<p><img src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/CTA-24-12-2025-shutterstock_2024640209-428x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="428" height="241" original-src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/CTA-24-12-2025-shutterstock_2024640209-428x241.jpg"/></p>
<p>LBL-047 旨在通过与自身免疫疾病相关的两个已验证途径，靶向先天和适应性免疫系统。来源：Sai Thaw Kyar/Shutterstock.com。</p>
<p>Leads Biolabs 和 Dianthus Therapeutics（DNTH）已启动一项针对健康志愿者和系统性红斑狼疮（SLE）患者的 I 期临床试验，研究 LBL-047。</p>
<p>该试验旨在评估 LBL-047 的药代动力学/药效学（PK/PD）、安全性和耐受性，这是一种靶向血树突状细胞抗原 2（BDCA2）和跨膜激活因子及钙调节因子和环孢素配体相互作用体（TACI）外域的双功能融合蛋白。</p>
<p>该试验采用两部分、安慰剂对照、双盲、随机、剂量递增（单次递增剂量）设计。</p>
<p><img src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.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://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png"/></p>
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<p>A 部分将招募健康志愿者，由上海公共卫生临床中心的孟宪敏教授领导。B 部分将招募 SLE 患者，由上海交通大学医学院的叶爽教授和陈晟教授领导。</p>
<p>LBL-047 旨在通过与自身免疫疾病相关的两个已验证途径，靶向先天和适应性免疫系统。</p>
<p>该方法旨在解决多种自身免疫指征并提供改善的结果。LBL-047 计划作为一线生物制剂，具有患者友好的皮下自我给药，每四周或更少频率给药一次。</p>
<p>Leads Biolabs 和 DNTH 于 2025 年 10 月 16 日形成了独家全球合作伙伴关系，总潜在交易价值高达 10 亿美元。</p>
<p>根据协议，DNTH 获得了开发、研究、商业化和生产 LBL-047 的全球独家权利，但不包括大中华区。</p>
<p>该疗法在大中华区以外被称为 DNTH212。DNTH 计划在 2026 年上半年更新优先指征的进展。</p>
<p>Leads Biolabs 首席医学官 Charles Cai 博士表示：“我们很高兴地宣布在 LBL-047 的 I 期试验中成功给药第一位受试者。通过同时靶向多个途径，LBL-047 旨在解决单一靶点疗法的局限性。</p>
<p>“我们期待与 Dianthus Therapeutics 合作推进该项目，为全球患者提供潜在的变革性选择。”</p>
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DNTH

<p>Leads Biolabs 和 Dianthus Therapeutics (DNTH) 已经启动了 LBL-047 的 I 期临床试验，参与者包括健康志愿者和系统性红斑狼疮 (SLE) 患者。该试验将评估 LBL-047 的药代动力学、安全性和耐受性，这是一种靶向 BDCA2 和 TACI 的双功能融合蛋白。该试验采用两部分、安慰剂对照、双盲、随机、剂量递增的设计。Leads Biolabs 和 DNTH 于 2025 年形成了独家全球合作伙伴关系，DNTH 获得了开发和商业化 LBL-047 的全球权利，但不包括大中华区，该药物在大中华区以外被称为 DNTH212</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/CTA-24-12-2025-shutterstock_2024640209-428x241.jpg" alt="" original-src="https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/CTA-24-12-2025-shutterstock_2024640209-428x241.jpg"/></p>
<p>LBL-047 is designed to target both innate and adaptive immune systems through two validated pathways associated with autoimmune disease. Credit: Sai Thaw Kyar/Shutterstock.com.</p>
<div class="lb-trans"><p>LBL-047 旨在通过与自身免疫疾病相关的两个已验证途径，靶向先天和适应性免疫系统。来源：Sai Thaw Kyar/Shutterstock.com。</p>
</div><p>Leads Biolabs and Dianthus Therapeutics (DNTH) have initiated a Phase I clinical trial investigating LBL-047 in healthy volunteers and patients with systemic lupus erythematosus (SLE).</p>
<div class="lb-trans"><p>Leads Biolabs 和 Dianthus Therapeutics（DNTH）已启动一项针对健康志愿者和系统性红斑狼疮（SLE）患者的 I 期临床试验，研究 LBL-047。</p>
</div><p>The trial aims to assess the pharmacokinetics/pharmacodynamics (PK/PD), safety, and tolerability of LBL-047, a bifunctional fusion protein targeting blood dendritic cell antigen 2 (BDCA2) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) ectodomain.</p>
<div class="lb-trans"><p>该试验旨在评估 LBL-047 的药代动力学/药效学（PK/PD）、安全性和耐受性，这是一种靶向血树突状细胞抗原 2（BDCA2）和跨膜激活因子及钙调节因子和环孢素配体相互作用体（TACI）外域的双功能融合蛋白。</p>
</div><p>It has a two-part, placebo-controlled, double-blind, randomised, dose-escalation (single ascending dose) design.</p>
<div class="lb-trans"><p>该试验采用两部分、安慰剂对照、双盲、随机、剂量递增（单次递增剂量）设计。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png" alt="" original-src="https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png"/></p>
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</div><p>Part A will enrol healthy volunteers, led by professor Meng Xianmin at Shanghai Public Health Clinical Centre. Part B will enrol SLE patients, led by professors Ye Shuang and Chen Sheng at Renji Hospital, Shanghai Jiaotong University School of Medicine.</p>
<div class="lb-trans"><p>A 部分将招募健康志愿者，由上海公共卫生临床中心的孟宪敏教授领导。B 部分将招募 SLE 患者，由上海交通大学医学院的叶爽教授和陈晟教授领导。</p>
</div><p>LBL-047 is designed to target both innate and adaptive immune systems through two validated pathways associated with autoimmune disease.</p>
<div class="lb-trans"><p>LBL-047 旨在通过与自身免疫疾病相关的两个已验证途径，靶向先天和适应性免疫系统。</p>
</div><p>The approach seeks to address multiple autoimmune indications and offer improved outcomes. LBL-047 is intended as a first-line biologic with patient-friendly subcutaneous self-administration and dosing every four weeks or less frequently.</p>
<div class="lb-trans"><p>该方法旨在解决多种自身免疫指征并提供改善的结果。LBL-047 计划作为一线生物制剂，具有患者友好的皮下自我给药，每四周或更少频率给药一次。</p>
</div><p>Leads Biolabs and DNTH formed an exclusive global partnership on 16 October 2025, with a total potential deal value up to $1bn.</p>
<div class="lb-trans"><p>Leads Biolabs 和 DNTH 于 2025 年 10 月 16 日形成了独家全球合作伙伴关系，总潜在交易价值高达 10 亿美元。</p>
</div><p>As part of the agreement, DNTH obtained exclusive global rights, excluding Greater China, to develop, research, commercialise, and manufacture LBL-047.</p>
<div class="lb-trans"><p>根据协议，DNTH 获得了开发、研究、商业化和生产 LBL-047 的全球独家权利，但不包括大中华区。</p>
</div><p>The therapy is referred to as DNTH212 outside Greater China. DNTH plans to update on prioritised indications in the first half of 2026.</p>
<div class="lb-trans"><p>该疗法在大中华区以外被称为 DNTH212。DNTH 计划在 2026 年上半年更新优先指征的进展。</p>
</div><p>Leads Biolabs chief medical officer Dr Charles Cai said: “We are pleased to announce the successful dosing of the first subject in our Phase I trial of LBL-047. By simultaneously targeting multiple pathways, LBL-047 is designed to address the limitations of single-target therapies.</p>
<div class="lb-trans"><p>Leads Biolabs 首席医学官 Charles Cai 博士表示：“我们很高兴地宣布在 LBL-047 的 I 期试验中成功给药第一位受试者。通过同时靶向多个途径，LBL-047 旨在解决单一靶点疗法的局限性。</p>
</div><p>“We look forward to advancing this programme in collaboration with Dianthus Therapeutics to deliver potentially transformative options for patients worldwide.”</p>
<div class="lb-trans"><p>“我们期待与 Dianthus Therapeutics 合作推进该项目，为全球患者提供潜在的变革性选择。”</p>
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Leads Biolabs 和 Dianthus Therapeutics 启动 LBL-047 在系统性红斑狼疮中的试验