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 - The clinical study of "Fusarium solani prick solution" developed by the company has successfully completed a Phase I clinical trial in Chinese volunteers, demonstrating good safety and effectiveness within the specified dosage range [1] Group 1: Clinical Study Results - The "Fusarium solani prick solution" showed good safety within the dosage range of 55DU/mL to 495000DU/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 the subjects, potentially related to the fungal nature of Fusarium [1] - The specificity of the product at all dosages was over 95%, with no dose-related effects observed; sensitivity increased with dosage, reaching 95% at a dosage of 55000DU/mL [1] Group 2: Recommendations for Future Research - Researchers recommend advancing the product to subsequent clinical studies using dosages of 55000DU/mL and above, based on the review requirements of other marketed allergen prick solutions [1] - It is suggested to explore better solutions to reduce delayed reactions from a pharmaceutical perspective before conducting further preclinical studies [1]