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Senhwa Biosciences' CX-5461 Teams Up with Global PD-1 Leaders to Enter the Immunotherapy Arena, Targeting Multi-Billion Dollar Global Market
Senhwa Biosciences, Inc. (TPEx: 6492, "Senhwa") today announced its official entry into the fast-growing global immuno-oncology market. The Company's novel investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the approved PD-1 inhibitor Cemiplimab (Libtayo®), provided by Sanofi and Regeneron Pharmaceuticals, in a Phase 1/2 clinical trial for patients with microsatellite-stable colorectal cancer (MSS CRC) who are refractory to immune checkpoint inhibitors.
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TAIPEI and SAN DIEGO, Sept. 16, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492, "Senhwa") today announced its official entry into the fast-growing global immuno-oncology market. The Company's novel investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the approved PD-1 inhibitor Cemiplimab (Libtayo®), provided by Sanofi and Regeneron Pharmaceuticals, in a Phase 1/2 clinical trial for patients with microsatellite-stable colorectal cancer (MSS CRC) who are refractory to immune checkpoint inhibitors.","length":553,"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/hyBQWbX_FTtRFjftnr2Otg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEwNjtjZj13ZWJw/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":"This strategic collaboration marks the third clinical trial under Senhwa's NCI-sponsored five-year cancer research program with the U.S. National Cancer Institute (NCI). An Investigational New Drug (IND) application has been submitted to the U.S. FDA. The partnership underscores the unique mechanism of action of CX-5461 and the strong interest from leading global pharmaceutical companies in its potential to enhance the immunotherapy efficacy.","length":450,"tagName":"p"},{"type":"text","content":"Dr. Pin-Yen Huang, Chief Medical Officer of Senhwa, stated:"This is more than a clinical trial—it is a transformative opportunity to redefine the future of cancer therapy. The compelling synergy between CX-5461 and PD-1 inhibitors holds the promise of bringing renewed hope to countless patients, while also showcasing Taiwan's spirit of innovation on the global stage."","length":385,"tagName":"p"},{"type":"text","content":" Breaking Through Solid Tumor Immunotherapy Barriers ","length":51,"tagName":"p"},{"type":"text","content":"While immune checkpoint inhibitors have revoluti...