Beijing Northland Biotechnology Co., Ltd. announced that its independently developed Class 1 innovative gene therapy, Sedominji Injection (brand name: Huasuoling®), completed its first nationwide shipment at the production base of contract manufacturer Jiangsu Yaohai Biopharmaceutical Co., Ltd. – a milestone that moves the world’s first officially approved HGF naked plasmid gene therapy drug from production line into commercial clinical supply for patients with chronic limb‑threatening ischemia (CLI) who are unsuitable for, or have failed, revascularization surgery.
Launch Snapshot
| Item | Detail |
|---|---|
| Product | Sedominji Injection (Huasuoling®) – HGF naked plasmid gene therapy |
| Developer | Beijing Northland Biotechnology Co., Ltd. |
| Contract Manufacturer | Jiangsu Yaohai Biopharmaceutical Co., Ltd. – sole global CMO for the product |
| First Shipment Ceremony | 14 Oct 2026, Yaohai Bio production base |
| Quality Release | First commercial batch completed full‑item quality testing and met release standards; released by Northland’s Quality Authorized Person |
| Initial Distribution | Cold‑chain shipment to pharmaceutical distributors serving hospitals in 9 provinces/municipalities: Beijing, Shanghai, Tianjin, Shandong, Henan, Liaoning, Zhejiang, Hunan, Hubei |
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Date | 27 May 2026 |
| Approval No. | Guo Yao Zhun Zi S20260032 |
| Classification | Class 1 innovative gene therapy drug |
| Indication | Limb ulcers caused by chronic limb‑threatening ischemia (CLI) – including lower‑extremity atherosclerotic occlusive disease, thromboangiitis obliterans and diabetic lower‑extremity ischemia – in patients unsuitable for revascularization surgery or with poor surgical outcomes |
| Distinction | World’s first officially approved HGF naked plasmid gene therapy drug |
Drug Profile & Mechanism of Action
- Molecule: Sedominji Injection, a naked plasmid gene therapy encoding hepatocyte growth factor (HGF) – non‑viral gene delivery without viral vector‑related safety and cost constraints.
- Mechanism – Therapeutic Angiogenesis: Administered via local intramuscular injection, the plasmid drives sustained expression of HGF in ischemic tissue, promoting neovascularization and establishment of collateral circulation to restore blood flow to the ischemic limb.
- Causal Treatment: Offers a disease‑modifying, etiology‑targeted option for patients trapped in the “no drug available, no surgery possible” dilemma – those anatomically unsuitable for revascularization, unable to tolerate procedures, or with poor surgical outcomes.
- Manufacturing Breakthrough: Northland and Yaohai Bio achieved a 500‑liter‑scale naked plasmid production process breakthrough, completing the full chain from technology transfer, process scale‑up and process validation to GMP production, and jointly passing drug registration testing and on‑site registration manufacturing inspection.
Disease Landscape – Chronic Limb‑Threatening Ischemia (CLI)
- Clinical Severity: CLI is the end‑stage manifestation of peripheral artery disease (PAD); patients commonly present with rest pain, ulcers and even gangrene, and face a 5‑year mortality rate exceeding 50%.
- Standard of Care Limits: Traditional treatment centers on revascularization (open surgery or endovascular intervention), but a substantial proportion of patients cannot benefit due to unfavorable anatomy, comorbidity or procedural failure.
- Clinical Consensus: The Expert Consensus on Clinical Application of HGF Naked Plasmid Gene Therapy for Chronic Limb‑Threatening Ischemia (2026 Edition) was published in September 2026 in the Chinese Journal of General Surgery (Vol. 41, No. 9) – the world’s first expert consensus on gene therapy for CLI, supporting standardized clinical adoption.
Market Impact & Outlook
- Commercialization Begins: The first shipment marks formal entry of the world’s first approved HGF naked plasmid gene therapy into clinical practice – a landmark for China’s gene therapy industry and validation of the naked‑plasmid modality at commercial scale.
- Access Expansion: Northland will continuously advance hospital access across all provinces and cities, expand product coverage, and improve affordability through patient assistance programs.
- Evidence Generation: The company will collaborate with clinical experts on post‑marketing studies to further build real‑world evidence in the CLI population.
- CDMO Partnership: Yaohai Bio – with deep expertise in microbial expression system CMO services – commits stable capacity and reliable quality to support the commercial rollout as the product’s sole global contract manufacturer.
- Unmet‑Need Value: For the significant subset of CLI patients ineligible for revascularization and facing high amputation and mortality risk, Sedominji introduces the first new causal treatment option in a therapeutic area long dominated by surgery‑centric management.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the commercial rollout of Sedominji Injection (Huasuoling®), including provincial market access expansion, patient assistance programs, post‑marketing studies, manufacturing capacity and supply stability. Actual results may differ materially due to risks including reimbursement and hospital‑access timelines, real‑world safety and efficacy outcomes, supply‑chain execution and competitive dynamics in vascular medicine.-Fineline Info & Tech
