9 March 2026, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced that data from the global multicenter Phase 3 MANEUVER study of pimicotinib (ABSK021), a novel, oral, highly selective and potent small-molecule colony-stimulating factor 1 receptor (CSF-1R) inhibitor developed in-house by Abbisko, have been published on March 5, WET in the prestigious international medical journal The Lancet ¹. This publication marks a significant milestone for Abbisko in terms of clinical research quality, data integrity, and international academic recognition for this innovative therapy.

The MANEUVER study enrolled 94 patients across more than 30 clinical centers worldwide, with patients from outside China accounting for more than half of the study population. The data show that pimicotinib achieved significant efficacy along with a generally favorable safety profile in patients with tenosynovial giant cell tumor (TGCT) ².

Pimicotinib, for which Merck holds worldwide commercialization rights, received approval from the China National Medical Products Administration (NMPA) in December 2025 for the treatment of adult patients with symptomatic TGCT for which surgical resection will potentially cause functional limitation or relatively severe morbidity ³. Meanwhile, a New Drug Application (NDA) has been formally accepted by the U.S. Food and Drug Administration (FDA), and additional applications are under review by regulatory bodies in other markets.

References

1.Xu H, Niu X, Ravi V, et al. Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomised, placebo-controlled, phase 3 trial. Lancet. Published online 2026.

2.Xiaohui Niu et al. Pimicotinib in tenosynovial giant cell tumor (TGCT): Efficacy, safety and patient-reported outcomes of phase 3 MANEUVER study. J Clin Oncol 43, 11500-11500(2025).

3.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20251222123420165.html

About Pimicotinib

Pimicotinib is a novel, oral, highly selective, and potent small-molecule CSF-1R inhibitor independently developed by Abbisko Therapeutics. Positive results from the global Phase 3 MANEUVER study of pimicotinib for the treatment of Tenosynovial Giant Cell Tumor (TGCT) were announced in November 2024. Currently, pimicotinib has been approved by the National Medical Products Administration (NMPA) in China for the treatment of adult patients with symptomatic TGCT for which surgical resection will potentially cause functional limitation or relatively severe morbidity. In December 2023, Abbisko entered into an agreement with Merck pertaining to the commercial rights to pimicotinib, pursuant to which Merck is responsible for the commercialization of pimicotinib globally.

Outside of China, pimicotinib has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and PRIME Designation by the European Medicines Agency (EMA).

About Abbisko Therapeutics

Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology.

Please visit www.abbisko.com for more information.