<div id="readability-page-1"><div> <div> , /PRNewswire/ -- Following its recent clinical collaboration with the multinational pharmaceutical company BeOne Medicines to explore combination therapy with its marketed PD-1 inhibitor in the challenging field of cold tumor treatment, Senhwa Biosciences, Inc. (TPEx: 6492, hereafter &#34;Senhwa&#34;), today announced another major milestone. The Company's first-in-class investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the globally recognized antibody-drug conjugate (ADC), Trastuzumab Deruxtecan (Enhertu®), in a Phase 1b clinical trial. The study is designed for HER2-positive solid tumors and breast cancer patients, including those with HER2-low expression and metastatic breast cancer. Supported by the U.S. National Cancer Institute's (NCI) NExT program, which funds multiple CX-5461 studies including combination strategies, Senhwa is positioning itself at the forefront of one of the most promising areas in oncology therapeutics, and this milestone marks CX-5461's entry into the fast-growing ADC market. World's First G4 Stabilizer Meets Leading ADC CX-5461 is the world's first and most advanced G-quadruplex (G4) stabilizer in development. It has shown promising activity in early-phase trials for breast cancer and other solid tumors in study sponsored by SU2C-CCTG in Canada. Its combination with Enhertu® is expected to enhance treatment efficacy in HER2-low patients and offer new therapeutic possibilities. Enhertu®, co-developed by AstraZeneca and Daiichi Sankyo, is the first HER2-directed ADC approved for HER2-low and HER2-ultralow metastatic breast cancer. This innovative drug uses a monoclonal antibody to precisely target tumor cells and deliver the chemotherapy payload Deruxtecan directly into the tumor, enabling highly effective cancer cell killing while minimizing harm to healthy cells. Entering a High-Growth Market The global ADC market is projected to grow at a CAGR of 28.4%, reaching approximately USD 47 billion by 2029. Analysts believe that Senhwa's clinical development strategy combining CX-5461 and Enhertu® positions the company to directly tap into this high-growth and highly competitive oncology market. Differentiated Advantage and Strategic Collaboration Potential Although existing HER2-targeted therapies have transformed the treatment landscape for breast and gastric cancers, their efficacy in HER2-low solid tumors remains limited. Experts suggest that if CX-5461's novel mechanism of action, when combined with ADC's precise delivery platform, proves effective, it could break through current treatment barriers, expand indications to additional tumor types, and establish a clear competitive edge. With global pharmaceutical companies racing into the ADC space, collaborations and licensing agreements have become mainstream. Should Senhwa's combination therapy demonstrate strong clinical efficacy, it could attract strategic partnerships with major international pharma players, bringing in substantial licensing revenues and long-term collaboration opportunities. Driving Long-Term Value Creation Analysts further note that the successful advancement of this trial would significantly enhance Senhwa's international visibility in oncology, elevate the company's market valuation, and deliver sustainable long-term returns for investors and shareholders. HER2 has been validated as a critical oncogenic driver across multiple tumor types. By leveraging the innovative combination of CX-5461 and Enhertu®, Senhwa aims to pioneer breakthrough therapies, capture a substantial share of the rapidly growing ADC market, and build a diverse oncology treatment platform. The company reiterated its commitment to strengthening its R&amp;D pipeline, integrating next-generation ADC technologies with its proprietary drug candidates, and advancing toward its vision of becoming a leading Asia-based oncology innovator with a global footprint. Senhwa Biosciences – CX-5461 NCI-NExT Program Clinical Trial Overview <div> <div> <div> <table> <tbody> <tr> <td colspan="1" rowspan="1">No.</td> <td colspan="1" rowspan="1">Study Title</td> <td colspan="1" rowspan="1">Total Subjects</td> <td colspan="1" rowspan="1">Primary Endpoints</td> <td colspan="1" rowspan="1">Global Market Forecast</td> </tr> <tr> <td colspan="1" rowspan="1">1</td> <td colspan="1" rowspan="1">Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors</td> <td colspan="1" rowspan="1">Up to 40 subjects HRD / Non-HRD (20 each)</td> <td colspan="1" rowspan="1">Evaluation of RAD51 response and DNA damage response</td> <td colspan="1" rowspan="1">2024: USD 362.2B CAGR: 20% 2032: USD 1,557.4B</td> </tr> <tr> <td colspan="1" rowspan="1">2</td> <td colspan="1" rowspan="1">Phase 1b/2 Trial of Pidnarulex in MYC Aberrant Lymphoma</td> <td colspan="1" rowspan="1">Up to 50 subjects Phase 1b: 36 Phase 2: 8–14</td> <td colspan="1" rowspan="1">1. Safety and DLT evaluation on CX-5461 2. RP2D for on CX-5461 3. ORR 4. CX-5461 PK 5. Effect on MYC-aberrant lymphoma gene expression</td> <td colspan="1" rowspan="1">2024: USD 4.9B CAGR: 5.79% 2035: USD 8.9B</td> </tr> <tr> <td colspan="1" rowspan="1">3</td> <td colspan="1" rowspan="1">A Phase 1 and Randomized Phase 2 Trial of Pidnarulex (CX-5461) and Cemiplimab (REGN2810) in Refractory Microsatellite Stable Colorectal Cancer</td> <td colspan="1" rowspan="1">Up to 86 subjects Phase 1: 18 Phase 2: 68</td> <td colspan="1" rowspan="1">1. CX-5461 RP2D combined with PD-1 inhibitor 2. Safety &amp; tolerability for CX-5461 monotherapy &amp; combination 3. PFS in refractory MSS CRC with liver metastases for CX-5461 monotherapy &amp; combination</td> <td colspan="1" rowspan="1">2025: USD 58.0B CAGR: 15% 2035: &gt; USD 250.0B</td> </tr> <tr> <td colspan="1" rowspan="1">4</td> <td colspan="1" rowspan="1">Phase 1b study of Pidnarulex and Trastuzumab Deruxtecan in patients with HER2 expressing Solid Tumors</td> <td colspan="1" rowspan="1">Up to 36 subjects</td> <td colspan="1" rowspan="1">1. MTD &amp; RP2D determination for combination of CX-5461 and Trastuzumab Deruxtecan 2. Safety and tolerability in HER2-low and HR+ HER2-ultra-low breast cancer for combination of CX-5461 and Trastuzumab Deruxtecan </td> <td colspan="1" rowspan="1">2023: USD 10.8B CAGR: 28.4% 2029: USD 47.0B</td> </tr> </tbody> </table> </div> </div> </div> <div> <div> <div> <table> <tbody> <tr> <td colspan="1" rowspan="1">Notes</td> <td colspan="1" rowspan="1"> </td> <td colspan="1" rowspan="1"> </td> </tr> <tr> <td colspan="3" rowspan="1">✽ All above clinical trial costs are funded by the U.S. National Cancer Institute (NCI) </td> </tr> <tr> <td colspan="3" rowspan="1">✽ Global market forecasts reference: Data Bridge, BioSpace, IQVIA, BCC Research</td> </tr> <tr> <td colspan="2" rowspan="1">✽ Source: Provided by Senhwa Biosciences</td> <td colspan="1" rowspan="1"> </td> </tr> </tbody> </table> </div> </div> </div> SOURCE Senhwa Biosciences, Inc. <img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjI4Jk5ld3NJdGVtSWQ9SEs1NDA1NCZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMjgyMTI0UFJfTkVXU19VU1BSX19fX19ISzU0MDU0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjI4Jk5ld3NJdGVtSWQ9SEs1NDA1NCZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMjgyMTI0UFJfTkVXU19VU1BSX19fX19ISzU0MDU0"/></div> </div></div>

Senhwa Biosciences announced a major milestone with its investigational drug CX-5461, which will be evaluated in combination with ADC Enhertu® in a Phase 1b clinical trial for HER2-positive solid tumors and breast cancer. Supported by the NCI's NExT program, this positions Senhwa in the fast-growing ADC market, potentially attracting strategic partnerships and enhancing its market valuation.

21:24 ET Senhwa Biosciences Aims at Multi-Billion Dollar Global Market with CX-5461 Combined with ADC "Blockbuster" Therapy