Pimicotinib was approved by EMA Priority Drug Program

On June 7, 2023, the company announced that its innovative CSF-1R inhibitor Pimicotinib (ABSK021) was granted priority drug status (PRIME) by the European Medicines Agency (EMA). It is used in the treatment of inoperable giant cell tumors of tendon sheath. The priority designation is based on the excellent results of Pimicotinib phase Ib clinical trial in patients with tendon sheath giant cell tumor. Similar to other national breakthrough designations, the Priority Drugs Program is designed to speed up the review process of priority drugs in areas of medicine shortage.

It is reported that Pimicotinib is the first potential CSF-1R best-in-class drug candidate in the world to obtain breakthrough therapy or priority drug status in China, the United States and Europe. Previously, Pimicotinib was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of China Medical Products Administration in July 2022 and by the US Food and Drug Administration (FDA) in January 2023. The triple designation of breakthrough therapy or priority drug in China, the United States and Europe shows the recognition of Pimicotinib clinical results by regulatory agencies around the world, which will accelerate the pace of Pimicotinib's global marketing and highlight the innovative research and development strength of the company.