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Published • China • Updated

China’s NMPA Approves Merck KGaA Treatment for Tenosynovial Giant Cell Tumor

Summary by pharmtech.com
NMPA’s Center for Drug Evaluation accepted Merck KGaA’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with TGCTs that require systemic treatment.

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pharmtech.compharmtech.com
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China’s NMPA Approves Merck KGaA Treatment for Tenosynovial Giant Cell Tumor

NMPA’s Center for Drug Evaluation accepted Merck KGaA’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with TGCTs that require systemic treatment.

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ANSAANSA
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China"s Center for Drug Evaluation Accepts Merck"s Application for Marketing Authorisation of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor - Business Wire

First global filling for powerfully 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 (ANSA)

·Italy
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cancernetwork.comcancernetwork.com

China’s CDE Accepts Marketing Application for Pimicotinib in TGCT

In the phase 3 MANEUVER trial, pimicotinib improved the objective response rate vs placebo in patients with tenosynovial giant cell tumor.

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ANSA broke the news in Italy on Tuesday, June 10, 2025.
Sources are mostly out of Italy (1)

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