BeijingMay 29, 2026 /PRNewswire/ — On May 28, 2026, Beijing Northland Biotech Co., Ltd. (“Northland Biotech”) announced that its self-developed Class 1 innovative therapeutic biological product, Cedomingi Injection (brand name: Huasoling®), has officially received marketing approval from the National Medical Products Administration (NMPA). This drug is the first and currently only* approved gene therapy drug in China for promoting angiogenesis, offering a new treatment option for patients with severe limb ischemia (CLI) who are unsuitable for revascularization surgery or have poor surgical outcomes, marking a new era of gene therapy in the field of CLI treatment in China.
Severe limb ischemia (CLI) is the most severe manifestation of peripheral artery disease, characterized by rest pain, tissue loss, or gangrene, posing dual threats of high amputation and mortality rates. Approximately 5% to 20% of CLI patients cannot undergo surgery or interventional therapy due to their physical condition, known as “no-option” patients. These patients face extremely high risks of major amputation and death within one year, creating an urgent clinical need for new treatment strategies[1],[2].
Cedomingi Injection employs a “therapeutic angiogenesis” strategy. Through local intramuscular injection, it introduces the recombinant human hepatocyte growth factor (HGF) gene into skeletal muscle cells at the ischemic site, enabling sustained and efficient secretion of two active isoforms of HGF. By activating the HGF/c-MET signaling pathway, it induces angiogenesis at the ischemic site and promotes collateral circulation reconstruction, improving distal blood flow in the limbs[3].
The approval of Cedomingi Injection is based on positive results from a pivotal Phase III clinical study named HOPE CLTI-2. Led by Peking Union Medical College Hospital, the study was conducted across 23 research centers nationwide, enrolling 242 CLI patients (Rutherford Grade 5) clinically assessed as “unsuitable for revascularization surgery or with poor postoperative outcomes” between June 2019 and April 2022. Compared to the placebo group, patients treated with Cedomingi showed significantly improved ulcer complete healing rates and efficacy at 180 days of treatment, along with a significantly reduced risk of amputation. Consistent treatment benefit trends were observed across subgroups of patients with different etiologies (arteriosclerosis obliterans, thromboangiitis obliterans) and those with comorbid diabetes. In terms of safety, adverse events reported in the Cedomingi group were mild to moderate, primarily injection site reactions, with incidence rates comparable to or lower than those in the placebo group. These results were published in the authoritative journal Molecular Therapy in 2025.
Professor Zheng Yuehong from Peking Union Medical College Hospital stated: “The success of the HOPE CLTI-2 study validates the feasibility of the ‘therapeutic angiogenesis strategy.’ For ‘no-option’ patients, Cedomingi Injection provides a novel treatment approach. The drug has shown encouraging positive performance in promoting ulcer healing and reducing amputation risk, bringing new ideas to CLI treatment. As a domestically developed gene therapy drug in China, the successful approval of Cedomingi Injection represents a significant milestone in independent innovation in the gene therapy field, injecting new vitality into clinical practice.”
Mr. Xu Songshan, Chairman of Beijing Northland Biotech Co., Ltd., stated: “The approval of Huasoling® is an important milestone in the company’s innovation strategy. We have overcome a series of technical challenges, including gene transfection efficiency, localized precise drug delivery, and large-scale production. As the first approved CLI gene therapy drug in China, the approval of Huasoling® marks a significant step in extending gene therapy from genetic diseases to common chronic diseases in China. In the future, Northland Biotech will continue to deepen its efforts in the gene therapy field, driving the development of more innovative drugs and contributing further to the advancement of China’s pharmaceutical industry.”
The approval of Huasoling® carries multiple strategic implications. On a clinical level, it fills a gap in the CLI gene therapy field, promoting a paradigm shift from traditional symptomatic treatment to etiological treatment for CLI. On a patient level, it can significantly reduce amputation risk, improve quality of life, and lower medical expenses, offering substantial social value. On an industrial level, it demonstrates that China’s pharmaceutical industry possesses a complete chain of capabilities, from gene vector design and large-scale production to clinical translation. This lays the foundation for the application of gene therapy in more areas, such as cardiovascular diseases and neurodegenerative diseases, and will drive the rapid development of China’s gene therapy industry.
About Huasoling®
Huasoling® is a gene therapy drug in injection form. It is indicated for treating limb ulcers caused by severe limb ischemia (including lower limb arteriosclerosis obliterans, thromboangiitis obliterans, and diabetic lower limb ischemia) in patients unsuitable for revascularization surgery or with poor surgical outcomes. The drug is administered via local intramuscular injection, with a recommended regimen of one dose every two weeks for a total of three doses, each dose being 8 mg. Before injection, the lesion site must be identified through vascular imaging, and the doctor plans the injection area and sites based on anatomical features, precisely injecting the prepared drug solution into the muscle tissue. The drug should be stored at -25 to -15°C, protected from light, with a shelf life of 24 months.
About Northland Biotech
Beijing Northland Biotech Co., Ltd. is an innovative biopharmaceutical company specializing in the research, development, production, and sales of gene therapy drugs, recombinant protein drugs, and ophthalmic drugs. Adhering to the philosophy of “Creating Value, Serving Health,” the company is committed to developing globally competitive innovative drugs and striving to become a leader in China’s gene therapy field, making positive contributions to the progress of China’s pharmaceutical industry and human health.
*As of May 2026, based on a search of marketed drug information published by the National Medical Products Administration (NMPA), Cedomingi Injection is the only gene therapy drug approved in China for promoting angiogenesis in CLI treatment.
Cedomingi Injection is a prescription drug, please purchase and use it with a doctor’s prescription. For specific indications, dosage, adverse reactions, and contraindications, please refer to the drug instructions approved by the NMPA. This article is for reference on drug approval information only and does not constitute any drug promotion, recommendation, or medication guidance. Drug use must strictly follow medical advice; for details, please refer to the drug instructions approved by the NMPA.
References
1. Ghare MI, Parikh SA. No-option critical limb ischemia: a review of current and future therapies. J Crit Limb Ischemia. 2021;1(3):E85-E92.
2. Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54(12):e132-e173.