WS Investor
23 Dec 2025, 14:30
Merck announced that China’s National Medical Products Administration (NMPA) has approved pimicotinib as a systemic treatment for adults with symptomatic tenosynovial giant cell tumor (TGCT) where surgery may cause functional limitation or severe morbidity. This marks the first regulatory approval globally for pimicotinib, a CSF-1R inhibitor developed by Abbisko Therapeutics and commercialized worldwide by Merck, strengthening the company’s position in rare tumor treatments.
The approval is based on results from the global Phase 3 MANEUVER study, in which pimicotinib demonstrated a statistically significant improvement in objective response rate at week 25 versus placebo (54.0% vs. 3.2%), alongside meaningful improvements in mobility, physical function, pain, and stiffness. Longer-term follow-up showed that more than 75% of patients achieved a response per RECIST v1.1, with the treatment remaining generally well tolerated.
Merck stated that additional regulatory submissions for pimicotinib are ongoing globally, following designations such as FDA Breakthrough Therapy and EMA PRIME. The company plans to make the therapy available to patients in China as quickly as possible while continuing international expansion efforts.
The approval is based on results from the global Phase 3 MANEUVER study, in which pimicotinib demonstrated a statistically significant improvement in objective response rate at week 25 versus placebo (54.0% vs. 3.2%), alongside meaningful improvements in mobility, physical function, pain, and stiffness. Longer-term follow-up showed that more than 75% of patients achieved a response per RECIST v1.1, with the treatment remaining generally well tolerated.
Merck stated that additional regulatory submissions for pimicotinib are ongoing globally, following designations such as FDA Breakthrough Therapy and EMA PRIME. The company plans to make the therapy available to patients in China as quickly as possible while continuing international expansion efforts.