Cotelet (Tagitanlimab) | Nasopharyngeal Carcinoma | DengYue

Tagitanlimab Application Scope

Recurrent or metastatic nasopharyngeal carcinoma (NPC):

• Approved in China as monotherapy for patients who failed ≥2 prior systemic therapies

• Also approved for first-line use in combination with cisplatin and gemcitabine

 Characteristics

• Ingredients:

  • Humanized IgG₁κ anti–PD-L1 monoclonal antibody (formerly KL-A167 / HBM-9167)

• Properties:

  • Binds PD-L1, blocks interaction with PD-1, restores T-cell anti-tumor immunity, enabling ADCC activity

• Packaging Specification:

  • Solution for intravenous infusion; 200mg (10ml) x 1 bottle

• Storage:

  • Not publicly specified — standard refrigeration likely required for mAbs.

• Expiry Date:

  • As per commercial product labeling (not disclosed).

• Executive Standard:

  • First PD-L1 mAb approved for NPC in China; meets NMPA biologics standards

• Approval Number:

  • NMPA authorized tagitanlimab injection in June 2025 (monotherapy) and Jan 2025 (combination)

• Date of Revision:

  • Label updates following newest approvals — most recently June 11, 2025

• Manufacturer:

  • Developed and commercialized by Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd.

Guidelines for the Use of Tagitanlimab

• Dosage and Administration:

  • Monotherapy (refractory NPC):

    • Tagitanlimab IV as per approved label (exact dosing details per package insert; not publicly detailed)

  • First-line combination (R/M NPC):

    • 1200 mg IV on Day 1 + cisplatin (80 mg/m² Day 1) + gemcitabine (1000 mg/m² Days 1,8), every 3 weeks for up to 6 cycles, followed by tagitanlimab monotherapy Q3W

• Adverse Reactions:

  • Hematologic ≥ grade 3:

    • Neutropenia (~58%), leukopenia (~53%), anemia (~39%)

  • Immune‑related AEs:

    • Grade 3 irAEs ~3.9% in monotherapy; no grade 4–5 irAEs observed

  • Other AEs:

    • Alopecia, rash, elevated liver enzymes, pruritus, neurotoxicity, anorexia, nausea/vomiting

• Contraindications: History of severe hypersensitivity to tagitanlimab or its excipients (standard for biologics).

• Precautions:

  • Monitor for infusion‑related reactions and immune‑mediated AEs (e.g., pneumonitis, colitis, hepatitis).

  • Monitor for serious infections when combining with cytotoxic chemotherapy.

Interactions

• Drug Interactions:​ No specific drug‑drug interactions known; caution due to additive immunosuppression with chemotherapy or other immune 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.