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.

China’s Center for Drug Evaluation Accepts Merck’s Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor. 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 therapy, which is expected to expedite the review process. Pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., also has been granted breakthrough therapy designation (BTD) by the NMPA.