Abbisko Therapeutics’ CSF-1R Inhibitor Pimicotinib Approved by the China NMPA, Addressing the Treatment Gap for Tenosynovial Giant Cell Tumor

Core Viewpoint - Abbisko Therapeutics has received approval from the China National Medical Products Administration (NMPA) for pimicotinib, a treatment for symptomatic tenosynovial giant cell tumor (TGCT), marking a significant advancement in therapeutic options for patients in China [1][6]. Group 1: Product Approval and Significance - The approval of pimicotinib is based on the positive results from the global Phase III MANEUVER study, which demonstrated a high objective response rate (ORR) for TGCT treatment [3][4]. - Pimicotinib is the first domestically developed systemic therapy for TGCT, filling a crucial gap for patients who have limited options beyond surgery [6][7]. - The approval process was notably efficient, with a zero-deficiency approval granted in just over six months following NDA acceptance [6]. Group 2: Clinical Study Results - In the MANEUVER study, pimicotinib showed a statistically significant ORR of 54.0% compared to 3.2% for placebo (p<0.0001) at week 25 [4]. - Long-term follow-up data indicated that the ORR increased to 76.2% with a median follow-up of 14.3 months, including four patients achieving a Complete Response (CR) [4]. - Secondary endpoints also showed significant improvements in patient daily life, including relative Range of Motion and physical function [4]. Group 3: Company Background and Future Plans - Abbisko Therapeutics, founded in April 2016, focuses on discovering and developing innovative oncology medicines to address unmet medical needs [10]. - The company aims to continue advancing breakthrough therapies that can reshape the future of oncology in China and globally [5][7]. - Merck KGaA, Darmstadt, Germany, holds worldwide commercialization rights for pimicotinib and is working to ensure timely patient access in China [1][8].