Ongericimab, also known as JS002 or JS-002, is a recombinant humanized monoclonal antibody designed to target proprotein convertase subtilisin/kexin type 9 (PCSK9). It belongs to the anti-PCSK9 monoclonal antibody class and is being developed as a lipid-lowering biological therapy for conditions associated with elevated low-density lipoprotein cholesterol (LDL-C), including hypercholesterolemia and hyperlipidemia. Ongericimab has been investigated clinically by Shanghai Junshi Biosciences Co., Ltd. and is administered by subcutaneous injection.
Unlike conventional synthetic APIs, Ongericimab is a complex biological molecule. Published clinical pharmacology data describe Ongericimab as a 145.6 kDa recombinant human monoclonal immunoglobulin G4-kappa (IgG4-κ) antibody. The reported antibody architecture consists of 438 amino acids in each gamma heavy chain and 213 amino acids in each kappa light chain.
Ongericimab is a biological macromolecule, so conventional small-molecule descriptors such as molecular formula, melting point, specific rotation and aqueous pH are not appropriate universal quality attributes for the intact antibody. The antibody is composed of protein chains with defined amino-acid sequences and post-translational characteristics rather than a single low-molecular-weight chemical structure.
The published clinical pharmacology study identifies Ongericimab as a 145.6 kDa recombinant human IgG4-kappa monoclonal antibody and describes the heavy and light chain composition. Research-grade references quote somewhat different apparent molecular weights, including 143.02 kDa and 143.04 kDa. This difference should not be treated as a discrepancy in chemical identity; antibody molecular mass can vary depending on analytical methodology, glycosylation and the reference material being characterized.
Ongericimab targets PCSK9, a protein involved in regulation of the hepatic LDL receptor. PCSK9 binding to the LDL receptor promotes receptor degradation, reducing the number of LDL receptors available on hepatocyte surfaces. Inhibition of PCSK9 allows greater LDL-receptor recycling and increases hepatic clearance of circulating LDL particles, resulting in reduced LDL-C concentrations.
Ongericimab has consequently been investigated as a potential long-acting PCSK9-targeting lipid-lowering antibody. Published clinical studies evaluated its pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles in healthy participants and patients with hypercholesterolemia.
Ongericimab is relevant to biological pharmaceutical development, cardiovascular research and lipid-management programs. Its principal development area is the reduction of LDL-C through inhibition of PCSK9.
Potential pharmaceutical and research applications include:
ClinicalTrials.gov records show Ongericimab being investigated in hypercholesterolemia-related clinical development and, more recently, in combination-based studies involving cardiovascular and oncology research settings. A 2026 registered study is evaluating 150 mg every two weeks or 300 mg every four weeks in an ischemic-stroke prevention setting alongside standardized lipid-lowering therapy.
Quality characterization of a monoclonal antibody such as Ongericimab differs substantially from that of a conventional chemical API. Appropriate characterization may include size-exclusion chromatography (SEC), ion-exchange chromatography, reversed-phase chromatography, peptide mapping, mass spectrometry, electrophoretic analysis, protein concentration, aggregation analysis, charge-variant analysis and biological activity testing.
Research-grade Ongericimab references report high purity. MedChemExpress currently lists a batch with 99.98% purity/assay, while other research-grade Ongericimab products report purity values above 95%. These are product- or batch-specific research-material values and should not be presented as a universal pharmaceutical release specification.
For a commercial biological API, quality specifications should be established against the applicable development or regulatory specification and may include identity, purity, aggregation, charge variants, potency, host-cell proteins, residual host-cell DNA, endotoxin, bioburden, sterility where applicable, particulate matter and other critical quality attributes.
Ongericimab research-grade material is generally supplied as a liquid antibody preparation rather than as a crystalline powder. MedChemExpress describes the material as colorless to light yellow and supplied in a lot-specific formulation, while Selleck identifies a formulation containing 100 mM Pro-Ac, 20 mM arginine at pH 5.0.
Research-grade storage recommendations commonly specify −20°C for the undiluted antibody solution and avoidance of repeated freeze-thaw cycles. Other recombinant-antibody references recommend refrigerated short-term storage followed by frozen long-term storage. Because these are product-specific conditions, the final commercial API page should state that storage must follow the validated stability data and batch-specific Certificate of Analysis rather than claiming one universal storage temperature.
Ongericimab Bulk API should be documented as a biological monoclonal-antibody active ingredient rather than as a conventional synthetic bulk chemical. Technical documentation should clearly identify the molecule as Ongericimab / JS002, CAS 2145096-91-7, humanized IgG4-kappa, anti-PCSK9, and should specify the actual molecular-mass convention used for the batch.
This distinction is especially important because publicly available sources report molecular masses ranging from approximately 143.02 kDa to 145.6 kDa. The 145.6 kDa value is supported by the peer-reviewed clinical pharmacology publication, while approximately 143 kDa values appear in commercial research-product records.
An Ongericimab API Manufacturer in India product page should emphasize biological-product quality, recombinant monoclonal-antibody characterization and PCSK9-targeted pharmacology. Because Ongericimab does not have the same type of public pharmacopoeial specification framework as many established small-molecule APIs, unsupported IP/BP/EP/USP claims should be avoided.
The most useful SEO identifiers include Ongericimab API, Ongericimab API Manufacturer, Ongericimab API Manufacturer India, Ongericimab Pharmaceutical API, Ongericimab Bulk API, Ongericimab CAS Number, JS002 API, JS-002 antibody, anti-PCSK9 monoclonal antibody, and CAS 2145096-91-7.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Water Content | NMT 0.5% |