China’s CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has approved clinical trials for its Category 1 chemical drug candidate SYH2039, a selective phosphodiesterase 4B (PDE4B) inhibitor, for advanced malignant tumors. The drug is also under study in China for interstitial lung diseases.
Drug Profile
SYH2039 exerts anti-inflammatory and anti-fibrotic effects by inhibiting PDE4B, which regulates inflammatory factor release and fibroblast proliferation. Preclinical data show superior selectivity and efficacy compared to existing PDE4B inhibitors, with strong results in animal models and favorable pharmacokinetics.
Clinical Development
The FDA approval follows China’s nod in January 2024 for SYH2039 trials in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. CSPC plans to leverage the U.S. trial to validate the drug’s potential in oncology and fibrotic diseases.
Strategic Outlook
CSPC aims to advance SYH2039 globally, targeting unmet needs in cancer and fibrosis. The FDA’s approval underscores the drug’s promise, positioning CSPC to expand its pipeline in high-value markets.-Fineline Info & Tech
