Description
Indication & Scope
YiSaiTuo® Amdokitug Injection provides long-term subcutaneous biologic therapy for adult patients living with moderate to severe plaque psoriasis eligible for systemic immune-modulating intervention.
- Mechanism: Selective neutralizing anti-interleukin-17A monoclonal antibody. It binds circulating IL-17A pro-inflammatory cytokine with high affinity, blocks IL-17A receptor activation on keratinocytes and dermal immune cells, suppresses downstream Th17-mediated cutaneous inflammation, reduces epidermal hyperproliferation and eliminates psoriatic skin plaque formation.
- Drug class: Anti-IL-17A fully human monoclonal antibody / Autoimmune dermatology anti-inflammatory biologic drug.
- Clinical use: Induction and long-term maintenance therapy for moderate-severe plaque psoriasis in adults; delivers high PASI 90 skin lesion clearance rates with extended quarterly maintenance dosing during stable disease remission.
| Generic Name | Amdokitug Injection |
| Brand Name | YiSaiTuo |
| Ingredient | Amdokitug |
| Dosage Form | Injection |
| Package | 80mg(1ml)*1 syringe/box |
| Conditions Treated | Moderate to severe plaque psoriasis in adult patients requiring systemic biological treatment |
| Taboos | Active uncontrolled severe systemic infectious disease including untreated latent tuberculosis; severe hypersensitivity to amdokitug or autoinjector formulation excipients; patients with active inflammatory bowel disease (Crohn’s disease or ulcerative colitis) |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Unopened intact autoinjector pens refrigerated at 2°C–8°C, avoid freezing and direct intense sunlight exposure |
| Manufacturer | Sunshine Guojian Pharmaceutical(Shanghai)Co.,Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20260010 |
| Approval Date | Feb 10, 2026 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Induction treatment phase: 300 mg subcutaneous injection administered at week 0, week 4 and week 8; maintenance remission phase: 150 mg subcutaneous injection once every 12 weeks after week 8 induction completion.
Time: Scheduled fixed-interval subcutaneous self-injections independent of daily meal timing cycles.
Instructions for use: Inject subcutaneously into abdominal, thigh or upper arm adipose tissue with regular site rotation; perform mandatory pre-treatment tuberculosis screening to rule out latent TB infection; avoid administration of live attenuated vaccines throughout amdokitug chronic therapy; monitor for new-onset diarrhea or abdominal pain signaling inflammatory bowel disease exacerbation.
Interaction: Concurrent live vaccines are contraindicated due to blunted protective immune response risk; combined use with other systemic immunosuppressants increases invasive bacterial/fungal infection susceptibility significantly.
Side effects:
1. Common mild adverse reactions: upper respiratory tract viral infection, injection site erythema and pruritus, mild headache, arthralgia.
2. Severe rare adverse events: reactivation of latent tuberculosis, new-onset inflammatory bowel disease, systemic anaphylactic hypersensitivity reactions.
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 pro-inflammatory cytokine is selectively neutralized by Amdokitug Injection anti-IL-17 monoclonal antibody to treat plaque psoriasis?
The drug specifically binds and blocks interleukin-17A (IL-17A), the primary Th17 cytokine driving psoriatic cutaneous inflammation.
What mandatory infectious disease screening procedure must all patients complete before initiating Amdokitug Injection therapy?
Complete latent tuberculosis screening (interferon-gamma release assay or tuberculin skin test) to prevent post-treatment TB reactivation.
What is the ultra-long maintenance dosing interval after completing the three-dose induction Amdokitug Injection for moderate-severe plaque psoriasis?
A 150 mg subcutaneous maintenance injection administered once every 12 weeks during stable disease remission.
What core therapeutic advantage of anti-IL-17 biologics distinguishes Amdokitug Injection from older anti-IL-23 psoriasis monoclonal antibody therapies?
Direct neutralization of terminal effector cytokine IL-17A delivers faster rapid skin plaque clearance during the early induction treatment phase.
YiSaiTuo® | Amdokitug Injection | Plaque Psoriasis | DengYueRX
INN: Amdokitug Injection
Indications: Plaque psoriasis
Dosage Form: Injection
Strength: 80mg(1ml)/syringe
