Description
Indication & Scope
XinBiAo® Loncipoetin Alfa Injection provides chronic subcutaneous injection therapy for anemia secondary to chronic kidney disease (CKD) in adult and adolescent patients on dialysis or non-dialysis CKD management.
- Mechanism: Recombinant human erythropoietin analog with extended serum half-life. It binds erythropoietin receptors on bone marrow erythroid progenitor stem cells, stimulates red blood cell maturation and proliferation, increases circulating hemoglobin concentrations, corrects renal insufficiency-induced hypoproliferative anemia and eliminates transfusion dependence in CKD patients.
- Drug class: Long-acting recombinant erythropoietin glycoprotein biologic / Renal anemia erythropoiesis-stimulating agent (ESA).
- Clinical use: Long-term maintenance therapy for chronic kidney disease-related anemia; reduces allogeneic red blood cell transfusion requirements, improves exercise tolerance and relieves fatigue secondary to renal anemia in both dialysis and non-dialysis CKD patient populations.
| Generic Name | Loncipoetin Alfa Injection |
| Brand Name | XinBiAo |
| Ingredient | Loncipoetin Alfa |
| Dosage Form | Injection |
| Package | 1ml: 25 μg*1 syringe/box |
| Conditions Treated | Anemia caused by chronic kidney disease in adolescents and adult patients, regardless of dialysis status |
| Taboos | Severe hypersensitivity to loncipoetin alfa, albumin or syringe excipients; uncontrolled severe hypertension; patients with pure red cell aplasia triggered by prior erythropoietin treatment; pregnant and breastfeeding women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed intact prefilled syringes stored at 2°C–8°C under refrigeration; avoid freezing and direct strong light exposure; do not shake violently |
| Manufacturer | GuangDong Sunshine Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20260018 |
| Approval Date | Mar 17, 2026 |
| Shelf Life | 30 months |
How to use ?
Recommended Dose: Initial loading dose: 0.75 μg/kg subcutaneous injection once every two weeks; adjust maintenance dose based on monthly hemoglobin test results to maintain target hemoglobin 100–120 g/L.
Time: Biweekly fixed-timing subcutaneous injection, no correlation with meal intake.
Instructions for use: Administer subcutaneously to abdomen or thigh; rotate injection sites regularly; monitor serum hemoglobin monthly during treatment; supply sufficient oral iron supplements simultaneously to guarantee effective erythropoiesis; stop medication permanently if pure red cell aplasia occurs.
Interaction: Concurrent intravenous or oral iron preparations enhance hemoglobin elevation efficacy; combined use of immunosuppressants suppresses erythroid progenitor proliferation and weakens therapeutic effects; antihypertensive drugs require close blood pressure monitoring to avoid hypertensive crisis.
Side effects:
1. Common mild adverse reactions: injection site tenderness, headache, mild elevated blood pressure, arthralgia, fatigue.
2. Severe grade ≥3 risks: uncontrolled severe hypertension, pure red cell aplasia, thromboembolic events, hypersensitivity anaphylaxis.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What bone marrow stem cell population does Loncipoetin Alfa Injection activate to reverse chronic kidney disease-induced anemia?
It stimulates proliferation and maturation of erythroid progenitor stem cells in bone marrow to raise circulating hemoglobin levels.
What absolute contraindication related to previous ESA treatment will permanently exclude patients from Loncipoetin Alfa Injection therapy?
Development of pure red cell aplasia induced by prior erythropoiesis-stimulating agent administration.
What concurrent supplementary treatment is mandatory to guarantee optimal therapeutic response of Loncipoetin Alfa Injection?
Continuous oral or intravenous iron supplementation to provide raw materials for red blood cell synthesis.
Why do nephrologists need to strengthen blood pressure surveillance after each Loncipoetin Alfa Injection?
Increased red blood cell mass raises blood viscosity and peripheral vascular resistance, which may worsen hypertension or trigger hypertensive emergencies.
XinBiAo® | Loncipoetin Alfa Injection | Anemia (CKD) | DengYueRX
INN: Loncipoetin Alfa Injection
Indications: Anemia caused by chronic kidney disease(CKD)
Dosage Form: Injection
Strength: 1ml: 25 μg/syringe
Low MOQ
WHO-GMP
Worldwide Delivery
Compliance and Regulatory Documents
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