Abbisko Therapeutics Announces China NMPA Acceptance of New Drug Application for Pimicotinib for the Treatment of TGCT

SHANGHAI, June 10, 2025 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. (02256.HK) today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective, small-molecule CSF-1R inhibitor, as a Class 1 innovative drug for adult patients with Tenosynovial Giant Cell Tumor (TGCT). Pimicotinib is the first internally discovered and self-developed program from Abbisko Therapeutics to enter the NDA approval process, and has the potential to provide patients with a best-in-class therapy to treat TGCT given its exceptional clinical efficacy, safety, and tolerability as demonstrated in multiple clinical trials.

"TGCT grows in and around the joints, primarily affecting young and middle-aged adults in their working years. The swelling, pain, stiffness and limited mobility caused by the disease can have a significant impact on the ability to perform daily activities, limiting patients' work and social lives," said Professor Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. "Based on these new data from the MANEUVER study, pimicotinib has the potential to establish a new treatment paradigm for patients with TGCT."

The submission follows the granting of Priority Review to pimicotinib by the Center for Drug Evaluation (CDE) of the NMPA in May for the treatment of patients with TGCT who require systemic therapy, which is expected to expedite the review process. Pimicotinib also has been granted breakthrough therapy designation (BTD) by the NMPA. 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.

Yao-Chang Xu, Chairman and CEO of Abbisko Therapeutics, said: "The acceptance of the New Drug Application for pimicotinib marks a significant milestone in the development journey of Abbisko Therapeutics. Pimicotinib demonstrates a meaningful clinical efficacy and safety profile that positions it to be an innovative treatment option for TGCT patients and clinicians. It will reinforce our strength and determination in innovative drug development. "

"With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country," said Hong Chow, Head of China and International, Healthcare business of Merck. "Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to the US Food and Drug Administration, with additional filings planned in other markets."

The application is based on results from Part 1 of the global Phase 3 MANEUVER study, in which once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain. The data were presented earlier this month at the 2025 ASCO Annual Meeting.

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.

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