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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.
Merck KGaA, Darmstadt, Germany, announced in a press release on June 10, 2025 that the Center for Drug Evaluation (CDE) of the China National Medical Products Association (NMPA) has accepted the company’s application for marketing authorization for pimicotinib, a novel, orally administered small-molecule inhibitor of the colony stimulating factor 1 receptor, or CSF-1R (1). CDE’s approval is for the treatment of adult patients with tenosynovial giant cell tumors (TGCTs) requiring systemic treatment.
Pimicotinib, which is in development by Abbisko Therapeutics, was granted priority review by CDE in May 2025, as well as breakthrough therapy designation by NMPA (1).
TGCT is described as a locally aggressive, often reoccurring tumor of the joints that can cause swelling, pain, stiffness, and limited mobility of the affected joints, potentially resulting in high morbidity in recurrent cases or if left untreated (1). Merck KGaA’s application—and the resultant actions of NMPA and CDE—was based on results from the first part of a global Phase III trial (MANEUVER) that demonstrated superiority in a once-daily administration of pimicotinib versus placebo at 25 weeks.
“With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country,” said Hong Chow, head of China and International, Healthcare business of Merck KGaA, in the press release (1). “Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to [FDA], with additional filings planned in other markets.”
FDA has already granted full approval to at least one treatment for TGCT. In February 2025, the agency approved Japan-based Ono Phamaceutical’s vimseltinib, a kinase inhibitor (brand name Romvimza), in adult patients with TGCT for which surgical resection could potentially cause worsening functional limitation or severe morbidity (2). This treatment comes in oral, capsule form and had previously received fast track designation and priority review from FDA.
As for Merck KGaA, the news of China’s approval of pimicotinib comes on the heels of the German company’s announcement in May 2025 that it would partner with Israel-based Peregrine Ventures, becoming a strategic partner in one of Peregrine’s dedicated investment vehicles, the Incentive Incubator (3). Under this agreement, Merck will gain early exposure to certain opportunities for and development of innovation from pharmaceutical and life science startup companies, helping to foster those companies’ future success.
1. Merck KGaA. China’s Center for Drug Evaluation Accepts Merck KGaA, Darmstadt, Germany’s Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor. Press Release. June 10, 2025.
2. Ono Pharmaceutical. US FDA Grants Full Approval of Deciphera’s Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT). Press Release. Feb. 14, 2025.
3. Merck KGaA. Merck Becomes a Strategic Partner in Peregrine Ventures’ Incentive Incubator. Press Release (received via email). May 15, 2025.
