<p><em>监管申请标志着公司在 2026 年第二季度全速推进 2/3 期试验启动的重要里程碑</em></p>
<p><em>该申请是在近期成功的毒理学研究、积极的德国监管反馈和强劲的临床前数据支持下提出的，显示出高达 99.7% 的癌细胞抑制率</em></p>
<p><em>计划在 2026 年第一季度提交德国和欧盟的监管文件，预计在安全运行后扩展到美国</em></p>
<p>开曼群岛大开曼，2025 年 12 月 16 日（GLOBE NEWSWIRE）—— Silexion Therapeutics 是一家临床阶段的生物技术公司，致力于推进基于 RNA 的肿瘤治疗，今天宣布在以色列启动其监管申请，计划进行 SIL204 在局部晚期胰腺癌（LAPC）患者中的 2/3 期临床试验，基于德国联邦药品和医疗器械研究所（BfArM）收到的积极科学建议反馈。</p>
<p>该申请代表了公司临床开发计划中的一个关键监管里程碑，并推动 Silexion 朝着在 2026 年第二季度启动 SIL204 的人体试验迈进。该申请还得到了最近完成的两项物种毒理学研究的支持，确认没有系统性器官毒性。Silexion 计划在 2026 年第一季度向德国和欧盟提交监管申请，预计在以色列和德国完成安全运行后扩展到美国临床站点。</p>
<p>以色列的申请是在与 Sheba 医疗中心合作进行的，该中心在《新闻周刊》评选的全球前十医院中名列前茅，公司计划在该中心进行其计划的 2/3 期临床试验的以色列部分，需遵循适用的监管和伦理批准。</p>
<p>Silexion 的董事长兼首席执行官 Ilan Hadar 评论道：“向 Sheba 医疗中心提交启动以色列人体研究的监管请求，代表了 Silexion 的重要时刻，并标志着我们认为 SIL204 从临床前开发转向高级临床试验。之前的临床前数据已显示在多种 KRAS 突变和癌症类型中高达 99.7% 的抑制率，德国当局的积极反馈，以及完成的安全包，我们相信 SIL204 在解决局部晚期胰腺癌这一治疗选择有限且生存结果不佳的关键未满足需求方面处于良好位置。该申请标志着我们 2025 年的最后一个里程碑，我为我们团队在这一变革性年份中的卓越执行感到自豪。我们期待在 2026 年第二季度启动 2/3 期试验。”</p>
<p>SIL204 是 Silexion 的下一代 siRNA 疗法，旨在在癌症驱动蛋白表达之前，沉默突变的 KRAS 癌基因——人类癌症中最常见的致癌驱动因子。计划中的 2/3 期试验将评估公司的创新双途径给药策略，结合肿瘤内给药以针对原发肿瘤和系统性给药以应对转移性疾病。</p>
<p><strong>关于 Silexion Therapeutics</strong> Silexion Therapeutics 是一家开创性的临床阶段、专注于肿瘤学的生物技术公司，致力于开发针对具有突变 KRAS 癌基因的治疗效果不佳的实体肿瘤癌症的创新疗法，该基因通常被认为是人类癌症中最常见的致癌基因驱动因子。公司在其第一代产品中进行了 2a 期临床试验，显示出与单纯化疗对照相比的积极趋势。Silexion 致力于推动肿瘤学领域治疗进展的边界，并进一步开发其针对局部晚期胰腺癌的领先产品候选药物。有关更多信息，请访问：https://silexion.com</p>
<p><strong>关于前瞻性声明的通知：</strong> 本新闻稿包含根据联邦证券法定义的前瞻性声明。除历史事实陈述外，本通讯中包含的所有陈述，包括关于以色列、德国和欧盟的监管提交流程的启动、进展和时间安排；计划于 2026 年第二季度启动和进行 SIL204 的 2/3 期临床试验；在安全运行后计划将临床开发扩展到其他司法管辖区；以及基于临床前数据的 SIL204 的潜在治疗特征和临床效用，均为前瞻性声明。这些前瞻性声明通常通过术语如 “可能”、“应该”、“可以”、“或许”、“计划”、“可能的”、“项目”、“努力”、“预算”、“预测”、“期望”、“打算”、“将”、“估计”、“预期”、“相信”、“预测”、“潜在” 或 “继续”，或这些术语的否定形式或变体或类似术语来识别。前瞻性声明涉及多种风险、不确定性和假设，实际结果或事件可能与这些声明中预测或暗示的结果有实质性差异。可能导致这些差异的重要因素包括但不限于：(i) Silexion 成功完成临床前研究和启动临床试验的能力；(ii) Silexion 的战略、未来运营、财务状况、预计成本、前景和计划；(iii) 监管环境和合规复杂性的影响；(iv) 关于未来与第三方的合作或其他关系的预期；(v) Silexion 未来的资本需求及现金的来源和使用，包括其获得额外资本的能力；(vi) Silexion 维持其纳斯达克上市的能力；以及 (vii) 公司向 SEC 提交的文件中列出的其他风险和不确定性，包括公司于 2025 年 3 月 18 日向 SEC 提交的截至 2024 年 12 月 31 日的年度报告（Form 10-K）。Silexion 提醒您不要对前瞻性声明过度依赖，这些声明反映了当前的信念，并基于截至前瞻性声明发布之日可用的信息。此处列出的前瞻性声明仅在作出之日有效。Silexion 没有义务修订前瞻性声明以反映未来事件、情况变化或信念变化，除非法律另有要求。</p>
<p><strong>公司联系方式：</strong> Silexion Therapeutics Corp，Mirit Horenshtein Hadar，首席财务官，mirit@silexion.com</p>
<p><strong>投资者联系方式：</strong> Arx Investor Relations</p>
<p>北美股票交易部</p>
<p>silexion@arxhq.com</p>
<hr/>
<p>1 https://www.shebaonline.org/sheba-ranks-8-on-newsweeks-best-hospitals-list/</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9TVRBd01URTBOVEU1TkNNME1ESXlPRFF4T0RNak1qSTVOalkzTWc9PQ?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://www.globenewswire.com/newsroom/ti/query-bmY9TVRBd01URTBOVEU1TkNNME1ESXlPRFF4T0RNak1qSTVOalkzTWc9PQ"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml-eu.globenewswire.com/media/NzUxMjA1OTctZTQzNy00NGQ3LWFiMmMtNWQxNTIzYTNhN2M5LTEzMDgyMjItMjAyNS0xMi0xNi1lbg==/tiny/Silexion-Therapeutics-Corp.png?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://ml-eu.globenewswire.com/media/NzUxMjA1OTctZTQzNy00NGQ3LWFiMmMtNWQxNTIzYTNhN2M5LTEzMDgyMjItMjAyNS0xMi0xNi1lbg==/tiny/Silexion-Therapeutics-Corp.png"/></p>

SLXN

<p>Silexion Therapeutics 已在以色列提交了 SIL204 的 2/3 期临床试验申请，目标是局部晚期胰腺癌。这标志着在成功的毒理学研究和德国监管机构的积极反馈之后的一个关键里程碑。试验计划于 2026 年第二季度开始，并计划在德国和欧盟进行进一步的监管申请。该申请与谢巴医疗中心合作，并预计在安全性试验后扩展至美国。SIL204 旨在沉默突变的 KRAS 癌基因，满足胰腺癌治疗中的未满足需求</p>

<p><em>Regulatory submission marks a significant milestone as the Company advances toward Phase 2/3 trial initiation in Q2 2026 at full speed</em></p>
<div class="lb-trans"><p><em>监管申请标志着公司在 2026 年第二季度全速推进 2/3 期试验启动的重要里程碑</em></p>
</div><p><em>Application follows recent successful toxicology studies, positive German regulatory feedback, and strong preclinical data demonstrating up to 99.7% cancer cell inhibition</em></p>
<div class="lb-trans"><p><em>该申请是在近期成功的毒理学研究、积极的德国监管反馈和强劲的临床前数据支持下提出的，显示出高达 99.7% 的癌细胞抑制率</em></p>
</div><p><em>Regulatory filings in Germany and the EU are planned for Q1 2026, with U.S. expansion anticipated following the safety run-in</em></p>
<div class="lb-trans"><p><em>计划在 2026 年第一季度提交德国和欧盟的监管文件，预计在安全运行后扩展到美国</em></p>
</div><p>Grand Cayman, Cayman Islands, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics, a clinical-stage biotechnology company advancing RNA-based therapies for oncology, today announced the initiation of its regulatory application in Israel for its planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer (LAPC), based on the positive Scientific Advice response received from the German Federal Institute for Drugs and Medical Devices (BfArM).</p>
<div class="lb-trans"><p>开曼群岛大开曼，2025 年 12 月 16 日（GLOBE NEWSWIRE）—— Silexion Therapeutics 是一家临床阶段的生物技术公司，致力于推进基于 RNA 的肿瘤治疗，今天宣布在以色列启动其监管申请，计划进行 SIL204 在局部晚期胰腺癌（LAPC）患者中的 2/3 期临床试验，基于德国联邦药品和医疗器械研究所（BfArM）收到的积极科学建议反馈。</p>
</div><p>The submission represents a key regulatory milestone in the Company's clinical development program and advances Silexion toward initiating human trials with SIL204, which are planned for the second quarter of 2026. The application is further supported by two recently completed species toxicology studies confirming no systemic organ toxicity. Silexion plans to file regulatory applications in Germany and the European Union in the first quarter of 2026, with expansion to U.S. clinical sites anticipated following completion of the safety run-in in Israel and Germany.</p>
<div class="lb-trans"><p>该申请代表了公司临床开发计划中的一个关键监管里程碑，并推动 Silexion 朝着在 2026 年第二季度启动 SIL204 的人体试验迈进。该申请还得到了最近完成的两项物种毒理学研究的支持，确认没有系统性器官毒性。Silexion 计划在 2026 年第一季度向德国和欧盟提交监管申请，预计在以色列和德国完成安全运行后扩展到美国临床站点。</p>
</div><p>The submissions in Israel are being conducted in collaboration with Sheba Medical Center, ranked among the top ten hospitals worldwide by Newsweek1, where the Company plans to conduct the Israeli portion of its planned Phase 2/3 clinical trial, subject to applicable regulatory and ethics approvals.</p>
<div class="lb-trans"><p>以色列的申请是在与 Sheba 医疗中心合作进行的，该中心在《新闻周刊》评选的全球前十医院中名列前茅，公司计划在该中心进行其计划的 2/3 期临床试验的以色列部分，需遵循适用的监管和伦理批准。</p>
</div><p>Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: &#34;The submission of the regulatory request to initiate the human studies in Israel with Sheba Medical Center represents an important moment for Silexion and marks what we see as the transition of SIL204 from preclinical development into advanced clinical trials. With preclinical data having previously demonstrated up to 99.7% inhibition across multiple KRAS mutations and cancer types, positive response feedback from German authorities, and a completed safety package, we believe SIL204 is well-positioned to address the critical unmet need in locally advanced pancreatic cancer - a disease with limited treatment options and poor survival outcomes. This submission marks our final milestone for 2025, and I am proud of our team's exceptional execution throughout this transformative year. We look forward to initiating the Phase 2/3 trial in the second quarter of 2026.&#34;</p>
<div class="lb-trans"><p>Silexion 的董事长兼首席执行官 Ilan Hadar 评论道：“向 Sheba 医疗中心提交启动以色列人体研究的监管请求，代表了 Silexion 的重要时刻，并标志着我们认为 SIL204 从临床前开发转向高级临床试验。之前的临床前数据已显示在多种 KRAS 突变和癌症类型中高达 99.7% 的抑制率，德国当局的积极反馈，以及完成的安全包，我们相信 SIL204 在解决局部晚期胰腺癌这一治疗选择有限且生存结果不佳的关键未满足需求方面处于良好位置。该申请标志着我们 2025 年的最后一个里程碑，我为我们团队在这一变革性年份中的卓越执行感到自豪。我们期待在 2026 年第二季度启动 2/3 期试验。”</p>
</div><p>SIL204 is Silexion's next-generation siRNA therapy designed to silence mutated KRAS oncogenes - the most common oncogenic driver in human cancers - before cancer-driving proteins are expressed. The planned Phase 2/3 trial will evaluate the Company's innovative dual-route administration strategy, combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease.</p>
<div class="lb-trans"><p>SIL204 是 Silexion 的下一代 siRNA 疗法，旨在在癌症驱动蛋白表达之前，沉默突变的 KRAS 癌基因——人类癌症中最常见的致癌驱动因子。计划中的 2/3 期试验将评估公司的创新双途径给药策略，结合肿瘤内给药以针对原发肿瘤和系统性给药以应对转移性疾病。</p>
</div><p><strong>About Silexion Therapeutics</strong> Silexion Therapeutics is a pioneering clinical stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer. For more information please visit: https://silexion.com</p>
<div class="lb-trans"><p><strong>关于 Silexion Therapeutics</strong> Silexion Therapeutics 是一家开创性的临床阶段、专注于肿瘤学的生物技术公司，致力于开发针对具有突变 KRAS 癌基因的治疗效果不佳的实体肿瘤癌症的创新疗法，该基因通常被认为是人类癌症中最常见的致癌基因驱动因子。公司在其第一代产品中进行了 2a 期临床试验，显示出与单纯化疗对照相比的积极趋势。Silexion 致力于推动肿瘤学领域治疗进展的边界，并进一步开发其针对局部晚期胰腺癌的领先产品候选药物。有关更多信息，请访问：https://silexion.com</p>
</div><p><strong>Notice Regarding Forward-Looking Statements:</strong> This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including statements regarding the initiation, progress, and timing of regulatory submission processes in Israel, Germany, and the European Union; the planned initiation and conduct of the Phase 2/3 clinical trial of SIL204 in the second quarter of 2026; the planned expansion of clinical development to additional jurisdictions following completion of a safety run-in; and the potential therapeutic profile and clinical utility of SIL204 based on preclinical data, are forward-looking statements. These forward-looking statements are generally identified by terminology such as &#34;may&#34;, &#34;should&#34;, &#34;could&#34;, &#34;might&#34;, &#34;plan&#34;, &#34;possible&#34;, &#34;project&#34;, &#34;strive&#34;, &#34;budget&#34;, &#34;forecast&#34;, &#34;expect&#34;, &#34;intend&#34;, &#34;will&#34;, &#34;estimate&#34;, &#34;anticipate&#34;, &#34;believe&#34;, &#34;predict&#34;, &#34;potential&#34; or &#34;continue&#34;, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion's ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) Silexion's ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 18, 2025. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.</p>
<div class="lb-trans"><p><strong>关于前瞻性声明的通知：</strong> 本新闻稿包含根据联邦证券法定义的前瞻性声明。除历史事实陈述外，本通讯中包含的所有陈述，包括关于以色列、德国和欧盟的监管提交流程的启动、进展和时间安排；计划于 2026 年第二季度启动和进行 SIL204 的 2/3 期临床试验；在安全运行后计划将临床开发扩展到其他司法管辖区；以及基于临床前数据的 SIL204 的潜在治疗特征和临床效用，均为前瞻性声明。这些前瞻性声明通常通过术语如 “可能”、“应该”、“可以”、“或许”、“计划”、“可能的”、“项目”、“努力”、“预算”、“预测”、“期望”、“打算”、“将”、“估计”、“预期”、“相信”、“预测”、“潜在” 或 “继续”，或这些术语的否定形式或变体或类似术语来识别。前瞻性声明涉及多种风险、不确定性和假设，实际结果或事件可能与这些声明中预测或暗示的结果有实质性差异。可能导致这些差异的重要因素包括但不限于：(i) Silexion 成功完成临床前研究和启动临床试验的能力；(ii) Silexion 的战略、未来运营、财务状况、预计成本、前景和计划；(iii) 监管环境和合规复杂性的影响；(iv) 关于未来与第三方的合作或其他关系的预期；(v) Silexion 未来的资本需求及现金的来源和使用，包括其获得额外资本的能力；(vi) Silexion 维持其纳斯达克上市的能力；以及 (vii) 公司向 SEC 提交的文件中列出的其他风险和不确定性，包括公司于 2025 年 3 月 18 日向 SEC 提交的截至 2024 年 12 月 31 日的年度报告（Form 10-K）。Silexion 提醒您不要对前瞻性声明过度依赖，这些声明反映了当前的信念，并基于截至前瞻性声明发布之日可用的信息。此处列出的前瞻性声明仅在作出之日有效。Silexion 没有义务修订前瞻性声明以反映未来事件、情况变化或信念变化，除非法律另有要求。</p>
</div><p><strong>Company Contact:</strong> Silexion Therapeutics CorpMs. Mirit Horenshtein Hadar, CFOmirit@silexion.com</p>
<div class="lb-trans"><p><strong>公司联系方式：</strong> Silexion Therapeutics Corp，Mirit Horenshtein Hadar，首席财务官，mirit@silexion.com</p>
</div><p><strong>Investor Contact:</strong> Arx Investor Relations</p>
<div class="lb-trans"><p><strong>投资者联系方式：</strong> Arx Investor Relations</p>
</div><p>North American Equities Desk</p>
<div class="lb-trans"><p>北美股票交易部</p>
</div><p>silexion@arxhq.com</p>
<div class="lb-trans"><p>silexion@arxhq.com</p>
</div><hr/>
<div class="lb-trans"><hr/>
</div><p>1 https://www.shebaonline.org/sheba-ranks-8-on-newsweeks-best-hospitals-list/</p>
<div class="lb-trans"><p>1 https://www.shebaonline.org/sheba-ranks-8-on-newsweeks-best-hospitals-list/</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9TVRBd01URTBOVEU1TkNNME1ESXlPRFF4T0RNak1qSTVOalkzTWc9PQ" alt="" original-src="https://www.globenewswire.com/newsroom/ti?nf=MTAwMTE0NTE5NCM0MDIyODQxODMjMjI5NjY3Mg=="/></p>
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Silexion Therapeutics Announces Submission of Phase 2/3 Clinical Trial Application to Israel for SIL204 in Locally Advanced Pancreatic Cancer | SLXN Stock News

Silexion Therapeutics 宣布已向以色列提交 SIL204 用于局部晚期胰腺癌的 2/3 期临床试验申请 | SLXN 股票新闻