SHR-A1904 (Garetatug Rezetecan): A Comprehensive Clinical and Strategic Analysis of a Novel CLDN18.2-Targeted Antibody-Drug Conjugate

I. Strategic Overview

Executive Summary

SHR-A1904, also known by the non-proprietary name garetatug rezetecan, is an investigational antibody-drug conjugate (ADC) at the forefront of a new wave of targeted cancer therapies.[1] Developed by the Chinese pharmaceutical leader Jiangsu Hengrui Pharmaceuticals Co., Ltd., SHR-A1904 is engineered to selectively target Claudin-18 isoform 2 (CLDN18.2), a protein antigen with highly restricted expression in normal tissues that becomes exposed on the surface of various cancer cells, particularly those of gastric and gastroesophageal junction (G/GEJ) origin.[2] The agent represents a sophisticated application of ADC technology, combining a high-specificity monoclonal antibody with a potent DNA topoisomerase I inhibitor payload via a stable, cleavable linker system.[2]

The clinical development program for SHR-A1904 has been aggressive and strategically multifaceted. Foundational Phase 1 data, notably published in the peer-reviewed journal Nature Medicine, have demonstrated a manageable safety profile and encouraging anti-tumor activity in heavily pre-treated patients with CLDN18.2-positive advanced G/GEJ cancer.[2] These results have propelled the asset into late-stage, pivotal Phase 3 trials in China for stomach adenocarcinoma and related indications, positioning it for potential near-term approval in its domestic market.[2] Concurrently, Hengrui has initiated a global development strategy, with trials underway in the United States and Australia to evaluate SHR-A1904 in a broader range of advanced solid tumors.[2]