CSPC PHARMA (01093) announced that the Nintedanib Esylate Inhalation Powder developed by the Group has received approval from China's National Medical Products Administration (NMPA) to commence clinical trials in China. This product is the first inhaled formulation approved for clinical trials in the country for the treatment of pulmonary fibrosis. Nintedanib Esylate is a multiple tyrosine kinase inhibitor that can delay the progression of idiopathic pulmonary fibrosis (IPF); the currently available dosage form on the market is an oral soft capsule. Compared to oral formulations, this product offers significant advantages, including markedly increased lung exposure, substantial improvement in lung function, reduced systemic exposure, and a significant decrease in gastrointestinal side effects. Preclinical studies indicate that the product can achieve equivalent efficacy at just 1/200th of the oral dosage, demonstrating favorable safety and effectiveness. The clinical indication approved this time is idiopathic pulmonary fibrosis. Furthermore, the product also holds potential for treating systemic sclerosis-associated interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF). This product represents a major achievement from the Group's inhalation technology platform, and its clinical trial approval lays a solid foundation for the development of subsequent inhaled formulations within the pipeline.
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