Ebronucimab is a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). It binds PCSK9 and prevents PCSK9-mediated degradation of low-density lipoprotein receptors (LDLR), thereby increasing LDLR availability and promoting the removal of LDL cholesterol from the bloodstream.
Ebronucimab, also known as AK102, is an IgG1 monoclonal antibody with a lambda light chain. It has been developed for lipid-lowering treatment, including primary hypercholesterolemia and mixed dyslipidemia. China’s NMPA approved Ebronucimab injection for adults whose LDL-C remains above recommended targets despite moderate- or high-intensity statin therapy, in combination with statins or other lipid-lowering therapies.
Synonyms: Ebronucimab, AK102, AK-102, Inusimab
Target: PCSK9
Molecular class: Fully human monoclonal antibody
Isotype: IgG1
Light chain: Lambda
Therapeutic area: Metabolic disorders / Lipid management
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |