Abbisko Therapeutics Co Ltd (HKEX:02256), a China-based, oncology-focused biopharmaceutical company, announced on Monday that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its novel, orally administered, small-molecule colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), for the systemic treatment of patients with tenosynovial giant cell tumour (TGCT).

Pimicotinib was independently developed by Abbisko Therapeutics and has been licensed to German science and technology company Merck KGaA (ETR:MRK) for worldwide commercialisation. In December 2025, pimicotinib was approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with symptomatic TGCT for which surgical resection will potentially cause functional limitation or relatively severe morbidity. Additional applications are under review by regulatory bodies in other markets.

The FDA's acceptance of the pimicotinib NDA is supported by efficacy and safety outcomes from the global, multicentre, randomised, double-blind, placebo-controlled Phase III MANEUVER trial.