Taiwan Food and Drug Administration Archives

Senhwa Biosciences advances CX-5461 into immuno-oncology as Taiwan clears a Phase 1b/2a trial combining pidnarulex with tislelizumab in advanced solid tumors. Representative image.

Can CX-5461 make resistant tumors respond to immunotherapy? Senhwa’s Taiwan clearance opens the clinical test

by Pallavi Madhiraju
August 7, 2026
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Senhwa Biosciences has secured Taiwan regulatory clearance for a multicenter Phase 1b/2a trial combining pidnarulex, or CX-5461, with BeOne Medicines’ PD-1 inhibitor tislelizumab in advanced solid tumors. The study will test whether DNA replication stress can make immunologically cold or checkpoint-resistant cancers more responsive to immunotherapy.

GlycoNex has dosed the first patient in a Phase I trial of GNX1021, beginning the clinical evaluation of its glycan-directed antibody-drug conjugate in advanced gastrointestinal cancers. Representative image.

Pharma & Biotech

GlycoNex has taken GNX1021 into humans, but its bold glycan-targeting theory now faces the real test

by Pallavi Madhiraju
August 3, 2026
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GlycoNex has dosed the first patient in a multinational Phase I trial of GNX1021, moving its lead glycan-directed antibody-drug conjugate from laboratory studies into human testing. The milestone begins a far more consequential phase in which investigators must establish whether targeting branched Lewis B/Y can produce a usable therapeutic window in advanced gastrointestinal cancers.