Description
Indication & Scope
EXDENSUR® Depemokimab Injection serves as add-on maintenance therapy for severe eosinophilic asthma in adults and adolescents aged 12 years and older whose asthma cannot be fully controlled by standard inhaled anti-asthma treatments. It cannot relieve acute asthma attacks or status asthmaticus.
- Mechanism: Depemokimab is a humanized anti-interleukin-5 (IL-5) IgG1 kappa monoclonal antibody. It specifically binds to circulating IL-5, neutralizes IL-5 signaling completely, blocks the maturation, survival and migration of eosinophils in blood and airway tissue, reduces eosinophilic inflammation in respiratory tract, and lowers the risk of repeated severe asthma exacerbations.
- Drug class: Humanized monoclonal antibody biologic; IL-5 antagonist; targeted anti-asthma therapeutic agent.
- Clinical use: Long-term maintenance control for type 2 high-eosinophil severe asthma. It remarkably cuts the annual frequency of severe asthma attacks, reduces reliance on oral corticosteroids, improves daily lung function and persistent asthma symptoms including cough, shortness of breath and chest tightness. It features ultra-long half-life for semi-annual injection.
| Generic Name | Depemokimab Injection |
| Brand Name | EXDENSUR |
| Ingredient | Depemokimab |
| Dosage Form | Injection |
| Package | Single dose pre filled automatic syringe: 100 mg(1 mL)*1 vial/box;
Single dose pre filled safety syringe: 100 mg(1 mL)*1 vial/box |
| Conditions Treated | Adults and adolescents ≥12 years old diagnosed with severe eosinophilic phenotype asthma with insufficient control under standard inhaled maintenance therapy |
| Taboos | Patients with severe hypersensitivity or anaphylactic history to depemokimab or any excipients in the prefilled syringe; patients with active severe parasitic helminth infections; pregnant women without specialist risk-benefit evaluation |
| Place of origin | Harmire Road, Barnard Castle, DL12 8DT, United Kingdom |
| Prescription type | Prescription-only |
| Storage Conditions | Unopened prefilled syringes must be refrigerated at 2°C to 8°C, stored in original light-proof packaging, protected from freezing and violent shaking. Do not freeze the liquid injection. Avoid direct sunlight exposure |
| Manufacturer | Glaxo Operations UK Limited |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | SJ20260023; SJ20260024 |
| Approval Date | May 7, 2026 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: Fixed 100mg single subcutaneous injection, administered once every 6 months. No weight-based dose adjustment is required for all eligible patients.
Time: Semi-annual fixed injection schedule. If a dose is missed, inject the drug as soon as possible, then restart the 6-month dosing cycle counting from the delayed injection date. Dosing timing has no connection with meals.
Instructions for use: Administer only via subcutaneous injection. Valid injection sites include upper outer arm, anterior thigh or abdominal wall (avoid the 5cm area surrounding navel). Rotate injection sites each time to reduce local skin reactions. Never inject intravenously or intramuscularly. Carry rescue bronchodilator inhalers at all times since this drug does not treat acute asthma flare-ups. Screen patients for parasitic infections before initial injection.
Interaction: No significant pharmacokinetic interactions with inhaled corticosteroids, long-acting beta agonists or leukotriene modifiers. If combined with immunosuppressants, patients have slightly elevated risk of parasitic infection, requiring regular parasite screening. Concomitant live vaccines are not recommended during treatment due to weakened eosinophil-mediated immune response.
Side effects:
1. Common mild adverse reactions: injection-site redness, itching, slight swelling or mild pain, headache, mild joint pain, throat irritation.
2. Rare severe adverse reactions: severe anaphylactic hypersensitivity, severe parasitic infection exacerbation, vasculitis, transient elevated blood eosinophil rebound after drug discontinuation.
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, indicatiaon, 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
How often to receive Depemokimab Injection for severe asthma control?
Only need one subcutaneous injection of 100mg every six months, which greatly reduces frequent hospital visits compared to monthly asthma biologics.
Can Depemokimab Injection be used to relieve sudden severe asthma attacks or breathing emergencies?
No, this medicine is only for long-term maintenance treatment. You must keep fast-acting rescue inhalers to handle acute shortness of breath or asthma flare-ups.
Who should not take Depemokimab Injection asthma biologic injection at all?
People with severe allergy to the drug liquid, patients suffering from active serious worm infections, and pregnant women without professional doctor assessment cannot use Depemokimab.
What common mild Depemokimab Injection might be experienced right after each injection?
Minor local skin redness or slight soreness at the injection spot, temporary mild headache or throat tickling are normal and will fade within 1–3 days without special treatment.
EXDENSUR® | Depemokimab Injection | Severe Eosinophilic Asthma | DengYueRX
INN: Depemokimab Injection
Indications: Severe eosinophilic asthma
Dosage Form: Injection
Strength: 100mg(1ml)/syringe
