Shaite (Aponermin) – Multiple Myeloma | HongKong DengYue Medicine

  • Generic Name/Brand Name: Aponermin/Shaite
  • Indications: Multiple Myeloma (Hematology)
  • Dosage Form: Injection
  • Specification: 100 mg
Category: Tag:

Aponermin Application Scope

Aponermin is a first-in-class DR4/DR5 agonist and recombinant TRAIL-based therapy approved in China for treating relapsed or refractory multiple myeloma by inducing tumor cell apoptosis.

aponermin

Characteristics

  • Ingredients: Recombinant circularly permuted human TRAIL peptide

  • Properties: A recombinant allosteric TRAIL, stable homotrimer with high affinity to DR4/DR5, inducing caspase-mediated apoptosis

  • Packaging Specification: Single-use vials (exact volume unspecified in public sources)

  • Storage: Standard requirements per NMPA; details not explicitly disclosed in sources

  • Expiry Date: ​Refer to labeling; typical shelf-life per Chinese regulations

  • Executive Standard: Approved by China’s NMPA under biologics standards – classified as a Class I biological new drug

  • Approval Number: Granted marketing authorization by China NMPA on Nov 1, 2023

  • Date of Revision: First approval date is Nov 1, 2023; any further revisions not yet disclosed in public domain

  • Manufacturer: Wuhan Hiteck Biological Pharma Co., Ltd (via Beijing Sunbio Biotech)

Guidelines for the Use of Aponermin

  • Dosage and Administration:

    • 10 mg/kg IV infusion once daily on days 1–5 of a 28‑day cycle

    • Infuse over 90 ± 15 minutes (initial rate ≤30 drops/min for first 30 min, then normal rate)

  • Adverse Reactions: Common: Transient hepatotoxicity (elevated ALT/AST/LDH), neutropenia, pneumonia, hyperglycemia (Grade 1–2 mostly)

  • Contraindications: Not explicitly stated; likely hypersensitivity to TRAIL components (standard for biologics)

  • Precautions: Monitor liver function and blood counts closely during treatment

Aponermin Interactions

  • Drug Interactions:

    • No formal interaction studies.

    • Animal data show no significant pharmacokinetic changes when combined with thalidomide/dexamethasone

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.
Contact Us
Contact Form Demo