To develop a scientifically sound and rational clinical trial protocol, our company organized a meeting on May 17, 2018, to discuss the Phase III clinical trial protocol for “Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection.” The meeting invited experts such as Director Liu Changwei from the Department of Vascular Surgery at Peking Union Medical College Hospital. During the meeting, participants engaged in thorough discussions on issues including inclusion and exclusion criteria for this trial, efficacy endpoints, and principles for selecting injection sites. Chairman Xu Songshan, Vice President Han Chengquan, and all members of the Clinical Research Department attended the meeting.

　　This is another expert review meeting following the communication session held with the Center for Drug Evaluation in April 2018. The convening of this meeting has further refined and clarified the Phase III clinical trial protocol, thereby meeting the requirements for project initiation.

　　The company is currently actively making all necessary preparations and will soon launch Phase III clinical trials. We will fully cooperate with the research institutions to ensure the high-quality completion of this product’s Phase III clinical trials.

　　 Project Overview:

　　The recombinant human hepatocyte growth factor naked plasmid injection is a gene therapy naked plasmid drug independently developed by Beijing Northland Biotechnology Co., Ltd. After local injection, this product can effectively promote angiogenesis in ischemic areas of patients, establishing a "molecular bridging" mechanism for blood vessels. It is indicated for the treatment of conditions such as lower limb arterial ischemic disease, coronary heart disease, and diabetic peripheral neuropathy. Currently, Phase II/III clinical trials are being conducted simultaneously in China and the United States. In the U.S., the clinical trials are focused on peripheral arterial ischemic disease, diabetic peripheral neuropathy, and amyotrophic lateral sclerosis; in China, the trials are aimed at severe lower limb ischemic disease. NORTHLAND obtained the Phase III clinical trial approval for this project in October 2017. The successful development of this drug holds promise to become the world's first angiogenic gene therapy drug.