Cejemly (Sugemalimab) – NSCLC | DengYue Medicine

Cejemly Application Scope

Cejemly is a fully human anti–PD‑L1 monoclonal antibody used with chemotherapy as a first-line treatment for metastatic non–small cell lung cancer (NSCLC).

Characteristics

• Ingredients: Sugemalimab (IgG4)

• Properties:

  • Binds PD‑L1 on tumor cells, blocking PD‑1/PD‑L1 interaction

  • Restores T-cell immune response, promoting tumor cell death

• Packaging Specification:

  • 600 mg concentrate for infusion in a 20 mL vial

  • Typically supplied in packs of 2 vials

• Storage:

  • Store per label (usually refrigerated)

  • Protect from light and use aseptically

• Expiry Date: As printed on vial; typically 2–3 years from manufacture

• Executive Standard: Complies with EMA and NMPA quality requirements

• Approval Number:

  • EU MAA: EU/1/24/1833/001

  • China NMPA approvals cover multiple cancer indications

• Date of Revision:

  • EU approval July 2024;

  • Label updated February 2025 to reflect ESMO guideline inclusion

• Manufacturer:

  • SFL Pharmaceuticals Deutschland GmbH (EU)

  • CStone Pharmaceuticals (China)

Guidelines for the Use of Cejemly

• Dosage and Administration:

  IV infusion:

  • 1200 mg (≤ 115 kg) or 1500 mg (> 115 kg)

  • Infuse for over 60 minutes, once every 3 weeks

  • In combination with platinum‑based chemo for 4 cycles

  • Then, maintenance every 3 weeks until progression

• Adverse Reactions:

  • Common (≥10%):

    • anemia, elevated liver enzymes, rash, hyperlipidemia, hyperglycemia

    • hyponatremia, hypokalemia, proteinuria, fatigue, arthralgia

    • hypoesthesia, hypothyroidism, hypocalcemia

  • Immune-mediated:

    • pneumonitis, colitis, nephritis, pancreatitis 

    • may require withholding or discontinuation

• Contraindications: History of severe hypersensitivity to antibodies

• Precautions:

  • Monitor immune-related adverse events

  • Avoid immunosuppressants/ high-dose steroids before treatment

Cejemly Interactions

• Drug Interactions:

  • No specific studies; avoid interference with other immunosuppressants

  • Monitor when used with other immune-modulating therapies

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.