<p><em>下一代非侵入性诊断平台在肝癌以外的实体肿瘤类型中具有潜在应用</em></p>
<p><em>许可协议反映了 Hepion 在新领导下推进临床验证的液体活检测试的战略转变</em></p>
<p>新泽西州莫里斯敦，2026 年 3 月 3 日（全球新闻稿）——Hepion Pharmaceuticals, Inc.（OTCQB:HEPA），一家精准诊断公司，今天宣布已从 Cirna Diagnostics LLC 获得许可，一种新型生物标志物检测方法可检测突变的循环肿瘤 RNA（ctRNA），以促进对高风险患者（肝硬化）早期诊断肝细胞癌（HCC）。大多数肝癌病例（75-90%）为 HCC，而 HCC 是全球第六大常见癌症，其高死亡率与发病率比使其成为全球第三大致命癌症。</p>
<p>在首席执行官（CEO）Kaouthar Lbiati 博士的领导下，此次许可协议推进了 Hepion 的战略演变，并补充了其最近获得的用于早期检测肝癌的甲基化 DNA 测试，即 mSEPT9 PCR 检测。Hepion 的新战略重点是推进临床验证的液体活检测试，以帮助早期诊断和监测 HCC，以及未来可能的其他实体肿瘤类型。为此，Hepion 还获得了潜在扩展 Cirna 的 ctRNA 平台用于其他适应症的权利，随着技术的成熟。HCC 的 ctRNA 许可及扩展权利增强了 Hepion 不断增长的产品线，因为公司正在为其 mSEPT9 PCR 检测的商业化做准备。公司相信这两种检测将满足一个主要的未满足需求，因为当前的 HCC 监测方法漏检高达 75% 的早期癌症。</p>
<p>“我们的诊断测试旨在在高风险患者中早期发现肿瘤，减少晚期诊断的发生，而晚期诊断的预后往往不佳，从而显著提高高风险患者的生存概率，” Hepion 首席执行官 Lbiati 博士表示。“我们通往 ctRNA 平台的监管提交和商业化的路径将为 CLIA 实验室合作伙伴关系提供众多机会，初期为制药伴随诊断的合作，未来则是通过平台生命周期的共同开发/共同商业化协议。我们相信这些机会将提升我们 ctRNA 资产的价值以及更广泛的生物标志物组合，惠及患者和股东。”</p>
<p>“与许多癌症一样，早期发现肝细胞癌是改善患者预后的关键，显然需要非侵入性生物标志物来检测 HCC，” 宾夕法尼亚州生物技术中心（PABC）、巴鲁克·S·布伦伯格研究所（BSBI）及 Cirna Diagnostics 的首席执行官 Louis P. Kassa III 评论道。“我们认为在 Kaouthar Lbiati 博士的领导下，Hepion Pharmaceuticals 是推进我们创新的 ctRNA 液体活检测试的理想许可合作伙伴。”</p>
<p>ctRNA 生物标志物检测是一种基于血液的测试，读取肿瘤释放到循环中的 RNA 信号。它检测血液中的癌症特异性突变 RNA 变体，提供了一种下一代液体活检的方法。与基于 DNA 的方法不同，ctRNA 捕获活跃表达的肿瘤特征，提供更早的检测和更高的特异性，适用于监测和早期检测的使用场景。该平台已在多个独立队列中验证了 HCC，标准化的 RNA 提取和一系列 HCC 特异性变体被整合到一个多参数血液测试中。</p>
<p>ctRNA 平台由 Hepion 董事会成员、肝炎 B 基金会、巴鲁克·S·布伦伯格研究所（BSBI）和宾夕法尼亚生物技术中心的共同创始人 Timothy Block 博士和 Cirna Diagnostics 的首席科学官、BSBI 副教授 Aejaz Sayeed 博士共同发明。</p>
<p>“循环肿瘤 RNA 液体活检提供了更丰富的信号，能够检测到基于 DNA 的测试无法识别的突变和剪接变体，” Sayeed 博士解释道。“我们的 ctRNA 平台还揭示了 ‘黑暗’ 或调控基因组，并突显与癌症相关的新型非编码元素。这是一个增强临床医生为其高风险患者寻求诊断清晰度的信心工具。该平台也是疾病无关的；它在肺癌、乳腺癌、胰腺癌和融合驱动癌症中具有直接应用，并在临床管理的整个过程中，包括监测、治疗监控、预后和治疗选择中具有潜在效用。”</p>
<p>凭借其 ctRNA 和 mSEPT9 诊断检测，Hepion 朝着一个能够实现治疗诊断的方向迈出了下一步，这为商业机会提供了巨大的潜力。全球液体活检市场目前估值为 100 亿美元，并在增长中，仅在美国预计到 2035 年将接近 90 亿美元。</p>
<p><strong>关于 Hepion Pharmaceuticals, Inc.</strong></p>
<p>Hepion Pharmaceuticals（OTCQB: HEPA）正在开创早期癌症检测解决方案，采用新型先进的液体活检诊断。凭借在肝脏生物学方面的深厚专业知识，Hepion 收购了用于精确诊断肝细胞癌（HCC）的互补平台——一种临床验证的甲基化 DNA（SEPT9）生物标志物测试，准备近期商业化，以及一种循环肿瘤 RNA（ctRNA）生物标志物检测，具有在多种实体肿瘤中应用的潜力。Hepion 拥有从临床实验室改进法（CLIA）启动到美国食品药品监督管理局（FDA）批准的清晰路线图和多条合作伙伴路径，旨在改变高风险患者中实体肿瘤的检测和监测方式。有关更多信息，请访问 https://hepionpharma.com 并在 LinkedIn 上关注 Hepion。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿中的某些声明属于 1995 年《私人证券诉讼改革法案》所定义的前瞻性声明。这些声明可能通过使用 “预期”、“相信”、“预测”、“估计” 和 “打算” 等前瞻性词汇来识别。这些前瞻性声明基于 Hepion Pharmaceuticals 当前的预期，实际结果可能会有重大差异。有许多因素可能导致实际事件与这些前瞻性声明所指示的情况存在重大差异。这些因素包括但不限于，激烈的竞争；我们作为持续经营实体的能力；我们对额外融资的需求；专利保护和诉讼的不确定性；与延迟相关的风险；政府或第三方支付者报销的不确定性；有限的销售和市场推广努力以及对第三方的依赖；以及与未能获得 FDA 许可或批准及不遵守 FDA 法规相关的风险。Hepion Pharmaceuticals 没有义务更新或修订任何前瞻性声明。投资者应阅读 Hepion Pharmaceuticals 截至 2024 年 12 月 31 日的 10-K 表格中列出的风险因素，以及向证券交易委员会提交的其他定期报告。</p>
<h3></h3>
<p>媒体联系人：</p>
<p>Reba Auslander</p>
<p>reba@raliancecommunications.com</p>
<p>917-836-9308</p>
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<p>Hepion Pharmaceuticals 已经从 Cirna Diagnostics 引进了一种新型 ctRNA 生物标志物检测，以增强对高风险患者肝细胞癌 (HCC) 的早期诊断。这一战略举措由首席执行官 Dr. Kaouthar Lbiati 领导，符合 Hepion 在推进液体活检测试方面的重点。该 ctRNA 检测能够在血液中检测突变 RNA，旨在提高早期发现率，填补当前 HCC 监测方法中的重大空白。全球液体活检市场预计将显著增长，为 Hepion 的诊断解决方案提供商业机会</p>

<p><em>Next-generation, non-invasive diagnostic platform has potential applications in solid tumor types beyond liver cancer</em></p>
<div class="lb-trans"><p><em>下一代非侵入性诊断平台在肝癌以外的实体肿瘤类型中具有潜在应用</em></p>
</div><p><em>Licensing deal reflects Hepion’s strategic shift to advancing clinically proven liquid biopsy tests under new leadership</em></p>
<div class="lb-trans"><p><em>许可协议反映了 Hepion 在新领导下推进临床验证的液体活检测试的战略转变</em></p>
</div><p>MORRISTOWN, N.J., March 03, 2026 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (OTCQB:HEPA), a precision diagnostics company, today announced that it has in-licensed from Cirna Diagnostics LLC, a novel biomarker assay that detects mutant circulating tumor RNA (ctRNA) to facilitate early diagnosis of hepatocellular carcinoma (HCC) in high-risk patients (cirrhosis). Most cases of liver cancer (75-90%) are HCC, and HCC is the sixth most common cancer worldwide, with a high mortality-to incidence ratio that makes it the third deadliest cancer globally.</p>
<div class="lb-trans"><p>新泽西州莫里斯敦，2026 年 3 月 3 日（全球新闻稿）——Hepion Pharmaceuticals, Inc.（OTCQB:HEPA），一家精准诊断公司，今天宣布已从 Cirna Diagnostics LLC 获得许可，一种新型生物标志物检测方法可检测突变的循环肿瘤 RNA（ctRNA），以促进对高风险患者（肝硬化）早期诊断肝细胞癌（HCC）。大多数肝癌病例（75-90%）为 HCC，而 HCC 是全球第六大常见癌症，其高死亡率与发病率比使其成为全球第三大致命癌症。</p>
</div><p>Driven by the leadership of Chief Executive Officer (CEO) Kaouthar Lbiati, MD, the in-licensing agreement advances Hepion’s strategic evolution and complements its recently acquired methylated DNA test for early detection of liver cancer, the mSEPT9 PCR-based assay. Hepion’s new strategic focus is advancing clinically proven liquid biopsy tests to aid in the early diagnosis and surveillance of HCC and potentially other solid tumor types in the near future, and to this end Hepion has also secured rights to potentially extend Cirna’s ctRNA platform for other indications as the technology matures. The ctRNA license for HCC, and extension rights, augment Hepion’s growing pipeline as the company prepares its mSEPT9 PCR-based assay for commercialization. The Company believes both assays will fulfill a major unmet need, as current HCC surveillance methods miss up to 75% of early-stage cancers.</p>
<div class="lb-trans"><p>在首席执行官（CEO）Kaouthar Lbiati 博士的领导下，此次许可协议推进了 Hepion 的战略演变，并补充了其最近获得的用于早期检测肝癌的甲基化 DNA 测试，即 mSEPT9 PCR 检测。Hepion 的新战略重点是推进临床验证的液体活检测试，以帮助早期诊断和监测 HCC，以及未来可能的其他实体肿瘤类型。为此，Hepion 还获得了潜在扩展 Cirna 的 ctRNA 平台用于其他适应症的权利，随着技术的成熟。HCC 的 ctRNA 许可及扩展权利增强了 Hepion 不断增长的产品线，因为公司正在为其 mSEPT9 PCR 检测的商业化做准备。公司相信这两种检测将满足一个主要的未满足需求，因为当前的 HCC 监测方法漏检高达 75% 的早期癌症。</p>
</div><p>“Our diagnostic tests are designed to catch tumors early in high-risk patients and minimize later-stage diagnoses where prognosis is grim, thereby significantly improving the probability of survival in high-risk patients,” said Dr. Lbiati, Hepion CEO. “Our pathway toward regulatory submission and commercialization of the ctRNA platform will present numerous opportunities for CLIA lab partnerships initially, pharma companion diagnostics collaborations in the midterm, and co-development/co-commercialization agreements through the platform’s lifecycle. We believe these opportunities will enhance the value of our ctRNA asset and the broader portfolio of biomarkers, benefiting both patients and shareholders.”</p>
<div class="lb-trans"><p>“我们的诊断测试旨在在高风险患者中早期发现肿瘤，减少晚期诊断的发生，而晚期诊断的预后往往不佳，从而显著提高高风险患者的生存概率，” Hepion 首席执行官 Lbiati 博士表示。“我们通往 ctRNA 平台的监管提交和商业化的路径将为 CLIA 实验室合作伙伴关系提供众多机会，初期为制药伴随诊断的合作，未来则是通过平台生命周期的共同开发/共同商业化协议。我们相信这些机会将提升我们 ctRNA 资产的价值以及更广泛的生物标志物组合，惠及患者和股东。”</p>
</div><p>“As with many cancers, early detection of hepatocellular carcinoma is key to improving patient outcomes, and there is a clear need for non-invasive biomarkers that detect HCC,” commented Louis P. Kassa III, MPA, Chief Executive Officer of the Hepatitis B Foundation, the Pennsylvania Biotechnology Center (PABC), the Baruch S. Blumberg Institute (BSBI) – which created the assay – and Cirna Diagnostics. “We view Hepion Pharmaceuticals, under the leadership of Dr. Kaouthar Lbiati, as the ideal licensing partner to advance our innovative ctRNA liquid biopsy test.”</p>
<div class="lb-trans"><p>“与许多癌症一样，早期发现肝细胞癌是改善患者预后的关键，显然需要非侵入性生物标志物来检测 HCC，” 宾夕法尼亚州生物技术中心（PABC）、巴鲁克·S·布伦伯格研究所（BSBI）及 Cirna Diagnostics 的首席执行官 Louis P. Kassa III 评论道。“我们认为在 Kaouthar Lbiati 博士的领导下，Hepion Pharmaceuticals 是推进我们创新的 ctRNA 液体活检测试的理想许可合作伙伴。”</p>
</div><p>The ctRNA biomarker assay is a blood-based test that reads the RNA signals shed by tumors into circulation. It detects cancer-specific mutant RNA variants in blood, offering a next-generation approach to liquid biopsy. Unlike DNA-based approaches, ctRNA captures actively expressed tumor signatures, providing earlier detection and improved specificity across both surveillance and early detection use cases. The platform has been validated for HCC across several independent cohorts, with standardized RNA extraction and a repertoire of HCC-specific variants being integrated into a single multiparametric blood test.</p>
<div class="lb-trans"><p>ctRNA 生物标志物检测是一种基于血液的测试，读取肿瘤释放到循环中的 RNA 信号。它检测血液中的癌症特异性突变 RNA 变体，提供了一种下一代液体活检的方法。与基于 DNA 的方法不同，ctRNA 捕获活跃表达的肿瘤特征，提供更早的检测和更高的特异性，适用于监测和早期检测的使用场景。该平台已在多个独立队列中验证了 HCC，标准化的 RNA 提取和一系列 HCC 特异性变体被整合到一个多参数血液测试中。</p>
</div><p>The ctRNA platform was co-invented by Timothy Block, PhD, a member of Hepion’s Board of Directors and co-founder of the Hepatitis B Foundation, Baruch S. Blumberg Institute (BSBI), and Pennsylvania Biotechnology Center, and Aejaz Sayeed, PhD, associate professor at the BSBI and chief scientific officer at Cirna Diagnostics.</p>
<div class="lb-trans"><p>ctRNA 平台由 Hepion 董事会成员、肝炎 B 基金会、巴鲁克·S·布伦伯格研究所（BSBI）和宾夕法尼亚生物技术中心的共同创始人 Timothy Block 博士和 Cirna Diagnostics 的首席科学官、BSBI 副教授 Aejaz Sayeed 博士共同发明。</p>
</div><p>“Circulating tumor RNA liquid biopsy offers a more abundant signal and detects mutations and splicing variants that are invisible to DNA-based tests,” explained Dr. Sayeed. “Our ctRNA platform also sheds light on the ‘dark’ or regulatory genome and highlights novel noncoding elements associated with cancer. It is a confidence-boosting tool for clinicians seeking diagnostic clarity for their at-risk patients. The platform is also disease-agnostic; it has direct applications in lung, breast, pancreatic, and fusion-driven cancers, and potential utility across the full arc of clinical management, encompassing surveillance, treatment monitoring, prognosis, and therapy selection.”</p>
<div class="lb-trans"><p>“循环肿瘤 RNA 液体活检提供了更丰富的信号，能够检测到基于 DNA 的测试无法识别的突变和剪接变体，” Sayeed 博士解释道。“我们的 ctRNA 平台还揭示了 ‘黑暗’ 或调控基因组，并突显与癌症相关的新型非编码元素。这是一个增强临床医生为其高风险患者寻求诊断清晰度的信心工具。该平台也是疾病无关的；它在肺癌、乳腺癌、胰腺癌和融合驱动癌症中具有直接应用，并在临床管理的整个过程中，包括监测、治疗监控、预后和治疗选择中具有潜在效用。”</p>
</div><p>With its ctRNA and mSEPT9 diagnostic assays, Hepion takes the next steps toward a theranostics-enabling approach that presents a tremendous commercial opportunity. The global liquid biopsy market is currently valued at $10 billion and growing, and in the U.S. alone is projected to reach nearly $9 billion by 2035.</p>
<div class="lb-trans"><p>凭借其 ctRNA 和 mSEPT9 诊断检测，Hepion 朝着一个能够实现治疗诊断的方向迈出了下一步，这为商业机会提供了巨大的潜力。全球液体活检市场目前估值为 100 亿美元，并在增长中，仅在美国预计到 2035 年将接近 90 亿美元。</p>
</div><p><strong>About Hepion Pharmaceuticals, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 Hepion Pharmaceuticals, Inc.</strong></p>
</div><p>Hepion Pharmaceuticals (OTCQB: HEPA) is pioneering early cancer detection solutions with novel advanced liquid biopsy diagnostics. Leveraging deep expertise in liver biology, Hepion acquired complementary platforms for precise diagnosis of early hepatocellular carcinoma (HCC) in people with cirrhosis – a clinically validated methylated DNA (SEPT9) biomarker test for near-term commercialization, and a circulating tumor RNA (ctRNA) biomarker assay with potential application across a variety of solid tumors. With a clear roadmap from Clinical Laboratory Improvement Amendments (CLIA) launch to U.S. Food and Drug Administration (FDA) approval and multiple partnership pathways, Hepion is positioned to transform how solid tumors are detected and monitored in high-risk patients. For more information visit https://hepionpharma.com and follow Hepion on LinkedIn.</p>
<div class="lb-trans"><p>Hepion Pharmaceuticals（OTCQB: HEPA）正在开创早期癌症检测解决方案，采用新型先进的液体活检诊断。凭借在肝脏生物学方面的深厚专业知识，Hepion 收购了用于精确诊断肝细胞癌（HCC）的互补平台——一种临床验证的甲基化 DNA（SEPT9）生物标志物测试，准备近期商业化，以及一种循环肿瘤 RNA（ctRNA）生物标志物检测，具有在多种实体肿瘤中应用的潜力。Hepion 拥有从临床实验室改进法（CLIA）启动到美国食品药品监督管理局（FDA）批准的清晰路线图和多条合作伙伴路径，旨在改变高风险患者中实体肿瘤的检测和监测方式。有关更多信息，请访问 https://hepionpharma.com 并在 LinkedIn 上关注 Hepion。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission.</p>
<div class="lb-trans"><p>本新闻稿中的某些声明属于 1995 年《私人证券诉讼改革法案》所定义的前瞻性声明。这些声明可能通过使用 “预期”、“相信”、“预测”、“估计” 和 “打算” 等前瞻性词汇来识别。这些前瞻性声明基于 Hepion Pharmaceuticals 当前的预期，实际结果可能会有重大差异。有许多因素可能导致实际事件与这些前瞻性声明所指示的情况存在重大差异。这些因素包括但不限于，激烈的竞争；我们作为持续经营实体的能力；我们对额外融资的需求；专利保护和诉讼的不确定性；与延迟相关的风险；政府或第三方支付者报销的不确定性；有限的销售和市场推广努力以及对第三方的依赖；以及与未能获得 FDA 许可或批准及不遵守 FDA 法规相关的风险。Hepion Pharmaceuticals 没有义务更新或修订任何前瞻性声明。投资者应阅读 Hepion Pharmaceuticals 截至 2024 年 12 月 31 日的 10-K 表格中列出的风险因素，以及向证券交易委员会提交的其他定期报告。</p>
</div><h3></h3>
<div class="lb-trans"><h3></h3>
</div><p>Media Contact:</p>
<div class="lb-trans"><p>媒体联系人：</p>
</div><p>Reba Auslander</p>
<div class="lb-trans"><p>Reba Auslander</p>
</div><p>reba@raliancecommunications.com</p>
<div class="lb-trans"><p>reba@raliancecommunications.com</p>
</div><p>917-836-9308</p>
<div class="lb-trans"><p>917-836-9308</p>
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