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<p>超过 120 名患有血液恶性肿瘤的患者参与了在加拿大、欧洲和美国进行的临床试验。图片来源：Anamaria Mejia / Shutterstock.com。</p>
<p>ExCellThera 及其全资子公司 Cordex Biologics 已获得德国 Neue Untersuchungs- und Behandlungsmethoden (NUB) 计划的状态 1 上市，针对 Zemcelpro（dorocubicel），也称为 UM171 细胞疗法。</p>
<p>这得益于 Zemcelpro 日益增长的临床证据以及该国 220 家医院对通过 NUB 机制在 2026 年潜在使用的兴趣。</p>
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<h4>LOA 和 PTSR 模型 - Zimberelimab 在多发性骨髓瘤（卡尔赫病）中的应用</h4>
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<p>欧洲委员会（EC）最近已向 Zemcelpro 授予有条件的市场授权，用于需要异体干细胞移植的成人血液恶性肿瘤患者，前提是没有其他合适的供体细胞可用。</p>
<p>凭借 NUB 状态，Cordex 计划与德国移植中心合作，进行个别 NUB 申请并扩大临床应用。</p>
<p>该公司还将参与市场后注册，并生成数据以促进长期报销和将 Zemcelpro 纳入临床指南。</p>
<p>该疗法在各个欧洲国家的可用性取决于国家报销程序的完成等多种因素。</p>
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<p>进一步的监管申请计划在美国、加拿大、瑞士和英国进行。Cordex 正在寻求战略合作伙伴，以支持 Zemcelpro 的全球商业化。</p>
<p>该冷冻保存的造血干细胞疗法由 UM171 扩展的 CD34+ 细胞（dorocubicel）和未扩展的 CD34-细胞组成，均来自单一脐带血单位。</p>
<p>超过 120 名患有血液恶性肿瘤的患者参与了在加拿大、欧洲和美国进行的临床试验。</p>
<p>ExCellThera 首席执行官 David Millette 表示：“NUB 状态 1 代表了 ExCellThera 和 Cordex 的重要里程碑，反映了 Zemcelpro（dorocubicel）的创新特性及其在满足异体造血干细胞移植中迫切的未满足医疗需求方面的益处。”</p>
<p>“根据其初始标签，Zemcelpro（dorocubicel）适用于那些治疗选择有限的危及生命的血癌患者。”</p>
<p>在 2025 年 8 月，ExCellThera 宣布 EC 已授予其 Zemcelpro 细胞疗法的有条件市场授权，以治疗没有合适供体细胞的血癌患者。</p>

<p>ExCellThera 已获得德国 NUB Status 1 的上市资格，针对其疗法 Zemcelpro，此前获得了积极的临床证据和 220 家医院的关注。欧洲委员会已为 Zemcelpro 授予有条件的市场授权，旨在帮助需要干细胞移植的血液恶性肿瘤成人患者。该公司计划与德国移植中心合作进行 NUB 申请，并扩大临床应用，同时参与市场后注册。还计划在美国、加拿大、瑞士和英国进行进一步的监管提交。首席执行官 David Millette 强调，这一里程碑是解决血癌治疗中未满足医疗需求的重要一步</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/02/PT-17-02-2026-shutterstock_2205585127-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/02/PT-17-02-2026-shutterstock_2205585127-430x241.jpg"/></p>
<p>Over 120 patients with haematologic malignancies took part in clinical trials across Canada, Europe, and the US. Credit: Anamaria Mejia / Shutterstock.com.</p>
<div class="lb-trans"><p>超过 120 名患有血液恶性肿瘤的患者参与了在加拿大、欧洲和美国进行的临床试验。图片来源：Anamaria Mejia / Shutterstock.com。</p>
</div><p>ExCellThera and its wholly owned subsidiary Cordex Biologics have received a Status 1 listing from the Neue Untersuchungs- und Behandlungsmethoden (NUB) programme in Germany for Zemcelpro (dorocubicel), also known as UM171 Cell Therapy.</p>
<div class="lb-trans"><p>ExCellThera 及其全资子公司 Cordex Biologics 已获得德国 Neue Untersuchungs- und Behandlungsmethoden (NUB) 计划的状态 1 上市，针对 Zemcelpro（dorocubicel），也称为 UM171 细胞疗法。</p>
</div><p>This follows growing clinical evidence for Zemcelpro and interest from 220 hospitals in the country for potential use through the NUB mechanism from 2026.</p>
<div class="lb-trans"><p>这得益于 Zemcelpro 日益增长的临床证据以及该国 220 家医院对通过 NUB 机制在 2026 年潜在使用的兴趣。</p>
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</div><p>The European Commission (EC) recently granted conditional marketing authorisation to Zemcelpro for use in adults with haematological malignancies needing allogeneic stem cell transplantation after myeloablative conditioning, where no other suitable donor cells are available.</p>
<div class="lb-trans"><p>欧洲委员会（EC）最近已向 Zemcelpro 授予有条件的市场授权，用于需要异体干细胞移植的成人血液恶性肿瘤患者，前提是没有其他合适的供体细胞可用。</p>
</div><p>With NUB status, Cordex plans to work with German transplant centres on individual NUB applications and expand clinical adoption.</p>
<div class="lb-trans"><p>凭借 NUB 状态，Cordex 计划与德国移植中心合作，进行个别 NUB 申请并扩大临床应用。</p>
</div><p>The company will also participate in post-market registries and generate data to facilitate long-term reimbursement and the inclusion of Zemcelpro in clinical guidelines.</p>
<div class="lb-trans"><p>该公司还将参与市场后注册，并生成数据以促进长期报销和将 Zemcelpro 纳入临床指南。</p>
</div><p>The availability of the therapy in individual European countries depends on various factors such as the completion of national reimbursement procedures.</p>
<div class="lb-trans"><p>该疗法在各个欧洲国家的可用性取决于国家报销程序的完成等多种因素。</p>
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</div><p>Further regulatory submissions are planned for the US, Canada, Switzerland, and the UK. Cordex is pursuing strategic partnerships to support the global commercialisation of Zemcelpro.</p>
<div class="lb-trans"><p>进一步的监管申请计划在美国、加拿大、瑞士和英国进行。Cordex 正在寻求战略合作伙伴，以支持 Zemcelpro 的全球商业化。</p>
</div><p>The cryopreserved haematopoietic stem cell therapy is composed of UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, both sourced from a single cord blood unit.</p>
<div class="lb-trans"><p>该冷冻保存的造血干细胞疗法由 UM171 扩展的 CD34+ 细胞（dorocubicel）和未扩展的 CD34-细胞组成，均来自单一脐带血单位。</p>
</div><p>More than 120 patients with haematologic malignancies took part in clinical trials across Canada, Europe, and the US.</p>
<div class="lb-trans"><p>超过 120 名患有血液恶性肿瘤的患者参与了在加拿大、欧洲和美国进行的临床试验。</p>
</div><p>ExCellThera CEO David Millette said: “NUB Status 1 represents a significant milestone for ExCellThera and Cordex and reflects both the innovative nature of Zemcelpro (dorocubicel) and its benefit in addressing a pressing unmet medical need in allogeneic haematopoietic stem cell transplantation.</p>
<div class="lb-trans"><p>ExCellThera 首席执行官 David Millette 表示：“NUB 状态 1 代表了 ExCellThera 和 Cordex 的重要里程碑，反映了 Zemcelpro（dorocubicel）的创新特性及其在满足异体造血干细胞移植中迫切的未满足医疗需求方面的益处。”</p>
</div><p>“Under its initial label, Zemcelpro (dorocubicel) is indicated for patients with life-threatening blood cancers who have limited therapeutic options.”</p>
<div class="lb-trans"><p>“根据其初始标签，Zemcelpro（dorocubicel）适用于那些治疗选择有限的危及生命的血癌患者。”</p>
</div><p>In August 2025, ExCellThera announced that the EC granted conditional marketing authorisation for its Zemcelpro cell therapy to treat blood cancer patients without access to suitable donor cells.</p>
<div class="lb-trans"><p>在 2025 年 8 月，ExCellThera 宣布 EC 已授予其 Zemcelpro 细胞疗法的有条件市场授权，以治疗没有合适供体细胞的血癌患者。</p>
</div>

ExCellThera 为 Zemcelpro 获得德国 NUB 状态 1 的上市资格