China's First Naked Plasmid Gene Therapy, Sedomigi Injection (Huasueling), Approved for Market Launch

On May 28, the National Medical Products Administration approved Beijing`Northland`The Sedominji Injection (Trade Name: Huasuoling) submitted by Beijing Northland Biotechnology Co., Ltd. has been approved for marketing for the treatment of limb ulcers caused by severe lower limb ischemia (including lower extremity arteriosclerosis obliterans, thromboangiitis obliterans, and diabetic lower limb ischemia, etc.) in patients who are unsuitable for revascularization surgery or for whom surgical outcomes are poor.

Cedomingji Injection (Code NL003) is aNaked Plasmid-Based Gene Therapy Drug, utilizing a novel target and mechanism of action. The drug acts throughLocal intramuscular injection of naked plasmid DNA enables its entry into skeletal muscle cells, utilizing the cell'sThrough its protein expression mechanism, the expression plasmid carries the target gene and secretes two HGF protein isoforms, which specifically activate the HGF/c-MET signaling pathway to promote microcirculation formation, improve the microcirculatory environment, establish collateral circulation, and restore blood flow supply to ischemic regions, thereby achieving the therapeutic objective while maximizing the avoidance and reduction of adverse reactions and potential risks associated with gene therapy.

In July 2024, based on the Phase III clinical trial results of Sedominji Injection for limb ulcers caused by severe lower extremity ischemia meeting expectations, Northland submitted a marketing authorization application to the National Medical Products Administration (NMPA), which was accepted, officially initiating the new drug registration review process.

April 2026,Northland inAnnounced at the 12th Chengdu Vascular Conference`` `Sedominji Injection` ``(Development code: NPhase III Study of L003)of the HOPE CLTI-2 StudyAchievements.

The study results showed that: on Day 180 of treatment, the ulcer improvement rate (ulcer area reduction ≥50%) in the Sedomingji Injection group reached 60.9%, of which 43.5% achieved complete healing (vs. placebo group 18.5%, P<0.0001); in terms of safety, the major amputation rate in the Sedomingji Injection group was 1.9%, compared with 8.8% in the placebo group, representing an 87% reduction in the risk of the composite endpoint of amputation or death (HR=0.13, P=0.0024).