Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 69 |
| INN | Nimotuzumab |
| Status | Approved |
| Drug code(s) | hu-R3 |
| Brand name | TheraCIM, BIOMAB-EGFR |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | EGFR |
| Indications of clinical studies | Head and neck cancer, nasopharyngeal cancer, glioma, Esophageal cancer, pancreatic cancer, non-small cell lung cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China, India, Cuba |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 1998 |
| Start of Phase 2 | |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2002 |
| Date of first US approval | |
| INN, US product name | Nimotuzumab |
| US or EU approved indications | None |
| Company | Center of Molecular Immunology |
| Licensee/Partner | InnoKeys PTE Ltd |
| Comments about company or candidate | Sold in countries outside the US and Europe by various companies. Licensees for nimotuzumab include Biocon BioPharmaceuticals Ltd. (BBPL) in India, Biotech Pharmaceutical Co. Ltd. in China, Delta Laboratories in Colombia, European Chemicals SAC, Quality Pharma in Peru, Eurofarma Laboratorios Ltda. in Brazil, Ferozsons Labs in Pakistan, Laboratorio Elea S.A.C.I.F.yA. in Argentina, EL KENDI Pharmaceutical in Algeria and Laboratorios PiSA in Mexico, South Korean rights licensed to Kuhnil Pharmaceutical Co., Ltd., Japanese rights licensd to Daiichi Sankyo and rights to certain countries in Asia and Africa to licensed to Innogene Kalbiotech Pte Ltd. First approved in Cuba (Saurez-Martinez, G. & Becomo-Yanes, A. Nimotuzumab, effective immunotherapy for the treatment of malignant epithelial tumors. Biotecnologia Aplicada 31, 159–167 (2014)). Nimotuzumab received its health registration in 2002 to treat head and neck tumors at advanced stages. |
| Full address of company | 15 Street and 216 Street, Siboney, Playa, La Habana, Cuba. A.P 16040, La Habana 11600, Cuba North America Republic of Cuba https://www.cim.cu/SobreNosotros/QuienesSomos |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |