CSPC PHARMA (01093): Nintedanib Ethanesulfonate Inhalation Powder Aerosol Approved for Clinical Trials in China.

CSPC PHARMA (01093) announced that the inhaled powder aerosol of nintedanib esylate developed by the group has been approved by the China National Medical Products Administration for clinical trials in China. This product is the first inhaled formulation approved for clinical use in China for the treatment of pulmonary fibrosis. Nintedanib esylate is a multiple tyrosine kinase inhibitor that can slow down the progression of idiopathic pulmonary fibrosis (IPF). The currently available formulation is in oral capsule form. Compared to oral formulations, this product has advantages such as significantly increased pulmonary exposure, improved lung function, reduced systemic exposure, and significantly reduced gastrointestinal side effects. Preclinical studies have shown that this product can achieve the same efficacy at a dosage of 1/200 of the oral dose, with good safety and effectiveness. The approved clinical indication for this product is idiopathic pulmonary fibrosis. Additionally, the product also has potential to be used in the treatment of systemic sclerosis-related interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF). This product is an important achievement of the group's inhalation technology platform, and the approval of clinical trials lays a solid foundation for the development of subsequent inhaled formulations in the pipeline.