Drug intelligence / Profile preview

SHR-A1201

Development stage
Unknown
Lead developer
Hengrui Pharmaceutical
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

SHR-A1201 is an antibody-drug conjugate (ADC) designed for the treatment of HER2-positive cancers, particularly advanced or metastatic breast cancer. It consists of a humanized anti-HER2 monoclonal antibody (trastuzumab, IgG1) chemically linked via a lysine-SMCC linker to DM1 (maytansine), a potent microtubule inhibitor. The ADC specifically targets HER2-expressing tumor cells, where it binds to the HER2 antigen on the cell surface, is internalized, and releases DM1 intracellularly to inhibit microtubule polymerization and induce cell death. SHR-A1201 has demonstrated safety and tolerability in phase I clinical trials with encouraging antitumor activity in heavily pretreated patients with advanced HER2-positive breast cancer[1][3][5]. The drug exhibits pharmacokinetic properties typical of ADCs and shows dose-proportional exposure over tested ranges[8].

Brand names
SHR-A1201SHR-A-1201SHR-A 1201
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)TUBB (Tubulin (alpha and beta subunits))

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