On December 9, 2025, the "Summary Meeting of Phase IIb Clinical Trial and Discussion on Phase IIc Clinical Trial Protocol for Recombinant Human Thymosin β4 Injection (NL005)," hosted by Beijing Northland Biotechnology Co., Ltd., was successfully held in Beijing. The meeting adopted a hybrid online-and-offline format, bringing together more than 20 experts from the fields of cardiovascular medicine and magnetic resonance imaging, representing over 10 clinical research centers across China, as well as representatives from the sponsor and the CRO team. The attending experts conducted in-depth scientific discussions and feasibility assessments centered on the previous research findings of NL005 and the design of the Phase IIc clinical trial protocol.

The meeting was chaired by Professor Dou Kefei from Fuwai Hospital, Chinese Academy of Medical Sciences, the leading unit of the project. As the principal investigator from the national leading institution of this project, Professor Dou Kefei pointed out: Acute myocardial infarction is one of the most common clinical diseases and a major cause of heart failure and cardiovascular death worldwide. Although PCI can promptly restore blood flow to occluded vessels and save myocardial tissue, it may subsequently lead to myocardial ischemia-reperfusion injury (MIRI), causing secondary damage to cardiomyocytes. This secondary injury significantly affects patients' long-term prognosis. Currently, there are still no clearly effective drugs available globally for the prevention and treatment of MIRI. It is truly encouraging to see that NLOO5, independently developed by NORTHLAND, has entered clinical research and has already achieved preliminary research results. Previously, Fuwai Hospital led the Phase IIa and Phase IIb clinical trials of this project and simultaneously conducted numerous studies on the drug’s mechanism of action, dosage, frequency of administration, and other related aspects. These studies have demonstrated that thymosin β4 closely matches multiple pathogenic mechanisms involved in myocardial infarction, highlighting its therapeutic potential and providing substantial evidence for the design of the current Phase IIc clinical trial protocol. Professor Dou also noted that the development of innovative drugs is a lengthy and challenging process with limited mature experience to draw upon, making the implementation process fraught with difficulties. NORTHLAND has already invested tremendous effort into this project. He expressed hope that the attending experts would provide strong support, further refine the Phase IIc clinical trial protocol, and ensure high-quality and efficient execution throughout the subsequent implementation phase.

Han Chengquan, Vice President of the company, briefed the attending experts on the company’s overall situation and the R&D journey of NL005. He expressed gratitude for the support provided by the research institutions and experts who participated in the earlier clinical trials of the project, and expressed his hope that they would continue to work closely together with experts from various research centers to design a Phase IIc clinical trial protocol that is more scientifically sound and highly feasible, thereby accelerating the subsequent R&D process. The company will also actively coordinate resources from all relevant parties and assemble a high-quality research and management team to ensure the smooth implementation of this project.

During the protocol discussion session, Dr. Yang Ning from the company’s Medical Department provided a detailed report on the mechanism of action of NL005 in treating ischemia-reperfusion injury following acute myocardial infarction, as well as the results from animal studies and preliminary clinical trials. She also presented the proposed Phase IIc clinical trial protocol. The attending experts engaged in a lively discussion on key issues such as inclusion and exclusion criteria for this clinical trial, dosage settings, primary endpoints, timing of first dosing, and exploratory endpoints. Participants exchanged views and shared their experiences extensively, offering valuable suggestions from various perspectives on the design of the clinical trial protocol and reaching a consensus. Through this protocol discussion meeting, the operational procedures of the trial have been further refined, and the selection of efficacy evaluation indicators has been clarified. In the next stage, we will fully incorporate the experts’ feedback to optimize the clinical trial protocol, ensuring that we develop a scientific, accurate, and comprehensive trial protocol.

Finally, Mr. Xu Songshan, Chairman of the company, summarized the meeting. He began by sincerely thanking all the experts who had participated in the NL005 clinical trial for their tremendous efforts in advancing the project. He noted that NL005 is one of the company’s key R&D projects, and that numerous studies had already been conducted in the earlier stages, yielding certain promising results. This meeting was of great significance for NL005. He expressed gratitude for the valuable insights provided by the experts and assured them that the company would fully incorporate their suggestions to further optimize the clinical trial protocol. At the same time, the company will continue to increase its investment in personnel and resources, making every effort to ensure the high-quality execution of the Phase IIc clinical trial and laying a solid foundation for the subsequent Phase III clinical study. We look forward to the early completion of this project, bringing safe and effective medications to clinical treatment of acute myocardial infarction and benefiting a broad range of patients.