Drug intelligence / Profile preview

ruzaltatug rezetecan

Development stage
Phase 3
Lead developer
Hengrui Pharmaceutical
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

**Ruzaltatug rezetecan (SHR-A2009)** is an investigational antibody-drug conjugate (ADC) developed by Jiangsu Hengrui Pharmaceuticals and Suzhou Suncadia Biopharmaceuticals, featuring a humanized monoclonal antibody targeting **HER3 (ErbB3)** conjugated via a cleavable linker to **rezetecan**, a DNA topoisomerase I inhibitor payload derived from camptothecin. It is designed for the treatment of advanced solid tumors, particularly **non-small cell lung cancer (NSCLC)** with EGFR mutations post-TKI progression, where phase 1 data showed an objective response rate of 30% in NSCLC patients and a tolerable safety profile with primarily hematologic toxicities. Clinical trials are ongoing in NSCLC, breast cancer, esophageal squamous cell carcinoma, and other solid tumors, with encouraging antitumor activity reported across multiple studies.[1][2][6][8][11]

Brand names
SHR-A2009SHR-A-2009SHR-A 2009
Other names
SHR-A2009SHR-A-2009SHR-A 2009
02

Targets

ERBB3 (Erb-b2 receptor tyrosine kinase 3)TOP1 (DNA Topoisomerase I)

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