亚宝药业集团股份有限公司关于ZY-A002获得药物临床试验批准通知书的公告

Core Viewpoint - ZY-A002, a new drug developed by Yabao Pharmaceutical, has received approval for clinical trials targeting cough variant asthma in children, marking a significant step in addressing a gap in the pediatric market for this condition [1][2]. Drug Information - Drug Name: ZY-A002 - Dosage Form: Granule - Registration Category: Traditional Chinese Medicine Class 1.1 - Applicant: Yabao Pharmaceutical Group Co., Ltd. - Acceptance Number: CXZL2500046 - Approval Conclusion: The clinical trial application for ZY-A002 was accepted on July 7, 2025, and is approved to conduct confirmatory clinical trials for cough variant asthma in children [1][3]. Market Context - The indication for ZY-A002 includes relieving wind and clearing the lungs, as well as stopping spasms and coughs, specifically for cough variant asthma in children, which is characterized by chronic, irritating cough [2]. - According to data from Minet, the sales amount for pediatric cough and phlegm-relieving traditional Chinese medicine in China is approximately 6.067 billion RMB in 2024, with public medical market sales around 4.159 billion RMB and retail pharmacy sales about 1.908 billion RMB [2]. R&D Investment - As of the announcement date, the company has invested approximately 12.5682 million RMB in the R&D of the ZY-A002 project [3].