<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?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.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/02/PT-17-02-2026-shutterstock_2205585127-430x241.jpg"/></p>
<p>超過 120 名患有血液惡性腫瘤的患者參與了在加拿大、歐洲和美國進行的臨牀試驗。圖片來源：Anamaria Mejia / Shutterstock.com。</p>
<p>ExCellThera 及其全資子公司 Cordex Biologics 已獲得德國 Neue Untersuchungs- und Behandlungsmethoden (NUB) 計劃的狀態 1 上市，針對 Zemcelpro（dorocubicel），也稱為 UM171 細胞療法。</p>
<p>這得益於 Zemcelpro 日益增長的臨牀證據以及該國 220 家醫院對通過 NUB 機制在 2026 年潛在使用的興趣。</p>
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<p>歐洲委員會（EC）最近已向 Zemcelpro 授予有條件的市場授權，用於需要異體幹細胞移植的成人血液惡性腫瘤患者，前提是沒有其他合適的供體細胞可用。</p>
<p>憑藉 NUB 狀態，Cordex 計劃與德國移植中心合作，進行個別 NUB 申請並擴大臨牀應用。</p>
<p>該公司還將參與市場後註冊，並生成數據以促進長期報銷和將 Zemcelpro 納入臨牀指南。</p>
<p>該療法在各個歐洲國家的可用性取決於國家報銷程序的完成等多種因素。</p>
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<p>進一步的監管申請計劃在美國、加拿大、瑞士和英國進行。Cordex 正在尋求戰略合作伙伴，以支持 Zemcelpro 的全球商業化。</p>
<p>該冷凍保存的造血幹細胞療法由 UM171 擴展的 CD34+ 細胞（dorocubicel）和未擴展的 CD34-細胞組成，均來自單一臍帶血單位。</p>
<p>超過 120 名患有血液惡性腫瘤的患者參與了在加拿大、歐洲和美國進行的臨牀試驗。</p>
<p>ExCellThera 首席執行官 David Millette 表示：“NUB 狀態 1 代表了 ExCellThera 和 Cordex 的重要里程碑，反映了 Zemcelpro（dorocubicel）的創新特性及其在滿足異體造血幹細胞移植中迫切的未滿足醫療需求方面的益處。”</p>
<p>“根據其初始標籤，Zemcelpro（dorocubicel）適用於那些治療選擇有限的危及生命的血癌患者。”</p>
<p>在 2025 年 8 月，ExCellThera 宣佈 EC 已授予其 Zemcelpro 細胞療法的有條件市場授權，以治療沒有合適供體細胞的血癌患者。</p>

<p>ExCellThera 已獲得德國 NUB Status 1 的上市資格，針對其療法 Zemcelpro，此前獲得了積極的臨牀證據和 220 家醫院的關注。歐洲委員會已為 Zemcelpro 授予有條件的市場授權，旨在幫助需要幹細胞移植的血液惡性腫瘤成人患者。該公司計劃與德國移植中心合作進行 NUB 申請，並擴大臨牀應用，同時參與市場後註冊。還計劃在美國、加拿大、瑞士和英國進行進一步的監管提交。首席執行官 David Millette 強調，這一里程碑是解決血癌治療中未滿足醫療需求的重要一步</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>超過 120 名患有血液惡性腫瘤的患者參與了在加拿大、歐洲和美國進行的臨牀試驗。圖片來源：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 及其全資子公司 Cordex Biologics 已獲得德國 Neue Untersuchungs- und Behandlungsmethoden (NUB) 計劃的狀態 1 上市，針對 Zemcelpro（dorocubicel），也稱為 UM171 細胞療法。</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>這得益於 Zemcelpro 日益增長的臨牀證據以及該國 220 家醫院對通過 NUB 機制在 2026 年潛在使用的興趣。</p>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Zimberelimab 在多發性骨髓瘤（卡爾赫病）中的應用</h4>
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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>歐洲委員會（EC）最近已向 Zemcelpro 授予有條件的市場授權，用於需要異體幹細胞移植的成人血液惡性腫瘤患者，前提是沒有其他合適的供體細胞可用。</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>憑藉 NUB 狀態，Cordex 計劃與德國移植中心合作，進行個別 NUB 申請並擴大臨牀應用。</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>該公司還將參與市場後註冊，並生成數據以促進長期報銷和將 Zemcelpro 納入臨牀指南。</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>該療法在各個歐洲國家的可用性取決於國家報銷程序的完成等多種因素。</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>進一步的監管申請計劃在美國、加拿大、瑞士和英國進行。Cordex 正在尋求戰略合作伙伴，以支持 Zemcelpro 的全球商業化。</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>該冷凍保存的造血幹細胞療法由 UM171 擴展的 CD34+ 細胞（dorocubicel）和未擴展的 CD34-細胞組成，均來自單一臍帶血單位。</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>超過 120 名患有血液惡性腫瘤的患者參與了在加拿大、歐洲和美國進行的臨牀試驗。</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 首席執行官 David Millette 表示：“NUB 狀態 1 代表了 ExCellThera 和 Cordex 的重要里程碑，反映了 Zemcelpro（dorocubicel）的創新特性及其在滿足異體造血幹細胞移植中迫切的未滿足醫療需求方面的益處。”</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>“根據其初始標籤，Zemcelpro（dorocubicel）適用於那些治療選擇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 宣佈 EC 已授予其 Zemcelpro 細胞療法的有條件市場授權，以治療沒有合適供體細胞的血癌患者。</p>
</div>

ExCellThera 為 Zemcelpro 獲得德國 NUB 狀態 1 的上市資格