海南葫芦娃药业集团股份有限公司关于获得药物临床试验批准通知书的公告

Group 1 - The company has received approval from the National Medical Products Administration for the clinical trial of "Children's Danqing Shuangjie Granules" aimed at treating pediatric influenza with a specific syndrome [1][4] - The drug is classified as a Category 1.1 innovative traditional Chinese medicine, focusing on clearing heat and detoxifying, and is intended for children with influenza presenting with both exterior and interior heat symptoms [2][3] - Following the approval, the drug must undergo clinical trials and receive further evaluation from the National Medical Products Administration before it can be manufactured and marketed [4] Group 2 - The clinical trial application for "Children's Danqing Shuangjie Granules" was accepted on August 11, 2025, and is in compliance with the relevant drug registration requirements [1][2] - The drug's core efficacy includes clearing heat, relieving fire, and detoxifying, specifically targeting the symptoms associated with pediatric influenza [2] - The company will fulfill its information disclosure obligations based on the progress of the drug development [5]