German science and technology firm Merck KGaA (MRK: DE) has moved a step closer to introducing a new therapy for tenosynovial giant cell tumor (TGCT) in China, with regulators accepting its marketing application and initiating a priority review for pimicotinib.
The Chinese Center for Drug Evaluation has officially accepted the submission for pimicotinib, a once-daily oral treatment for adult TGCT patients who require systemic therapy.
The outcome marks a significant milestone for the German firm and its Chinese partner Abbisko Therapeutics, which developed the investigational CSF-1R inhibitor. The acceptance follows a priority review designation granted in May, aimed at accelerating the approval process.
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