ABBISKO-B (02256) announced on January 13, 2026, that its subsidiary, Shanghai Abbisko Biopharmaceuticals (Abbisko), declared 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, ABSK021), 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 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 may lead to functional limitations or severe complications.

Marketing applications for the product in other markets are currently under review by the relevant regulatory authorities.

The FDA's acceptance of this NDA for Bejema® is based on positive efficacy and safety results from the global, multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study.

The study demonstrated that TGCT patients receiving a once-daily oral dose of Bejema® achieved statistically significant improvements in the primary endpoint, which was the Objective Response Rate (ORR) at week 25 as assessed by a Blinded Independent Review Committee (BIRC) according to RECIST v1.1 criteria.

Furthermore, all secondary endpoints related to the assessment of key clinical outcomes in TGCT patients showed significant and clinically meaningful improvements, including increased range of motion and physical function, as well as reduced stiffness and pain.

Long-term data from 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, potentially leading 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.

As regulatory submissions for Bejema® advance in major global markets, this drug is expected to offer TGCT patients worldwide a convenient, once-daily, oral treatment option that is both effective and well-tolerated, helping to address the significant unmet clinical need in this disease area.