Aixinan® is the commercial brand name of Recaticimab, a fully human monoclonal antibody targeting PCSK9, developed by Hengrui Medicine of China. It binds to PCSK9, blocks the combination of PCSK9 and LDL receptor, increases the number of LDL receptors on liver cell surface, thereby reducing serum LDL‑C level.
Main Indications
On the basis of dietary control, combined with statins, or combined with statins and other lipid-lowering therapies, for adult patients with primary hypercholesterolemia who cannot reach LDL-C target with at least moderate-dose statin treatment.
Clinical Research
Pivotal phase III trials demonstrated that recaticimab achieved substantial and sustained LDL-C reduction. After 48 weeks of treatment, LDL-C decreased by 64.0%. The trial validated the efficacy of the 8-week dosing interval, met the primary endpoint, and confirmed stable long-term lipid-lowering effect.
Common Side Effects
The most frequent adverse reactions include injection site reactions, influenza-like illness, myalgia, arthralgia, back pain and headache. Severe hypersensitivity reactions may occur rarely.
Approval Status in China
Original drug Aixinan® (Recaticimab for Injection) was officially approved for marketing in China in 2025, with the specification of 150mg per vial. It is currently a prescription drug.
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