Another Domestic Gene Therapy Approved in China: SEDOMING Injection Offers New Hope for Critical Limb Ischemia Patients

(Source: Cell and Gene Therapy Field)

Recently, the official website of the National Medical Products Administration (NMPA) disclosed that BeijingNorthlandBiotechnology Co., Ltd. (hereinafter referred to as "Northland")'s independently developed innovative gene therapy drug "Saiduomingji Injection" has officially received marketing approval, indicated forTreatment of limb ulcers induced by critical limb ischemia (CLI)。

Ischemic diseases of the lower extremities are highly prevalent in clinical practice. Their pathogenesis typically stems from stenosis and occlusion of the lower limb arteries secondary to arteriosclerosis obliterans, diabetic arteriosclerosis obliterans, or thromboangiitis obliterans. As blood perfusion becomes inadequate, patients present with intermittent claudication and rest pain, which may progress to severe ulceration and gangrene. Clinically, the Rutherford classification is routinely employed to assess disease severity, with grades 4 to 6 denoting critical limb ischemia. This condition is associated with a high disability rate; if infection and ulceration continue to worsen, patients ultimately face the risk of amputation or even mortality. Historically, there has been a global lack of effective pharmacological therapies for such severe cases, and clinical management has primarily relied on revascularization via endovascular intervention or surgical bypass. However, certain patients are unsuitable for surgery due to poor general condition or complete occlusion of distal arteries, or they experience suboptimal postoperative outcomes, placing them at a markedly high risk of limb amputation.

Saidomingji Injection offers a novel therapeutic solution for these patients in dire straits. This drug is aNaked Plasmid-based Gene Therapy Drug, employs a mechanism of action distinctly different from conventional therapies. Through local intramuscular injection, the drug vector transfects skeletal muscle cells, enabling them to continuously express and secrete hepatocyte growth factor (HGF) with pro-angiogenic properties, thereby promoting neovascularization and the formation of collateral circulation. This mechanism establishes a "molecular bypass" at the ischemic site, effectively restoring local blood supply.

It is reported that the successful approval of this drug is based on robust clinical trial data. The multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial (HOPE-CLTI-2), led by Peking Union Medical College Hospital and involving over 20 major vascular surgery centers in China, demonstrated that: after 180 days of treatment, the complete ulcer healing rate in the treatment group reached 43.5%, significantly higher than that in the placebo group; meanwhile, the amputation rate in the treatment group was only 1.9% (8.8% in the placebo group), substantially reducing the risks of amputation and mortality for patients. Furthermore, no drug-related serious adverse events were observed, confirming its favorable safety profile.

As the developer, Beijing Northland Biotechnology Co., Ltd. was established in 2004 and is one of the first innovative biopharmaceutical companies in China to enter the gene therapy sector. It was among the first batch of companies listed on the Beijing Stock Exchange in 2021. The company has long adhered to a clinical needs-driven approach, accumulating extensive R&D experience in cardiovascular diseases, metabolic diseases, and ophthalmic therapeutics. Currently, Northland is in Tongzhou, BeijingConstruct a biopharmaceutical production base covering an area of 36,000 square meters， to ensure the large-scale production of the drug in the future. The approval of Sedomingi Injection is not only the culmination of the company's years of dedicated research and development, but also brings to the vast number of patients suffering from severe lower limb ischemiaNew Hope。

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