Core Viewpoint - The National Medical Products Administration (NMPA) has approved Pimicotinib capsules for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients, which may lead to functional limitations or serious complications [1] Group 1: Product Approval - Pimicotinib (development code: ABSK021) is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor developed independently by He Yu Pharmaceutical [1] - The approval was granted through the CDE priority review process [1] Group 2: Licensing Agreement - In December 2023, He Yu Pharmaceutical entered into an exclusive licensing agreement with Merck for Pimicotinib [1] - Under the agreement, Merck obtained exclusive rights for the commercialization of Pimicotinib for all indications in mainland China, Hong Kong, Macau, and Taiwan, along with exclusive options for global commercialization rights [1]
和誉医药：首个自研新药获批上市