On April 1, 2021, the Phase IIa clinical trial training meeting for NORTHLAND’s “Recombinant Human Thymosin β4 Injection” (abbreviated as NL005) was successfully held at TEDA International Cardiovascular Hospital (referred to as “TEDA Heart Hospital”). More than 20 researchers from six internal medicine departments of TEDA Heart Hospital attended the training. Lin Wenhua, Director of the First Department of Internal Medicine at TEDA Heart Hospital, served as the principal investigator of this research center and chaired the training meeting.

　　At the meeting, our company’s Clinical Research Department Manager provided an overview of the company’s overall situation and its drug development pipeline. The Project Manager presented the existing research findings on NL005 and focused on the protocol design, inclusion and exclusion criteria, and trial procedures for the Phase II clinical study. Additionally, targeted training was conducted on GCP-related knowledge.

　　Director Lin Wenhua, the principal investigator of the center, provided an explanation of the specific plan for this study, which involves the joint collaboration of six departments. He stated that Tai Xin Hospital will mobilize the relevant departments and expand the scope of subject screening to jointly advance the implementation of the project. Director Cao from the clinical trial institution said that they would actively coordinate the trial procedures to ensure the smooth conduct of the trial.

　　Tai Xin Hospital is a public, Grade III-A cardiovascular specialty hospital and cardiovascular research institute invested in and constructed by the Tianjin Economic-Technological Development Zone. It is under the management system of Peking Union Medical College, Chinese Academy of Medical Sciences. The hospital serves as the Clinical College of Cardiovascular Diseases at Tianjin Medical University, a national training base for interventional diagnosis and treatment of coronary heart disease and arrhythmias, and one of the first national demonstration bases for specialized nursing and technical training in cardiovascular diseases. With 500 beds, the hospital offers a full range of cardiovascular surgical procedures—from routine cardiovascular surgeries to heart transplantation—as well as various interventional cardiology procedures. It boasts a team of highly qualified physicians and extensive clinical trial experience in the field of cardiovascular diseases.

　　“Recombinant Human Thymosin β4 for Injection” is a Class 1 innovative drug independently developed by NORTHLAND. Its indication is ischemia-reperfusion injury (MIRI) caused by acute myocardial infarction. Currently, there are no effective drugs available worldwide for the prevention or treatment of MIRI. This project has been successively included in the national special programs for “Major New Drug Creation” during the 11th Five-Year Plan, the 12th Five-Year Plan, and the 13th Five-Year Plan. It possesses independent intellectual property rights and has been granted invention patents in China, the United States, Europe, Japan, and South Korea. It has also received the “China Patent Excellence Award.”

　　Currently, this project is led by Fuwai Hospital of the Chinese Academy of Medical Sciences and is conducting a Phase IIa clinical trial at six research centers nationwide. Five of these centers have now officially launched the trial, with completion expected within this year. The Phase I clinical trial for this project was completed at Beijing Century Tan Hospital, and the results indicate that the drug exhibits good tolerability and safety in the treatment of MIRI. Once successfully developed, this drug will provide a new therapeutic solution for MIRI, playing a crucial role in preserving cardiac function and improving patients’ quality of life. According to data from Yaodu Consulting, the market size for this drug is projected to reach 5.07 billion yuan by 2025.

　　This time, Tai Xin Hospital, in collaboration with six internal medicine departments within the hospital, is jointly participating in the patient screening for the Phase IIa clinical trial, fully demonstrating the center’s high regard for this clinical trial project and its positive expectations for the future of clinical research. Our company will also organize and mobilize all relevant resources to ensure that the Phase IIa clinical trial management for this project is carried out in strict accordance with GCP and regulatory requirements, and that the clinical study is completed scientifically, rigorously, and in compliance with the planned schedule.