Enweida (Envafolimab) | Advanced Solid Tumors | DengYue

Envafolimab Application Scope

• Approved in China (NMPA, Nov 2021) for adult patients with microsatellite instability-high (MSI‑H) or mismatch repair–deficient (dMMR) advanced solid tumors, after prior systemic therapy

• U.S. FDA Orphan Drug Designation for soft tissue sarcoma and advanced biliary tract cancer (biliary tract = subset of liver cancers)

 

 Characteristics

• Ingredients: Humanized single-domain (nanobody) anti–PD‑L1 antibody fused with human IgG1 Fc

• Properties:

  • Subcutaneously administered PD‑L1 immune checkpoint inhibitor

  • First globally available SC PD‑L1 antibody

• Packaging Specification:​ 200 mg/10 mL x 1 vial

• Storage: Standard biologic storage; stable at ambient temperatures, no cold-chain needed

• Expiry Date: ​Typically per label (often ~24 months). Specific to regional packaging.

• Executive Standard: ​Conforms to NMPA GMP standards; in development under ICH-conforming trial protocols.

• Approval Number: Chinese NMPA approval (November 2021) for MSI‑H/dMMR tumors

• Date of Revision: ​Label updated upon NMPA approval in Nov 2021; orphan designations around Jun/Sep 2021

• Manufacturer: Developed by Alphamab Oncology; commercialized via Simcere & 3DMed partnership in China

Guidelines for the Use of Envafolimab

• Dosage and Administration:

  • Proven regimens include:

    • 150 mg SC QW (28-day cycle)

    • 300 mg SC every 2–3 weeks or 400 mg SC Q3W (choice based on convenience)

  • Administered subcutaneously in ~30 seconds; no IV infusion needed

• Adverse Reactions:

  Generally well tolerated; common drug-related adverse events include:

  • Injection‑site reactions (mostly grade 1–2, ~9%)

  • Immune‑related AEs: hypothyroidism, rash, asthenia, decreased WBC/neutrophils

  • Grade 3–4 events in ~14–16%: lymphopenia, liver enzyme elevations, diarrhea, pancreatitis, myocarditis, etc.

  • No infusion reactions reported (vs intravenous PD‑1/PD‑L1 antibodies)

• Contraindications:

  • Known hypersensitivity to envafolimab or excipients

  • Pregnancy and lactation: Immune‑checkpoint inhibitors may affect fetus; avoid unless benefit outweighs risk.

• Precautions:

  • Monitor for immune‑related AEs: thyroid dysfunction, hepatitis, colitis, pneumonitis, myocarditis, pancreatitis

  • Caution in patients with comorbid lung disease (ILD risk)

  • Monitor injection‑site reactions and systemic AEs.

Interactions

• Drug Interactions:​

• As a biologic, minimal CYP metabolism—no known major drug–drug interactions reported

• Interactions with immunosuppressive agents possible: immunosuppressants may reduce efficacy or increase infection risk.

• Refer to full prescribing info/regional label for details.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
• Prescription drugs must be purchased from designated suppliers based on a doctor’s prescription.