Phase III Data of Sedominji Injection (NL003) Presented at the 12th Chengdu Vascular Conference Highlights a Novel Gene Therapy for No-Option CLTI Patients

(Source:Northland）

April 24-26, 2026The 12th Chengdu Vascular Conference andThe 4th Vascular and Endovascular Surgery Group of Chengdu Medical Association2026 Annual Academic ConferenceIt was held at the Jinjiang Hotel in Chengdu. This conference, hosted by the Chengdu Anti-Cancer Association and organized by the Third People's Hospital of Chengdu, is one of the largest annual academic platforms in the vascular surgery field in Southwest China, covering the widest range of subspecialties. Beijing Northland Biotechnology Co., Ltd. (hereinafter referred to as"Northland") was invited to attend, bringingCedomidine Injection (R&D Code:NL003）ThePhase III research achievements participated in this academic exchange.

Annual Conference of Southwest Vascular Surgery: Multidisciplinary Exchange Sparks Intellectual Collision

This year's Chengdu Vascular Conference spans more than ten specialized sessions, including aorta, peripheral arteries, veins, neurointervention, comprehensive intervention, hemodialysis access, geriatric vascular diseases, artificial intelligence, etc., and specially featuresThe VTE Quality Control Work Conference and Sichuan Province Continuing Education Training Course fully reflect the conference's positioning of "broad fields, focus on quality control, and promotion of standards."

During the three-day conference, leading vascular surgery experts from top centers across China took the stage successively to discuss endovascular treatment of aortic dissection, branch reconstruction of complex abdominal aortic aneurysms, and new technologies for limb artery volume reduction.In-depth discussions on cutting-edge topics such as standardized VTE management and AI-assisted diagnosis and treatment, with a lively academic atmosphere.

In-depth InterpretationHOPE CLTI-2, Cedomin InjectionⅢPeriod Data Sparks Heated Discussion

On April 26th, during the Peripheral Artery专场, Northland was invited to deliver a special report on "Key Research Achievements and Real-World Research Prospects of Cedominogene for CLI Treatment."IntroductionLisdoming InjectionHOPE CLTI-2Core Data of Phase III StudyDirection of subsequent real-world studies。

The report points out that for patients who have lost the opportunity for traditional revascularizationCLI patients have very limited existing drug treatment options, and there is an urgent clinical need for innovative mechanisms that promote therapeutic angiogenesis to fundamentally improve tissue perfusion. The HOPE CLTI-2 study provides rigorous evidence-based data support for this clinical issue. On the 180th day of treatment, the ulcer improvement rate (ulcer area reduction ≥50%) in the Cedominogene Inj group reached60.9%, among which43.5% achieved complete healing (vs 18.5% in the placebo group, P<0.0001); in terms of safety, the rate of major amputations in the Cedominogene injecofill group1.9%, compared with the placebo group8.8% reduction in the risk of the composite endpoint of amputation or death87%（HR=0.13，P=0.0024）1。

Cedominje Injection is administered via intramuscular injection, exerting its effects by promoting local angiogenesis in ischemic tissues. The administration route is simple, with well-established and standardized procedures, making the exploration of real-world data in the future highly anticipated. After the presentation, several experts at the conference discussed topics such as the screening of suitable populations for Cedominje Injection and its synergistic application with existing revascularization methods, creating a lively academic atmosphere on-site.

During the conference, Northland set up Cedominogene Injection.Phase Ⅲ Study Special Exhibition Panel: Presenting the HOPE CLTI-2 study design and data overview in intuitive charts. Vascular surgeons and interventional physicians from Sichuan, Yunnan, Chongqing, Guizhou, and other southwestern provinces and cities engaged in in-depth discussions with the Medical Department regarding study details, enrollment criteria, and subsequent registration progress.

Cedomidine Injection isCLI Treatment Opens New Pathways

CLI is the end-stage manifestation of peripheral arterial disease, where patients face the dual threat of limb gangrene and amputation. The rates of major amputations and mortality within one year remain alarmingly high. However, a significant proportion of CLI patients, due to poor vascular conditions and multiple comorbidities, are unable to undergo surgical bypass or are unsuitable for endovascular intervention, thus falling into a "gray area" of clinical treatment. This drug delivers therapeutic genes to the ischemic target area through injection, enabling localized and sustained expression of hepatocyte growth factor (HGF), which drives the formation of new blood vessels in ischemic tissues, improving tissue perfusion at the source. This treatment approach differs fundamentally from the mechanisms of traditional drugs that dilate blood vessels or prevent thrombosis, representing a directional exploration in the field of CLI treatment. Currently, the New Drug Application (NDA) for Cedominogene Injection for the treatment of severe lower limb ischemia with limb ulcers has been officially accepted by the National Medical Products Administration (NMPA).

Deepen the Academic Layout in Southwest China, Promote Gene Therapy from Research to Clinical Application

Chengdu Vascular Conference is one of the important academic events that Northland has participated in this year in Southwest China. The vascular surgery cause in Southwest ChinaIn progressThe vigorous development has led clinical experts to continuously delve deeper into the diagnosis and treatment of critical limb ischemia, a complex condition. Their academic discussions on innovative treatment solutions remain highly enthusiastic, aligning closely with Northland's goal of deepening academic engagement and promoting clinical awareness of Cedominogene Inj. Northland will continue to strengthen academic cooperation with clinical centers in Southwest China, actively advancing real-world studies and medical education initiatives around Cedominogene Inj. These efforts aim to assist more clinicians in gaining an in-depth understanding of gene therapy.Application scenarios in the CLI field are driving innovative therapies from evidence-based data to clinical practice, allowing more patients in need to receive standardized and timely diagnosis and treatment.

[Statement] The content of this article is for reference by healthcare professionals only and should not be considered as any medical advice. Cedominji Injection (NL003) is currently in the registration application stage and has not yet been approved for marketing in China. The clinical data cited in this article are sourced from the HOPE CLTI-2 Phase III clinical study.

References

1.Xiao D, Liu CW, Zheng YH, et al. Seltoplasmid promotes ulcer healing vs placebo for patients with CLTI: insights from the HOPE CLTI-2 trial.Mol Ther. 2025. doi:10.1016/j.ymthe.2025.04.009