<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 旨在通過與自身免疫疾病相關的兩個已驗證途徑，靶向先天和適應性免疫系統。來源：Sai Thaw Kyar/Shutterstock.com。</p>
<p>Leads Biolabs 和 Dianthus Therapeutics（DNTH）已啓動一項針對健康志願者和系統性紅斑狼瘡（SLE）患者的 I 期臨牀試驗，研究 LBL-047。</p>
<p>該試驗旨在評估 LBL-047 的藥代動力學/藥效學（PK/PD）、安全性和耐受性，這是一種靶向血樹突狀細胞抗原 2（BDCA2）和跨膜激活因子及鈣調節因子和環孢素配體相互作用體（TACI）外域的雙功能融合蛋白。</p>
<p>該試驗採用兩部分、安慰劑對照、雙盲、隨機、劑量遞增（單次遞增劑量）設計。</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 部分將招募健康志願者，由上海公共衞生臨牀中心的孟憲敏教授領導。B 部分將招募 SLE 患者，由上海交通大學醫學院的葉爽教授和陳晟教授領導。</p>
<p>LBL-047 旨在通過與自身免疫疾病相關的兩個已驗證途徑，靶向先天和適應性免疫系統。</p>
<p>該方法旨在解決多種自身免疫指徵並提供改善的結果。LBL-047 計劃作為一線生物製劑，具有患者友好的皮下自我給藥，每四周或更少頻率給藥一次。</p>
<p>Leads Biolabs 和 DNTH 於 2025 年 10 月 16 日形成了獨家全球合作伙伴關係，總潛在交易價值高達 10 億美元。</p>
<p>根據協議，DNTH 獲得了開發、研究、商業化和生產 LBL-047 的全球獨家權利，但不包括大中華區。</p>
<p>該療法在大中華區以外被稱為 DNTH212。DNTH 計劃在 2026 年上半年更新優先指徵的進展。</p>
<p>Leads Biolabs 首席醫學官 Charles Cai 博士表示：“我們很高興地宣佈在 LBL-047 的 I 期試驗中成功給藥第一位受試者。通過同時靶向多個途徑，LBL-047 旨在解決單一靶點療法的侷限性。</p>
<p>“我們期待與 Dianthus Therapeutics 合作推進該項目，為全球患者提供潛在的變革性選擇。”</p>
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DNTH

<p>Leads Biolabs 和 Dianthus Therapeutics (DNTH) 已經啓動了 LBL-047 的 I 期臨牀試驗，參與者包括健康志願者和系統性紅斑狼瘡 (SLE) 患者。該試驗將評估 LBL-047 的藥代動力學、安全性和耐受性，這是一種靶向 BDCA2 和 TACI 的雙功能融合蛋白。該試驗採用兩部分、安慰劑對照、雙盲、隨機、劑量遞增的設計。Leads Biolabs 和 DNTH 於 2025 年形成了獨家全球合作伙伴關係，DNTH 獲得了開發和商業化 LBL-047 的全球權利，但不包括大中華區，該藥物在大中華區以外被稱為 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 旨在通過與自身免疫疾病相關的兩個已驗證途徑，靶向先天和適應性免疫系統。來源：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）已啓動一項針對健康志願者和系統性紅斑狼瘡（SLE）患者的 I 期臨牀試驗，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>該試驗旨在評估 LBL-047 的藥代動力學/藥效學（PK/PD）、安全性和耐受性，這是一種靶向血樹突狀細胞抗原 2（BDCA2）和跨膜激活因子及鈣調節因子和環孢素配體相互作用體（TACI）外域的雙功能融合蛋白。</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>該試驗採用兩部分、安慰劑對照、雙盲、隨機、劑量遞增（單次遞增劑量）設計。</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>Explore a selection of report samples we have handpicked for you. Get a preview of the insights inside. Download your free copy today.</p>
<div class="lb-trans"><p>探索我們為您精心挑選的一系列報告樣本。獲取內部見解的預覽。今天就下載您的免費副本。</p>
</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 部分將招募健康志願者，由上海公共衞生臨牀中心的孟憲敏教授領導。B 部分將招募 SLE 患者，由上海交通大學醫學院的葉爽教授和陳晟教授領導。</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 旨在通過與自身免疫疾病相關的兩個已驗證途徑，靶向先天和適應性免疫系統。</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>該方法旨在解決多種自身免疫指徵並提供改善的結果。LBL-047 計劃作為一線生物製劑，具有患者友好的皮下自我給藥，每四周或更少頻率給藥一次。</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 於 2025 年 10 月 16 日形成了獨家全球合作伙伴關係，總潛在交易價值高達 10 億美元。</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>根據協議，DNTH 獲得了開發、研究、商業化和生產 LBL-047 的全球獨家權利，但不包括大中華區。</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>該療法在大中華區以外被稱為 DNTH212。DNTH 計劃在 2026 年上半年更新優先指徵的進展。</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 首席醫學官 Charles Cai 博士表示：“我們很高興地宣佈在 LBL-047 的 I 期試驗中成功給藥第一位受試者。通過同時靶向多個途徑，LBL-047 旨在解決單一靶點療法的侷限性。</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>“我們期待與 Dianthus Therapeutics 合作推進該項目，為全球患者提供潛在的變革性選擇。”</p>
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Leads Biolabs 和 Dianthus Therapeutics 啓動 LBL-047 在系統性紅斑狼瘡中的試驗