xinmeiyue picankibart injection 100mg 1ml per auto injector per box

Description

Indication & Scope

XinMeiYue® (Picankibart) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Mechanism: Picankibart is a humanized IgG1κ monoclonal antibody that selectively binds to the IL-23 p19 subunit, preventing IL-23 from interacting with its receptor and inhibiting downstream inflammatory pathways involved in plaque psoriasis. Its engineered YTE Fc modification prolongs serum half-life, enabling an extended maintenance dosing interval.
Drug Class: Interleukin-23 (IL-23) p19 inhibitor.
Clinical Use: Treatment of adult patients with moderate-to-severe plaque psoriasis who require systemic therapy.

Specification

Generic Name	Picankibart Injection
Brand Name	XinMeiYue®
Ingredient	Picankibart
Dosage Form	Injection
Package	100 mg(1 mL) /auto‑injector/box
Conditions Treated	Moderate-to-severe plaque psoriasis
Taboos	Hypersensitivity to Picankibart or any component of the formulation.
Place of origin	China
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store refrigerated at 2–8°C. Protect from light. Do not freeze or shake.
Manufacturer	Innovent Biologics (Hangzhou) Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	S20250066
Date of Revision	2025
Shelf Life	Refer to the approved package labeling.

How to use ?

Recommended Dose: Administer by subcutaneous injection according to the approved prescribing information. The recommended induction regimen is followed by a maintenance dose administered once every 12 weeks.

Time: Administer by subcutaneous injection into the abdomen, thigh, or upper arm. The maintenance dosing interval is every 12 weeks.

Instructions for use: Before treatment, patients should complete all age-appropriate vaccinations. Live vaccines should not be administered during treatment. No dose adjustment is required in patients with mild or moderate hepatic or renal impairment, while caution is recommended in patients with severe impairment.

Interaction: Picankibart is not metabolized through the CYP450 enzyme system and has a low potential for clinically significant drug-drug interactions. Concomitant administration with live vaccines should be avoided during treatment.

Side effects: Common adverse reactions include injection-site reactions, nasopharyngitis, headache, upper respiratory tract infection, fatigue, and transient elevations in liver enzymes. Most adverse reactions are mild to moderate, and serious infections occur infrequently.

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 is XinMeiYue® (Picankibart Injection)?

XinMeiYue® is a long-acting IL-23 p19 monoclonal antibody indicated for the treatment of moderate-to-severe plaque psoriasis.

What is XinMeiYue® used for?

It is used to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

How should XinMeiYue® be administered?

It is administered by subcutaneous injection according to the approved induction and maintenance dosing schedule.

What precautions should be considered?

Patients should be screened for infections before treatment, avoid live vaccines during therapy, and seek medical attention if signs of serious infection develop.