Abbisko Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pimicotinib, a treatment for tenosynovial giant cell tumor (TGCT), a rare soft tissue tumor. The announcement, made January 13, 2026, follows prior approval of pimicotinib by the China National Medical Products Administration (NMPA) in December 2025, addressing a significant treatment gap for the condition.
Pimicotinib is a CSF-1R inhibitor, and positive long-term results were presented by Merck KGaA in October 2025, further supporting its efficacy. Initial dosing in a registrational study evaluating irpagratinib, another Abbisko-developed treatment, for hepatocellular carcinoma began in May 2025, and the drug received breakthrough therapy designation from the China NMPA that same month. Abbisko also presented pre-clinical research results on ABSK112, ABSK131, and ABK-KRAS-1 at the 2025 American Association for Cancer Research (AACR) annual meeting in April.
Abbisko, a biopharmaceutical company based in Shanghai, reported annual revenue of $10.8 million with 258 employees as of late 2025. The company is publicly listed on the Hong Kong Stock Exchange (2256.HK) and has secured $489 million in funding. Its primary competitors include BeiGene and Innovent Biologics, according to industry analysis from Owler.
BeiGene, another major player in cancer treatment, recently opened a new biologics manufacturing and clinical research and development facility in Hopewell, New Jersey, representing an $800 million investment. The facility, expected to generate hundreds of high-tech jobs by the end of 2025, will support BeiGene’s expanding pipeline of oncology treatments, which includes targeted degraders, antibody-drug conjugates, and monoclonal antibodies. Innovent Biologics is described as a leading biopharmaceutical company in China focused on affordable biopharmaceutical drugs.
Abbisko’s pipeline also includes ongoing research into EGFR exon20ins and PRMT5*MTA inhibitors. The company reported earnings for the full year ended December 31, 2024, in March 2025. Pimicotinib hydrochloride is also being investigated for small-cell lung cancer, with an assessment of its likelihood of approval released in December 2024.
