By Fineline Cube 
Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that its self-developed, highly selective small-molecule CSF-1R inhibitor, Pimitinib (ABSK021), has been granted priority review by the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) for the treatment of tenosynovial giant cell tumor (TGCT) patients. This designation is based on the drug’s potential to address a significant unmet medical need.
Previous Designations and Partnerships
Pimitinib has previously received Breakthrough Therapy Designation (BTD) from both China’s NMPA and the U.S. FDA. It has also been granted PRIME status by the European Medicines Agency. In December 2023, Abbisko entered into a global commercialization partnership agreement with Merck, further underscoring the drug’s promising profile.
Clinical Trial Results
In the global Phase III MANEUVER study, Pimitinib demonstrated impressive efficacy, achieving all primary and secondary endpoints. At Week 25, the drug showed an objective response rate (ORR) of 54.0%, compared to just 3.2% in the placebo group. Additionally, Pimitinib exhibited good tolerability, with no observed cholestatic hepatotoxicity.-Fineline Info & Tech