Enlonstobart is a recombinant human anti-PD-1 monoclonal antibody belonging to the immunoglobulin G4-kappa (IgG4κ) class. It is also identified by the development codes SG-001, SG001 and SYSA1802. Enlonstobart binds to programmed cell death protein 1 (PD-1) and blocks PD-1-mediated immune checkpoint signaling, helping restore T-cell-mediated antitumor immune responses.
Enlonstobart is marketed in China under the brand name Enshuxing and has been developed for oncology applications, including cervical cancer. Public antibody databases classify it as a full-length, naked monospecific IgG4 antibody targeting PD-1.
Enlonstobart is a biological therapeutic antibody designed to inhibit the PD-1/PD-L1/PD-L2 immune checkpoint pathway. PD-1 is an inhibitory receptor expressed on T cells. Blocking this pathway can enhance T-cell activation and immune responses against tumor cells.
Swapnroop Drugs and Pharmaceuticals provides Enlonstobart for qualified pharmaceutical, biotechnology, oncology research and biologics development requirements.
Because Enlonstobart is a complex monoclonal antibody, it should not be treated like a conventional small-molecule API. Manufacturing and quality control require specialized biological and biopharmaceutical processes.
Enlonstobart binds to PD-1/CD279 on T cells and inhibits PD-1 signaling mediated by its ligands PD-L1 and PD-L2. This removes an immune-inhibitory signal and may enhance T-cell-mediated immune responses against cancer cells.
Enlonstobart is associated with:
| 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 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |