Core Viewpoint - The approval of Xidabena by the ISAF marks a significant milestone for the company, being the first subtype-selective histone deacetylase (HDAC) inhibitor from China to receive patent authorization in Europe and the United States [1] Group 1: Product Approval - The ISAF has officially approved the launch of Xidabena tablets in the Macao Special Administrative Region [1] - Xidabena has been approved for three indications in mainland China: peripheral T-cell lymphoma, breast cancer, and diffuse large B-cell lymphoma [1] - The drug has also received approvals for adult leukemia and peripheral T-cell lymphoma in Japan, and for breast cancer in Taiwan [1] Group 2: Ongoing Clinical Trials - 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]
微芯生物:澳门药物监督管理局批准西达本胺上市