PIMJETMI® (pimicotinib) Developed by Abbisko Therapeutics and Licensed by Merck KGaA, Darmstadt, Germany Receive U.S. FDA Approval for TGCT

Résumé détaillé

PIMJETMI® (pimicotinib) is a new systemic treatment option for certain U.S. adult patients with symptomatic tenosynovial giant cell tumor (TGCT), demonstrating durable* tumor…

SHANGHAI, Nov. 10, 2026 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced that the U.S. Food and Drug Administration (FDA) has approved PIMJETMI® (pimicotinib), a small-molecule colony-stimulating factor 1 receptor (CSF-1R) inhibitor, as a systemic treatment for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity.

Yao-Chang Xu, PhD, Founder and Chief Executive Officer of Abbisko Therapeutics, highlights, "The U.S. FDA approval of PIMJETMI® marks a significant milestone in Abbisko Therapeutics' innovation and global development journey. As our first proprietary innovative medicine to reach commercialization, PIMJETMI® is now approved in China, Canada, Switzerland and the United States, and our global commercialization partnership with Merck KGaA, Darmstadt, Germany is accelerating its availability to more patients worldwide. This achievement demonstrates Abbisko's end-to-end capabilities spanning early-stage drug discovery, global clinical development, and regulatory submission.

"People living with TGCT have long faced difficult treatment decisions as they navigate a disease that can significantly affect their daily lives including their mobility," said Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany. "Translating scientific innovation into clinically meaningful advances for people living with rare tumors is a strategic imperative for our company, as we continue our commitment to addressing significant unmet needs. With the approval of PIMJETMI® in the U.S., we strengthen our leadership position and growing portfolio in rare tumors and bring real hope to patients and their families."

PIMJETMI® is an orally available and potent small-molecule CSF-1R inhibitor independently developed by Abbisko Therapeutics, with global commercialization rights granted…

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