微芯生物(688321.SH):澳门药物监督管理局批准西达本胺上市

Core Viewpoint - Microchip Biotech (688321.SH) has received approval from the Macao Special Administrative Region's Drug Regulatory Authority (ISAF) for the marketing of Chidamide tablets, marking a significant milestone for Chinese innovative drugs in the global market [1] Group 1: Product Approval - ISAF has officially approved the marketing of Chidamide (brand name "Epidaza") [1] - Chidamide is the world's first subtype-selective histone deacetylase (HDAC) inhibitor [1] - This approval represents a pioneering achievement for Chinese innovative drugs in obtaining license-out agreements with Europe and the United States [1] Group 2: Indications and Clinical Trials - Chidamide has been approved for three indications in mainland China: peripheral T-cell lymphoma, breast cancer, and diffuse large B-cell lymphoma [1] - In Japan, it has been approved for adult leukemia and peripheral T-cell lymphoma [1] - In Taiwan, it has been approved for breast cancer [1] - The company is currently conducting Phase III clinical trials for follicular helper T-cell phenotype peripheral T-cell lymphoma (PTCL-TFH), colorectal cancer (CRC), and melanoma (MM) in China and overseas [1]