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创新疗法那米司特片在华获批,用于特发性肺纤维化
Xin Jing Bao·2025-10-23 03:41

Core Insights - Boehringer Ingelheim's oral selective phosphodiesterase 4B (PDE4B) inhibitor, Namilusit, has received approval from the National Medical Products Administration (NMPA) for the treatment of adult idiopathic pulmonary fibrosis (IPF), marking the first new drug approval in this area in over a decade [1][2] - Namilusit achieved its primary endpoint in phase III clinical trials, breaking a long-standing drought of new drug approvals for IPF, and represents a significant advancement in the treatment of this serious and often fatal lung disease [1] - The drug was developed and approved in China in sync with global timelines, highlighting a significant achievement in providing timely access to innovative therapies for Chinese patients [1] Industry Context - IPF is characterized by progressive and irreversible decline in lung function, severely impacting patients' quality of life, with a median survival of approximately three years post-diagnosis and a five-year survival rate lower than many common cancers [1] - Current treatment options for IPF have been limited, and the disease's pathogenesis remains unclear, creating a substantial unmet clinical need [1][2] - Namilusit demonstrates dual effects of antifibrotic and immunomodulatory properties by selectively inhibiting the PDE4B isoenzyme, which is highly expressed in the lungs and closely associated with fibrosis and inflammation [1]