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aixinan recaticimab for injection hypercholesterolemia and mixed dyslipidemia 150mg

Description

 Indication & Scope

AiXinAn® Recaticimab for Injection reduces LDL-C levels in patients with non-familial hypercholesterolemia, mixed dyslipidemia, primary hypercholesterolemia including heterozygous familial and non-familial types.

  • Mechanism: PCSK9 inhibitory monoclonal antibody binds circulating PCSK9, prevents hepatic LDL receptor degradation, increases LDL receptor quantity to accelerate LDL cholesterol clearance.
  • Drug class: PCSK9 inhibitor, injectable lipid-lowering biologic agent.
  • Clinical use: Adjunct lipid-lowering therapy with statins or monotherapy for statin-intolerant hyperlipidemia patients.
Specification
Generic Name Recaticimab for Injection
Brand Name AiXinAn
Ingredient Recaticimab for Injection
Dosage Form Injection
Package 150mg*1 vial/box
Conditions Treated Primary hypercholesterolemia and mixed dyslipidemia
Taboos Severe hypersensitivity to recaticimab or excipients, decompensated severe liver dysfunction, unexplained severe myopathy and rhabdomyolysis
Place of origin China
Prescription type Prescription-only
Storage Conditions Refrigerate at 2°C~8°C, no freezing, avoid direct sunlight and violent shaking
Manufacturer HengRui Pharmaceutical, Ltd.
Registration Authority National Medical Products Administration (NMPA), China
Approval number S20250002
Approval Date Sept 10, 2025
Shelf Life 24 months

How to use ?

Recommended Dose: Long-acting fixed maintenance dose at regular intervals.

 

Time: Low-frequency scheduled subcutaneous injection for chronic long-term lipid management.

 

Instructions for use: Subcutaneous injection into abdomen, thigh or upper outer arm.

 

Interaction: Safe combination with statins, ezetimibe and other oral lipid-lowering agents without dose adjustment.

 

Side effects: Injection site erythema and pain, myalgia, influenza-like symptoms, fatigue.

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

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What conditions can Recaticimab for Injection improve?

It reduces LDL-C levels in patients with primary hypercholesterolemia and mixed dyslipidemia.

What is the mechanism of Recaticimab for Injection?

It inhibits PCSK9 protein, protects hepatic LDL receptors from degradation and accelerates blood LDL clearance.

What is the administration route and frequency of Recaticimab for Injection?

It is a long-acting subcutaneous injection for chronic long-term lipid management.

Can Recaticimab for Injection be used with statins?

Yes, it can be safely combined with statins and other oral lipid-lowering drugs without dose adjustment.

AiXinAn® | Recaticimab for Injection | Hypercholesterolemia and Mixed Dyslipidemia | DengYueRX

INN: Recaticimab for Injection
Indications: Hypercholesterolemia and mixed dyslipidemia
Dosage Form: Injection
Strength: 150mg/vial

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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