#China #Shanghai #Pimicotinib #Abbisko Therapeutics #Tenosynovial Giant Cell Tumor

Abbisko Therapeutics Gains FDA Acceptance of Pimicotinib NDA

On January 12, 2026, Abbisko Therapeutics Co., Ltd., identified by its HKEX code 02256.HK, announced a major achievement in the field of oncology with the acceptance of its New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for its innovative medication, pimicotinib. This novel treatment is designed for patients suffering from tenosynovial giant cell tumor (TGCT), a rare but serious condition that can significantly impact patients' daily lives.

What is Pimicotinib?

Pimicotinib is an orally administered and highly selective small-molecule colony-stimulating factor 1 receptor (CSF-1R) inhibitor. Developed independently by Abbisko, this medication has now been licensed to Merck KGaA, Darmstadt, Germany, for its global commercialization. This collaboration promises to extend the availability of pimicotinib to a broader patient population more rapidly.

Previously, in December 2025, pimicotinib received approval from the China National Medical Products Administration (NMPA) for adult patients with symptomatic TGCT when surgical options could lead to significant functional impairment or severe morbidity. As regulatory reviews progress across multiple markets, the expectations are high for pimicotinib to become a front-line treatment option for this challenging condition.

Positive Clinical Trial Results

The FDA's acceptance of the NDA for pimicotinib is underpinned by robust data from the Phase III MANEUVER trial—a global, multicenter, randomized, double-blind, placebo-controlled study. The trial revealed that patients treated with daily doses of pimicotinib showed a statistically significant improvement in the primary endpoint of objective response rate (ORR). This was measured at Week 25 by an independent review committee using RECIST v1.1 criteria.

Moreover, the study demonstrated noteworthy enhancements in secondary endpoints, particularly regarding key patient-reported outcomes, such as increases in active range of motion and improvements in physical function. These findings indicate that patients experienced significant reductions in pain and stiffness associated with TGCT. The longer-term follow-up data, with a median of 14.3 months, further illustrated that the ORR continued to rise steadily over the duration of the study among those receiving treatment.

Understanding Tenosynovial Giant Cell Tumor

TGCT is characterized as a rare and locally aggressive tumor that primarily occurs in or around joints. It can lead to progressive symptoms such as swelling, stiffness, and a marked reduction in joint mobility, severely affecting the quality of life for those afflicted. If not adequately addressed, TGCT can cause irreversible damage to surrounding bone and tissues, emphasizing the urgent need for effective treatment solutions.

With the acceptance of pimicotinib's NDA by the FDA, Abbisko Therapeutics is poised to offer patients a highly effective oral treatment option that is both well-tolerated and simplifies the management of TGCT. The company is committed to fulfilling the unmet clinical needs associated with this condition.

About Abbisko Therapeutics

Founded in April 2016, Abbisko Therapeutics is a biopharmaceutical firm focused on oncology, headquartered in Shanghai. The company was established by a team of experienced professionals with extensive expertise in drug research and development from leading multinational pharmaceutical corporations. Since its inception, Abbisko has built an impressive pipeline focused on precision oncology and immuno-oncology, addressing the pressing needs within the medical landscape.

For more information about Abbisko Therapeutics and its innovations, visit www.abbisko.com.