Envafolimab is a recombinant anti-PD-L1 immune checkpoint inhibitor designed as a humanized single-domain antibody fused to a human IgG1 Fc fragment. It is also known by the development codes KN035, KN-035 and ASC22.
Unlike conventional full-length monoclonal antibodies, Envafolimab is a smaller single-domain antibody-Fc fusion protein designed for subcutaneous administration. It binds to programmed death-ligand 1 (PD-L1) and blocks PD-L1-mediated immune checkpoint signaling.
Envafolimab is an anti-PD-L1 antibody used in immuno-oncology. It binds PD-L1, preventing its interaction with PD-1 and helping restore T-cell-mediated antitumor immune activity.
Envafolimab was approved in China in 2021 for previously treated MSI-H/dMMR advanced solid tumors.
Swapnroop Drugs and Pharmaceuticals provides Envafolimab for qualified pharmaceutical, biotechnology, oncology research and biologics-development requirements.
Because Envafolimab is a complex recombinant antibody fusion protein, it should be evaluated using biologics-specific quality attributes rather than conventional small-molecule API specifications.
Envafolimab binds to PD-L1 (CD274/B7-H1) and inhibits the interaction of PD-L1 with its immune-cell receptors, particularly PD-1. This blocks an inhibitory immune-checkpoint pathway and can enhance T-cell-mediated antitumor responses.
Envafolimab 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 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 |