Tagitanlimab API is a humanized monoclonal antibody directed against programmed death-ligand 1 (PD-L1/CD274). Also known by the development codes A-167, KL-A167 and HBM-9167, Tagitanlimab is an IgG1κ therapeutic antibody designed to inhibit the PD-1/PD-L1 immune checkpoint pathway.
Tagitanlimab binds to PD-L1 and blocks its interaction with PD-1 on T cells. This mechanism can restore T-cell activity and enhance antitumor immune responses against PD-L1-expressing tumor cells.
The active biological substance is a recombinant humanized monoclonal antibody and should therefore be manufactured, characterized, stored and released using biologics-specific quality controls rather than conventional small-molecule API testing.
Tagitanlimab is a humanized anti-PD-L1 IgG1κ monoclonal antibody. Its molecular target is PD-L1, also known as B7-H1 or CD274. Public databases identify Tagitanlimab as an approved antibody drug in China, with Cotelet® as a reported brand name.
FDA's Substance Registration System identifies Tagitanlimab under UNII GUY458P83P and CAS 2417649-97-7.
Unlike a conventional chemically synthesized API, Tagitanlimab does not have a simple molecular formula suitable for routine small-molecule CMS fields such as molecular formula-based molecular weight, melting point or aqueous solubility. Its quality is characterized through biologics-specific physicochemical, purity, identity, potency and safety assays.
| Parameter | Details |
|---|---|
| Generic Name | Tagitanlimab |
| Development Codes | A-167 / KL-A167 / HBM-9167 |
| CAS Number | 2417649-97-7 |
| FDA UNII | GUY458P83P |
| Molecular Type | Recombinant monoclonal antibody |
| Antibody Class | Humanized IgG1κ |
| Target | PD-L1 / CD274 |
| Therapeutic Class | Immune checkpoint inhibitor |
| Biological Category | Anti-PD-L1 monoclonal antibody |
| Approx. Molecular Mass | 144.95 kDa |
| Stereochemistry | Complex protein stereochemistry; not applicable to small-molecule optical-rotation specification |
| Physical Form | Typically supplied as an aqueous protein formulation or controlled biologic drug-substance preparation |
Public commercial antibody data report Tagitanlimab as a colorless to light-yellow liquid with an approximate molecular mass of 144.95 kDa.
Tagitanlimab is an immune checkpoint inhibitor developed for the treatment of malignant diseases in which the PD-1/PD-L1 pathway contributes to immune evasion.
The Chinese NMPA approved Tagitanlimab in 2024 in combination with cisplatin and gemcitabine for recurrent/metastatic nasopharyngeal cancer.
Clinical development has also investigated Tagitanlimab in other solid tumors, including breast cancer and non-small-cell lung cancer.
Tagitanlimab specifically binds to PD-L1 on tumor cells and other cells within the tumor microenvironment.
Normally, interaction between PD-L1 and PD-1 transmits an inhibitory signal that reduces T-cell activation and allows tumor cells to evade immune surveillance. By blocking PD-L1/PD-1 interaction, Tagitanlimab releases this immune checkpoint inhibition and can restore cytotoxic T-lymphocyte activity.
The resulting increase in antitumor immune activity forms the pharmacological basis for its use as a PD-L1 immune checkpoint inhibitor.
As a monoclonal antibody, Tagitanlimab requires biologics-specific analytical characterization. Typical quality-control programs may include:
Commercial research-grade Tagitanlimab characterization packages demonstrate the use of orthogonal methods including SEC-HPLC, RP-HPLC, NP-HPLC, MS/LC-MS and other protein characterization techniques. These methods demonstrate appropriate analytical approaches but should not be interpreted as universal pharmaceutical release specifications.
Tagitanlimab manufacturing requires a controlled recombinant biologics production process.
A typical manufacturing platform for an IgG1κ monoclonal antibody includes:
Manufacturing controls should address product identity, purity, aggregation, charge heterogeneity, glycosylation, potency and process-related impurities.
The approximate molecular mass of 144.95 kDa and liquid physical form are reported in current public Tagitanlimab antibody-product data.
Tagitanlimab drug substance should be stored in qualified pharmaceutical/biologic containers under validated temperature conditions appropriate for the specific formulation.
Because monoclonal antibodies are sensitive to temperature, agitation, interfaces and repeated freeze-thaw cycles, storage and transportation conditions should be based on validated stability data.
Public research-grade material is commonly shipped under dry-ice conditions, but this should not be interpreted as the approved commercial storage condition for every Tagitanlimab drug-substance presentation.
Documentation for Tagitanlimab biologic API/drug substance may include:
A reliable Tagitanlimab API Manufacturer in India should have the technical capability to handle recombinant monoclonal antibodies and provide biologics-specific quality and analytical controls.
Important considerations include:
Swapnroop can position Tagitanlimab as a specialized biologics/API offering supported by appropriate analytical characterization and documentation for pharmaceutical development and manufacturing requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |