Description

Indication & Scope

Spesolimab Injection is an anti-inflammatory monoclonal antibody for adult patients with generalized pustular psoriasis (GPP) flare-ups, indicated for rapid clearance of pustules and skin lesions to control acute inflammatory episodes of this rare autoimmune skin disorder.

Mechanism
As a humanized antagonistic IgG1 monoclonal antibody, it specifically binds to IL-36R and blocks activation induced by IL-36α/β/γ, suppressing pro-inflammatory signaling pathways to halt neutrophil infiltration and alleviate skin pustulation and inflammation.
Drug class
Novel therapeutic biological product, humanized anti-IL-36R monoclonal antibody, targeted immunotherapy for autoinflammatory skin diseases.
Clinical use
Phase II global multicenter trials confirm rapid efficacy and tolerable safety; administered via intravenous infusion at a single 900 mg dose, repeatable after 1 week if needed. The first approved IL-36R inhibitor for GPP flare-ups in China

Specification

Generic Name	Spesolimab Injection
Brand Name	Spevigo®
Ingredient	Spesolimab
Dosage Form	Solution for injection
Package	450mg/7.5ml/vial
Conditions Treated	flares of generalized pustular psoriasis in adult patients
Taboos	Contraindicated for patients with hypersensitivity to spesolimab or any excipients of this product
Place of origin	Germany
Priscription Type	Prescription drug (Rx)
Storage Conditions	Store at 2–8℃, avoid freezing and light
Manufacturer	Boehringer Ingelheim Pharma GmbH & Co.KG
Registration Authority	National Medical Products Administration (NMPA)
Approval number	S20230008
Date of Revision	April 06, 2025
Shelf Life	24 months

How to use ?

Recommended Dose: Single intravenous infusion of 900 mg over 90 minutes; an additional 900 mg dose may be administered one week after initial treatment if symptoms persist.
Time: Administer during acute GPP flares; long-term maintenance dosing is available for recurrent episodes.
Interaction: For intravenous infusion only; subcutaneous injection not recommended. Avoid concurrent use with other immunosuppressants without close monitoring for infection risk.
Side effects: Mostly mild to moderate; common adverse reactions encompass fatigue, headache, pruritus, and injection-related reactions; rare severe infections and interstitial lung disease; fatal adverse events are extremely uncommon.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

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