我武生物(300357.SZ)：取得烟曲霉点刺液I期临床试验总结报告

Core Viewpoint - Iwu Biologics (300357.SZ) has completed a Phase I clinical study on its developed "Fusarium solani prick test solution," demonstrating good safety and effectiveness in a defined dosage range [1] Group 1: Clinical Study Results - The clinical study was a single-center, open-label Phase I trial conducted on volunteers in China [1] - The solution showed good safety within the dosage range of 55 DU/mL to 495,000 DU/mL, with adverse events being classified as Grade 1 or 2, and no serious adverse reactions or events leading to withdrawal [1] - A certain proportion of delayed reactions were observed among subjects, potentially related to the fungal nature of Fusarium [1] Group 2: Efficacy Metrics - The specificity of the product at all dosages was above 95%, with no dose-related effects observed [1] - Sensitivity increased with dosage, reaching 95% at a dosage of 55,000 DU/mL [1] Group 3: Recommendations for Future Research - Researchers recommend advancing the product to subsequent clinical studies using dosages of 55,000 DU/mL and above, based on the evaluation requirements of other marketed allergen prick test solutions [1] - It is suggested to explore better strategies to reduce delayed reactions from a pharmaceutical perspective before conducting further preclinical studies [1]