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xinmeiyue picankibart injection plaque psoriasis 100mg 1ml

Description

 Indication & Scope

XinMeiYue® Picankibart Injection provides systemic treatment for adult patients living with moderate to severe plaque psoriasis eligible for biological therapy.

  • Mechanism: Human monoclonal antibody selectively targeting IL-23p19 subunit. It neutralizes interleukin-23, blocks downstream Th17 inflammatory pathway activation, reduces keratinocyte hyperproliferation and cutaneous inflammatory plaque formation in psoriasis.
  • Drug class: Anti-IL-23p19 monoclonal antibody / Anti-inflammatory biologic for autoimmune dermatology.
  • Clinical use: Long-term maintenance therapy for moderate-severe plaque psoriasis; achieves sustained PASI 90 skin clearance with extended dosing intervals during stable remission.
Specification
Generic Name Picankibart Injection
Brand Name XinMeiYue
Ingredient Picankibart
Dosage Form Injection
Package 100mg(1ml)*1 syringe/box
Conditions Treated Moderate to severe plaque psoriasis in adult patients
Taboos Active severe uncontrolled systemic infection including tuberculosis; severe hypersensitivity to picankibart or formulation excipients; patients with active demyelinating neurological disease
Place of origin China
Prescription type Prescription-only
Storage Conditions Unopened autoinjectors refrigerated at 2°C–8°C, avoid freezing and direct sunlight
Manufacturer XinDa Biopharmaceutical Technology, Ltd.
Registration Authority National Medical Products Administration (NMPA), China
Approval number S20250066
Approval Date May 26, 2025
Shelf Life 24 months

How to use ?

Recommended Dose: Induction phase: 200 mg subcutaneous injection at week 0, week 4 and week 8; maintenance phase: 100 mg every 12 weeks after week 8.

 

Time: Fixed scheduled subcutaneous injections regardless of mealtime; maintenance doses administered every 12 weeks long-term.

 

Instructions for use: Inject subcutaneously into abdomen, thigh or upper arm; rotate injection sites per cycle; screen for latent tuberculosis before initiating treatment.

 

Interaction: Concurrent live vaccines are contraindicated during therapy; monitor infection risk when combined with other immunosuppressive agents.

 

Side effects:

1. Common: upper respiratory tract infection, injection site erythema, headache, mild arthralgia.

2. Rare severe adverse events: serious invasive fungal/bacterial infection, inflammatory bowel disease exacerbation.

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

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What inflammatory cytokine subunit does Picankibart Injection specifically neutralize?

It targets and blocks the IL-23p19 protein subunit.

What is the maintenance dosing interval after the initial three induction shots when using Picankibart Injection?

Maintenance dose 100 mg is injected once every 12 weeks.

What infectious screening is mandatory before starting Picankibart Injection?

Patients must receive tuberculosis screening to rule out latent TB infection.

What patient group cannot receive live vaccines during treatment of Picankibart Injection?

All patients receiving picankibart therapy are contraindicated for live vaccines.

XinMeiYue® | Picankibart Injection | Plaque Psoriasis | DengYueRX

INN: Picankibart Injection
Indications: Plaque psoriasis
Dosage Form: Injection
Strength: 100mg(1ml)/syringe

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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