Baiyunshan subsidiary's pediatric drug enters phase II trials

Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited announced that its subsidiary, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd., has registered its Children's Xiaochaihu Granules for Phase II clinical trials. This registration was recently published on the National Medical Products Administration's Clinical Trial Registration and Information Disclosure Platform. The drug, primarily for pediatric gastrointestinal colds, will undergo a randomized, double-blind, parallel-controlled, multi-center study to assess its efficacy and safety.

Guanghua Pharmaceutical received approval for the clinical trials in May 2023 and subsequently completed ethical review and obtained approval. Currently, there are no similar Children's Xiaochaihu Granules products on the market domestically or internationally, with no associated sales data.

As of the announcement date, the project has incurred research and development expenses of approximately RMB 18,587,900. The company highlighted the high-tech, high-risk, and high-value-added nature of pharmaceutical products, cautioning investors about the uncertainties and lengthy development cycles involved in drug commercialization.