Zhitong Finance App News, Shiyao Group (01093) announced that the phase II clinical trial of SYH 9061 developed by the group to treat idiopathic pulmonary fibrosis (IPF) has been officially launched at the first research center in China.
This product is a nidanib inhalation powder, registered as a Class 2.2 new chemical drug. Nidanib is a tyrosine kinase inhibitor that inhibits vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR) by competitively binding to adenosine triphosphate (ATP) binding sites on the intracellular receptor kinase domain, thereby blocking intracellular signal transmission and inhibiting the proliferation, migration, and transformation of fibroblasts. Nidanib has anti-fibrosis and anti-inflammatory activity, which can slow the progression of pulmonary fibrosis and delay the progression of IPF. The product prepares nidanib as an inhaled powder and directly delivers it to target organs. While increasing pulmonary drug exposure, it also reduces systemic blood concentration, thereby reducing gastrointestinal adverse reactions.
Previously, the Group was issued a “Drug Clinical Trial Approval Notice” for this product by the China Drug Administration in December 2025, and immediately initiated a single-center, randomized, double-blind, placebo and positive-controlled, single and multiple dose escalations to evaluate the safety, tolerability and pharmacokinetic characteristics of the product among healthy male participants in China. The phase I clinical trial data have initially verified the pharmacokinetic characteristics of this product in humans and showed good results.
The clinical trial launched this time is a multi-center, randomized, blinded, placebo, and positive-controlled phase II clinical trial aimed at evaluating the efficacy and safety of this product among adult Chinese IPF participants. Currently, the recruitment and screening of participants in this clinical trial is being actively promoted.