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