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全球首发 中国率先批准那米司特用于治疗进展性肺纤维化
Xin Jing Bao· 2025-12-11 14:23
Core Insights - The approval of Namilizumab (brand name: Bo Yu Wei) by the National Medical Products Administration for the treatment of adult progressive pulmonary fibrosis (PPF) marks the first new therapy approved for PPF in over five years, showcasing the "China speed" in patient-centered healthcare [1][2] - PPF affects up to 5.6 million people globally, particularly those with underlying conditions such as rheumatoid arthritis or systemic sclerosis, and is associated with increased mortality risk as the disease progresses [1] - Namilizumab is the only selective phosphodiesterase 4B (PDE4B) inhibitor approved for this indication, demonstrating immunomodulatory, vascular protective, and anti-fibrotic effects [1] Clinical Trial Results - The approval is based on the largest clinical trial project for PPF to date, with the key Phase III trial FIBRONEER-ILD showing that Namilizumab effectively slows lung function decline in PPF patients and improves survival rates, with a nominally significant reduction in mortality risk [1] - Namilizumab also exhibited good safety and tolerability, with a low discontinuation rate and no need for liver function monitoring [1][2] Market Context - Currently, treatment options for progressive pulmonary fibrosis are very limited, highlighting the urgent need to improve patient survival and quality of life [2] - The U.S. Food and Drug Administration is prioritizing the review of Namilizumab for the treatment of adult PPF, with applications for its use in treating idiopathic pulmonary fibrosis and PPF under review in the EU, UK, Japan, and other regions [2]