ABBISKO-B (02256.HK): PIMJETMI wins FDA approval for TGCT, fourth marketing approval, US$20 million milestone

NewTimeSpace News: On 11 November 2026, Abbisko Medicine Co., Ltd. (02256.HK) announced inside information that its subsidiary Shanghai Abbisko Biomedical Technology Co., Ltd. said Pimjetmi^® (generic name pimicotinib hydrochloride capsules), a CSF-1R small molecule inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the systemic treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Pimjetmi^® was independently developed by Abbisko, and its global commercial rights have been licensed to Merck KGaA, Darmstadt, Germany. The approval is the fourth new drug application approval for Pimjetmi^®, following approval by China's National Medical Products Administration in December 2025, Health Canada in June 2026 and Swissmedic in October 2026. Upon the first commercial sale in the United States, Abbisko will receive a US$20 million milestone payment, tiered double-digit percentage royalties on global net sales, and may receive further payments tied to other regulatory, development and commercial milestones.

The approval was primarily based on primary results and long-term follow-up data from the global Phase III MANEUVER study and its open-label extension study. At week 25, the objective response rate assessed by a blinded independent review committee per RECIST v1.1 was 56% versus 3% for placebo (p<0.0001). Secondary endpoints relevant to patients' daily lives, including range of motion (p=0.0003), physical function (p=0.0074) and pain (p<0.0001), also showed clinically meaningful and statistically significant improvements. In the long-term follow-up (median follow-up of 14.3 months for patients initially randomised to Pimjetmi^®), median duration of response was not reached, and most patients (77%) who responded at week 25 maintained clinical benefit after an additional 12 months of follow-up. The US and Canadian applications were reviewed under the Project Orbis framework.