Aixinan Recaticimab for Injection

1. Indications and Usage
Primary Hypercholesterolemia: Adjunct to diet and statin therapy (or other lipid-lowering therapies) for adult patients with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) who have not achieved their LDL-C goals with moderate or high doses of statins.
2. Dosage and Administration
Route of Administration: For Subcutaneous (SC) Injection ONLY.
Recommended Dosage: 150 mg administered once every 4 weeks or once every 8 weeks.
Critical Administration Instructions:
Reconstitution: Reconstitute each 150 mg vial with 1 mL Sterile Water for Injection. Gently swirl for approximately 6-8 minutes until dissolved. The solution should be clear to pale yellow.
Inspection: Visually inspect the solution; discard if particulates or discoloration are observed.
Injection Sites: Administer in the abdomen, thigh, or upper arm. Rotate injection sites as needed.
3. Mechanism of Action
PCSK9 Inhibition: Recaticimab is a monoclonal antibody that specifically binds to Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9).
LDL-R Protection: By inhibiting PCSK9, it prevents PCSK9 from binding to low-density lipoprotein receptors (LDL-R) on hepatocyte surfaces, thereby protecting LDL-R from lysosomal degradation.
Cholesterol Clearance: This allows for increased recycling of LDL-R to the cell surface, enhancing the clearance of low-density lipoprotein cholesterol (LDL-C) from the bloodstream.
4. Safety and Warnings
Hypersensitivity: Serious allergic reactions (e.g., rash, urticaria, angioedema) have been reported. The drug must be discontinued immediately if severe hypersensitivity occurs.
Anti-Drug Antibodies: As with all biologics, the development of anti-drug antibodies may occur, though clinical impact remains low.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Injection site reactions (pain, erythema, swelling), upper respiratory tract infection, rhinitis, and arthralgia.
Clinical Research Highlights: Phase 3 trials (e.g., RECITE study) demonstrated that Recaticimab significantly reduced LDL-C levels compared to placebo, with durable efficacy supporting 4-week or 8-week dosing intervals.
6. Drug Interactions
Lipid-Lowering Agents: No significant pharmacokinetic interactions with statins or ezetimibe are expected, though they are commonly co-administered.
Vaccines: Live or attenuated vaccines should be avoided.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Recaticimab. Excipients: Sucrose, Polysorbate 80, Histidine, and Histidine Hydrochloride.
Appearance: White to off-white lyophilized cake or powder.
Packaging: Single-use vial (150 mg).
Storage: Store in the original carton at 2°C to 8°C. Do not freeze.