Junshida (Ongericimab) – Hypercholesterolemia | HongKong DengYue Medicine

Ongericimab Application Scope

Treatment of adult patients with:

• Primary hypercholesterolemia (non-familial) and mixed dyslipidemia, in combination with statins (or statins + ezetimibe).

• Heterozygous familial hypercholesterolemia (HeFH) in adults.

• For statin‑intolerant or statin‑contraindicated patients with non-familial hypercholesterolemia or mixed dyslipidemia, ongericimab may be used alone or combined with ezetimibe.

  

Ongericimab Characteristics

• Ingredients: Ongericimab

• Properties:​ Slightly opalescent, colorless or light‑yellow liquid

• Packaging Specification:​ 150 mg / 1 mL

• Storage:​ Refrigerate at 2–8 °C, protect from light, avoid freezing

• Expiry Date: Must be taken from the actual carton or prescribing information accompanying your specific vial

• Executive Standard: ​Must be taken from the actual carton or prescribing information accompanying your specific vial

• Approval Number: Must be taken from the actual carton or prescribing information accompanying your specific vial

• Date of Revision: This is product-specific and should be checked on the latest package insert

• Manufacturer: Shanghai Junshi Biosciences Co., Ltd.

Guidelines for the Use of Ongericimab

• Dosage and Administration:

  • Recommended Dose:

    • 150 mg subcutaneous injection every 2 weeks (Q2W) OR

    • 300 mg (or 450 mg, per some protocols) every 4 weeks (Q4W) depending on regimen and patient profile.

  • Administration: Subcutaneous injection, using pre-filled syringe or auto-injector.

  • Missed Dose:​ No publicly available official guidance found for missed dose protocol.

• Adverse Reactions:

  • Common Adverse Reactions:

    • In clinical studies, the incidence of treatment-emergent adverse events (TEAEs) was comparable to placebo.

    • In supplier‑provided non‑official sheet: injection site reactions (e.g., erythema, pain), upper respiratory tract infections.

  • Serious Adverse Reactions:

    • Publicly available sources do not yet indicate new safety signals or frequent serious AEs from the published Phase 3 trials over one-year exposure.

    • As with all monoclonal antibodies: potential for immunogenicity (anti‑drug antibodies), though no published long-term immunogenicity data yet.

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• Contraindications: Publicly disclosed sources do not yet list specific contraindications beyond standard considerations (e.g., known hypersensitivity to the active substance or excipients).

• Precautions:

  • As with other PCSK9 inhibitors, monitor for potential immunogenicity/hypersensitivity. (Long-term safety data still accumulating.)

  • Use according to approved indication (i.e., hypercholesterolemia / dyslipidemia). Off-label use not recommended without thorough risk/benefit evaluation.

Ongericimab Interactions

• No publicly reported drug–drug interaction studies for Ongericimab have been published yet. Sources do not provide a defined interaction profile.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.