Abbisko’s pimicotinib wins FDA approval for TGCT
China-origin CSF-1R inhibitor cleared in the U.S. after NMPA, Canada, and Switzerland—Merck KGaA holds global rights.
What moved. Abbisko Therapeutics said the FDA approved pimicotinib (PIMJETMI / 贝捷迈) for symptomatic tenosynovial giant cell tumor (TGCT) in adults where surgery may worsen function or cause serious complications, matching the U.S. regulator’s 10 Nov 2026 approval notice and Abbisko’s same-week Hong Kong filings.
The number. In the Phase 3 MANEUVER study, blinded independent review by RECIST v1.1 at week 25 showed an objective response rate of 56% on drug versus 3% on placebo. Abbisko says this is the drug’s fourth major-market approval after China (Dec 2025), Canada (Jun 2026), and Switzerland (Oct 2026).
Why it matters. Global rights sit with Merck KGaA. A U.S. first commercial sale triggers another milestone for Abbisko, plus double-digit royalties on global net sales. For BD readers, this is a China-origin small molecule moving through a classic out-license path: local originator, multinational commercial owner, sequential major-market stamps.
Industry information only—not medical or investment advice.
