<p>/PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492)，一家临床阶段的生物制药公司，今天宣布启动一项全球多中心临床试验。该公司还向美国食品药品监督管理局（FDA）提交了新药研究申请（IND），标志着 Senhwa 全球临床开发的一个关键里程碑。</p>
<p>该研究将评估 Senhwa 的首创研究药物 Pidnarulex (CX-5461) 与 BeOne Medicines 已上市的 PD-1 抑制剂 tislelizumab 联合使用，适用于多种晚期或转移性实体瘤，包括胰腺癌、结直肠癌和黑色素瘤——这些领域存在显著的未满足医疗需求。全球多中心设计预计将加速临床验证，同时提升资产的可见性，支持未来的外部授权和商业化机会。</p>
<p>该公司旨在利用联合治疗方法进入快速扩张的免疫肿瘤市场，并建立可持续的长期增长动力。</p>
<p>CX-5461 具有独特的双重作用机制。除了抑制核糖体 RNA 合成和抑制肿瘤细胞增殖外，它还稳定 G-四链体结构，诱导 DNA 损伤并激活 cGAS–STING 通路。这一独特机制不仅赋予了直接的抗肿瘤活性，还增强了肿瘤的免疫原性，与免疫检查点抑制剂形成强大的协同作用。前临床和转化研究表明，CX-5461 能够有效重塑肿瘤微环境，增加肿瘤浸润淋巴细胞（TILs），并上调 PD-L1 表达。这些发现表明其有潜力克服耐药性，提高对当前免疫疗法反应有限患者的反应率，使 CX-5461 成为联合免疫治疗策略中的有前景的基础药物。</p>
<p>根据市场研究分析，全球癌症免疫治疗市场在 2025 年超过 1500 亿美元，预计将以两位数的复合年增长率增长，可能在 2035 年超过 3000 亿美元。在这一扩展的市场中，联合治疗已成为制药行业的核心焦点，成为生命周期延长和下一代收入增长的关键驱动力。</p>
<p>与此同时，制药行业正面临来自重磅药物专利到期的压力，推动对具有差异化机制和临床潜力的创新资产的强烈需求。战略性许可和并购活动已成为大型制药公司确保高价值管线资产的主要途径，竞争加剧了早期机会的争夺。</p>
<p>在这种背景下，目前的临床试验预计将成为 CX-5461 的关键验证点。如果疗效和安全性结果积极，该资产有潜力吸引全球制药公司对其进行许可或收购，显著提升其商业前景和整体市场价值。</p>
<p>来源：Senhwa Biosciences, Inc.</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA1Jk5ld3NJdGVtSWQ9SEs1MTI3MiZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDUwMzQwUFJfTkVXU19VU1BSX19fX19ISzUxMjcy?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA1Jk5ld3NJdGVtSWQ9SEs1MTI3MiZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDUwMzQwUFJfTkVXU19VU1BSX19fX19ISzUxMjcy"/></p>

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百济神州

<p>Senhwa Biosciences, Inc. 已启动其研究药物 CX-5461 的全球临床试验，该药物与 tislelizumab 联合使用，针对难以治疗的癌症，如胰腺癌和结直肠癌。该试验旨在验证该药物的疗效和安全性，可能吸引制药公司对其进行许可或收购的兴趣。这项举措是 Senhwa 进入不断增长的免疫肿瘤市场的战略的一部分，该市场预计到 2035 年将超过 3000 亿美元。CX-5461 独特的机制可能增强肿瘤的免疫原性，并改善患者对现有疗法的反应</p>

<p>, /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.</p>
<div class="lb-trans"><p>/PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492)，一家临床阶段的生物制药公司，今天宣布启动一项全球多中心临床试验。该公司还向美国食品药品监督管理局（FDA）提交了新药研究申请（IND），标志着 Senhwa 全球临床开发的一个关键里程碑。</p>
</div><p>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.</p>
<div class="lb-trans"><p>该研究将评估 Senhwa 的首创研究药物 Pidnarulex (CX-5461) 与 BeOne Medicines 已上市的 PD-1 抑制剂 tislelizumab 联合使用，适用于多种晚期或转移性实体瘤，包括胰腺癌、结直肠癌和黑色素瘤——这些领域存在显著的未满足医疗需求。全球多中心设计预计将加速临床验证，同时提升资产的可见性，支持未来的外部授权和商业化机会。</p>
</div><p>The Company aims to leverage combination therapy approaches to enter the rapidly expanding immuno-oncology market and build sustainable long-term growth momentum.</p>
<div class="lb-trans"><p>该公司旨在利用联合治疗方法进入快速扩张的免疫肿瘤市场，并建立可持续的长期增长动力。</p>
</div><p>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 pathway. This unique mechanism not only confers direct anti-tumor activity but also enhances tumor immunogenicity, creating strong synergy with immune checkpoint inhibitors. Preclinical and translational studies have demonstrated that CX-5461 can effectively remodel the tumor microenvironment, increase tumor-infiltrating lymphocytes (TILs), and upregulate PD-L1 expression. These findings suggest its potential to overcome resistance and improve response rates in patients with limited benefit from current immunotherapies, positioning CX-5461 as a promising backbone agent in combination immunotherapy strategies.</p>
<div class="lb-trans"><p>CX-5461 具有独特的双重作用机制。除了抑制核糖体 RNA 合成和抑制肿瘤细胞增殖外，它还稳定 G-四链体结构，诱导 DNA 损伤并激活 cGAS–STING 通路。这一独特机制不仅赋予了直接的抗肿瘤活性，还增强了肿瘤的免疫原性，与免疫检查点抑制剂形成强大的协同作用。前临床和转化研究表明，CX-5461 能够有效重塑肿瘤微环境，增加肿瘤浸润淋巴细胞（TILs），并上调 PD-L1 表达。这些发现表明其有潜力克服耐药性，提高对当前免疫疗法反应有限患者的反应率，使 CX-5461 成为联合免疫治疗策略中的有前景的基础药物。</p>
</div><p>According to market research analyses, the global cancer immunotherapy market exceeded US$150 billion in 2025 and is projected to grow at a double-digit compound annual growth rate, potentially surpassing US$300 billion by 2035. Within this expanding landscape, combination therapies have emerged as a central focus for the pharmaceutical industry, serving as a key driver for lifecycle extension and next-generation revenue growth.</p>
<div class="lb-trans"><p>根据市场研究分析，全球癌症免疫治疗市场在 2025 年超过 1500 亿美元，预计将以两位数的复合年增长率增长，可能在 2035 年超过 3000 亿美元。在这一扩展的市场中，联合治疗已成为制药行业的核心焦点，成为生命周期延长和下一代收入增长的关键驱动力。</p>
</div><p>At the same time, the pharmaceutical sector is facing increasing pressure from patent expirations of blockbuster drugs, driving strong demand for innovative assets with differentiated mechanisms and clinical potential. Strategic licensing and M&amp;A activities have become primary pathways for large pharmaceutical companies to secure high-value pipeline assets, intensifying competition for early-stage opportunities.</p>
<div class="lb-trans"><p>与此同时，制药行业正面临来自重磅药物专利到期的压力，推动对具有差异化机制和临床潜力的创新资产的强烈需求。战略性许可和并购活动已成为大型制药公司确保高价值管线资产的主要途径，竞争加剧了早期机会的争夺。</p>
</div><p>Against this backdrop, the current clinical trial is expected to serve as a critical validation point for CX-5461. Pending positive efficacy and safety outcomes, the asset has the potential to attract strong interest from global pharmaceutical companies for licensing or acquisition, significantly enhancing its commercial prospects and overall market value.</p>
<div class="lb-trans"><p>在这种背景下，目前的临床试验预计将成为 CX-5461 的关键验证点。如果疗效和安全性结果积极，该资产有潜力吸引全球制药公司对其进行许可或收购，显著提升其商业前景和整体市场价值。</p>
</div><p>SOURCE Senhwa Biosciences, Inc.</p>
<div class="lb-trans"><p>来源：Senhwa Biosciences, Inc.</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTA1Jk5ld3NJdGVtSWQ9SEs1MTI3MiZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MDUwMzQwUFJfTkVXU19VU1BSX19fX19ISzUxMjcy" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=HK51272&amp;Transmission_Id=202605050340PR_NEWS_USPR_____HK51272&amp;DateId=20260505"/></p>

03:40 ETSenhwa Biosciences Launches Global Study, Targeting Breakthrough in Hard-to-Treat Cancers with CX-5461 and Tislelizumab Combination

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Senhwa Biosciences 启动全球研究，旨在通过 CX-5461 和 Tislelizumab 的组合在难治癌症中实现突破