The Phase II clinical trial of SYH 9061 developed by CSPC PHARMA (01093) for the treatment of idiopathic pulmonary fibrosis has officially been initiated at the first research site in China.

CSPC PHARMA (01093) announced that the Phase II clinical trial of SYH 9061 developed by the group for the treatment of idiopathic pulmonary fibrosis (IPF) has officially been initiated at the first research site in China. The product is a nintedanib inhalation powder aerosol, with a registration classification of Class 2.2 new chemical drug. Nintedanib is a tyrosine kinase inhibitor that competitively binds to the adenosine triphosphate (ATP) binding site on the kinase domain of intracellular receptors, inhibiting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR), thereby blocking intracellular signal transduction and inhibiting the proliferation, migration, and transformation of fibroblasts. Nintedanib possesses anti-fibrotic and anti-inflammatory activities, which can slow the progression of lung tissue fibrosis and delay the progression of IPF. The product prepares nintedanib as an inhalation powder aerosol for direct delivery to the target organ, increasing pulmonary drug exposure while reducing systemic blood drug concentration, thereby reducing gastrointestinal adverse reactions. Previously, the group obtained the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration of the People's Republic of China for the product in December 2025, and immediately after approval initiated a single-center, randomized, double-blind, placebo- and positive-controlled, single- and multiple-dose escalation Phase I clinical trial in healthy male participants in China to evaluate the safety, tolerability, and pharmacokinetic characteristics of the product. The Phase I clinical trial data have preliminarily validated the pharmacokinetic characteristics of the product in humans and demonstrated favorable results. The clinical trial initiated this time is a multicenter, randomized, blinded, placebo- and positive-controlled Phase II clinical trial aimed at evaluating the efficacy and safety of the product in adult IPF participants in China. Currently, participant recruitment and screening for this clinical trial are being actively advanced.