Hybribio subsidiary gains key medical device approval for respiratory pathogen kit

Guangdong Hybribio Biotech's wholly-owned subsidiary, Guangzhou Hybribio Medical Technology Co., Ltd., has obtained a medical device registration certificate from the National Medical Products Administration. The Class III certificate, valid from September 29, 2025, to September 28, 2030, is for a "Six-Plex Respiratory Pathogen Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)."

This diagnostic kit is designed for in vitro qualitative detection of nucleic acids from common respiratory pathogens in human nasopharyngeal swab samples. These include Respiratory Syncytial Virus, Influenza A Virus, Influenza B Virus, Adenovirus, Parainfluenza Virus, and Mycoplasma Pneumoniae. The kit aligns with national health guidelines emphasizing differential diagnosis for respiratory infections and quality control for antiviral drug use, as outlined in the "Quality Control Indicators for Infectious Diseases" (2023 edition).

The company expects this new registration to diversify its product portfolio, enhance its core competitiveness, and support its strategic goal of becoming a leader in nucleic acid molecular diagnostics. While this approval is a positive development, actual sales performance and impact on future operating results depend on market promotion effectiveness and cannot be accurately predicted at this time.