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On July 16, Northland announced that on July 12, the company's self-developed Class 1 new biologic therapeutic drug, Sedomidene Injection – "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection (code name NL003)," received the Notice of Acceptance issued by the National Medical Products Administration (NMPA), with the acceptance number CXSS2400066. This marks the formal acceptance of the NL003 new drug registration application, entering the new drug registration evaluation process.
NL003 belongs to Category 1 therapeutic biological products not yet marketed in or outside of China.Is an innovative gene therapy drug, used for treating severe lower limb ischemic disease (CLI). When locally injected into the muscular tissue of the ischemic area in the lower limbs, this product (a naked plasmid) enters skeletal muscle cells and utilizes the cell's protein expression mechanism to express the target gene carried by the plasmid. It secretes two HGF protein isoforms, promoting the formation of new blood vessels and collateral circulation, increasing local blood flow in the ischemic area, thereby achieving the therapeutic effect for lower limb arterial ischemic diseases.Peripheral Artery Disease (PAD) is a group of conditions caused by various factors leading to stenosis or occlusion of the lower limb arteries, insufficient blood perfusion, and resulting in ischemic manifestations such as intermittent claudication, ulcers, and gangrene in the lower limbs. Epidemiological data indicate that PAD affects the physical and mental health of more than 200 million people worldwide, among which lower limb PAD is the most common type of peripheral artery disease. According to the 2022 Report on Cardiovascular Health and Diseases in China, the prevalence of lower limb PAD in the general population over 35 years old in China is 6.6%, with approximately 45.3 million cases. Critical Limb Ischemia (CLI) is the most severe stage of PAD. Literature shows that about 10% of patients with lower limb PAD will progress to CLI, which has a high incidence, long disease course, high disability rate, and a 5-year mortality rate exceeding 50%, much higher than most critical illnesses, including many types of cancer.Currently, there is no effective therapeutic drug available worldwide. Clinical treatment mainly relies on surgical methods such as interventional procedures and vascular bypass, but the outcomes are unsatisfactory, indicating a significant unmet medical need. Compared with existing treatment options, the NL003 therapeutic strategy is innovative, achieving its therapeutic goal by promoting therapeutic angiogenesis to address distal ischemia caused by vascular occlusion. This approach helps avoid progression to life-threatening conditions or significantly impacts on patients' quality of life, offering sustained clinical benefits.NL003 Phase III Clinical TrialDivided into two trial protocols, ulcer and rest pain, conducted simultaneously. The indication applied for in this submission is limb ulcers caused by severe lower limb ischemia (lower extremity arteriosclerosis obliterans, thromboangiitis obliterans, and diabetic lower limb ischemia). The Phase III clinical trial results met expectations, showing significant clinical importance compared to placebo in key clinical outcomes (complete ulcer healing rate) (P<0.0001). Additionally, the primary endpoint was achieved across subgroups with different diseases such as arteriosclerosis obliterans, thromboangiitis obliterans, and diabetic lower limb ischemia. This is the first time that efficacy has been confirmed through a large-scale Phase III trial in global studies of similar drugs. The rest pain indication for this project also completed the last subject's exit from the group at the end of June. Data cleaning and statistical analysis are currently underway, and if the results meet expectations, a new drug registration application is planned within the year.The acceptance notice for the new drug registration application for NL003 ulcer indication marks a significant milestone in this project.A Significant Milestone: NL003 Completes All R&D Content, Taking a Key Step Towards New Drug Launch. Our company will fully cooperate with the pharmaceutical regulatory authorities in carrying out on-site inspections and other tasks. Meanwhile, the company is actively promoting the industrialization of bioengineering projects and conducting sales strategy research. We look forward to NL003 obtaining marketing approval as soon as possible, bringing new hope to patients suffering from lower limb ischemic diseases.
Source of the article: Northland
