Core Viewpoint - The approval of the inhalation powder formulation of Nintedanib by the National Medical Products Administration of China marks a significant advancement for the company in the treatment of idiopathic pulmonary fibrosis (IPF) [1] Group 1: Product Development - The inhalation powder formulation of Nintedanib is the first inhalation preparation approved for clinical use in China for the treatment of pulmonary fibrosis [1] - Nintedanib is a multi-tyrosine kinase inhibitor that can slow the progression of IPF, with the current available formulation being an oral soft capsule [1] - Compared to the oral formulation, the inhalation product offers significant advantages, including improved lung exposure, better lung function, reduced systemic exposure, and significantly lower gastrointestinal side effects [1] Group 2: Clinical Research and Potential - Preclinical studies indicate that the inhalation formulation can achieve equivalent efficacy at a dosage of 1/200 of the oral dose, demonstrating good safety and effectiveness [1] - The approved clinical indication is for idiopathic pulmonary fibrosis, with potential applications for systemic sclerosis-related interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF) [1] - This approval is a key achievement of the company's inhalation technology platform and lays a solid foundation for the development of subsequent inhalation formulations in the pipeline [1]
石药集团(01093)：乙磺酸尼达尼布吸入粉雾剂在中国获临床试验批准