In adults with obesity seeking treatment, weight loss would ideally be composed almost exclusively of fat mass. However, loss of muscle mass and bone are unintentional consequences of weight loss, which may have negative effects on health by lessening improvements in glucose and insulin levels, reducing resting metabolic rate, and increasing the risk of falls and fractures. Data in animals and humans suggest that bimagrumab, an investigational new drug for obesity that inhibits the activin type II receptor (ActRII) inhibitor, may help maximize loss of fat mass while maintaining muscle mass when used in combination with a glucagon-like peptide 1 receptor agonist (GLP-1 RA). The investigators hypothesize that in a randomized, placebo-controlled trial of 63 adults with obesity randomized to tirzepatide (GLP-1/GIP RA) + bimagrumab, tirzepatide alone, or bimagrumab alone, the combination of tirzepatide + bimagrumab will result in improvements in muscle, fat, and bone compared to tirzepatide alone or bimagrumab alone when given in addition to a lifestyle intervention for weight loss over 52 weeks.

开始日期2025-11-05

申办/合作机构

The Schwartz Center for Compassionate Healthcare

NCT07030127

/ Active, not recruiting临床1期

A Phase 1, Participant- and Investigator-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Doses of LY3985863 in Healthy Chinese Participants

The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

开始日期2025-08-11

申办/合作机构

Eli Lilly & Co.

NCT06901349

/ Withdrawn临床2期

A Phase 2b Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

开始日期2025-05-23

申办/合作机构

Eli Lilly & Co.

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100 项与比马格鲁单抗相关的转化医学

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100 项与比马格鲁单抗相关的专利（医药）

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项与比马格鲁单抗相关的文献（医药）

2026-02-01·DIABETES OBESITY & METABOLISM

Pharmacological intervention: Challenges and promising outcomes for fat loss and preservation of lean body mass in the treatment of overweight and type 2 diabetes

Review

作者: Aimelet, Viktor ; Holst, Jens Juul

Abstract:

Treatment with GLP‐1 receptor agonists (GLP‐1 RAs) is effective in reducing body weight in individuals with overweight and type 2 diabetes (T2D). However, measurements indicate that a considerable portion of the weight loss derives from fat‐free mass (FFM), including skeletal muscle, which may compromise metabolic health and physical function. We aimed to evaluate the evidence for the ability of pharmacological interventions to preserve or increase lean body mass (LBM) during weight loss with GLP‐1 RAs, assess their clinical potential and limitations, and identify knowledge gaps requiring further research. A literature review was conducted using PubMed, JAMA, Wiley, ResearchGate, The Royal Danish Library, and ClinicalTrials.gov. Included were preclinical and clinical studies on compounds with documented anabolic effects and established safety profiles. The primary outcomes assessed were changes in LBM, fat mass (FM), physical function, and adverse events. Activin II receptor inhibition with bimagrumab demonstrated significant preservation and increases in LBM, along with FM reduction, in both preclinical and phase 2 studies in individuals with overweight and T2D. Similar effects were observed for myostatin and activin A inhibitors (trevogrumab, garetosmab), latent myostatin inhibitors (apitegromab, SRK‐439), and Selective Androgen Receptor Modulators (enobosarm). Notably, enobosarm also improved physical function. Adverse events were generally mild and reversible; however, long‐term data remain limited. Pharmacological adjunct therapies show potential for improving body composition and physical function during GLP‐1 RA‐induced weight loss. Preliminary findings are promising, but larger, controlled trials are necessary to confirm efficacy and safety before clinical implementation can be considered.

2025-12-01·Bone Reports

High-fat diet induced obesity and anti-activin receptor antibody: Effects on bone properties in mice

Article

作者: Bromer, Frederik Duch ; Sylow, Lykke ; Andersen, Christian Brix Folsted ; Brüel, Annemarie ; Carlsson, Michala ; Thomsen, Jesper Skovhus ; Lodberg, Andreas

Aim:

Weight-loss therapy often results in an unintended loss of muscle and bone mass. Inhibitors of the activin receptor signaling pathway, such as bimagrumab, an anti-activin receptor antibody (αActRIIA/IIB ab), are under investigation to counteract weight-loss induced muscle loss, but their skeletal effects in obesity remain unclear. This study investigates αActRIIA/IIB ab on bone in mice exposed to a high-fat diet (HFD) model of obesity or standard chow.

Materials and methods:

Male C57BL/6 J mice were stratified into four groups (n = 10/group, standard chow or HFD for 10 weeks ± αActRIIA/IIB ab). αActRIIA/IIB ab (10 mg/kg) was administered twice weekly during the final three weeks. The femur and vertebral body were assessed using DEXA, μCT, mechanical testing, and histomorphometry.

Results:

HFD did not affect bone density, microstructure, or strength but reduced histological bone formation markers. In standard chow mice, αActRIIA/IIB ab increased trabecular bone volume fraction (BV/TV) and volumetric bone mineral density (vBMD) by 36 %. In HFD mice, the effect of αActRIIA/IIB ab was less pronounced but still increased BV/TV (+16 %) and vBMD (+13 %). For cortical bone, μCT parameters remained largely unaffected by αActRIIA/IIB ab, while the treatment increased periosteal mineralizing bone surfaces in standard chow mice (+217 %), but not in HFD mice.

Conclusions:

αActRIIA/IIB ab enhanced trabecular bone properties in standard chow-fed mice, but its anabolic effects were blunted in HFD-fed mice. Furthermore, αActRIIA/IIB ab improved cortical histological bone formation markers, while morphology remained unaffected, suggesting a site- or time-specific difference. Thus, αActRIIA/IIB ab holds potential for mitigating weight-loss-associated bone deterioration.

2025-12-01·Journal of Cachexia Sarcopenia and Muscle

Muscle Loss in Obesity Therapy as a Therapeutic Target: Trial Design and Endpoints for Regulatory Discussions

Article

作者: Sato, Ryosuke ; Langer, Henning ; Anker, Stefan D. ; Heymsfield, Steven ; von Haehling, Stephan ; Coats, Andrew J. S. ; Evans, William ; Khan, Muhammad Shahzeb

ABSTRACT:

The Society on Cachexia and Wasting Disorders (SCWD) convened a Regulatory and Trial Update Workshop in Washington, D.C., in December 2024, assembling experts from academic institutions, the pharmaceutical industry and the US Food and Drug Administration (FDA) for focused discussions. This article summarizes the latter half of the meeting, which primarily focused on novel anti‐obesity therapies based on incretin pathway alteration. Discussions highlighted the impact of glucagon‐like peptide‐1 (GLP‐1) receptor agonists or GLP‐1/glucose‐dependent insulinotropic polypeptide (i.e., GLP‐1/GIP) agonists on body composition and muscle health; the challenges of distinguishing ‘true’ skeletal muscle from fat‐free tissue; the impact of treatment discontinuation and weight regain; advances in imaging and quantitative assessment of lean body mass; as well as insights from emerging muscle‐preserving therapies (e.g., bimagrumab, pemvidutide and enobosarm). There are significant challenges in defining meaningful structural, functional and patient‐reported endpoints for the use of muscle‐‘protective’ drug therapies in the context of weight loss therapies. These also involve significant regulatory considerations for future drug development and approval pathways, for instance related to the very large number of individuals that may be considered for these therapeutic approaches as well as from the potential long (or life‐long) duration of therapy considered with these drugs. Together, these discussions highlight the growing importance of integrating body composition and functional assessments in future clinical trials.

202

项与比马格鲁单抗相关的新闻（医药）

2026-02-24

·EndPoints

Abcuro plans to proceed with drug that failed pivotal muscle weakness trial

Abcuro’s monoclonal antibody failed the main endpoint and key secondary goals in a Phase 2b/3 trial for a rare and chronic autoimmune disease with no FDA-approved treatments. The Newton, MA-based biotech said Tuesday that the investigational medicine, called ulviprubart or ABC008, wasn’t statistically significantly better than placebo at Week 76. The data mark a major setback for Abcuro, which had planned to file for a biologics license application this year based on the trial. Despite the multi-endpoint miss, Abcuro aims to keep developing the drug, CEO Alex Martin said in a statement. The so-called MUSCLE trial included 272 patients with inclusion body myositis. The condition is mainly found in people 50 years of age and older. Patients lose muscle strength, making it more difficult to walk, swallow and perform other daily functions. The main endpoint was the IBM Functional Rating Scale total score. Trial investigators also looked at muscle measurements, including hand grip and quadriceps strength. No detailed results were given. More data will be released at next month’s Global Conference on Myositis meeting in Lisbon. The biotech said it will move forward with the drug by focusing on patients with mild to moderate forms of the condition, as they showed signs of a “clinically meaningful” slowdown in disease progression. The biotech is encouraged by those results, as well as the drug’s safety and tolerability profile, and expects to meet with the FDA soon, chief medical officer Jeffrey Wilkins said in the statement. The experimental medicine is constructed to go after cytotoxic T cells that express killer cell lectin-like receptor G1, or KLRG1. Wilkins previously told Endpoints News that the approach, which spares regulatory and memory T cells, should reduce inflammation and help muscles “regenerate and decrease the chronic pathogenesis of the disease.” Novartis, Zevra and other companies have tried treating IBM with different mechanisms of action. Novartis’ candidate, bimagrumab, is now owned by Eli Lilly, which is testing the drug for obesity to help preserve muscle mass. Abcuro had passed on acquisition offers and partnership talks with mid- and large-sized drugmakers, Martin told Endpoints last year, as the biotech wanted to work toward an independent commercialization strategy. Instead, the company raised a $200 million Series C last February — about three times as much as it initially sought. The IBM data were going to inform Abcuro’s expansion plans, and whether the biotech would “stick in the neurology area” or look elsewhere, Martin said at the time of the fundraise. He noted there are implications in additional conditions, such as type 1 diabetes and lupus. The biotech is backed by major investors such as Bain Capital Life Sciences, BlackRock, Foresite Capital, RA Capital, Sanofi’s venture arm and others.

2026-02-18

·EndPoints

Updated: Novartis signs macrocyclic deal with Unnatural Products

Novartis will pay $100 million in upfront and pre-IND milestone payments to tap into a macrocyclic peptide platform from Unnatural Products, a deal that could lead to new cardiovascular disease medicines. The move allows the Swiss pharma giant to delve into a niche but growing area of drug R&D that seeks to combine the precision and potency of biologics with the easier-to-use delivery of oral medicines. The progress of macrocyclic chemistry is “opening entirely new avenues in drug discovery,” said Muneto Mogi, head of global discovery chemistry at Novartis Biomedical Research. Those advances enable target engagement “at a dose and with a pharmacological versatility not possible with many other approaches,” he added in a Wednesday press release . Multiple startups are trying to pave those new avenues. That includes Danish contender Orbis Medicines , Boehringer Ingelheim- paired Circle Pharma, and Vilya , which was co-founded by Nobel Prize winner David Baker. Novartis’ bet could pay off big time for Unnatural Products. The startup could get up to $1.7 billion in biobucks spread across development, regulatory and commercial milestones. Novartis will be in the driver’s seat for everything beginning at the IND-enabling stage. Novartis joins companies like BridgeBio and Merck in tapping into Unnatural Products’ macrocyclic territory. Those partnerships have kept the biotech’s engine humming; it has not disclosed a funding round since its $32 million Series A in 2023. Unnatural Products CEO Cameron Pye said in an email to Endpoints News on Wednesday that the original Merck collaboration has “completed.” The company continues to “stay close” with the Merck Research Laboratories team and “have their continued partnership through their Global Health Innovation Fund,” Pye added. Unnatural Products’ pipeline was initially focused on oncology, but has shifted in recent years. At the time of its argenx deal announcement last year, Pye told Endpoints that Unnatural Products was working on an oral activin type 2 receptor antagonist. That area is drawing attention due to Eli Lilly’s bimagrumab , which seeks to promote fat loss while keeping muscle mass intact. Pye told Endpoints in the same email thread that Unnatural Products’ pipeline contains multiple programs, including a project in the field of obesity and metabolic diseases. He declined to disclose further details, including when the biotech could enter human trials. Pye co-founded Unnatural Products with chief scientific officer Joshua Schwochert in the final year of their PhD at UC Santa Cruz. Editor’s note: This story was updated to clarify the nature of the $100 million payment.

2026-02-16

·药研策语

千亿牌桌的“新游戏规则”：辉瑞百亿押注Metsera背后的GLP-1赛道2026入场券

2025年11月13日，辉瑞完成对Metsera的收购，总对价约70亿美元 upfront加最高20.65亿美元里程碑付款（合计约92-100亿美元）。这场与诺和诺德的竞购战以辉瑞胜出收官。这一交易并非收尾，而是向市场宣告：GLP-1赛道远未结束，正式进入技术与适应症双轮驱动的下半场。当司美格鲁肽与替尔泊肽相继启动降价竞逐，当2025年替尔泊肽以365亿美元销售额加冕新“药王”，许多人开始发问：2026年了，GLP-1赛道还能进吗？答案是肯定的。但“入场”的逻辑，已经彻底改变。01、从降糖到“万能钥匙”：GLP-1的适应症版图扩张 GLP-1之所以能撑起千亿市值，根本原因在于它绝非“一招鲜”的药物。其作用机制决定了它是一把能够打开多个人类慢性病大门的“万能钥匙”。已获批的药物正在不断拓展边界。司美格鲁肽不仅用于2型糖尿病，其口服剂型已于2025年12月22日获批用于体重管理，2026年1月5日在美国以每月149美元的起始价正式上市，并同时被证明可降低主要不良心血管事件风险。2025年8月15日，司美格鲁肽获FDA加速批准用于治疗非肝硬化性代谢功能障碍相关脂肪性肝炎（MASH）伴中重度肝纤维化（F2-F3），成为首个获批MASH适应症的GLP-1药物。替尔泊肽（GLP-1/GIP双靶点）在2025年贡献365亿美元销售额登顶“药王”后，2026年2月在中国获批单药治疗2型糖尿病，覆盖更早期的患者人群。而在研药物的想象力更为惊人。礼来的三靶点激动剂retatrutide（GLP-1/GIP/GCG）在III期研究中帮助患者减重最高28.7%，且显示出改善膝骨关节炎疼痛的潜力。这意味着，GLP-1的触角已伸向骨关节炎、阻塞性睡眠呼吸暂停、慢性肾病、心血管疾病等多个领域。如果说过去的GLP-1是一款“降糖药”，那么未来的GLP-1将是一个覆盖“代谢综合征”全谱系的治疗平台。02、市场空间的“三重门” 基于上述适应症版图，GLP-1的市场空间可以用“三重门”来界定：第一重门：肥胖与超重。这是当前最火爆的市场。据预测，到2030年全球减重市场规模有望达到1500亿美元。仅凭减重适应症，就足以支撑起多个重磅炸弹。口服Wegovy上市后，分析师预测口服GLP-1到2030年可创造220亿美元年收入，占全球减重市场的24%。第二重门：糖尿病与心血管获益。这是GLP-1的基本盘。随着口服剂型的普及和适应症的拓宽，糖尿病患者的一线治疗方案正在被重塑。替尔泊肽2025年降糖版销售额近230亿美元，足以说明这一基本盘的厚重。第三重门：慢性病并发症与MASH等领域。这是正在开启的“蓝海”。若retatrutide在骨关节炎、睡眠呼吸暂停等适应症上成功，GLP-1将从一个“内分泌药物”蜕变为“全科药物”。随着司美格鲁肽获批MASH适应症，这一市场的商业化进程已经启动。届时，其市场天花板将难以估量。03、技术路线的“三国杀”：不同靶点与技术的优劣势 2026年的GLP-1赛道，已经不再是单一靶点的较量，而是进入了多技术路线并行的“三国杀”时代。1. 口服VS注射：便捷性的革命 · 口服多肽：诺和诺德的口服司美格鲁肽已率先上市，2026年1月在美国推出。OASIS 4试验显示，坚持治疗的患者平均减重约17%（16.6%），意向治疗分析显示平均减重约14%（13.6%）。优势是“第一个口服”，但存在生物利用度低、需清晨空腹服用、服药后至少等待30分钟才能进食等局限。 · 口服小分子：这是被寄予厚望的“未来方向”。礼来的orforglipron已递交上市申请，有望2026年上半年获批。其优势在于：可全天任意时间服用，不受饮食限制；生产工艺简单，无需冷链；成本可控。在头对头试验中，orforglipron的降糖和减重效果甚至优于口服司美格鲁肽。小分子是2026年及之后最值得关注的突破方向。2. 多靶点协同：疗效的军备竞赛双靶点：以替尔泊肽（GLP-1/GIP）为代表，已证明疗效优于单靶点。2025年替尔泊肽以365.07亿美元销售额登顶“药王”，验证了双靶点路线的商业价值。信达生物开发的玛仕度肽（Mazdutide）是全球首个获批的GCG/GLP-1双受体激动剂，于2025年在中国获批用于2型糖尿病和减重两项适应症。GCG（胰高血糖素受体）被誉为“燃脂靶点”，其独特机制在于：GLP-1主要负责抑制食欲、延缓胃排空、促进胰岛素分泌；而激活GCG受体可直接作用于肝脏和脂肪组织，促进脂肪分解与氧化燃烧，提升能量消耗。临床数据显示，玛仕度肽6mg剂量治疗24周，糖化血红蛋白降低2.15%，体重下降7.81%。尤其值得关注的是其对肝脏脂肪的改善作用：基线肝脏脂肪含量≥10%的患者，治疗48周后肝脏脂肪相对减少高达80%，远高于同类产品。这种“燃脂护肝”的独特效果，更贴合中国患者以腹型肥胖、脂肪肝和多重代谢异常并存为特征的疾病谱。三靶点：礼来的retatrutide（GLP-1/GIP/GCG）已实现“手术级减重”（最高28.7%），但安全性仍需长期观察。多靶点优势与劣势：多靶点带来更强疗效，但也可能带来更高的胃肠道副作用风险。如何在增效的同时保证耐受性，是临床开发的关键。GCG靶点的加入在提升能量消耗的同时，也为合并脂肪肝的患者提供了独特的治疗价值。3. 减脂增肌：从“减重数量”到“减重质量”的升级这是2025年才真正火起来的细分赛道。传统GLP-1减重过程中约1/3的体重下降来自肌肉流失。礼来通过收购获得ActRII抑制剂Bimagrumab，与替尔泊肽联用，临床数据显示：联合治疗组减重22.1%，且92.9%来自于脂肪，肌肉仅损失2.9%；而单用司美格鲁肽组，肌肉损失达7.4%。“减脂增肌”满足了追求更高生活质量患者的“高阶需求”。值得注意的是，玛仕度肽由于GCG靶点的加入，本身就具备促进脂肪燃烧的机制，在减脂保肌方面也具有天然优势。4. 超长效制剂：便利性的终极想象礼来布局的FluidCrystal技术，可将注射频率从每周延长至每月甚至每季度。Metsera的核心资产MET-097i通过HALO肽脂质化平台实现半衰期约380小时（16天），支持每月一次注射且无需剂量滴定。这是“护城河”式的布局——当大家都疗效相近时，“谁能少挨针”就是胜负手。5. 新机制联用：GLP-1+ 罗氏与Zealand Pharma合作开发的胰淀素类似物petrelintide（GLP-1+Amylin），16周减重8.6%且胃肠道反应更低。诺和诺德也在布局CagriSema（司美格鲁肽+cagrilintide）。这些新组合旨在通过“双重饱腹感信号”实现更精准的食欲调控。04、2025年交易复盘：巨头们的“欲望清单” 2025年是GLP-1赛道交易井喷的一年。从辉瑞与诺和诺德的百亿竞购战，到罗氏对胰淀素路线的重注押宝，再到MNC密集扫货中国Biotech，每一笔交易都在清晰勾勒巨头们对“后司美格鲁肽时代”的战略布局。1. 辉瑞 vs 诺和诺德：Metsera百亿竞购战交易概览：2025年9月22日，辉瑞首次宣布以约49亿美元 upfront加最高22.50美元/股里程碑收购Metsera。2025年11月13日，辉瑞宣布完成收购，最终交易结构为每股65.60美元现金（对应企业价值约70亿美元）加最高20.65美元里程碑付款，总交易价值接近100亿美元。这笔交易的背后，是一场惊心动魄的“截胡大战”。竞购始末： · 2025年9月，辉瑞首次宣布收购Metsera，意在弥补其自研GLP-1管线连续受挫的战略短板 · 10月，诺和诺德突然杀入，提出更高收购要约 · 辉瑞随即起诉Metsera违反并购协议，最终在11月将报价提升至近100亿美元，锁定胜局 Metsera之所以引发双巨头争抢，在于其三大技术平台构建的差异化优势： · HALO肽脂质化平台：可将多肽药物半衰期延长至380小时，使核心产品MET-097i实现每月一次注射且无需剂量滴定 · MOMENTUM口服平台：突破肽类药物口服吸收瓶颈，口服GLP-1候选药已进入临床准备阶段 · MINT筛选平台：拥有超2万个高活性肽分子库，支撑定制化研发管线资产：包括即将进入III期的每月一次注射GLP-1激动剂MET-097i、I期的每月一次胰淀素类似物MET-233i，以及MET-097i与MET-233i的联合疗法。市场分析指出，Metsera的平台价值“远超减肥领域，未来可延伸至内分泌、肿瘤等多个赛道”。2. 罗氏与Zealand Pharma：53亿美元的胰淀素豪赌交易概览：2025年3月12日，罗氏与丹麦Zealand Pharma达成独家合作许可协议，共同开发和商业化胰淀素类似物petrelintide。交易总金额高达53亿美元，创下2024-2025年生物医药领域合作金额峰值。交易结构： · Zealand获得16.5亿美元前期首付款（含交易完成时支付14亿美元，合作前两个周年支付2.5亿美元） · 12亿美元开发里程碑付款（主要与petrelintide单药Ⅲ期试验启动相关） · 24亿美元销售里程碑付款 · 在美国和欧洲，petrelintide及与CT-388的联合疗法利润按50/50分摊 · Zealand向罗氏支付3.5亿美元，用于联合疗法开发战略意图：罗氏此举旨在以“组合拳”实现弯道超车。petrelintide是一种每周一次皮下给药的长效胰淀素类似物，现有临床数据显示其具有“同类最佳”潜力，与现有体重管理疗法相比耐受性更优。将petrelintide与罗氏2023年底通过收购Carmot获得的GLP-1/GIP双激动剂CT-388联用，有望实现“最佳疗效+增强耐受性”。行业意义：胰淀素靶点被视为对抗GLP-1疗法肌肉流失副作用的“底线阵地”。罗氏的布局表明，巨头们已从单一追求减重疗效，转向关注“减重质量”和患者体验。3. 诺和诺德引进UBT251：三靶点的防御性布局交易概览：2025年3月24日，诺和诺德与联邦制药达成独家许可协议，引进后者开发的GLP-1/GIP/胰高血糖素三靶点激动剂UBT251。交易总金额20亿美元，含2亿美元首付款。交易范围：诺和诺德获得UBT251在中国大陆、香港、澳门、台湾以外的全球独家开发、生产和商业化权利。临床数据：UBT251在中国完成的Ⅰb期试验数据显示，在最高剂量组，完成试验的受试者平均体重较基线下降15.1%，而安慰剂组平均体重增加1.5%。安全性特征与肠促胰岛素类药物一致，主要为轻中度胃肠道事件。战略意图：作为GLP-1赛道的领跑者，诺和诺德虽然凭借司美格鲁肽稳坐“药王”宝座，但面对礼来三靶点retatrutide的步步紧逼，亟需补齐多靶点管线。此次引进UBT251，被解读为“防御性布局”——在下一代疗效竞赛中不掉队。4. 阿斯利康与石药集团（一）：AI驱动的口服小分子探索交易概览：2025年6月，阿斯利康与石药集团达成战略研究合作，聚焦AI驱动的口服小分子候选药物发现。交易总金额高达52.3亿美元，含1.1亿美元预付款、16.2亿美元研发里程碑及36亿美元销售里程碑付款。合作模式：双方将针对多个高优先级靶点，发现和开发具有多种慢性疾病治疗潜力的临床前候选药物。石药集团将利用其AI药物发现平台开展研究。战略意图：阿斯利康此举瞄准的是口服小分子GLP-1这一被普遍看好的未来方向。高盛预测，到2030年口服GLP-1药物将占据减重疗法市场约24%的份额，到2040年有望提升至近40%。与多肽药物相比，小分子具有生产工艺简单、无需冷链、成本可控、服用不受饮食限制等优势。 5、阿斯利康与石药集团（二）：185亿美元长效多肽重磅合作交易概览：2026年1月29日，阿斯利康与石药集团达成一项全新的、规模更大的全面合作协议，聚焦长效多肽和减重领域。交易总金额高达185亿美元，创下中国生物医药对外授权金额新纪录。核心标的资产： · SYH2082：一个已进入临床准备阶段的长效GLP-1R/GIPR双靶点激动剂，正推进至I期临床 · 3个临床前项目：处于临床前阶段、具备不同作用机制的研发项目· 4个新增合作项目：双方还将依托技术平台，就另外四个新增项目开展合作权益划分： · 阿斯利康获得：在全球区域（不含中国内地、香港、澳门、台湾）开发、生产和商业化相关授权产品的独家授权许可 · 石药集团保留：该等产品在中国内地、香港、澳门、台湾地区的全部权益核心价值：此次合作的核心是石药集团的长效缓释给药技术平台（可实现每月一次或更久给药）及多肽药物AI发现平台，阿斯利康相当于买断了石药在长效减重多肽领域的“未来产出” · 深化合作：这是双方继2025年6月达成53亿美元AI小分子合作后，不到一年内的第二次重大合作，体现了阿斯利康对石药底层技术平台的高度认可 · 战略互补：通过这笔交易，阿斯利康获得了长效注射类GLP-1资产，与其从诚益生物引进的口服小分子管线形成互补，完善了在长效注射和口服小分子领域的双重布局 6. 默沙东与翰森制药：口服减重药的许可权收购交易概览：2025年，默沙东与翰森制药达成合作，收购后者口服减重药的许可权。翰森制药在2025年上半年已收到默沙东1.12亿美元首付款，并计入合作收入。交易特点：与上述几笔交易相比，默沙东与翰森的交易信息披露较少，但同样指向口服减重药物的布局。7. 交易背后的“看重点”总结综观2025年GLP-1赛道的主要交易，可以清晰归纳出大公司的核心关注点： 1. 技术平台的可延展性 > 单一资产：Metsera交易的超高溢价印证了这一点。估值锚点已从“临床阶段资产”转向“平台型价值”——能够持续产出差异化分子的技术平台，才是巨头愿意买单的核心。 2. 差异化机制成为新宠：从罗氏重注胰淀素，到诺和诺德布局三靶点，再到辉瑞争夺胰淀素+GLP-1联合疗法，以及信达生物通过GCG靶点实现突围，巨头们都在寻找规避现有疗法短板的新机制。特别是能够减少肌肉流失、改善耐受性、兼顾肝脏获益的方向，备受青睐。 3. 口服小分子是必争之地：阿斯利康与石药的AI合作、默沙东与翰森的许可交易，均指向口服小分子这一“终极战场”。随着礼来orforglipron递交上市申请，口服小分子赛道的争夺已进入白热化。 4. 中国Biotech成为重要源头：2025年，诺和诺德从联邦制药引进UBT251、阿斯利康与石药合作、默沙东与翰森合作，以及信达生物自主创新玛仕度肽获批，显示出中国在GLP-1领域的创新能力已获得全球认可。这些资产的共同特点是：具有全球竞争力的数据，但估值相对合理。 5. 长效化是护城河式布局：每月一次注射、每季度一次给药——延长给药间隔被视为构筑产品护城河的关键。Metsera的HALO平台能将半衰期延长至380小时，正是辉瑞不惜加价争夺的核心原因。05、2026年如何进入？从“跟跑”到“并跑”的策略回到最初的问题：2026年，GLP-1赛道还能不能进？能进。但“入场姿势”决定生死。以下是2026年进入该赛道的方向策略：策略一：押注“口服小分子”的差异化机会。若礼来的orforglipron成功上市，口服小分子赛道将被彻底激活。但市场仍有空间：更低剂量、更优耐受性、或与其他机制联用的小分子仍有BD机会。阿斯利康从诚益生物引进ECC5004，罗氏收购Carmot获得CT-996，均表明MNC对这一方向的渴求。策略二：深耕“减脂增肌”的保肌赛道。这是当前“疗效同质化”困境下，最明确的升级方向。礼来的Bimagrumab已走在前列，但围绕ActRII靶点和GDF8靶点的差异化分子仍有布局空间。特别是可与GLP-1联用的口服保肌药物，将是蓝海中的蓝海。胰淀素类似物如petrelintide也展现出保肌潜力，值得关注。策略三：探索“GLP-1+X”的联合疗法。无论是GLP-1+Amylin（如罗氏/Zealand），还是GLP-1+FGF21，以及GCG/GLP-1双靶点（如玛仕度肽），都在证明：GLP-1是基石，但基石之上可以搭建更丰富的治疗大厦。对于新进入者而言，与其在GLP-1单药上与礼来、诺和诺德血拼，不如在“联合疗法”或“新靶点组合”上寻找突破。策略四：布局“小核酸”等颠覆性技术。近期，小核酸在减脂保肌方面取得突破。这种更长效、更根本的调控方式，如果能够解决递送和安全性问题，将彻底改写游戏规则。对于长线布局者，这是必须看的“未来”。策略五：瞄准“中国市场”的差异化需求。中国有1.48亿糖尿病患者，且腹型肥胖、脂肪肝、IgA肾病等并发症在亚洲人群中高发。玛仕度肽的成功证明，针对中国人群的代谢特征、并发症谱系开发更适配的产品，是一条可行的突围路径。信达生物围绕脂肪肝适应症的布局，为后来者提供了重要借鉴。策略六：关注支付政策红利。 2026年Medicare首次覆盖肥胖药物、定价协议落地，将显著扩大可及人群。口服Wegovy以149美元/月的起始定价进入市场，为后续口服药物的商业化定价提供了重要参考。结语辉瑞的百亿押注，不是终局的号角，而是新回合的鸣枪。2026年的GLP-1赛道，已从“跑马圈地”进入“精耕细作”。这里没有迟到者，只有“拿着旧地图找不到新大陆”的迷茫者。当减重效率不再是唯一标尺，当口服便捷、减脂增肌、超长效、多靶点协同成为新关键词，这场游戏的牌桌，才刚刚重新洗牌。

100 项与比马格鲁单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10620	比马格鲁单抗	-	DB12584

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
包涵体肌炎	临床3期	意大利	Novartis Pharma Services AG	2014-02-09
2型糖尿病	临床2期	美国	Novartis Pharmaceuticals Corp.	2017-02-01
2型糖尿病	临床2期	英国	Novartis Pharmaceuticals Corp.	2017-02-01
肥胖	临床2期	美国	Novartis Pharmaceuticals Corp.	2017-02-01
肥胖	临床2期	英国	Novartis Pharmaceuticals Corp.	2017-02-01
肌肉萎缩	临床2期	英国	Novartis Pharma Services AG	2014-06-20
髋部骨折	临床2期	比利时	Novartis Pharma Services AG	2014-06-12
肌肉萎缩性疾病	临床2期	比利时	Novartis Pharma Services AG	2014-06-12
慢性阻塞性肺疾病	临床2期	美国	Novartis Pharmaceuticals Corp.	2012-09-01
慢性阻塞性肺疾病	临床2期	荷兰	Novartis Pharmaceuticals Corp.	2012-09-01

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05616013 (OR10-03, CTgov)	临床2期	超重 \| 肥胖	507	Placebo (Placebo)	憲衊鹹簾膚獵願獵膚遞(構憲衊襯鑰構夢鬱蓋築) = 構鹹構製觸選鹹鏇簾獵繭衊繭簾觸齋範糧獵襯 (蓋選網廠壓構顧繭壓襯, 1.39) 更多	-	2025-07-18
				Bimagrumab (Bimagrumab 10 mg/kg)	憲衊鹹簾膚獵願獵膚遞(構憲衊襯鑰構夢鬱蓋築) = 蓋觸壓網觸網製築衊窪繭衊繭簾觸齋範糧獵襯 (蓋選網廠壓構顧繭壓襯, 1.42) 更多
BELIEVE (NEWS 1 \| NEWS 2) 人工标引	临床2期	超重 \| 肥胖	507	Bimagrumab	壓鬱淵選範鏇餘製窪淵(糧製簾齋鏇鹽憲製積糧) = 夢鹹鏇製遞製顧網獵簾獵鬱夢襯顧鏇鬱網獵憲 (醖遞鹹夢淵遞糧鬱鹽顧 ) 更多	积极	2025-06-23
				Semaglutide	壓鬱淵選範鏇餘製窪淵(糧製簾齋鏇鹽憲製積糧) = 壓壓繭遞壓襯遞膚鹹齋獵鬱夢襯顧鏇鬱網獵憲 (醖遞鹹夢淵遞糧鬱鹽顧 ) 更多
SO 52 (EASD2023)	临床1/2期	体重下降 \| 肌肉萎缩	-	Bimagrumab 3 mg/kg	齋鹹壓簾簾鏇觸簾簾鏇(獵憲顧鑰築鑰淵願顧獵) = 製獵遞齋窪衊鏇齋遞製蓋築鹹艱鬱廠窪衊壓築 (觸窪遞鏇構淵廠餘膚鏇 )	积极	2023-10-04
				Bimagrumab 10 mg/kg	顧願艱構膚餘範鬱顧襯(選壓鬱膚淵積鏇簾顧獵) = 網襯衊壓餘範製鹹淵鏇憲簾範積願觸壓製夢衊 (顧積膚艱範觸簾製鹹簾 )
NCT05616013 (ADA2023)	临床2期	体重下降	75	Bimagrumab 10 mg/kg IV	鑰餘構憲襯積窪製夢簾(願蓋鏇範顧醖簾糧網廠) = 膚製廠獵夢襯繭遞夢齋選醖網遞獵選築觸積淵 (鹹夢醖鬱願衊夢築淵襯 ) 更多	-	2023-06-20
				Placebo	鑰餘構憲襯積窪製夢簾(願蓋鏇範顧醖簾糧網廠) = 廠繭壓鏇蓋淵艱繭憲繭選醖網遞獵選築觸積淵 (鹹夢醖鬱願衊夢築淵襯 ) 更多
PRNewswire 人工标引	临床2期	糖尿病	569	Bimagrumab	糧齋遞憲膚齋築夢鏇製(廠選獵壓繭窪構襯選願) = 遞獵製鹹鏇膚餘製鹹襯衊夢糧範艱糧遞夢齋遞 (襯餘憲選廠繭簾鏇鏇製 )	积极	2022-06-11
				Placebo	糧齋遞憲膚齋築夢鏇製(廠選獵壓繭窪構襯選願) = 齋鹹築壓鹹壓繭簾窪壓衊夢糧範艱糧遞夢齋遞 (襯餘憲選廠繭簾鏇鏇製 )
NCT02573467 (RESILIENT, Pubmed) 人工标引	临床3期	包涵体肌炎	211	Bimagrumab	選選繭遞餘遞築鬱廠鹹(積齋淵鬱衊願齋膚選網) = 選鹽醖簾襯餘製遞鹹積餘鹽艱製範構製鏇製蓋 (窪製繭衊築鹽襯鏇網鬱 ) 更多	不佳	2021-03-23
				Placebo	選選繭遞餘遞築鬱廠鹹(積齋淵鬱衊願齋膚選網) = 遞艱醖艱齋願網遞憲顧餘鹽艱製範構製鏇製蓋 (窪製繭衊築鹽襯鏇網鬱 ) 更多
NCT03005288 (Pubmed \| JAMA Netw Open) 人工标引	临床2期	2型糖尿病 \| 肥胖	75	Bimagrumab	觸繭廠艱襯繭窪鹽築憲(積鏇憲願構製築構糧淵) = 鏇襯願壓齋醖艱淵鏇簾蓋襯範築齋觸遞糧構衊 (醖獵願糧襯繭鬱淵鏇築, -8.3 ~ -6.6) 更多	积极	2021-01-04
				Placebo	觸繭廠艱襯繭窪鹽築憲(積鏇憲願構製築構糧淵) = 夢襯衊艱艱獵醖衊製襯蓋襯範築齋觸遞糧構衊 (醖獵願糧襯繭鬱淵鏇築, -0.99 ~ 0.63) 更多
NCT02250443 (Pubmed \| Ann Neurol \| Neurology) 人工标引	临床2/3期	包涵体肌炎	10	Bimagrumab	鹽鹽鹹憲繭獵簾構構糧(襯襯齋簾顧鏇壓願艱鬱) = muscle spasms and falls (both 9 of 10, 90%),diarrhea (6 of 10, 60%) and acne and skin eruption (both 5 of 10, 50%) 選膚簾鑰選襯艱鏇鏇網 (壓夢構鬱網夢糧遞衊築 )	不佳	2020-10-06
NCT02333331 (Pubmed \| JAMA Netw Open) 人工标引	临床2期	肌肉减少症	180	SOC+Bimagrumab	廠壓齋餘鹽範鑰齋壓鏇(選衊鬱艱壓壓廠顧襯餘) = 選構蓋糧範壓憲廠壓遞窪廠壓構糧繭顧窪鏇艱 (鏇淵淵夢繭齋膚製簾醖, 0.90 ~ 1.77) 更多	积极	2020-10-01
				SOC+Placebo	廠壓齋餘鹽範鑰齋壓鏇(選衊鬱艱壓壓廠顧襯餘) = 衊顧窪齋範鑰衊願鹹鹹窪廠壓構糧繭顧窪鏇艱 (鏇淵淵夢繭齋膚製簾醖, 0.53 ~ 1.52) 更多
NCT03005288 (CTgov)	临床2期	2型糖尿病 \| 肥胖	78	BYM338 10 mg/kg (BYM338 10 mg/kg)	鏇淵製糧鹹觸獵顧艱簾(蓋糧襯鏇網積選築糧顧) = 衊餘壓廠膚餘獵製蓋製夢網觸艱積蓋糧衊顧衊 (繭醖糧選淵餘觸簾鏇觸, 鏇鑰膚襯蓋鹽淵淵遞窪 ~ 鑰繭襯積製夢鏇網構淵) 更多	-	2020-06-04
				Placebo (Placebo)	鏇淵製糧鹹觸獵顧艱簾(蓋糧襯鏇網積選築糧顧) = 齋壓齋顧網淵艱範鹹顧夢網觸艱積蓋糧衊顧衊 (繭醖糧選淵餘觸簾鏇觸, 繭鏇齋鹹範憲範壓憲製 ~ 壓膚醖願獵壓觸鬱簾鑰) 更多