Brand of Merck KgA, Merck is a German multinational science and know-how firm. | Picture Credit score: © Robert – inventory.adobe.com
Merck KGaA, Darmstadt, Germany, introduced in a press launch on June 10, 2025 that the Middle for Drug Analysis (CDE) of the China Nationwide Medical Merchandise Affiliation (NMPA) has accepted the corporate’s software for advertising and marketing authorization for pimicotinib, a novel, orally administered small-molecule inhibitor of the colony stimulating issue 1 receptor, or CSF-1R (1). CDE’s approval is for the therapy of grownup sufferers with tenosynovial large cell tumors (TGCTs) requiring systemic therapy.
Pimicotinib, which is in growth by Abbisko Therapeutics, was granted precedence evaluation by CDE in Might 2025, in addition to breakthrough remedy designation by NMPA (1).
TGCT and trial outcomes defined
Key Takeaways
- China’s CDE has accepted Merck KGaA’s software for pimicotinib, a CSF-1R inhibitor developed for TGCT, following its precedence evaluation designation.
- Part III trial information help pimicotinib’s once-daily use to scale back joint tumors and enhance mobility and ache, addressing a serious unmet want in TGCT care.
- Merck KGaA’s submitting follows FDA approval of a competing oral TGCT remedy, vimseltinib, and aligns with its broader innovation technique through Peregrine Ventures.
TGCT is described as a regionally aggressive, typically reoccurring tumor of the joints that may trigger swelling, ache, stiffness, and restricted mobility of the affected joints, probably leading to excessive morbidity in recurrent instances or if left untreated (1). Merck KGaA’s software—and the resultant actions of NMPA and CDE—was based mostly on outcomes from the primary a part of a world Part III trial (MANEUVER) that demonstrated superiority in a once-daily administration of pimicotinib versus placebo at 25 weeks.
“With the acceptance of our software for pimicotinib and the initiation of the precedence evaluation, we goal to supply sufferers in China the primary permitted systemic remedy for TGCT, addressing an incredible unmet want on this nation,” mentioned Hong Chow, head of China and Worldwide, Healthcare enterprise of Merck KGaA, within the press launch (1). “Pimicotinib has demonstrated the power to not solely shrink tumors that have an effect on their joints but additionally enhance outcomes like mobility, ache and stiffness, highlighting its potential to be a best-in-class therapy for TGCT. In parallel, we’re working to file a New Drug Utility to [FDA], with further filings deliberate in different markets.”
Different TGCT remedies within the works
FDA has already granted full approval to at the very least one therapy for TGCT. In February 2025, the company permitted Japan-based Ono Phamaceutical’s vimseltinib, a kinase inhibitor (model title Romvimza), in grownup sufferers with TGCT for which surgical resection might probably trigger worsening practical limitation or extreme morbidity (2). This therapy is available in oral, capsule kind and had beforehand acquired quick monitor designation and precedence evaluation from FDA.
As for Merck KGaA, the information of China’s approval of pimicotinib comes on the heels of the German firm’s announcement in Might 2025 that it could companion with Israel-based Peregrine Ventures, changing into a strategic companion in one in all Peregrine’s devoted funding autos, the Incentive Incubator (3). Beneath this settlement, Merck will acquire early publicity to sure alternatives for and growth of innovation from pharmaceutical and life science startup corporations, serving to to foster these corporations’ future success.
References
1. Merck KGaA. China’s Middle for Drug Analysis Accepts Merck KGaA, Darmstadt, Germany’s Utility for Advertising Authorization of Pimicotinib for Remedy of Tenosynovial Big Cell Tumor. Press Launch. June 10, 2025.
2. Ono Pharmaceutical. US FDA Grants Full Approval of Deciphera’s Romvimza (vimseltinib) for the Remedy of Symptomatic Tenosynovial Big Cell Tumor (TGCT). Press Launch. Feb. 14, 2025.
3. Merck KGaA. Merck Turns into a Strategic Accomplice in Peregrine Ventures’ Incentive Incubator. Press Launch (acquired through e-mail). Might 15, 2025.
