On January 13, 2026, Abbisko-B (02256) announced that the New Drug Application (NDA) for its self-developed, novel, oral, highly selective, and potent small molecule Colony-Stimulating Factor 1 Receptor (CSF-1R) inhibitor, Bejema® (Pimitesinib Hydrochloride Capsules), for the systemic treatment of patients with Tenosynovial Giant Cell Tumor (TGCT), has been formally accepted by the U.S. Food and Drug Administration (FDA). Bejema® was independently developed by Abbisko-B and has been licensed to Merck & Co. for global commercialization. In December 2025, Bejema® received marketing approval from China's National Medical Products Administration (NMPA) for use in adult patients with symptomatic TGCT where surgical resection could lead to functional limitations or severe complications. Currently, marketing applications for the product in other markets are under review by the relevant regulatory authorities. The acceptance of this NDA by the FDA is primarily based on positive results from the global, multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study. The study demonstrated that TGCT patients treated with once-daily oral Bejema® showed significantly superior Objective Response Rate (ORR)—the primary endpoint assessed by a Blinded Independent Review Committee (BIRC) according to RECIST v1.1 criteria at week 25—compared to the placebo group. Furthermore, all secondary endpoints related to key clinical outcome assessments in TGCT patients showed significant and clinically meaningful improvements, including increases in joint range of motion and physical function, as well as reductions in stiffness and pain. Long-term data with a median follow-up of 14.3 months further indicated a continued increase in ORR for patients who received Bejema® treatment from the start of the study. TGCT is a rare, locally aggressive tumor that occurs in or around joints, which can lead to progressive swelling, stiffness, and limited mobility in the affected joint, significantly impacting patients' daily activities and quality of life. If left untreated or if it recurs, TGCT can cause irreversible damage to bones, joints, and surrounding tissues. With the successive submission and potential future approval of Bejema® in major global markets, this drug is expected to provide TGCT patients worldwide with an innovative treatment option that is once-daily, oral, effective, and well-tolerated, helping to address the unmet clinical needs in this disease area.