CSPC Group (01093): Nidanib ethanesulfonate inhalation powder approved for clinical trials in China

According to Zhitong Finance App, Shiyao Group (01093) issued an announcement. Nidanib ethanesulfonate inhalation powder developed by the Group has been approved by the China National Drug Administration and can conduct clinical trials in China.

This product is the first domestically approved inhalation preparation for the treatment of pulmonary fibrosis clinically. Nidanib ethanesulfonate is a multiple tyrosine kinase inhibitor that can slow the process of idiopathic pulmonary fibrosis (IPF). The dosage form currently on the market is an oral softgel. Compared with oral formulations, this product has the advantages of significantly increasing lung exposure, significantly improving lung function, reducing systemic exposure, and significantly reducing gastrointestinal side effects. Preclinical studies have shown that the product can achieve the same efficacy at 1/200 of the oral dose, and has good safety and efficacy.

The approved clinical indication is idiopathic pulmonary fibrosis. Furthermore, the product also has potential for treating 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 its clinical trial approval lays a good foundation for the development of subsequent inhalation formulations within the pipeline.