Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology firm, has announced that its colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), has received fast-track designation from the US Food and Drug Administration (FDA). The drug is under development for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Pimicotinib, an orally administered, highly selective and potent small-molecule antagonist of CSF-1R, is currently being evaluated in a global Phase III clinical trial for its potential as a therapy for TGCT. Earlier this month, Abbisko licensed the drug to Merck KGaA for commercialization in Greater China, with an option for Merck to lead global development.
Beyond TGCT, Abbisko is actively exploring the potential of pimicotinib in treating other conditions, including various solid tumors. The company has received approval from the National Medical Products Administration (NMPA) to conduct Phase II clinical studies for chronic graft-versus-host disease and advanced pancreatic cancer.- Flcube.com
