CSPC Pharma (01093.HK) Receives NMPA Green Light for Clinical Trials of Inhaled PDE4B Inhibitor SYH2059

Bulletin Express03-16 19:02

CSPC Pharmaceutical Group Limited (CSPC Pharma, 01093.HK) announced that its Class 1 chemical drug SYH2059, a highly selective phosphodiesterase-4B (PDE4B) inhibitor formulated as a powder for inhalation, has secured clinical-trial approval from China’s National Medical Products Administration (NMPA).

Pre-clinical data showed SYH2059 significantly increases pulmonary drug concentration while reducing systemic exposure, potentially mitigating gastrointestinal side-effects. Animal studies indicated superior efficacy versus existing therapies, favourable pharmacokinetics and a broad safety margin.

The upcoming trial will target interstitial lung disease, an area with limited treatment options. SYH2059 had already obtained U.S. Food and Drug Administration clearance for clinical trials in March 2026, underscoring its international development trajectory.

Management highlighted the approval as a milestone for CSPC Pharma’s high-end innovative inhalation technology platform and a foundation for future pipeline expansion.

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