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PimicotinibApprovedasSystemicTreatmentinChinaforTenosynovialGiantCellTumor
===2025/12/23 8:47:41===
发布时间:2025-12-22 16:02 First regulatory approval in the world for pimicotinib based on positive data from global Phase 3 MANEUVER study
In MANEUVER, pimicotinib significantly improved objective response rate at week 25 (54% vs. 3.2% for placebo), while providing clinically meaningful and statistically significant improvements across all patient-reported outcomes
With longer-term follow-up, 3 out of 4 patients treated with pimicotinib achieved response per RECIST v1.1, and treatment continued to be well-tolerated
Approval strengthens Merck’s leadership in rare tumors, with additional ongoing regulatory filings for pimicotinib underway globally



DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, announced today that following Priority Review, the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgica
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