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| Stem definition | Drug id | CAS RN |
|---|---|---|
| primate origin | 5512 | 2049079-64-1 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Sutimlimab-jome is an immunoglobulin G (IgG), subclass 4 (IgG4) monoclonal antibody (mAb) that inhibits the classical complement pathway (CP) and specifically binds to complement protein component 1, s subcomponent (C1s), a serine protease which cleaves C4. Sutimlimab-jome does not inhibit the lectin and alternative pathways. Inhibition of the classical complement pathway at the level of C1s prevents deposition of complement opsonins on the surface of RBCs, resulting in inhibition of hemolysis in patients with CAD.
|
| Dose | Unit | Route |
|---|---|---|
| 0.46 | g | P |
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 4, 2022 | FDA | BIOVERATIV THERAPEUTICS INC | |
| June 20, 2022 | PMDA | SANOFI K.K | |
| Nov. 15, 2022 | EMA | GENZYME EUROPE BV |
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| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Haemolysis | 56.06 | 43.62 | 11 | 170 | 15628 | 110573490 |
| Disseminated varicella zoster virus infection | 49.93 | 43.62 | 7 | 174 | 1274 | 110587844 |
| Hepatitis viral | 48.95 | 43.62 | 7 | 174 | 1468 | 110587650 |
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| Source | Code | Description |
|---|---|---|
| ATC | L04AJ04 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Complement inhibitors |
| FDA MoA | N0000193990 | Classical Complement Pathway Inhibitors |
| FDA EPC | N0000193991 | Classical Complement Pathway Inhibitor |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Cold autoimmune hemolytic anemia | indication | 398937006 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Complement C1s subcomponent | Enzyme | INHIBITOR | Kd | 9.59 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:757276 | CHEBI |
| CHEMBL4297832 | ChEMBL_ID |
| C000634098 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9807 | IUPHAR_LIGAND_ID |
| DB14996 | DRUGBANK_ID |
| 548401000202100 | SNOMEDCT_US |
| 4041155 | VANDF |
| 4041156 | VANDF |
| C4727016 | UMLSCUI |
| D11530 | KEGG_DRUG |
| 10737 | INN_ID |
| 356904 | MMSL |
| 40469 | MMSL |
| d09855 | MMSL |
| 018948 | NDDF |
| GNWE7KJ995 | UNII |
| 2591404 | RXNORM |
| C000623343 | MESH_SUPPLEMENTAL_RECORD_UI |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Enjaymo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55292-820 | INJECTION, SOLUTION, CONCENTRATE | 50 mg | INTRAVENOUS | BLA | 28 sections |
| Enjaymo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80203-347 | INJECTION, SOLUTION, CONCENTRATE | 50 mg | INTRAVENOUS | BLA | 28 sections |