Recaticimab is a recombinant humanized monoclonal antibody that selectively targets proprotein convertase subtilisin/kexin type 9 (PCSK9). It is also known by the development code SHR-1209 and is marketed in China as Ai Xin'an. Recaticimab is designed to inhibit the interaction between PCSK9 and the low-density lipoprotein receptor (LDLR), helping increase LDLR availability and promote clearance of LDL cholesterol from the bloodstream.
Recaticimab is a biologic API rather than a conventional synthetic small molecule. Its quality evaluation therefore focuses on antibody identity, protein concentration, purity, aggregation, charge variants, glycosylation, biological activity, PCSK9 binding and other product-specific critical quality attributes.
Recaticimab is a humanized IgG1-kappa monoclonal antibody targeting PCSK9. The molecule incorporates Fc-engineering modifications intended to extend its circulating half-life. Recent literature identifies the Fc YTE substitutions as M252Y, S254T and T256E.
The current chemical-reference data identify Recaticimab with CAS No. 2361290-85-7 and an approximate molecular weight of 148.42 kDa. NCATS identifies Recaticimab as a validated protein substance with FDA UNII 20IE6M67UX.
| Parameter | Value |
|---|---|
| Molecular Type | Recombinant monoclonal antibody |
| Antibody Class | Humanized IgG1-kappa |
| Target | PCSK9 |
| Molecular Weight | Approximately 148.42 kDa |
| CAS Number | 2361290-85-7 |
| FDA UNII | 20IE6M67UX |
| Development Code | SHR-1209 |
| Fc Engineering | YTE mutations: M252Y, S254T, T256E |
| Expression System | CHO cells |
| Pharmaceutical Category | Biological Active Pharmaceutical Ingredient |
| Therapeutic Area | Lipid-lowering / cardiovascular |
| Mechanism | PCSK9 inhibition |
NCATS identifies the substance as a humanized-mouse-derived IgG1 monoclonal antibody, while current analytical-reference sources identify the molecule as approximately 148.4 kDa.
Recaticimab is used as a PCSK9 inhibitor for lipid management. China’s NMPA approved Recaticimab injection for adults with primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia, and mixed dyslipidemia in specified treatment settings. It is also approved as monotherapy for adult patients with non-familial hypercholesterolemia and mixed dyslipidemia.
Clinical Phase 3 studies evaluated subcutaneous regimens including 150 mg every 4 weeks, 300 mg every 8 weeks and 450 mg every 12 weeks, demonstrating significant LDL-C reductions compared with placebo.
As a monoclonal antibody, Recaticimab requires biologic-specific analytical testing rather than the conventional small-molecule API tests used for tablets and synthetic chemicals.
Important quality attributes include:
Commercial analytical references report Recaticimab as a liquid monoclonal-antibody preparation and provide batch-specific purity/assay data, but these values should not be represented as universal regulatory API specifications.
Recaticimab API manufacturing requires specialized biologics manufacturing and analytical capabilities because the active ingredient is a complex monoclonal antibody. Manufacturing controls should cover cell-culture production, purification, viral safety, protein characterization, aggregation, charge heterogeneity, glycosylation, potency and process-related impurities.
The molecule has already received NMPA marketing approval in China, making Recaticimab an established approved biological drug rather than solely an early-stage investigational antibody.
Recaticimab is a protein biologic and should be maintained under validated temperature-controlled conditions. Research-grade reference products are commonly supplied as sterile liquid formulations and shipped under cold-chain conditions. Lot-specific buffer composition and storage requirements should be followed according to the applicable Certificate of Analysis and validated stability program.
Typical Recaticimab biological API documentation may include:
Recaticimab is a specialized PCSK9-targeting monoclonal antibody API requiring biologics-specific quality control. A suitable manufacturing and analytical program should focus on molecular identity, purity, protein concentration, structural characterization, potency, aggregation, charge variants and process-related impurities rather than conventional small-molecule specifications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |