发布时间：2025-06-10 12:37 First global filing for potentially best-in-class TGCT treatment based on strong positive data from Phase 3 MANEUVER study
Potential for pimicotinib to be first systemic TGCT therapy approved in China, following recent granting of Priority Review by CDE
Additional applications planned in the US and other markets around the world
Not intended for Canada-, UK- or US-based media



DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment. The submission follows the granting of Priority Review to pimicotinib by the CDE in May for the treatment of patients with TGCT who require systemic the
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