Recently, NORTHLAND’s key innovative drug candidate under development, “Donaperminogene Seltoplasmid Injection” (project code NL003), has received U.S. invention patent authorization for its PCT international patent application. The patent title is “HUMAN HEPATOCYTE GROWTH FACTOR MUTANT AND USES THEREOF” (Patent No.: US012264186B2). As of now, the company’s innovative drug project NL003 has established an intellectual property protection system covering core technologies such as plasmid constructs and manufacturing processes, thereby forming a comprehensive and systematic patent layout.

Cedominqi Injection is NORTHLAND’s first gene therapy drug independently developed by the company, indicated for chronic lower-limb ischemic disease (CLI). It was submitted for NDA in July 2024 and has now completed all technical review procedures. As a brand-new naked-plasmid gene therapy drug, NL003 boasts three globally pioneering advancements: First, NL003 is the world’s first gene therapy drug for the treatment of lower-limb ischemic disease, offering CLI patients a novel therapeutic option beyond conventional medications and surgery; second, NL003 is the world’s first therapeutic agent that promotes angiogenesis. By stimulating the regeneration of new blood vessels and establishing a “molecular bridging” mechanism, it enables a shift from “symptomatic treatment” to “causal treatment”; third, NL003 is the world’s first gene therapy drug using a naked-plasmid vector. Using a naked plasmid as its vector, NL003, after local injection, transfects striated muscle cells, enabling sustained expression and secretion of HGF protein, which promotes vascular growth, thereby significantly enhancing therapeutic efficacy and patient compliance. Compared with traditional drug and surgical treatments, Cedominqi Injection qualifies as an Advanced Regenerative Medicine Therapy (RMAT), providing clinicians with a third, safer, and more effective treatment option for lower-limb arterial ischemia. This approach not only alleviates patient suffering and improves their quality of life but also reduces the burden on families and society, yielding substantial economic and social benefits.
Currently, there are no effective therapeutic drugs available worldwide for CLI. Clinical treatment primarily relies on surgical interventions such as percutaneous coronary intervention and vascular bypass surgery, leaving treatment options limited and outcomes suboptimal. NL003 is an innovative gene therapy drug that uses a naked plasmid as its vector. By locally injecting NL003 into the ischemic tissue via intramuscular injection, the plasmid transfects skeletal muscle cells, enabling them to continuously express and secrete hepatocyte growth factor (HGF), a protein with potent angiogenic properties. This promotes the regeneration of new blood vessels, establishes collateral circulation in the ischemic area, and creates a "molecular bypass" mechanism, thereby enhancing blood flow to the ischemic site and achieving therapeutic effects. Compared with traditional vascular reconstruction procedures, NL003 offers distinct advantages in terms of reduced invasiveness, ease of administration, efficacy, and durability, providing patients with sustained clinical benefits. According to the 2022 China Cardiovascular Health and Disease Report, among the general population aged 35 and above in China, the prevalence of lower-limb peripheral arterial disease (PAD) is 6.6%, affecting approximately 45.3 million people. About 10% of these PAD patients will progress to CLI. CLI is characterized by high incidence, prolonged disease course, and a high disability rate; its 5-year mortality rate exceeds 50%, significantly higher than that of most serious diseases such as cancer. With the socioeconomic development and improved medical conditions in China, life expectancy has increased, the elderly population continues to grow, and the aging process is accelerating. Consequently, the number of CLI patients is expected to keep rising in the future, creating a substantial unmet medical need.
The company places great importance on comprehensive intellectual property protection for its pipeline new drugs. As an original, physically targeted new drug developed by the company, NL003 has benefited from a meticulously crafted patent and trademark protection strategy tailored to its innovative nature and unique characteristics. In terms of patent protection, the recently granted U.S. invention patent covers both the drug itself and its intended uses, thereby establishing robust intellectual property rights over a series of core technologies underlying the development of the naked plasmid gene therapy platform. This has enabled the company to build an efficient patent protection network and create a patent portfolio that strongly supports the project’s protection efforts. Moving forward, in line with the established patent protection strategy, the company will continue to optimize its global patent layout and extend intellectual property protection throughout the entire product lifecycle. Regarding trademark and brand building, the company is focusing on brand development and protection under the product name “Hua Suo Ling,” aiming to enhance product market recognition and distinctiveness.
The recent grant of a U.S. patent for the Sedominject solution project marks a further consolidation of NORTHLAND's technological leadership in the field of naked plasmid gene therapy drugs. The company will continue to take intellectual property as its core driving force, pursue ongoing innovation, and provide patients with higher-quality treatment options, while also laying a solid foundation for the company's long-term development.