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]

Core Viewpoint - The initiation of the clinical trial marks the completion of the "last piece of the puzzle" for the clinical research network in the Guangdong-Hong Kong-Macao Greater Bay Area [1] Group 1 - The first new drug clinical trial in Macau officially commenced on August 29 [1] - The trial is initiated by the multinational pharmaceutical company Boehringer Ingelheim and will be conducted at the Macau University of Science and Technology Clinical Trial Center [1] - This clinical trial is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of nerandomilast in patients with systemic autoimmune rheumatic disease-related interstitial lung disease [1]

Core Viewpoint - The company has received FDA approval for the IND application of IMM2510/AXN-2510, a bispecific antibody developed in collaboration with InstilBio, Inc. [1] Group 1 - The clinical trial for IMM2510/AXN-2510 is planned to start by the end of 2025, focusing on patients with recurrent/refractory solid tumors in a Phase 1b/2 study [1] - The trial aims to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of the drug in solid tumor patients [1] - Concurrently, a Phase 2 study in China is ongoing, assessing IMM2510/AXN-2510 in combination with chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC), with data expected to be released in the second half of 2025 [1]

Core Viewpoint - The report from the National Medical Products Administration (NMPA) indicates a significant increase in new drug clinical trial registrations in China, highlighting a growing trend in the pharmaceutical industry towards innovative therapies, particularly in cell and gene therapy, as well as pediatric drug development [1][2]. Summary by Sections Clinical Trial Registration Growth - In 2024, the number of new drug clinical trial registrations reached a record high of 4,900, marking a 13.9% increase from the previous year [1][2]. - The efficiency of initiating clinical trials has improved, with over 60% of trials obtaining the first informed consent within six months, and 70.2% for biological products [1]. Regional Concentration of Trials - The report notes a concentration of clinical trials in specific regions, with six areas having over 2,000 participating units, an increase from three regions the previous year. Guangdong Province led with 2,892 participations [3]. Focus on Metabolic Drugs - The competition in the development of metabolic drugs is intensifying, driven by the rising prevalence of sub-health populations, diabetes, and obesity. In 2024, 86 clinical trials for the top 10 chemical drugs were registered, accounting for 6.1% of the total [4]. Pediatric Drug Development - The number of clinical trials targeting pediatric populations has been increasing, with a focus on respiratory diseases, allergies, and preventive vaccines. The NMPA has established a special group for pediatric drug review to address the shortage of medications for children [9][10]. Rare Disease Drug Trials - Clinical trials for rare disease medications are also on the rise, with a stable focus on blood system diseases, neurological disorders, and anti-tumor drugs. In 2024, trials for blood system disease drugs accounted for nearly 30% of the total rare disease clinical trials [10]. Advances in Cell and Gene Therapy - There has been a notable increase in clinical trials for cell and gene therapy products, with the NMPA moving towards a more open regulatory environment for advanced therapies. This includes the potential inclusion of CAR-T and tumor vaccines as advanced treatment drugs [11].