Zhejiang Wolwo Bio-Pharmaceutical (300357.SZ) Receives Phase I Clinical Trial Summary Report for Aspergillus fumigatus Prick Test Solution

Stock News09-25

Zhejiang Wolwo Bio-Pharmaceutical Co.,Ltd. (300357.SZ) announced that its self-developed "Aspergillus fumigatus prick test solution" has completed a clinical study titled "A Clinical Study Exploring the Safety and Efficacy of Aspergillus fumigatus Prick Test Solution in Chinese Volunteers - A Single-Center, Open-Label Phase I Clinical Study," and has obtained the Phase I clinical trial summary report.

The Aspergillus fumigatus prick test solution demonstrated good safety within the established dose range (55DU/mL-495000DU/mL), with all adverse events being Grade 1 or 2, and no serious adverse reactions or adverse events leading to withdrawal occurred. A certain proportion of subjects experienced delayed reactions, suggesting a possible correlation with the fungal characteristics of Aspergillus fumigatus.

The specificity of all doses exceeded 95% without showing dose-related correlation. Sensitivity showed an upward trend with increasing doses, reaching 95% at a dose of 55000DU/mL. Based on the regulatory requirements for other marketed allergen prick test solutions, researchers recommend adopting a dose of 55000DU/mL or higher for subsequent clinical studies. They also suggest exploring optimal solutions from pharmaceutical perspectives to reduce delayed reactions before conducting further clinical trials.

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