Senhwa Biosciences aims at multi-billion dollar global market with CX-5461 combined with ADC “blockbuster” therapy

CAR-T Digest - August 2020

28 December 2025: Senhwa Biosciences aims at a multi-billion dollar global market with CX-5461 combined with ADC “blockbuster” therapy

Senhwa Biosciences announced a Phase 1 clinical trial evaluating its first-in-class investigational G-quadruplex (G4) stabilizer Pidnarulex (CX-5461) in combination with the blockbuster ADC Enhertu for HER2-positive solid tumors and breast cancer, including HER2-low and metastatic disease
The trial is supported by the National Cancer Institute (NCI) through its NExT program, which funds multiple CX-5461 studies and combination strategies, marking CX-5461’s formal entry into the rapidly expanding ADC treatment landscape
CX-5461 is the world’s most advanced G4 stabilizer in development and has already shown encouraging activity in early-phase trials for breast cancer and other solid tumor. Its combination with Enhertu is expected to further improve efficacy, particularly in HER2-low patients
Enhertu, co-developed by AstraZeneca and Daiichi Sankyo, is the first HER2-directed ADC approved for HER2-low and HER2-ultralow metastatic breast cancer, using targeted antibody delivery to release the cytotoxic payload deruxtecan directly into tumor cells while limiting damage to healthy tissue
Global ADC market projected to grow at a ~28.4% CAGR to about USD 47 billion by 2029, analysts believe this combination strategy could significantly boost Senhwa’s global oncology profile, enhance long-term valuation, and support its ambition to build a diversified, globally competitive oncology pipeline