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Senhwa Biosciences Launches Global Study, Targeting Breakthrough in Hard-to-Treat Cancers with CX-5461 and Tislelizumab Combination

Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company today announced the initiation of a global, multi-center clinical trial. The Company has also submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), marking a key milestone in Senhwa's global clinical development.

articleSenhwa Biosciences IncMay 5, 20262/company/senhwa-biosciences-inc/news/senhwa-biosciences-launches-global-study-targeting-breakthrough-in-hard-to-treat-cancers-with-cx-5461-and-tislelizumab-combination
Senhwa Biosciences Launches Global Study, Targeting Breakthrough in Hard-to-Treat Cancers with CX-5461 and Tislelizumab Combination

About this update from Senhwa Biosciences Inc

[{"type":"text","content":"TAIPEI and SAN DIEGO, May 5, 2026 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company today announced the initiation of a global, multi-center clinical trial. The Company has also submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), marking a key milestone in Senhwa's global clinical development.","length":398,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Senhwa Biosciences, Inc.)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Senhwa Biosciences, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":213,"height":54,"url":"https://media.zenfs.com/en/prnewswire.com/733155187d97c2430a91423c1587523b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/3NCDoiso4s2Ko03dxAmxgQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEwNg--/https://media.zenfs.com/en/prnewswire.com/733155187d97c2430a91423c1587523b","width":213,"height":54},"resize_sm":{"url":"https://s.yimg.com/ny/api/res/1.2/3NCDoiso4s2Ko03dxAmxgQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEwNg--/https://media.zenfs.com/en/prnewswire.com/733155187d97c2430a91423c1587523b","width":213,"height":54}},"href":"https://mma.prnewswire.com/media/1933477/Senhwa_Logo_Logo_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The study will evaluate Senhwa's first-in-class investigational drug, Pidnarulex (CX-5461), in combination with BeOne Medicines' marketed PD-1 inhibitor, tislelizumab, across multiple advanced or metastatic solid tumors, including pancreatic cancer, colorectal cancer, and melanoma—areas with significant unmet medical needs. The global multi-center design is expected to accelerate clinical validation while enhancing the asset's visibility, supporting future out-licensing and commercialization opportunities.","length":523,"tagName":"p"},{"type":"text","content":"The Company aims to leverage combination therapy approaches to enter the rapidly expanding immuno-oncology market and build sustainable long-term growth momentum.","length":162,"tagName":"p"},{"type":"text","content":"CX-5461 features a differentiated dual mechanism of action. In addition to inhibiting ribosomal RNA synthesis and suppressing tumor cell proliferation, it stabilizes G-quadruplex structures, inducing DNA damage and activating the cGAS–STING pathwa...

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Senhwa Biosciences, Inc.global clinical developmentThe Companybiopharmaceutical companycolorectal cancerFood and Drug Administrationtumor microenvironmentpancreatic cancercombination therapyInvestigational New Drug