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SIBP-01
- Development stage
- Phase 3
- Lead developer
- Shanghai Institute of Biological Products
- Modality
- Nucleic Acid-Directed Small Molecules → Small Molecules, Vaccines & Immunotherapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
- Administration
- Intravenous
01
Overview
SIBP-01 is a biosimilar to trastuzumab (Herceptin), developed by the Shanghai Institute of Biological Products and Fudan University. It is a recombinant humanized monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER2/ERBB2). The drug exerts its antitumor effects primarily through antibody-dependent cell cytotoxicity and antagonism of the ERBB2 receptor. SIBP-01 has demonstrated pharmacokinetic bioequivalence to Herceptin in phase I studies and is being evaluated for efficacy, safety, and immunogenicity in combination with docetaxel and carboplatin for HER2-positive breast cancer in phase III clinical trials[1][2][3][6]. The molecular structure, biological activity, and purity are highly similar to those of reference trastuzumab[2].
- Other names
- Herceptin Biosimilar - Shanghai Institute of Biological Productstrastuzumab biosimilar
02
Targets
ERBB2 (Erb-b2 receptor tyrosine kinase 2)
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