DUPIXENT® – Dupilumab Injection

DUPIXENT® – Dupilumab Injection | U.S.-Manufactured Monoclonal Antibody for Global Supply

Product Overview

DUPIXENT® (dupilumab) is a fully human monoclonal antibody (IgG4 subclass) developed jointly by Regeneron Pharmaceuticals and Sanofi, approved by the U.S. FDA and other global regulatory bodies for the treatment of multiple Type 2 inflammatory conditions. The product offered here is manufactured in the United States by the originator company and designated for export to the China market under the supervision of local regulatory protocols.

While the outer packaging may be adapted for regulatory or language compliance in China, the drug formulation, origin, dosage form, and manufacturing standards are identical to those of the U.S.-marketed version. This ensures complete consistency in quality, safety, and clinical efficacy across global batches.

Key Features & Advantages

• ✅ Manufactured in the U.S. by Regeneron Pharmaceuticals, Inc.
  Originator product with full FDA and global EMA compliance.

• ✅ Biologically Identical to U.S.-Marketed Version
  Same active pharmaceutical ingredient (API), strength, and device system; only carton and labeling differ for regulatory purposes.

• ✅ Approved for Multiple Indications
  Including moderate-to-severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis, and prurigo nodularis (indication varies by country/label).

• ✅ Well-Documented Safety & Efficacy
  Backed by extensive Phase III trials and global post-marketing data.

• ✅ Global Distribution Compliance
  Suitable for B2B buyers, hospital distributors, and licensed importers operating under China NMPA or equivalent systems.

Product Specifications

• Product Name: DUPIXENT® (dupilumab injection)

• Active Ingredient: Dupilumab (recombinant human monoclonal antibody, IgG4)

• Concentration: 300 mg/2 mL prefilled syringe or autoinjector

• Dosage Form: Subcutaneous injection

• Manufacturer: Regeneron Pharmaceuticals, Inc. (USA)

• Packaging: Chinese-language carton and insert (for China regulatory compliance); inner formulation identical to U.S. version

• Storage: 2°C–8°C (refrigerated); do not freeze

• Shelf Life: As indicated per batch, typically 24 months from manufacture

• Supply Type: Original manufacturer export; not a biosimilar or generic

Mechanism of Action

DUPIXENT® blocks the shared receptor component for interleukin-4 (IL-4) and interleukin-13 (IL-13), two key cytokines driving type 2 inflammation. By inhibiting this pathway, dupilumab reduces the immune overactivation involved in multiple chronic inflammatory conditions including atopic dermatitis, eosinophilic asthma, and CRSwNP.

Its targeted mechanism allows for steroid-sparing treatment and long-term disease control, with a favorable safety profile established through over a decade of research.

Learn more: NIH Clinical Pharmacology Resource

Compliance Statement

This product is manufactured in the United States by the original license holder and is intended for legal export to the Chinese market under applicable international pharmaceutical trade agreements. It is identical in formulation and quality to the U.S.-market version and complies with FDA cGMP as well as international safety and pharmacovigilance standards. Importers and end users are responsible for ensuring compliance with local NMPA regulations in mainland China.

Tags / Keywords

Dupilumab, DUPIXENT China Edition, IL-4 IL-13 Inhibitor, Regeneron Biologic, U.S. Original Drug, Monoclonal Antibody Export, Atopic Dermatitis Biologic, Asthma MAb, Anti-inflammatory Injection, NMPA Biologics Import