Description
Indication & Scope
HuaSuoLing (Donaperminogene seltoplasmid) contains donaperminogene seltoplasmid, a plasmid-based gene therapy product designed to express hepatocyte growth factor (HGF) for promoting angiogenesis and improving blood perfusion in ischemic tissues.
- Mechanism: Delivers the HGF gene through a plasmid vector. After intramuscular administration, HGF expression promotes activation of the c-Met signaling pathway, stimulating endothelial cell proliferation and migration, inducing angiogenesis, and improving blood flow in ischemic limbs.
- Drug class: HGF-based plasmid gene therapy product.
- Clinical use: Treatment of limb ulcers caused by severe lower limb ischemia in patients who are unsuitable for revascularization surgery or have poor outcomes after revascularization procedures.
| Generic Name | Donaperminogene seltoplasmid |
| Brand Name | HuaSuoLing® |
| Ingredient | Each vial contains 2 mg donaperminogene seltoplasmid in 1 mL. |
| Dosage Form | Solution for Injection. |
| Package | One vial (1 mL). |
| Conditions Treated | Treatment of limb ulcers caused by severe lower limb ischemia (including lower extremity arteriosclerosis obliterans, thromboangiitis obliterans, and diabetic lower limb ischemia) in patients who are unsuitable for revascularization surgery or have poor outcomes after surgery. |
| Taboos | Hypersensitivity to donaperminogene seltoplasmid or any component of the product. |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store at -25°C to -15°C, protected from light. |
| Manufacturer | Beijing Northland Biotechnology Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20260032 |
| Date of Revision | 2026 |
| Shelf Life | Refer to the approved package labeling |
How to use ?
Recommended Dose: 8 mg per administration, administered by local intramuscular injection once every 2 weeks for a total of 3 administrations.
Time: Administer once every 2 weeks for a total of 3 doses according to the approved treatment regimen.
Instructions for use: Each administration requires 4 vials of the product. Thaw at room temperature for approximately 30 minutes before preparation. Reconstitute each vial with 3 mL sterile normal saline and mix thoroughly. The total volume after preparation is 4 mL per vial. The prepared solution should be used within 4 hours.Administer by local intramuscular injection at physician-selected injection sites based on vascular imaging evaluation of the affected lower limb. The prepared solution is injected into multiple muscle sites according to the approved administration procedure.
Interaction: No formal drug interaction studies have been conducted. Drugs with anti-angiogenic effects may reduce the efficacy of this product. Concomitant use of high-dose aspirin (>100 mg/day) is not recommended during treatment.
Side effects: In clinical trials, reported adverse reactions were mainly mild to moderate. Common adverse reactions include hyperuricemia, injection-site edema, injection-site swelling, and insomnia. Other reported reactions include injection-site pain, injection-site rash, fever, injection-site bleeding, inguinal nodules, somnolence, superficial thrombophlebitis, superficial venous thrombosis, erythema nodosum, panniculitis, increased blood lactate dehydrogenase, gastroenteritis, and nausea.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is the mechanism of action of Donaperminogene seltoplasmid?
Donaperminogene seltoplasmid delivers the HGF gene through a plasmid vector. The expressed HGF protein activates the c-Met signaling pathway, promoting endothelial cell proliferation and migration, inducing angiogenesis, and improving blood perfusion in ischemic tissues.
Q: What is HuaSuoLing (Donaperminogene seltoplasmid)?
HuaSuoLing contains donaperminogene seltoplasmid, a plasmid-based gene therapy product designed to promote angiogenesis through hepatocyte growth factor (HGF) expression for the treatment of ischemic limb ulcers.
What is HuaSuoLing used for?
HuaSuoLing is indicated for the treatment of limb ulcers caused by severe lower limb ischemia, including lower extremity arteriosclerosis obliterans, thromboangiitis obliterans, and diabetic lower limb ischemia, in patients who are unsuitable for revascularization surgery or have poor outcomes after surgery.
How should HuaSuoLing be stored?
Store at -25°C to -15°C, protected from light.
HuaSuoLing® Donaperminogene Seltoplasmid | Severe Lower Limb Ischemia (CLI) Gene Therapy | DengYueRX
INN: Donaperminogene seltoplasmid
Indications: Reatment of limb ulcers caused by severe lower limb ischemia.
Dosage Form: Solution for Injection
Strength: 2mg(1mL)
