20 May 2025, Shanghai – Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics, 02256.HK) today announced that its highly selective small-molecule CSF-1R inhibitor, pimicotinib (ABSK021), has been granted Priority Review status by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with Tenosynovial Giant Cell Tumor (TGCT). In December 2023, Abbisko entered into an agreement with Merck pertaining to the commercial rights to pimicotinib, and Merck will be responsible for the commercialization of pimicotinib globally.

Priority Review status is expected to expedite pimicotinib's review process in TGCT, potentially providing more timely access for eligible patients. Pimicotinib was previously granted Breakthrough Therapy Designation (BTD) by the China NMPA and US Food and Drug Administration (FDA), as well as Priority Medicine (PRIME) designation by the European Medicines Agency (EMA) for the treatment of patients with TGCT.

About Pimicotinib

Pimicotinib is a novel, orally administered, highly selective, and potent small molecule CSF-1R inhibitor, independently developed by Abbisko Therapeutics. Abbisko reported positive topline results from the Global Phase III MANEUVER Study with pimicotinib for the treatment of Tenosynovial Giant Cell Tumor (“TGCT”) in November 2024. Pimicotinib met all primary and secondary endpoints, demonstrating an objective response rate (“ORR”) at Week 25 of 54.0% compared to 3.2% for placebo (p<0.0001). Treatment with oral, once-daily pimicotinib was well-tolerated, with discontinuation due to treatment-related adverse events in 1.6% of patients, and no evidence of cholestatic hepatotoxicity.