On July 5, 2025, the "Phase III Clinical Study Summary Meeting for Donaperminogene Seltoplasmid Ingection," hosted by Beijing Northland Biotechnology Co., Ltd., was successfully held in Yanji City, Jilin Province. The meeting was themed "Innovation Leads the Way, Efficacy Speaks Volumes," and provided a comprehensive review of the Phase III clinical study of Donaperminogene Seltoplasmid Ingection. Participants engaged in thorough discussions on the research findings from this clinical trial, the current clinical treatment landscape for critical limb ischemia (CLI), and the real-world research plan following the product's market launch. More than 40 researchers from 24 research centers across the country, along with company leaders and colleagues from the Clinical Department, Medical Department, and Marketing Department, attended the meeting. The meeting was chaired by Sun Yinjian, Manager of the Clinical Research Department, and reached a consensus on the results of the Phase III clinical trial of Donaperminogene Seltoplasmid Ingection as well as the subsequent research plans.

         Dr. Di Xiao, associate chief physician of the Department of Vascular Surgery at Peking Union Medical College Hospital, delivered a speech on behalf of the leading institution, entrusted by Professor Liu Changwei. He stated: The Phase III clinical trial of Donaperminogene Seltoplasmid Ingection lasted nearly five years and, despite being impacted by the COVID-19 pandemic, was ultimately completed successfully, achieving several world firsts. It is the world’s first Phase III clinical trial of gene therapy for lower-limb ischemic disease that fully met its clinical trial objectives. Not only did the drug demonstrate efficacy in terms of complete ulcer healing rates, but it was also the only Phase III clinical trial to show survival benefits without amputation under double-blind conditions. Developing innovative drugs is no easy feat; the successful completion of this clinical trial owes not only to its high-quality and well-designed protocol but also to the sponsor’s more than 20 years of unwavering dedication and commitment. We would also like to extend our heartfelt gratitude to every participating research center and every single investigator for their meticulous oversight and hard work throughout the trial. Currently, there remains a significant unmet need for safe and effective treatments for CLI. Donaperminogene Seltoplasmid Ingection has the potential to become a groundbreaking drug that could fundamentally alter the prognosis of patients with severe lower-limb ischemia—particularly those with poor outflow vessels, who are ineligible for surgical intervention or have repeatedly undergone unsuccessful surgeries. As a globally leading gene therapy drug in the field of CLI treatment, Donaperminogene Seltoplasmid Ingection brings new therapeutic options to the clinical management of CLI. We sincerely hope that Donaperminogene Seltoplasmid Ingection will soon receive regulatory approval and be made available to patients.

         Vice President Han Chengquan of the company introduced the overall profile of the NORTHLAND Group, reviewed the clinical trial process of Sedominject, and provided a detailed report on its mechanism of action and the results of the Phase III clinical trial. He stated that Sedominject boasts a high degree of innovation, delivering safe and precise treatment through a unique approach—local administration, local expression, and local efficacy. It is the world’s first gene therapy drug to undergo large-scale confirmatory trials for CLI, a journey that has been challenging yet yielded encouraging results. The experts attending the meeting highly praised the results of the Phase III clinical trial of Sedominject. They pointed out that severe lower-limb ischemic disease is characterized by a long disease course, difficulty in cure, high amputation and mortality rates, which not only severely impact patients’ quality of life but also impose enormous economic burdens on patients, their families, and society. Although vascular reconstruction surgery is an established standard treatment with mature techniques, its efficacy remains suboptimal for some patients, leaving substantial unmet clinical needs. The experts expressed hope that NORTHLAND will continue to expand real-world studies following the product’s market launch, providing more robust evidence to support the clinical application of Sedominject.

In the second half of the meeting, Liu Yue, Manager of the Company’s Medical Department, presented to the attending experts on the company’s follow-up research plans, including long-term safety monitoring and real-world efficacy validation of Cedomin. In addition to conducting Phase IV clinical trials, the company will continue to carry out IIT studies and real-world research, expand the scope of indications, optimize Cedomin’s dosing regimens and administration methods through clinical practice, explore combination therapies involving surgical procedures, conduct epidemiological surveys on CLI, further enrich pharmacoeconomic and evidence-based data, and comprehensively validate Cedomin’s drug characteristics. Peng Wei, Manager of the Marketing Department, briefed the experts on the commercial readiness and commercialization strategy for Cedomin injection, covering topics such as patient profiles, product positioning, new drug policies in the CGT field, market access pathways, and innovative payment models. Experts at the scene engaged in lively discussions based on their clinical experience, sharing their insights from multiple perspectives—including clinical treatment needs, target patient populations, product pricing, key considerations for innovative payment design, and health economic evaluations—providing valuable recommendations that will help the company refine its marketing strategy going forward.

         Finally, Xu Songshan, Chairman of the company, summarized the meeting. He began by expressing his heartfelt gratitude to all the researchers who participated in the clinical trials of Donaperminogene Seltoplasmid Injection. He noted that the development of Donaperminogene Seltoplasmid Injection had taken 20 years, and the three-phase clinical trials had cumulatively enrolled a total of 800 subjects. He thanked all the researchers for their support of NORTHLAND’s new drug development and for the scientific, rigorous, and standardized professional attitude they demonstrated throughout the clinical trials. He then introduced to the experts the company’s plans for industrialization and commercialization, expressing his hope to continue working closely with clinical experts and research partners to deepen evidence generation, optimize treatment protocols, and, through large-scale real-world studies, continuously evaluate the long-term efficacy and clinical application value of the drug in a broader and more diverse patient population. He also pointed out that the recently jointly issued “Several Measures to Support the High-Quality Development of Innovative Drugs” by the National Healthcare Security Administration and the National Health Commission provide systematic safeguards for the research, clinical trials, and market access of innovative drugs. NORTHLAND will remain patient-centered, integrating its capabilities across the entire value chain—from R&D and manufacturing to commercialization—speeding up the commercialization of Donaperminogene Seltoplasmid Ingectionand enhancing the accessibility of this gene therapy drug. This will offer new treatment options to more CLI patients, benefit patients, alleviate the burden on families and society, and fully realize the clinical and social value of this innovative drug.