chemotherapy.