Description
Indication & Scope
Stapokibart Injection proceeds systemic treatment for adults with moderate to severe atopic dermatitis when topical therapy cannot achieve effective control.
- Mechanism: Monoclonal antibody blocks core type 2 inflammatory cytokines, suppresses allergic inflammatory cascade of atopic dermatitis, relieves pruritus and skin lesions.
- Drug class: Anti-type 2 inflammation monoclonal antibody, dermatological biologic agent.
- Clinical use: Long-term systemic control of moderate-severe atopic dermatitis.
| Generic Name | Stapokibart Injection |
| Brand Name | KangYueDa |
| Ingredient | Stapokibart Injection |
| Dosage Form | Injection |
| Package | 300mg(2ml)*1 vial/box |
| Conditions Treated | Moderate to severe atopic dermatitis |
| Taboos | 1. Active untreated severe systemic infection
2. Severe hypersensitivity to the active drug or auxiliary materials 3. Patients with uncontrolled autoimmune diseases 4. Pregnant women without medical risk assessment |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Refrigerate at 2°C ~ 8°C, avoid shaking and freezing |
| Manufacturer | KangNuoXing Biopharmaceutical, Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20258022 |
| Approval Date | Nov 7, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Weight-based loading dose, followed by fixed maintenance dose at regular intervals.
Time: Periodic repeated subcutaneous injections for chronic disease control.
Instructions for use: Subcutaneous injection into lower abdomen, thigh or upper outer arm.
Interaction: Combined use with systemic glucocorticoids and immunosuppressants will increase the risk of infection.
Side effects: Injection site redness and pain, upper respiratory tract infection, arthralgia, fatigue.
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
What is the core pharmacological effect of Stapokibart Injection?
It blocks key type 2 inflammatory cytokines and suppresses the allergic inflammatory cascade of atopic dermatitis.
What administration route does Stapokibart Injection adopt?
It is administered through subcutaneous injection into the abdomen, thigh or upper outer arm.
What risk will increase when Stapokibart Injection combined with immunosuppressants?
Concomitant use with systemic glucocorticoids or immunosuppressants will significantly raise the risk of systemic infection.
What patients are prohibited from using Stapokibart Injection?
Patients with untreated severe systemic infections, uncontrolled autoimmune diseases and severe drug hypersensitivity cannot use this drug.
KangYueDa® | Stapokibart Injection | Dermatitis | DengYueRX
INN: Stapokibart Injection
Indications: Treatment of dermatitis
Dosage Form: Injection
Strength: 300mg(2ml)/vial
