CSPC Pharmaceutical Group Limited (CSPC Pharma, 01093) announced that SYH2059 powder for inhalation, categorized as a new Class 1 chemical drug, has received U.S. Food and Drug Administration approval to commence clinical trials in the United States. The product, a novel and highly selective phosphodiesterase 4B (PDE4B) inhibitor, has demonstrated in preclinical studies the ability to increase pulmonary drug concentrations and reduce systemic exposure, thereby lowering gastrointestinal side effects. Animal models have also shown efficacy that surpasses existing drugs, supported by favorable pharmacokinetic properties and a broad safety margin.

The approved clinical indication targets pulmonary fibrosis, specifically idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. These conditions currently have limited treatment options available on the market. The approval showcases CSPC Pharma’s high-end innovative inhalation technology platform and establishes a foundation for further development of subsequent inhalation formulations in the company’s pipeline.