<p><strong>由中国医科大学附属医院和永盛生物科技共同开发，该平台在多个模型中展示了令人信服的临床前肿瘤清除效果</strong></p>
<p>, /PRNewswire/ -- 癌症长期以来一直是台湾主要死亡原因之一，而实体肿瘤占全球癌症病例的 90% 以上——使其成为 CAR-T 细胞治疗最具挑战性的前沿。中国医科大学附属医院（CMUH）今天宣布，与永盛生物科技合作，成功开发了全球首个 EXO 001 靶向外泌体平台，这是一项突破性技术，能够直接在体内对 T 细胞进行编程，以生成多靶点纳米抗体基础的 CAR-T 细胞。</p>
<p>继续阅读</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null?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.prnewswire.com/news-releases/null"/></p>
<p>EXO 001 体内 CAR-T：全球首个靶向外泌体平台实现多靶点 CAR-T 细胞的体内生成。中国医科大学附属医院和永盛生物科技报告在特定动物模型中完全消除肿瘤。患有实体肿瘤的患者——包括肺癌、胰腺癌、结直肠癌和恶性脑癌——可能会受益。</p>
<p>在多个实体肿瘤动物模型中，EXO 001 展示了显著的治疗效果，包括在特定案例中完全消除肿瘤，为晚期实体恶性肿瘤患者提供了一种全新的治疗策略。</p>
<p><strong>体内免疫编程克服了传统 CAR-T 治疗的局限性</strong></p>
<p>根据 CMUH 院长 Dr. Der-Yang Cho 的说法，目前自体和异体 CAR-T 治疗都依赖于复杂且耗时的体外细胞制造过程。对于快速进展的实体肿瘤患者，这些方法往往太慢，无法满足临床需求，并受到免疫排斥、制造失败和高成本的限制。</p>
<p>EXO 001 的核心创新在于将外泌体重新定位为体内免疫编程的载体，代表了目前正在临床评估的 CAR001 平台的先进演变。</p>
<p>在静脉注射后，EXO 001 通过脾脏等关键免疫器官循环，精确地将 Nb-CAR.BiTE 基因递送到 CD3 阳性 T 细胞。这使得在患者体内直接进行基因编程，将原生 T 细胞转化为能够渗透实体肿瘤、杀死癌细胞并拆解免疫抑制肿瘤微环境的多靶点 CAR-T 细胞。</p>
<p>这种设计使免疫细胞能够 “在体内训练并立即部署”，结合了自体 CAR-T 治疗的免疫兼容性与通常与异体方法相关的现货可用性和可扩展性——这是 EXO 001 在对抗实体肿瘤时有效性的一个重要因素。</p>
<p>令人信服的动物数据</p>
<p><strong>令人信服的临床前结果：肿瘤清除和延长生存</strong></p>
<p>Cho 博士指出，在结直肠癌、胰腺癌、恶性脑肿瘤和卵巢癌的小鼠模型中，静脉注射 EXO 001 成功在体内生成 CAR-T 细胞。这些细胞有效渗透肿瘤微环境，显著抑制肿瘤生长，并将生存期延长两到三倍。在某些动物中，肿瘤被完全消除，且长期无复发。</p>
<p>通过使用外泌体作为基因和药物递送载体，EXO 001 相比于病毒载体或合成脂质材料实现了更高的生物相容性和安全性。这种方法降低了免疫原性，最小化了细胞因子风暴和抗药物抗体形成的风险，并降低了整体免疫相关风险。</p>
<p><strong>具有明确临床和产业优势的平台</strong></p>
<p>永盛生物科技总经理黄文良强调，EXO 001 不仅提供学术创新，还具有强大的转化和商业化潜力，包括：</p>
<ol>
<li>单细胞系来源，质量稳定</li>
</ol>
<p>来自单一工程细胞系的外泌体最小化了供体变异性，并支持标准化生产和质量控制。
2. 符合国际标准的可扩展制造</p>
<p>生产可以在完全封闭的自动化系统中进行，符合美国 FDA 对细胞治疗的规定。
3. 现货准备</p>
<p>消除了对患者或供体特定的体外细胞培养的需求，使得对快速进展的实体肿瘤能够及时干预。
4. 成本优势和改善的可及性</p>
<p>相比于传统自体 CAR-T 制造，显著降低了整体生产成本。
5. 平台可扩展性</p>
<p>除了实体肿瘤，该平台还可以适应携带不同的 CAR 基因、核酸或小分子药物，支持多种治疗适应症。
6. 长期抗肿瘤免疫的潜力</p>
<p>动物研究表明诱导的 CAR-T 细胞具有免疫记忆特征，暗示更持久的抗癌效果。</p>
<p><strong>全球体内 CAR-T 开发的势头</strong></p>
<p>近年来，体内 CAR-T 已成为全球制药领导者的重点关注领域。吉利德科学（Kite）、阿斯利康、百时美施贵宝和艾伯维等公司积极投资于病毒载体、脂质纳米颗粒和基于纳米载体的免疫编程技术，以克服传统 CAR-T 治疗在实体肿瘤中的局限性。</p>
<p>在这一全球背景下，由 CMUH 和永盛生物科技共同开发的 EXO 001 靶向外泌体平台因其使用高生物相容性、天然来源的外泌体而脱颖而出，提供了一种差异化且具有国际竞争力的方法。</p>
<p><strong>迈向临床转化的下一步</strong></p>
<p>这项研究已被国际知名期刊《先进科学》接受发表（2026 年 1 月），并在美国及其他国家获得专利，完成了技术转让。目前正在进行制造开发和临床试验准备，预计明年将开展首个人体试验，目标患者为结直肠癌、胰腺癌、恶性脑肿瘤和卵巢癌患者。</p>
<p>EXO 001 平台代表了实体肿瘤免疫疗法的新视野，是为晚期癌症患者迈出的有希望的一步。</p>
<p>来源：中国医科大学附属医院</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjEzJk5ld3NJdGVtSWQ9SEs4NzczMCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMTMwMjI4UFJfTkVXU19VU1BSX19fX19ISzg3NzMw?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-RGF0ZUlkPTIwMjYwMjEzJk5ld3NJdGVtSWQ9SEs4NzczMCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMTMwMjI4UFJfTkVXU19VU1BSX19fX19ISzg3NzMw"/></p>

神州细胞

上海细胞治疗集团股份有限公司

<p>中国医科大学附属医院与永盛生物科技共同开发了全球首个 EXO 001 外泌体平台，使得在体内进行多靶点 CAR-T 细胞治疗实体肿瘤成为可能。这项突破性技术在前临床试验中显示出显著的疗效，包括在结直肠癌、胰腺癌和恶性脑肿瘤的动物模型中实现完全肿瘤消除。EXO 001 允许在体内直接对 T 细胞进行基因编程，克服了传统 CAR-T 疗法的局限性。该平台具有可扩展的生产能力、降低成本和潜在的长期抗肿瘤免疫等优势，使其在全球 CAR-T 领域中具备竞争力</p>

<p><strong>Jointly developed by China Medical University Hospital and Ever Supreme Bio Technology, the platform demonstrates compelling preclinical tumor clearance across multiple models</strong></p>
<div class="lb-trans"><p><strong>由中国医科大学附属医院和永盛生物科技共同开发，该平台在多个模型中展示了令人信服的临床前肿瘤清除效果</strong></p>
</div><p>, /PRNewswire/ -- Cancer has long ranked among the leading causes of death in Taiwan, and solid tumors account for more than 90% of cancer cases worldwide—making them the most challenging frontier for CAR-T cell therapy. China Medical University Hospital (CMUH) announced today that, in collaboration with Ever Supreme Bio Technology, it has successfully developed the world's first EXO 001 targeted exosome platform, a breakthrough technology that enables direct in vivo programming of T cells to generate multi-target nanobody-based CAR-T cells.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- 癌症长期以来一直是台湾主要死亡原因之一，而实体肿瘤占全球癌症病例的 90% 以上——使其成为 CAR-T 细胞治疗最具挑战性的前沿。中国医科大学附属医院（CMUH）今天宣布，与永盛生物科技合作，成功开发了全球首个 EXO 001 靶向外泌体平台，这是一项突破性技术，能够直接在体内对 T 细胞进行编程，以生成多靶点纳米抗体基础的 CAR-T 细胞。</p>
</div><p>Continue Reading</p>
<div class="lb-trans"><p>继续阅读</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null" alt="" original-src="https://www.prnewswire.com/news-releases/null"/></p>
<p>EXO 001 In Vivo CAR-T: World-First Targeted Exosome Platform Enables In Vivo Generation of Multi-Target CAR-T Cells. China Medical University Hospital and Ever Supreme Bio Technology Report Complete Tumor Elimination in Select Animal Models. Patients with Solid Tumors—including Lung, Pancreatic, Colorectal, and Malignant Brain Cancers—May Benefit.</p>
<div class="lb-trans"><p>EXO 001 体内 CAR-T：全球首个靶向外泌体平台实现多靶点 CAR-T 细胞的体内生成。中国医科大学附属医院和永盛生物科技报告在特定动物模型中完全消除肿瘤。患有实体肿瘤的患者——包括肺癌、胰腺癌、结直肠癌和恶性脑癌——可能会受益。</p>
</div><p>In multiple solid tumor animal models, EXO 001 demonstrated significant therapeutic efficacy, including complete tumor eradication in select cases, offering a fundamentally new treatment strategy for patients with advanced solid malignancies.</p>
<div class="lb-trans"><p>在多个实体肿瘤动物模型中，EXO 001 展示了显著的治疗效果，包括在特定案例中完全消除肿瘤，为晚期实体恶性肿瘤患者提供了一种全新的治疗策略。</p>
</div><p><strong>In Vivo Immune Programming Overcomes the Limitations of Conventional CAR-T Therapy</strong></p>
<div class="lb-trans"><p><strong>体内免疫编程克服了传统 CAR-T 治疗的局限性</strong></p>
</div><p>According to CMUH Superintendent Dr. Der-Yang Cho, both autologous and allogeneic CAR-T therapies currently rely on complex and time-consuming ex vivo cell manufacturing processes. For patients with rapidly progressing solid tumors, these approaches are often too slow to meet clinical needs and remain constrained by immune rejection, manufacturing failure, and high costs.</p>
<div class="lb-trans"><p>根据 CMUH 院长 Dr. Der-Yang Cho 的说法，目前自体和异体 CAR-T 治疗都依赖于复杂且耗时的体外细胞制造过程。对于快速进展的实体肿瘤患者，这些方法往往太慢，无法满足临床需求，并受到免疫排斥、制造失败和高成本的限制。</p>
</div><p>The core innovation of EXO 001 lies in repositioning exosomes as carriers for in vivo immune programming, representing an advanced evolution of the CAR001 platform currently under clinical evaluation.</p>
<div class="lb-trans"><p>EXO 001 的核心创新在于将外泌体重新定位为体内免疫编程的载体，代表了目前正在临床评估的 CAR001 平台的先进演变。</p>
</div><p>Following intravenous administration, EXO 001 circulates through key immune organs such as the spleen, where it precisely delivers Nb-CAR.BiTE genes to CD3-positive T cells. This enables direct genetic programming within the patient's body, converting native T cells into multi-target CAR-T cells capable of infiltrating solid tumors, killing cancer cells, and dismantling the immunosuppressive tumor microenvironment.</p>
<div class="lb-trans"><p>在静脉注射后，EXO 001 通过脾脏等关键免疫器官循环，精确地将 Nb-CAR.BiTE 基因递送到 CD3 阳性 T 细胞。这使得在患者体内直接进行基因编程，将原生 T 细胞转化为能够渗透实体肿瘤、杀死癌细胞并拆解免疫抑制肿瘤微环境的多靶点 CAR-T 细胞。</p>
</div><p>This design enables immune cells to be &#34;trained in vivo and deployed immediately,&#34; combining the immune compatibility of autologous CAR-T therapy with the off-the-shelf availability and scalability typically associated with allogeneic approaches—an essential factor in EXO 001's effectiveness against solid tumors.</p>
<div class="lb-trans"><p>这种设计使免疫细胞能够 “在体内训练并立即部署”，结合了自体 CAR-T 治疗的免疫兼容性与通常与异体方法相关的现货可用性和可扩展性——这是 EXO 001 在对抗实体肿瘤时有效性的一个重要因素。</p>
</div><p>Compelling Animal Data</p>
<div class="lb-trans"><p>令人信服的动物数据</p>
</div><p><strong>Compelling Preclinical Results: Tumor Clearance and Extended Survival</strong></p>
<div class="lb-trans"><p><strong>令人信服的临床前结果：肿瘤清除和延长生存</strong></p>
</div><p>Dr. Cho noted that in mouse models of colorectal cancer, pancreatic cancer, malignant brain tumors, and ovarian cancer, intravenous administration of EXO 001 successfully generated CAR-T cells in vivo. These cells effectively penetrated the tumor microenvironment, significantly inhibited tumor growth, and extended survival by two- to three-fold. In some animals, tumors were completely eliminated with long-term, recurrence-free outcomes.</p>
<div class="lb-trans"><p>Cho 博士指出，在结直肠癌、胰腺癌、恶性脑肿瘤和卵巢癌的小鼠模型中，静脉注射 EXO 001 成功在体内生成 CAR-T 细胞。这些细胞有效渗透肿瘤微环境，显著抑制肿瘤生长，并将生存期延长两到三倍。在某些动物中，肿瘤被完全消除，且长期无复发。</p>
</div><p>By using exosomes as a gene and drug delivery vehicle, EXO 001 achieves higher biocompatibility and safety compared with viral vectors or synthetic lipid materials. This approach reduces immunogenicity, minimizes the risk of cytokine storm and anti-drug antibody formation, and lowers overall immune-related risks.</p>
<div class="lb-trans"><p>通过使用外泌体作为基因和药物递送载体，EXO 001 相比于病毒载体或合成脂质材料实现了更高的生物相容性和安全性。这种方法降低了免疫原性，最小化了细胞因子风暴和抗药物抗体形成的风险，并降低了整体免疫相关风险。</p>
</div><p><strong>A Platform with Clear Clinical and Industrial Advantages</strong></p>
<div class="lb-trans"><p><strong>具有明确临床和产业优势的平台</strong></p>
</div><p>Wen-Liang Huang, General Manager of Ever Supreme Bio Technology, emphasized that EXO 001 offers not only academic innovation but also strong translational and commercialization potential, including:</p>
<div class="lb-trans"><p>永盛生物科技总经理黄文良强调，EXO 001 不仅提供学术创新，还具有强大的转化和商业化潜力，包括：</p>
</div><ol>
<li>Single-cell-line sourcing with stable quality</li>
</ol>
<div class="lb-trans"><ol>
<li>单细胞系来源，质量稳定</li>
</ol>
</div><p>Exosomes derived from a single engineered cell line minimize donor variability and support standardized production and quality control.
2. Scalable manufacturing aligned with international standards</p>
<div class="lb-trans"><p>来自单一工程细胞系的外泌体最小化了供体变异性，并支持标准化生产和质量控制。
2. 符合国际标准的可扩展制造</p>
</div><p>Production can be carried out in fully closed, automated systems compliant with U.S. FDA regulations for cell-based therapies.
3. Off-the-shelf readiness</p>
<div class="lb-trans"><p>生产可以在完全封闭的自动化系统中进行，符合美国 FDA 对细胞治疗的规定。
3. 现货准备</p>
</div><p>Eliminates the need for patient- or donor-specific ex vivo cell cultivation, enabling timely intervention for rapidly progressing solid tumors.
4. Cost advantages and improved accessibility</p>
<div class="lb-trans"><p>消除了对患者或供体特定的体外细胞培养的需求，使得对快速进展的实体肿瘤能够及时干预。
4. 成本优势和改善的可及性</p>
</div><p>Significantly reduces overall production costs compared with traditional autologous CAR-T manufacturing.
5. Platform extensibility</p>
<div class="lb-trans"><p>相比于传统自体 CAR-T 制造，显著降低了整体生产成本。
5. 平台可扩展性</p>
</div><p>Beyond solid tumors, the platform can be adapted to carry different CAR genes, nucleic acids, or small-molecule drugs, supporting multiple therapeutic indications.
6. Potential for long-term anti-tumor immunity</p>
<div class="lb-trans"><p>除了实体肿瘤，该平台还可以适应携带不同的 CAR 基因、核酸或小分子药物，支持多种治疗适应症。
6. 长期抗肿瘤免疫的潜力</p>
</div><p>Animal studies indicate the induction of CAR-T cells with immune memory characteristics, suggesting more durable anti-cancer effects.</p>
<div class="lb-trans"><p>动物研究表明诱导的 CAR-T 细胞具有免疫记忆特征，暗示更持久的抗癌效果。</p>
</div><p><strong>Global Momentum in In Vivo CAR-T Development</strong></p>
<div class="lb-trans"><p><strong>全球体内 CAR-T 开发的势头</strong></p>
</div><p>In recent years, in vivo CAR-T has emerged as a key focus for global pharmaceutical leaders. Companies such as Gilead Sciences (Kite), AstraZeneca, Bristol Myers Squibb, and AbbVie have actively invested in viral vectors, lipid nanoparticles, and nanocarrier-based immune programming technologies to overcome the limitations of conventional CAR-T therapy in solid tumors.</p>
<div class="lb-trans"><p>近年来，体内 CAR-T 已成为全球制药领导者的重点关注领域。吉利德科学（Kite）、阿斯利康、百时美施贵宝和艾伯维等公司积极投资于病毒载体、脂质纳米颗粒和基于纳米载体的免疫编程技术，以克服传统 CAR-T 治疗在实体肿瘤中的局限性。</p>
</div><p>Within this global landscape, the EXO 001 targeted exosome platform—developed jointly by CMUH and Ever Supreme Bio Technology—stands out for its use of high-biocompatibility, naturally derived exosomes, offering a differentiated and internationally competitive approach.</p>
<div class="lb-trans"><p>在这一全球背景下，由 CMUH 和永盛生物科技共同开发的 EXO 001 靶向外泌体平台因其使用高生物相容性、天然来源的外泌体而脱颖而出，提供了一种差异化且具有国际竞争力的方法。</p>
</div><p><strong>Next Steps Toward Clinical Translation</strong></p>
<div class="lb-trans"><p><strong>迈向临床转化的下一步</strong></p>
</div><p>This research has been accepted for publication in the internationally recognized journal Advanced Science (January 2026), has secured patents in the United States and other countries, and has completed technology transfer. Manufacturing development and clinical trial preparation are currently underway, with first-in-human trials anticipated as early as next year, targeting patients with colorectal cancer, pancreatic cancer, malignant brain tumors, and ovarian cancer.</p>
<div class="lb-trans"><p>这项研究已被国际知名期刊《先进科学》接受发表（2026 年 1 月），并在美国及其他国家获得专利，完成了技术转让。目前正在进行制造开发和临床试验准备，预计明年将开展首个人体试验，目标患者为结直肠癌、胰腺癌、恶性脑肿瘤和卵巢癌患者。</p>
</div><p>The EXO 001 platform represents a new horizon for solid tumor immunotherapy and a promising step forward for patients with advanced cancer.</p>
<div class="lb-trans"><p>EXO 001 平台代表了实体肿瘤免疫疗法的新视野，是为晚期癌症患者迈出的有希望的一步。</p>
</div><p>SOURCE China Medical University Hospital</p>
<div class="lb-trans"><p>来源：中国医科大学附属医院</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjEzJk5ld3NJdGVtSWQ9SEs4NzczMCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMTMwMjI4UFJfTkVXU19VU1BSX19fX19ISzg3NzMw" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=HK87730&amp;Transmission_Id=202602130228PR_NEWS_USPR_____HK87730&amp;DateId=20260213"/></p>

02:28 ET 世界首个 EXO 001 外泌体平台实现体内多靶点 CAR-T 疗法用于实体肿瘤