BI-3034701

BI 3034701 靶向 GLP-1R/GIPR/NPY2R 三重通路，旨在实现更优减重与心血管-肾脏-代谢（CRM）综合获益，目前已在美、中及澳洲启动国际多中心 II 期试验 德国殷格翰 / 丹麦霍斯霍尔姆，2026年7月16日 —— 全球领先的生物制药企业 勃林格殷格翰（Boehringer Ingelheim） 今日宣布，其与 Gubra A/S 联合开发的潜在同类首创（First-in-Class）长效三受体激动剂 BI 3034701 已正式进入 II 期临床开发阶段，用于治疗肥胖或超重人群。这一里程碑标志着公司在心血管-肾脏-代谢（CRM）疾病领域差异化管线的进一步深化，也是对现有 GLP-1 单/双靶点疗法的重要迭代尝试。核心机制：GLP-1/GIP/NPY2R 三重协同的“下一代”逻辑 BI 3034701 是一种每周一次皮下注射的长效多肽类药物，通过同时激动 GLP-1 受体（GLP-1R）、GIP 受体（GIPR）及神经肽 Y2 受体（NPY2R），从多维度调控能量平衡与食欲： GLP-1R & GIPR：延续并增强现有双靶点激动剂的减重、血糖控制及代谢改善效应； NPY2R：靶向下丘脑饱腹感通路，旨在进一步提升体重管理的持久性与耐受性，并可能对能量稳态产生保护性调节。 该分子基于 Gubra 的肽发现平台开发，由勃林格殷格翰负责全球临床开发与商业化，是双方合作管线中首个进入 II 期临床的资产。II 期试验设计：国际多中心剂量探索 此次启动的 II 期研究（NCT07662122 / CTR20262605） 是一项随机、双盲、平行分组、安慰剂对照的 42 周剂量探索试验，计划在全球（包括美国、中国及澳洲等）入组约 300 例肥胖或超重受试者。 主要终点：第 42 周时体重较基线的百分比变化； 次要目标：评估安全性、耐受性、药代动力学及剂量-效应关系，为后续 III 期关键研究确定目标剂量（共设 6 个活性剂量组 vs 安慰剂）。 前期验证：I 期安全窗与减重信号积极 BI 3034701 的 II 期推进建立在 I 期（NCT06352437） 积极数据之上。该 I 期试验在健康志愿者及超重/肥胖人群中完成了单剂量与多剂量递增评估，结果显示： 安全性与耐受性良好，未出现超出预期的不良事件； 观察到具有临床意义的早期体重减轻信号，为 II 期进一步验证疗效提供了支撑 勃林格殷格翰心血管代谢疾病研究全球负责人 Søren Tullin 表示： “尽管 BI 3034701 仍处于中期开发阶段，但它是我们全面战略中的重要一环——不仅着眼于减重，更致力于为肥胖相关的心血管、肾脏及代谢并发症患者改善生存质量与长度。三重受体协同机制有望带来超越现有标准的综合获益。” Gubra CEO Henrik Blou 指出： “BI 3034701 是 Gubra 研发合作中首个迈入 II 期的资产，印证了我们肽发现平台在难成药代谢靶点上的差异化能力。我们很高兴看到勃林格殷格翰持续推进这一潜在同类首创疗法的开发。”管线协同与行业格局 在肥胖症治疗从“单靶点”向“多靶点/三靶点”演进的 2026 年，BI 3034701 与勃林格殷格翰另一款处于 III 期的 GLP-1/胰高血糖素双激动剂 Survodutide 形成互补矩阵：前者聚焦下一代口服/注射三协同机制，后者已在 III 期实现 16.6% 减重与显著内脏脂肪/肝脂削减。两者共同构筑了公司在后 GLP-1 时代的竞争护城河。 根据许可协议，Gubra 将有权获得基于开发、监管及商业化里程碑的付款及后续销售分成。 关于 BI 3034701 BI 3034701 是一种靶向 GLP-1R、GIPR 和 NPY2R 的长效三受体激动肽，目前处于 II 期临床开发阶段，拟用于肥胖或超重及相关代谢疾病的治疗。 关于勃林格殷格翰 勃林格殷格翰致力于研究突破，改变生命，在心血管-肾脏-代谢（CRM）、肿瘤、免疫及呼吸系统等疾病领域拥有深厚管线，总部位于德国殷格翰，全球约 5.3 万名员工。 关于 Gubra A/S Gubra 是一家专注于代谢疾病（如肥胖、糖尿病）肽药物发现、临床前服务及影像分析的丹麦生物技术公司。

Boehringer moves new kind of triple agonist into mid-stage obesity testingUS lawmakers want the FTC to look into foreign money in the drug supply chainDrug shortages continue to tick upBoehringer moves new kind of triple agonist into mid-stage obesity testingBoehringer Ingelheim started a Phase II obesity trial on Thursday of BI 3034701, a triple agonist developed by partner Gubra — though with a slightly different mechanism of action than Eli Lilly's GLP-1/GIP/glucagon-targeting "triple G" agonist, retatrutide. Like retatrutide, BI 3034701 agonises GLP-1 and GIP, but instead of glucagon, it activates neuropeptide Y2 (NPY2), which is thought to modulate central hunger signalling, according to Boehringer. The candidate's advancement was prompted by Phase I findings, which demonstrated a "generally favourable safety and tolerability profile" for BI 3034701. "We expect obesity care to become much more differentiated, and with BI 3034701, we aim to go beyond short-term weight loss and address both the biological and behavioural drivers of obesity," said Shashank Deshpande, chairman of the board of managing directors and Boehringer's head of human pharma.US lawmakers want the FTC to look into foreign money in the drug supply chainSenators Elizabeth Warren (D-Mass.) and Rick Scott (R-Fla.), both a part of the Senate Special Committee on Aging, have introduced a bill that would have the Federal Trade Commission (FTC) and the Department of Treasury investigate foreign investments in pharmaceutical manufacturing capacity and supply chains. "America has let the Chinese Communist Party and other foreign entities quietly buy their way into our drug supply for too long, and it needs to end," Scott said in a release. According to the senators, about 80% of active pharmaceutical ingredients (APIs) and close to 100% of the raw materials used to make generic drugs in the US are shipped in from other countries, making the supply chain vulnerable to disruptions. The Pharmaceutical Investment Oversight and Accountability Act would require the FTC to look into, and report to Congress, the US's reliance on foreign manufacturing, the impact of foreign investment on domestic production, and the effect of relocating US manufacturing facilities to foreign countries. Drug shortages continue to tick upThe American Society of Health-System Pharmacists (ASHP) released a report this week that found there were 227 active drug shortages at the end of the second quarter of 2026. Shortages have been steadily rising since the fourth quarter of 2025, when there were 216 cases at the end of the period.According to ASHP, 48% of all new shortages this year are sole-source products, meaning that it's made by only one manufacturer. Hit particularly hard were chemotherapies, with ifosfamide in a "severe" shortage this quarter due to manufacturing quality problems. The ASHP also noted that 16% of shortages were controlled substances.