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# Abbisko’s pimicotinib wins FDA approval for TGCT
- URL: https://chinapharmadesk.com/abbisko-pimicotinib-fda-tgct-brief-2026-11-12/
- Published: 2026-11-12T04:46:43.000Z
- Updated: 2026-11-12T08:41:26.000Z
- Description: China-origin CSF-1R inhibitor cleared in the U.S. after NMPA, Canada, and Switzerland—Merck KGaA holds global rights.
- Author: LinYi
- Tags: Desk brief, Deals & BD, Regulation, Pipeline

**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.*