On March 13, the Phase III clinical trial of "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection," a new drug project of Beijing Northland Biotechnology Co., Ltd., received approval from the Drug Clinical Trial Ethics Committee of Peking Union Medical College Hospital, the leading unit—the Chinese Academy of Medical Sciences—marking the official launch of the Phase III clinical study for this project.

　　“The Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” is a naked-plasmid gene therapy drug developed using a novel hepatocyte growth factor (HGF) gene and a highly efficient pCK vector. It is currently undergoing clinical research in China for the treatment of lower-limb arterial ischemic disease. Building on a comprehensive analysis of the Phase II clinical trial results, the project has engaged in thorough communication with the Center for Drug Evaluation and has organized multiple expert workshops to refine the study protocol. For the Phase III clinical trial, Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences has been selected as the leading center, with Professor Changwei Liu, a renowned vascular surgeon, serving as the principal investigator. The trial will be conducted according to two separate protocols: one focusing on resting pain and the other on ulcers.

　　The company recently signed a cooperation agreement with Kantuo Xincheng Company regarding the commissioning of Phase III clinical trials for this project. Our company will organize all participating clinical trial institutions to actively advance the project’s progress and ensure that the Phase III clinical study is conducted in a scientific, standardized, and high-quality manner.