澳门首个国际标准新药临床试验正式启动

Core Insights - The launch of the first international standard clinical trial for new drugs in Macau marks a historic step, establishing the capability to conduct clinical trials and completing the clinical research network in the Greater Bay Area [1][2] Group 1: Clinical Trial Details - The FIBRONEER™-SARD trial is a global multicenter Phase IIIb clinical trial initiated by Boehringer Ingelheim, focusing on the efficacy and safety of nerandomilast in patients with Systemic Autoimmune Disease-related Interstitial Lung Disease (SARD-ILD) [1] - The trial will be conducted in approximately 15 countries and regions worldwide, with the Macau University of Science and Technology Clinical Trial Center (MUST-CTC) as the implementing site and Hong Kong University Clinical Trial Center (HKU-CTC) providing strategic support [1] Group 2: Drug Information - Nerandomilast, a PDE4B selective inhibitor developed by Boehringer Ingelheim, has shown good efficacy and safety in Phase III studies for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) [2] - The drug has received "Breakthrough Therapy" designation from the FDA and priority review qualifications in multiple regions, including the US and Europe [2] Group 3: Strategic Collaborations - Boehringer Ingelheim signed a strategic cooperation agreement with MUST-CTC, indicating the HOPE project has achieved full coverage in the Greater Bay Area [2] - This collaboration aims to enhance regional synergy, capacity building, and the transformation of research outcomes, ultimately creating more value for patients [2]