Core Viewpoint - The approval of clinical trials for the pediatric medication "Xiaoer Reliqing Granules" marks a significant advancement in the company's product development, potentially enhancing its competitiveness in the pediatric market [1][2]. Group 1: Drug Information - Drug Name: Xiaoer Reliqing Granules - Indication: Acute upper respiratory tract infections classified as wind-heat with dampness according to traditional Chinese medicine - Registration Category: Innovative Chinese Medicine Class 1.1 - Acceptance Number: CXZL2500015 - Notification Number: 2025LP01422 - The clinical trial application for Xiaoer Reliqing Granules was accepted on March 14, 2025, and meets the requirements for drug registration [1]. Group 2: Product Efficacy - Preclinical studies indicate that Xiaoer Reliqing Granules exhibit significant antipyretic effects in rabbit and rat fever models, extend cough latency, reduce cough frequency in guinea pigs, and show notable anti-inflammatory effects in acute inflammatory models [2]. - Toxicological studies suggest that the drug has good safety with a wide safety dosage range [2]. Group 3: Approval Process and Company Impact - Following the approval of the clinical trial notification, the company must conduct Phase II and III clinical trials and complete related work to prepare for product registration [2]. - The approval is a crucial step in the product's development, although the drug development process is characterized by high investment, long cycles, and significant risks, which may not have an immediate impact on the company's financial performance [2].
奇正藏药: 关于子公司收到药物临床试验批准通知书的公告