Hybio Pharmaceutical Co.,Ltd. (300199.SZ) has announced that its Pingshan branch underwent a routine Current Good Manufacturing Practice (cGMP) inspection by the U.S. Food and Drug Administration (FDA) from June 18 to 26, 2026. The company recently received the Establishment Inspection Report (EIR) issued by the FDA following the inspection.

The inspection covered the cGMP compliance of the branch's liraglutide injection (18mg/3mL, produced on the cartridge filling line) manufactured for the U.S. market, as well as requirements under the Drug Supply Chain Security Act (DSCSA). This marked the second time the Pingshan branch has undergone an FDA inspection and successfully passed, following its first Pre-Approval Inspection (PAI) in July-August 2023.

The company's peptide formulation production base at the Pingshan branch, the API production base at its Wuhan subsidiary, and the R&D laboratory at its Longhua headquarters have all obtained FDA EIRs. Notably, the Longhua headquarters R&D laboratory and the Wuhan subsidiary API production base had previously passed inspections with a No Action Indicated (NAI) classification, indicating zero deficiencies.

The receipt of this inspection report is expected to accelerate the U.S. approval process for the company's peptide drugs, laying a solid foundation for its internationalization strategy.