A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.

开始日期2025-08-05

申办/合作机构

Amgen, Inc.

NCT07037433

/ Recruiting临床3期

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

开始日期2025-07-25

申办/合作机构

Amgen, Inc.

NCT07037459

/ Recruiting临床3期

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)

This study will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part study with a double-blind period and an open-label extension (OLE). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

开始日期2025-06-25

申办/合作机构

Amgen, Inc.

100 项与抗GIPR 抗体（安进）相关的临床结果

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项与抗GIPR 抗体（安进）相关的文献（医药）

2025-12-01·VASCULAR PHARMACOLOGY

Hypothalamic regulation of obesity: Revealing the therapeutic potential of a novel anti-obesity peptide

Review

作者: Subramaniyan, Vetriselvan ; Choo, Yi Ning ; Narayanan, Ram

Obesity is a chronic, complex condition defined by excessive fat buildup due to an imbalance between caloric consumption and energy expenditure. The significant global rise in prevalence of obesity is associated with numerous comorbidities, such as cardiovascular disease, type 2 diabetes, and non-alcoholic fatty liver disease. Conventional management approaches, including diet, exercise, pharmacotherapy, and bariatric surgery, may demonstrate restricted long-term effectiveness owing to inadequate adherence and physiological adjustments. Recent advancements in neuroscience underscore the hypothalamus as a pivotal regulator of energy balance via essential nuclei, including the arcuate nucleus (ARC), paraventricular nucleus (PVN), lateral hypothalamic area (LHA), and ventromedial nucleus (VMN). This review examines the therapeutic potential of a new anti-obesity peptide that targets hypothalamic signalling pathways. Preclinical and clinical evidence endorses the utilization of glucagon-like peptide-1 receptor (GLP-1R) agonists and novel multi-receptor drugs such as AMG 133, which integrate GLP-1R activation with glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonism. These therapies exhibit improved weight reduction and metabolic enhancement. Moreover, the integration of hypothalamic peptide therapy with lifestyle modifications or post-bariatric care provides synergistic advantages. Notwithstanding favorable results, peptide therapy encounters obstacles such as administration methods, sustained effectiveness, and expense. Overcoming these obstacles is crucial for the effective implementation of peptide-based treatments in sustained clinical obesity control.

2025-09-04·NEW ENGLAND JOURNAL OF MEDICINE

Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial

Article

作者: Abbasi, Siddique A. ; Burns, Cassandra E ; Liu, Yimeng ; Ross, Leorah ; Ryan, Donna H. ; Jastreboff, Ania M. ; Pannacciulli, Nicola ; Mackowski, Mia G. ; Bays, Harold E. ; Philipose, Nisha ; Ebeling, Peter R.

BACKGROUND:

Maridebart cafraglutide (known as MariTide) is a long-acting peptide-antibody conjugate that combines glucagon-like peptide-1 receptor agonism and glucose-dependent insulinotropic polypeptide receptor antagonism and that is intended for the treatment of obesity.

METHODS:

We conducted a phase 2, double-blind, randomized, placebo-controlled, dose-ranging trial that included 11 groups as two cohorts. Participants with obesity (obesity cohort) were randomly assigned in a 3:3:3:2:2:2:3 ratio to receive maridebart cafraglutide subcutaneously at a dose of 140, 280, or 420 mg every 4 weeks without dose escalation; 420 mg every 8 weeks without dose escalation; 420 mg every 4 weeks with 4-week dose escalation; 420 mg every 4 weeks with 12-week dose escalation; or placebo. Participants with obesity with type 2 diabetes (obesity-diabetes cohort) were randomly assigned in a 1:1:1:1 ratio to receive maridebart cafraglutide at a dose of 140, 280, or 420 mg every 4 weeks (all without dose escalation) or placebo. The primary end point was the percent change in body weight from baseline to week 52.

RESULTS:

We enrolled 592 participants. In the obesity cohort (465 participants; female sex, 63%; mean age, 47.9 years; mean body-mass index [BMI, the weight in kilograms divided by the square of the height in meters], 37.9), the mean percent change in body weight from baseline to week 52 on the basis of the treatment policy estimand (intention-to-treat approach) ranged from -12.3% (95% confidence interval [CI], -15.0 to -9.7) to -16.2% (95% CI, -18.9 to -13.5) with maridebart cafraglutide, as compared with -2.5% (95% CI, -4.2 to -0.7) with placebo. In the obesity-diabetes cohort (127 participants; female sex, 42%; mean age, 55.1 years; mean BMI, 36.5), the mean percent change in body weight from baseline to week 52 on the basis of the treatment policy estimand ranged from -8.4% (95% CI, -11.0 to -5.7) to -12.3% (95% CI, -15.3 to -9.2) with maridebart cafraglutide, as compared with -1.7% (95% CI, -2.9 to -0.6) with placebo. The mean change in the glycated hemoglobin level on the basis of the treatment policy estimand in this cohort was -1.2 to -1.6 percentage points in the maridebart cafraglutide groups and 0.1 percentage points in the placebo group. Gastrointestinal adverse events were common with maridebart cafraglutide, although less frequent with dose escalation and a lower starting dose. No unexpected safety signals emerged.

CONCLUSIONS:

In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes. (Funded by Amgen; ClinicalTrials.gov number, NCT05669599.).

2025-05-01·PEPTIDES

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities

Review

作者: Flatt, Peter R ; Bailey, Clifford J ; Conlon, J Michael

Recent studies with peptide-based incretin therapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). Randomised clinical trials and 'real-world' studies have confirmed the marked glucose-lowering and weight-lowering efficacy of these agents across diverse populations. These include different ethnic groups, young and elderly individuals with and without diabetes and/or overweight or obesity. Recent studies have also confirmed protections against the development and progression of cardiovascular and renal diseases that are additive to the benefits conferred by improved control of blood glucose and body weight. Emerging evidence suggests that incretin therapies could additionally ameliorate fatty liver disease, chronic inflammation, sleep apnea and possibly degenerative bone disorders and cognitive decline. New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The aim of the review is to acquaint the reader with developments in the field from 2023 to the present (February 2025).

265

项与抗GIPR 抗体（安进）相关的新闻（医药）

2025-10-24

·东楠逸锦

【深度】安进公司专利悬崖挑战与战略转型

引言安进公司（Amgen Inc.）作为全球领先的生物技术公司，正面临着前所未有的专利悬崖挑战。截至 2025 年 10 月 21 日，公司股价为 300.18 美元，总市值达 1616.05 亿美元(1)，位列全球第 14 大制药公司。然而，这家成立于 1980 年、拥有超过 21,000 名员工的行业巨头，其核心产品组合正处于关键的专利到期期。专利悬崖的严峻性不容忽视。根据最新数据，2025-2030 年间，全球将有价值约 3500 亿美元的药物失去专利保护，其中前 20 大制药公司承担了 80% 的收入损失风险(149)。对安进而言，其九款核心产品将在 2021-2030 年间陆续失去专利保护，其中Prolia/Xgeva 和 Otezla 合计占公司 2025 年预计总收入的 41%(125)。更令人担忧的是，公司面临 67% 的收入风险，前四大产品均面临专利到期威胁(132)。本研究旨在深入分析安进公司如何应对这一关键挑战，重点关注其核心产品专利到期后的市场影响、生物类似药竞争格局，以及公司的战略转型措施。通过对公司财务数据、产品管线、研发投入和并购策略的全面评估，我们将揭示安进能否成功跨越专利悬崖，维持其在生物技术领域的领导地位。一、安进核心产品专利到期全景图 1.1 专利到期时间轴与市场分布安进的专利悬崖呈现出集中爆发的特征，主要集中在 2025-2028 年这一关键时期。根据最新的专利到期数据，各核心产品的专利保护情况如下：已到期产品： •Enbrel（依那西普）：物质专利于 2012 年到期，但通过制剂和制备方法专利的扩展，目前活性组分制备专利期已延长至 2029 年，制剂专利期最长延长至 2034 年(12)。在美国市场，Enbrel 的新专利将于 2028 年 11 月 22 日到期，届时该药物将已上市 30 年(16)。 2025 年到期产品： •Prolia/Xgeva（地诺单抗）：主要专利已于 2025 年 2 月到期(6)。在美国，专利到期日为 2025 年 2 月 19 日；在欧洲，除法国、意大利、西班牙和英国外，其他国家已于 2022 年 6 月 25 日到期，而这四个主要市场将在 2025 年到期。 •Kyprolis（卡非佐米）：治疗方法专利已于 2025 年 4 月 14 日到期，而化合物专利将于 2027 年 12 月 7 日到期(19)。 2026-2028 年到期产品： •Xgeva：作为地诺单抗的另一个品牌，将于 2026 年到期(101)。 •Otezla（阿普米司特）：专利原定于 2024 年到期，但获得了超过 3 年的专利延期，现定于 2028 年 2 月 16 日到期(23)。法院裁决阻止了仿制药制造商在 2028 年前销售仿制药(8)。 •Enbrel：核心专利将于 2028 年到期(101)。 •Repatha（依洛尤单抗）：专利将于 2028 年 8 月到期(29)。 1.2 生物类似药获批与上市情况随着专利到期，生物类似药的竞争格局正在快速形成。截至 2025 年 6 月，安进核心产品的生物类似药获批情况如下：地诺单抗（Prolia/Xgeva）生物类似药： •Sandoz 的 Jubbonti®/Wyost® 已于 2025 年 6 月 2 日在美国上市，成为首个获批的可互换生物类似药(72)。根据与安进的和解协议，Sandoz 可于 2025 年 5 月 31 日或更早上市(76)。 •在欧洲，已有三家公司的生物类似药获批：Celltrion 的 Stoboclo®/Ozenvelt®（2025 年 2 月）、Samsung Bioepis 的 Obodence™和 Xbryk™（2025 年 2 月）以及 Sandoz 的产品（2024 年 5 月）(74)。依那西普（Enbrel）生物类似药： •Sandoz 的 Erelzi® 早在 2016 年 8 月就获得了 FDA 批准，但由于专利诉讼，预计要到 2029 年才能在美国上市(50)。 •Samsung Bioepis 的 Eticovo® 于 2019 年 4 月获批，但同样受到专利限制。其他产品的生物类似药进展： •Repatha：已有生物类似药在研，如 Henlius 开发的 evolocumab 生物类似药，但仍在专利保护期内(78)。 •Blincyto：Teva 和武田正在开发生物类似药，计划 2026 年进入市场，目前正在进行分子验证研究(84)。二、专利到期对核心产品的市场冲击分析 2.1 Enbrel：从巅峰到衰退的转折 Enbrel 作为安进的明星产品，其市场表现的变化最能体现专利到期和生物类似药竞争的影响。根据公司财报数据，Enbrel 的销售趋势呈现出明显的下滑态势： •2022 年：销售额 36.97 亿美元(122) •2023 年：销售额 36.97 亿美元(122) •2024 年：销售额 33.2 亿美元，同比下降 10%(63) •2025 年 Q1：销售额 5.1 亿美元，同比下降 10%(124) •2025 年 Q3：销售额 8.25 亿美元，同比下降 20%，主要由 13% 的销售扣除和 12% 的价格下降驱动(115) 欧洲市场的惨烈教训为美国市场提供了预警。在欧洲，安进已经失去了约 25% 的市场份额给 Samsung Bioepis 的生物类似药。法国市场的数据更为惊人，etanercept 生物类似药的渗透率已达 74%。价格方面，欧洲市场的生物类似药竞争导致 Enbrel 和同类产品价格下降了 30%-50%(66)。辉瑞作为 Enbrel 的共同开发者，其分得的收入也呈现下滑趋势。2024 年辉瑞从 Enbrel 分得 6.90 亿美元，同比下降 17%(58)，这进一步印证了该产品面临的市场压力。 2.2 Prolia/Xgeva：下一个面临冲击的重磅产品 Prolia 和 Xgeva 作为地诺单抗的两个品牌，合计占安进 2023 年销售额的 22% 以上(1)，是公司的第一大收入来源。2024 年的数据显示： •Prolia 全年销售额 40.48 亿美元(122) •2025 年 Q4 销售额 12 亿美元，全年 37.9 亿美元 •2025 年 Q1 销售额 11.7 亿美元，同比增长 5% 然而，随着 2025 年 2 月专利到期和 Sandoz 生物类似药的上市，Prolia/Xgeva 的销售前景堪忧。安进管理层在 2025 年 Q1 财报会议上明确指出，预计 2025 年下半年将出现销售侵蚀(128)。考虑到 Enbrel 在欧洲市场的经验，Prolia/Xgeva 可能面临类似的市场份额损失。 2.3 其他核心产品的风险评估除了 Enbrel 和 Prolia/Xgeva，安进的其他核心产品也面临不同程度的专利到期风险： Otezla（阿普米司特）： •2024 年销售额 21.88 亿美元(122) •占 2024 年产品销售额的 6.73% •虽然专利延期至 2028 年，但已面临激烈的市场竞争，2024 年销售额下降 3%，主要由 8% 的价格下降驱动 Repatha（依洛尤单抗）： •2024 年销售额 22.2 亿美元，同比增长 36%(121) •占 2024 年产品销售额的 7.58% •作为 PCSK9 抑制剂，技术结构相对清晰，未来可能面临生物类似药挑战(77) Kyprolis（卡非佐米）： •2024 年销售额 14.03 亿美元(122) •占 2024 年产品销售额的 4.32% •虽然治疗方法专利已到期，但化合物专利保护至 2027 年 12 月，短期内风险相对可控三、安进的战略应对：多管齐下的转型之路 3.1 重磅收购：通过外延式增长填补专利悬崖面对专利悬崖，安进采取了激进的并购策略。2023 年 10 月，公司以 278 亿美元收购 Horizon Therapeutics，这是安进历史上最大的一笔收购(101)。这笔交易的战略意图十分明确：通过获得罕见病药物来弥补核心产品专利到期带来的收入损失。 Horizon 带来的核心资产： •Tepezza（teprotumumab-trbw）：甲状腺眼病治疗药物，2024 年销售额达 18.5 亿美元(139)，成为安进新的增长引擎。2024 年 Q4 销售额 4.6 亿美元，全年近 19 亿美元(114)。 •Krystexxa（pegloticase）：痛风治疗药物，2024 年 Q3 销售额 3.1 亿美元，同比增长 116%。安进在全球静脉用 pegloticase 市场占据 60-65% 的份额(119)。 •Uplizna（inebilizumab-cdon）：视神经脊髓炎谱系疾病治疗药物，2024 年 Q4 销售额 1.01 亿美元，全年 3.79 亿美元。 •Tavneos（avacopan）：抗中性粒细胞胞浆抗体相关性血管炎治疗药物，2024 年 Q4 销售额 8100 万美元，全年 2.96 亿美元，同比增长 111%。通过这笔收购，安进在 2024 年 Q3 实现了 12 亿美元的罕见病产品销售额，这些产品大多处于生命周期早期，有望在未来几年持续增长(115)。 3.2 创新研发：押注下一代重磅产品在内部研发方面，安进展现出了强大的创新能力和资金实力。2024 年，公司研发投入达到创纪录的 60 亿美元，同比增长 25%(108)。公司的研发策略结合了人类遗传学、蛋白质工程和人工智能等前沿技术(106)。最具潜力的在研产品：MariTide（AMG 133） MariTide 是安进在减肥药市场的重磅赌注。作为一种长效肽 - 抗体偶联物，每月或更少频率给药，在 2025 年 6 月公布的 Phase 2 研究中展现出令人瞩目的效果： •非糖尿病肥胖患者：52 周平均体重减轻高达 20%，安慰剂组仅为 2.6% •糖尿病肥胖患者：52 周平均体重减轻高达 17%，安慰剂组仅为 1.4% •更重要的是，52 周时体重减轻尚未达到平台期，提示有进一步减重潜力 MariTide 的差异化优势在于其给药频率。与诺和诺德的 Wegovy（每周注射）相比，MariTide 的每月给药方案有望显著提高患者依从性。目前，公司正在进行 72 周的 Phase 3 MARITIME 慢性体重管理研究，并计划在 2025 年启动动脉粥样硬化性心血管疾病、心力衰竭和阻塞性睡眠呼吸暂停的 Phase 3 研究。其他重要研发进展： •IMDELLTRA（tarlatamab-dlle）：2024 年 5 月获得 FDA 加速批准用于广泛期小细胞肺癌，2024 年 Q3 销售额 3600 万美元，季度环比增长 200%(110) •Tezspire（tezepelumab-ekko）：哮喘治疗药物，2024 年 Q3 销售额 2.69 亿美元，同比增长 67% •Evenity（romosozumab-aqqg）：骨质疏松治疗药物，2024 年 Q3 销售额 3.99 亿美元，同比增长 30% 3.3 生物类似药布局：从防守到进攻面对生物类似药的威胁，安进采取了 **"以其人之道还治其人之身"** 的策略，积极布局生物类似药业务。公司利用其在生物制剂领域的丰富经验，开发了多款生物类似药： •2024 年，安进的生物类似药销售额达到 7 亿美元，同比增长 35% •成功推出了强生 Stelara 的生物类似药 Wezlana，标志着公司在生物类似药领域的突破(140) •继续扩大在肿瘤学和自身免疫疾病领域的生物类似药组合这种策略不仅能够部分抵消原研药专利到期的影响，还能为公司开辟新的收入来源。 3.4 产品组合优化：聚焦高增长领域安进正在重新平衡其产品组合，减少对即将失去专利保护产品的依赖，加大对高增长领域的投入：重点发展领域： 1.罕见病：通过 Horizon 收购，罕见病已成为公司重要的增长引擎。预计到 2030 年，罕见病药物可能贡献公司收入的 25%(126)。 2.肿瘤学：IMDELLTRA、Blincyto 等创新产品展现出强劲增长势头。2024 年，10 个产品实现双位数增长，包括多款肿瘤药物(116)。 3.代谢疾病：MariTide 有望在 2030 年达到 1000 亿美元的肥胖药物市场中占据重要份额。产品生命周期管理： •为即将到期的产品寻找新适应症，如 Otezla 在 2024 年获批用于中重度斑块型银屑病(89) •开发新剂型和给药方案，如 Enbrel 的每周给药方案(44) •通过价格策略和患者支持项目维持市场份额四、财务影响的量化评估与前景展望 4.1 专利悬崖的财务冲击预测基于各产品的销售占比和专利到期时间，我们可以对安进未来几年的财务影响进行量化分析：短期影响（2025-2026 年）： •Prolia/Xgeva 占 2025 年预计收入的 22% 以上(1)，随着生物类似药上市，预计将出现 30-50% 的销售下滑 •Enbrel 占 2024 年销售额的 10.3%(121)，已呈现加速下滑趋势，2025 年 Q1 同比下降 10%(124) •管理层预计 2025 年下半年将出现明显的销售侵蚀，但新增长将抵消大部分损失中长期影响（2027-2030 年）： •到 2030 年，安进面临 67% 的收入风险，前四大产品均将失去专利保护(132) •九款产品将在 2021-2030 年间失去专利保护，累计影响可能超过 100 亿美元 4.2 新增长引擎的贡献评估尽管面临专利悬崖，安进的新增长引擎正在加速运转： 2024 年业绩亮点： •总收入 334.24 亿美元，同比增长 19%(123) •产品销售增长 19%，主要由 23% 的销量增长驱动(123) •21 个产品创下销售记录(123) •自由现金流 104 亿美元，同比增长 41%(123) 2025 年展望：公司对 2025 年保持谨慎乐观，预计： •总收入 343-357 亿美元 •非 GAAP 每股收益 20.00-21.20 美元 •生物类似药销售额预计达到 10 亿美元以上 4.3 关键成功因素与风险提示成功跨越专利悬崖的关键因素： 1.MariTide 的市场成功：作为潜在的重磅产品，MariTide 需要在 2026-2027 年成功上市并快速放量，以弥补 Enbrel 和 Prolia/Xgeva 的收入损失。 2.罕见病产品的持续增长：Tepezza、Krystexxa 等产品需要保持高速增长，特别是 Tepezza 需要从目前的 18.5 亿美元增长到 30 亿美元以上。 3.生物类似药业务的扩张：需要从目前的 7 亿美元增长到 20 亿美元以上，成为重要的收入来源。 4.研发管线的执行力：需要持续推出创新产品，特别是在肿瘤学和罕见病领域。主要风险因素： 1.竞争加剧：在肥胖药物市场，诺和诺德和礼来已经建立了强大的先发优势，MariTide 面临激烈竞争。 2.监管风险：新药审批的不确定性，特别是对于创新药物如 MariTide。 3.执行风险：大规模并购的整合挑战，以及新产品上市的商业化风险。 4.宏观环境：美国《通胀削减法案》的价格谈判压力，可能影响新产品的定价策略。结语安进公司正站在一个关键的十字路口。专利悬崖的挑战是严峻的，2025-2028 年间，公司将失去多款核心产品的专利保护，预计将影响超过 100 亿美元的年收入。Enbrel 在欧洲市场的教训表明，生物类似药的冲击可能比预期更加猛烈。然而，安进的应对策略是全面而富有远见的。通过 278 亿美元收购 Horizon，公司成功获得了 Tepezza 等极具潜力的罕见病药物；通过 60 亿美元的研发投入，培育了 MariTide 等下一代重磅产品；通过生物类似药布局，实现了从防守到进攻的转变。更重要的是，公司正在从一家以成熟产品为主的传统生物技术公司，转型为以创新和罕见病为驱动的新型生物制药企业。对投资者的建议：安进的股票在短期内可能面临波动，特别是 2025 年下半年 Prolia/Xgeva 生物类似药全面上市后。但从长期来看，公司的转型战略是正确的。建议投资者关注以下几个关键指标：(1) MariTide 的临床进展和商业化前景；(2) Tepezza 等罕见病产品的增长轨迹；(3) 生物类似药业务的扩张速度；(4) 研发管线中其他创新产品的进展。对行业观察者的启示：安进的转型之路为整个生物技术行业应对专利悬崖提供了重要借鉴。成功的关键在于：(1) 提前布局，通过并购快速获得新的增长引擎；(2) 持续创新，保持强大的研发能力；(3) 灵活应变，在生物类似药时代找到新的商业模式；(4) 聚焦优势，在核心治疗领域建立领导地位。对公司管理层的建议： 1.加快 MariTide 的开发和上市进程，确保其成为新的增长支柱。 2.深化与医疗机构和支付方的合作，确保新产品的市场准入。 3.优化成本结构，提高运营效率，为转型期提供财务缓冲。 4.加强人才管理，特别是在创新研发和商业化领域吸引顶尖人才。总的来说，虽然专利悬崖是安进面临的最大挑战，但公司已经展现出了强大的战略定力和执行能力。如果能够成功执行既定战略，安进有望在 2030 年后以一个更加强大和多元化的姿态出现在全球生物制药舞台上。正如公司 CEO Robert Bradway 所说："2024 年销售和收益的强劲增长反映了我们业务的发展势头。凭借全球强劲表现，我们正在大力投资快速推进的管线，专注于在四个治疗领域提供创新疗法。"(123) 这种信心并非毫无根据，而是建立在扎实的战略布局和执行能力之上。参考资料 [1] Biotech Moat Overview | June 1(pdf) https://www.morningstar.com/content/cs-assets/v3/assets/blt4eb669caa7dc65b2/blt73f6a3d6d16ac04a/Biotech_Moat_Report.pdf?refid=cvent_2023_archive [2] Patent Expiration https://www.drugpatentwatch.com/blog/category/patent-expiration/ [3] Patent Cliff: Can small healthcare firms dictate terms for bigger Pharma on the M&A deals? https://www.acuitykp.com/blog/patent-cliff/ [4] Amgen Update on Patent Litigation Related to Sandoz 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Hoffmann-LaRoche LTD et al :: Justia Dockets & Filings(pdf) https://cases.justia.com/federal/district-courts/massachusetts/madce/1:2005cv12237/100734/491/0.pdf [41] Amgen Update on Patent Litigation Related to Sandoz Denosumab Biosimilar Products https://www.amgen.com/newsroom/company-statements/amgen-update-on-patent-litigation-related-to-sandoz-denosumab-biosimilar-products [42] U.S. Biosimilar Landscape Deve(pdf) https://www.amerisourcebergen.com/-/media/assets/corporate/global/campaign-pages/cencora-biosimilars-usmarketlandscape-jul25.pdf [43] Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap https://www.centerforbiosimilars.com/view/medicare-price-negotiations-will-slow-biosimilar-momentum-widening-market-gap [44] FDA Approves ENBREL for Once-Weekly Dosing https://www.amgen.com/newsroom/press-releases/2003/10/fda-approves-enbrel-for-once-weekly-dosing [45] Pearce IP BioBlast® for the week ending 3 October 2025 https://www.pearceip.law/2025/10/09/pearce-ip-bioblast-for-the-week-ending-3-october-2025/ [46] 专利战升级背后:安进三星再次对簿公堂，生物类似药市场生变?_手机新浪网 https://finance.sina.cn/stock/relnews/us/2024-08-23/detail-inckryae1111936.d.html [47] Amgen Raises Forecast for Year Even as Biosimilars Encroach https://www.ndtvprofit.com/business/amgen-raises-forecast-even-as-biosimilars-encroach-on-top-drugs [48] The Value of Biosimilars and Amgen's Commitment https://wwwext.amgen.com/science/biosimilars/value-of-biosimilars-and-amgens-commitment [49] [重磅]Enbrel生物类似药Erelzi获FDA批准上市 https://m.sohu.com/a/112882965_465956/ [50] Approval and launch dates for US biosimilars https://gabionline.net/reports/Approval-and-launch-dates-for-US-biosimilars [51] Lupin to launch etanercept and pegfilgrastim biosimilars in the US https://gabionline.net/biosimilars/news/Lupin-to-launch-etanercept-and-pegfilgrastim-biosimilars-in-the-US [52] Etanercept biosimilar - Sandoz https://adisinsight.springer.com/drugs/800038107 [53] 中年安进，如何安全度过专利悬崖期? // • 第一核心支柱Prolia将在2025年下半年迎接生物类似药的竞争; • 第二大核心支柱Enbrel增速放缓，... https://xueqiu.com/4376152234/343318494 [54] AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2023/10/amgen-reports-third-quarter-financial-results [55] Amgen, Merck, Teva Provide First-Quarter Biosimilars Info https://www.centerforbiosimilars.com/view/amgen-merck-teva-provide-first-quarter-biosimilars-reports [56] Amgen Raises Forecast for Year Even as Biosimilars Encroach https://www.ndtvprofit.com/business/amgen-raises-forecast-even-as-biosimilars-encroach-on-top-drugs [57] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [58] 2024年全球制药巨头自免业务排名TOP10 https://www.phirda.com/artilce_37907.html?module=trackingCodeGenerator [59] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [60] Amgen's 2013 Revenues Increased 8 Percent To $18.7 Billion And Adjusted Earnings Per Share (EPS) Increased 17 Percent To $7.60 https://www.amgen.com/newsroom/press-releases/2014/01/amgens-2013-revenues-increased-8-percent-to-187-billion-and-adjusted-earnings-per-share-eps-increased-17-percent-to-760 [61] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [62] Amgen 2024: Building a portfolio with longevity https://www.pharmalive.com/amgen-2024-building-a-portfolio-with-longevity/ [63] 安进2024年财报:业绩超预期，多样化药物组合推动高增长_财富号_东方财富网 https://caifuhao.eastmoney.com/news/20250207185319444019870 [64] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [65] Drug Price Trends for ENBREL https://www.drugpatentwatch.com/p/drug-price/drugname/ENBREL [66] 生物类似药欧美市场两重天-四川省医药行业协会 http://scyyhyxh.com/list_51/8209.html [67] +44 20 8123 2220 info@marketpu(pdf) https://pdf.marketpublishers.com/la_merie/competitor-analysis-biosimilar-n-biosuperior-anti-tnf-antibodies-2016-update.pdf [68] Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals https://www.centerforbiosimilars.com/view/eye-on-pharma-korean-drugmakers-impact-in-europe-new-denosumab-eculizumab-deals [69] Korean drugmakers control more than half of European biosimilar market https://openkorea.org/feeds/news/korean-drugmakers-control-more-than-half-of-european-biosimilar-market/ [70] Biosimilars’ Power or Not? https://www.dcatvci.org/features/biosimilars-power-or-not/ [71] SAT0161 PRELIMINARY REAL WORLD DATA ON SWITCHING PATTERNS BETWEEN ETANERCEPT, ITS RECENTLY MARKETED BIOSIMILAR COUNTERPART AND ITS COMPETITOR ADALIMUMAB, USING SWEDISH PRESCRIPTION REGISTRY(pdf) http://gooa.las.ac.cn/apipaperc/api/paper/pdfdown?wid=JA202307270024340WH&roid=RO202307270024340WH [72] New denosumab and ustekinumab biosimilar launches in US, Canada and Japan https://gabionline.net/pharma-news/new-denosumab-and-ustekinumab-biosimilar-launches-in-us-canada-and-japan [73] Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1] https://www.thesudburystar.com/globe-newswire/sandoz-launches-first-and-only-interchangeable-denosumab-biosimilars-in-us-providing-new-affordable-treatment-options-for-over-10-million-patients1 [74] CuraTeQ Biologics Completes Biosimilar Denosumab Phase I Trial https://www.pearceip.law/2025/04/10/curateq-biologics-completes-biosimilar-denosumab-phase-i-trial/ [75] Amgen Expands US BPCIA Denosumab Litigation to include Biocon https://www.pearceip.law/2025/06/30/amgen-expands-us-bpcia-denosumab-litigation-to-include-biocon/ [76] Amgen Update on Patent Litigation Related to Sandoz Denosumab Biosimilar Products https://www.amgen.com/newsroom/company-statements/amgen-update-on-patent-litigation-related-to-sandoz-denosumab-biosimilar-products [77] 2025-2029年关键生物制剂药物专利到期盘点_CPHI制药在线移动官网 https://m.cphi.cn/news/show-285728.html [78] Lesser-Known Biosimilar Candidates to Watch For https://www.centerforbiosimilars.com/view/lesser-known-biosimilar-candidates-to-watch-for [79] SEC Filings | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/0000318154-21-000005.pdf;%20filename_=UTF-8''0000318154-21-000005.pdf [80] Competition and price among brand-name drugs in the same class: A systematic review of the evidence https://pmc.ncbi.nlm.nih.gov/articles/PMC6667132/ [81] KYPROLIS Drug Patent Profile https://www.drugpatentwatch.com/p/tradename/KYPROLIS [82] BRIEF—China’s Hansoh files for approval of generic Kyprolis https://www.thepharmaletter.com/in-brief/brief-china-s-hansoh-files-for-approval-of-generic-kyprolis [83] Amgen Data To Be Presented At ASCO 2016 Demonstrates More Insights Into Treatment Options For Patients https://www.amgen.com/newsroom/press-releases/2016/05/amgen-data-to-be-presented-at-asco-2016-demonstrates-more-insights-into-treatment-options-for-patients [84] Blincyto Market Size, Share, Growth, and Industry Analysis, By Type (IV Infusion), By Application (B-cell Acute Lymphoblastic Leukemia (ALL), Relapsed/Refractory Cancer), Regional Insights and Forecast to 2033 https://www.marketgrowthreports.com/market-reports/blincyto-market-113987 [85] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results [86] Pipeline Report: Oncology Biosimilars to Advance in 2020 https://www.centerforbiosimilars.com/view/pipeline-report-oncology-biosimilars-to-advance-in-2020 [87] Stivarga (regorafenib) https://veri.larvol.com/news/stivarga-regorafenib/drug [88] Amgen Announces Top-Line Results of Vectibix® (panitumumab) Phase 3 Head-to-Head Study Against Erbitux® (cetuximab) in Metastatic Colorectal Cancer https://www.amgen.com/newsroom/press-releases/2013/05/amgen-announces-topline-results-of-vectibix-panitumumab-phase-3-headtohead-study-against-erbitux-cetuximab-in-metastatic-colorectal-cancer [89] Advancing Health Through Innov(pdf) https://www.fda.gov/files/drugs/published/new-drug-therapy-2025-annual-report.pdf [90] Otezla (apremilast) https://www.pharmakb.com/drug-report/apremilast [91] Otezla上市多久? - 1健康 https://www.jiankang1.com/ask/a179602.html [92] OTEZLA Drug Patent Profile https://www.drugpatentwatch.com/p/tradename/OTEZLA [93] Amgen History https://www.amgen.com/about/amgen-history [94] Only 1 patent barrier remains for launch of Amgen's Otezla generics in Korea https://www.koreabiomed.com/news/articleViewAmp.html?idxno=20115 [95] RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY OF MONTHLY MARITIDE PRESENTED AT THE AMERICAN DIABETES ASSOCIATION 85TH SCIENTIFIC SESSIONS https://www.amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions [96] 安进AMG 133公布II期结果:52周减重20% - 医药产业专区 - 生物谷 https://news.bioon.com/article/9da785381257.html [97] maridebart cafraglutide (AMG 133) Trials - LARVOL Sigma http://sigma.larvol.com/sigma/product.php?e1=856617&sourcepg=TZP&tab=ott [98] AMGEN PROVIDES STATEMENT ON MARITIDE PHASE 1 DATA https://www.amgen.com/newsroom/press-releases/2024/11/amgen-provides-statement-on-maritide-phase-1-data [99] Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus https://ctv.veeva.com/study/dose-ranging-study-to-evaluate-the-efficacy-safety-and-tolerability-of-amg-133-in-adult-participan [100] Amgen's big reveal of obesity data falls a little flat https://pharmaphorum.com/news/amgens-big-reveal-obesity-data-falls-little-flat [101] 278亿美元超级并购之后，安进仍陷“专利悬崖”之困_财经头条 https://cj.sina.cn/articles/view/6066470577/16996feb1027016dgk [102] Queen Mary Knowledge Group\nTh(pdf) https://www.qmbfs.com/s/Week-9-MA-2023.pdf [103] Amgen concludes $27.8bn acquisition of Horizon Therapeutics https://www.practical-patient-care.com/news/amgen-concludes-27-8bn-acquisition-of-horizon-therapeutics/ [104] Amgen buys Horizon for $27.8 billion in bold step into the rare disease market https://www.cphi-online.com/news/amgen-buys-horizon-for-27-8-billion-in-bold-step-into-the-rare-disease-market/ [105] IMDELLTRA® SIGNIFICANTLY REDUCED RISK OF DEATH BY 40% IN SMALL CELL LUNG CANCER PATIENTS https://www.amgen.com/newsroom/press-releases/2025/06/imdelltra-significantly-reduced-risk-of-death-by-40-in-small-cell-lung-cancer-patients [106] Research & Development Strategy https://www.amgen.com/science/research-and-development-strategy [107] Amgen's Strategic Momentum at the Bank of America Healthcare Conference: Key Takeaways for Investors https://www.ainvest.com/news/amgen-strategic-momentum-bank-america-healthcare-conference-key-takeaways-investors-2505/ [108] Amgen 2025: The future of American science and innovation https://www.pharmalive.com/amgen-2025-the-future-of-american-science-and-innovation/ [109] Fighting the World's Toughest Diseases https://www.amgen.com/fighting-the-worlds-toughest-diseases [110] FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer#:~:text=On [111] Oncology (Cancer) / Hematologic Malignancies Approval Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications [112] FDA Approves Tarlatamab for Extensive-Stage Small Cell Lung Cancer https://www.medscape.com/viewarticle/fda-approves-tarlatamab-extensive-stage-small-cell-lung-2024a10009ds?src=rss [113] Immunotherapy Drug Tarlatamab Approved for Advanced Small Cell Lung Cancer https://www.cancertodaymag.org/cancer-talk/immunotherapy-drug-tarlatamab-approved-for-advanced-small-cell-lung-cancer/ [114] 安进强劲业绩背后，减肥药开发按下暂停键|仿制药|减肥药开发|安进|治疗|知名企业_手机网易网 http://m.163.com/news/article/JNL90Q6M055619KF.html [115] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [116] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results [117] Amgen quarterly profit slips, obesity data on track for late 2024 https://www.streetinsider.com/dr/news.php?id=23558679 [118] Amgen quarterly profit rises 15% as Horizon deal boosts results https://www.xmza.com/research/markets/allNews/reuters/amgen-quarterly-profit-rises-15-as-horizon-deal-boosts-results-53758299 [119] Intravenous Pegloticase Market Size, Production, Sales, Average Product Price, Market Share, Import vs Export https://datavagyanik.com/reports/intravenous-pegloticase-market-research-report-analysis-and-forecast-till-2030/ [120] Hyperuricemia Drugs Global Market Report 2024 https://www.giiresearch.com/report/tbrc1619667-hyperuricemia-drugs-global-market-report.html [121] 安进2024年财报:业绩超预期，多样化药物组合推动高增长 2月4日，安进 $安进(AMGN)$1nbsp;公布了2024年财务业绩，超预期，股价随后大涨6.5%。公司2024年总收入同比... https://xueqiu.com/2319443919/322608173 [122] Amgen 2024: Building a portfolio with longevity https://www.pharmalive.com/amgen-2024-building-a-portfolio-with-longevity/ [123] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [124] 中年安进，如何安全度过专利悬崖期? // • 第一核心支柱Prolia将在2025年下半年迎接生物类似药的竞争; • 第二大核心支柱Enbrel增速放缓，... https://xueqiu.com/4376152234/343318494 [125] Patent Cliff: Can small healthcare firms dictate terms for bigger Pharma on the M&A deals? https://www.acuitykp.com/blog/patent-cliff/ [126] Amgen's Strategic Resilience Amid Patent Cliffs: Leveraging Acquisitions and Rare Diseases for Long-Term Growth https://www.ainvest.com/news/amgen-strategic-resilience-patent-cliffs-leveraging-acquisitions-rare-diseases-long-term-growth-2506/ [127] Amgen Reports Second Quarter 2019 Financial Results https://investors.amgen.com/news-releases/news-release-details/amgen-reports-second-quarter-2019-financial-results [128] Amgen Q1: Volume-Driven Sales Rise 11%, Cash Flow Doubles Amidst Biosimilar, IRS Tax Threats https://www.panabee.com/news/amgen-q1-quarterly-earnings-2025 [129] Amgen Reports First Quarter 2021 Financial Results https://www.amgen.com/newsroom/press-releases/2021/04/amgen-reports-first-quarter-2021-financial-results [130] Quarterly Newsletter | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/IR%20Newsletter_Q2_2019_Final.pdf [131] Annual Reports | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/2019%20Annual%20Letter_10-K%20Bookmarked.pdf [132] The $183B Impact of Patent Expirations On Biopharma Giants https://www.worldpharmatoday.com/news/the-183b-impact-of-patent-expirations-on-biopharma-giants/ [133] 2025至2030生物相似行业产业运行态势及投资规划深度研究报告.docx-原创力文档 https://m.book118.com/html/2025/0728/6052055203011205.shtm [134] Vizient Report Projects Price Inflation for Originators With Biosimilars in the Pipeline https://www.centerforbiosimilars.com/view/vizient-report-projects-price-inflation-for-originators-with-biosimilars-in-the-pipeline [135] Biosimilars Regulatory Roundup: May 2025 https://www.centerforbiosimilars.com/view/biosimilars-regulatory-roundup-may-2025 [136] 25 High-Value Drugs Losing Patent Protection in 2025: What It Means for Healthcare https://biopharmaapac.com/analysis/60/5727/25-high-value-drugs-losing-patent-protection-in-2025-what-it-means-for-healthcare.html [137] Global Biosimilars Market Size, Share, Growth, Trends & Analysis Report 2025 https://meditechinsights.com/global-biosimilars-market/ [138] The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market https://www.drugchannels.net/2025/07/the-stelara-biosimilar-price-war-how.html?m=1 [139] 全球前20大制药公司营收最新排名及分析!涉及强生、罗氏、默沙东、辉瑞等-腾讯新闻 https://news.qq.com/rain/a/20250427A0836Y00 [140] With patent losses on the horizon, Amgen refocuses its business strategy https://www.pharmavoice.com/news/amgen-patent-loss-business-strategy-otezla-enbrel-biosimilars/741572/ [141] Amgen's SWOT analysis: stock outlook amid obesity drug race By Investing.com https://www.investing.com/news/swot-analysis/amgens-swot-analysis-stock-outlook-amid-obesity-drug-race-93CH-3846730 [142] Johnson & Johnson Competitors – Top 10 Major Competitors of Johnson & Johnson | Competitors Analysis https://www.managementnote.com/johnson-johnson-competitors/ [143] Amgen: Business Model, SWOT Analysis, and Competitors 2024 https://pitchgrade.com/companies/amgen [144] 讨论详情 - 雪球 https://xueqiu.com/3692999302/346615026/372553727 [145] Biosimilar boom ahead: Patent expirations set to reshape the global biologics market https://www.biospectrumasia.com/analysis/29/25972/biosimilar-boom-ahead-patent-expirations-set-to-reshape-the-global-biologics-market.html [146] Navigating the Recession and Patent Expirations https://www.pharmexec.com/view/navigating-recession-patent-expirations [147] The Patent Cliff is Coming: What It Means for Pharma Investors in 2025 https://www.crispidea.com/pharma-investing-patent-cliff-2025/ [148] Assessing the Biosimilar Void in the U.S. - IQVIA https://www.iqvia.com/es-mx/insights/the-iqvia-institute/reports-and-publications/reports/assessing-the-biosimilar-void-in-the-us [149] Biopharma Trends 2025(pdf) https://web-assets.bcg.com/80/70/7fee493b4991934742b68e87dc3d/biopharma-trends-focusing-on-innovation-amid-complexity-jan-2025.pdf （注：文档部分内容可能由 AI 生成）

专利到期并购生物类似药

2025-10-24

·霁因生物医药转化基地

行业分析 | GLP-1赛道竞争加速：中国药企竞逐千亿市场蓝海

全球代谢性疾病治疗格局正经历深刻变革。GLP-1药物已成为生物医药创新中最具爆发力的板块之一，其应用已从传统的糖尿病治疗，拓展至减重、心肾保护、阿尔茨海默病等多个重大疾病领域。2025年上半年，全球GLP-1药物市场规模突破350亿美元，历史性超越PD-1/PD-L1抑制剂；全年市场规模有望突破700亿美元。长期以来，诺和诺德与礼来主导GLP-1药物市场格局，形成“双雄争霸”之势。在巩固降糖减重核心市场优势的同时，两家巨头正加速拓展新适应症。随着多靶点药物、口服制剂、超长效技术等持续突破，GLP-1赛道在患者覆盖范围和市场潜力方面仍有巨大空间。中国药企正积极切入这一高速增长的黄金赛道。 Part 1 / GLP-1：血糖与体重的“智能调节器” GLP-1是什么？胰高血糖素样肽-1（GLP-1）：一种由肠道L细胞分泌的肠促胰岛素激素，具有多种生理功能，包括刺激胰岛素分泌、抑制胰高血糖素释放、延缓胃排空等，在维持血糖稳态中发挥核心作用。胰高血糖素样肽-1受体激动剂（GLP-1RAs）：一类模拟天然GLP-1功能的药物。它们不仅广泛应用于血糖调控，其适应症也正扩展至肥胖症及其他代谢性疾病治疗。 GLP-1的作用机制 GLP-1通过与细胞膜上的GLP-1受体（GLP-1R）结合发挥作用。该受体属于G蛋白偶联受体家族，广泛分布于胰腺β细胞以及肺、脑、肝、骨骼肌、脂肪组织及肾脏等多种器官。促进胰岛素分泌：GLP-1结合胰岛β细胞受体后激活信号通路，促进胰岛素合成与分泌。其作用强度依赖于葡萄糖浓度，即高血糖时作用增强，血糖正常或偏低时作用减弱，从而有效避免低血糖风险。抑制胰高血糖素分泌：抑制胰岛α细胞分泌胰高血糖素，减少肝脏葡萄糖生成，协助维持血糖稳定。延缓胃排空：作用于胃肠道神经与肌肉组织，延缓胃内容物排空，减缓碳水化合物吸收，有助于控制餐后血糖上升。抑制食欲与摄食行为：作用于下丘脑等中枢区域，增强饱腹感，减少食物摄入，对体重管理具有积极意义。保护胰岛β细胞功能：除促进胰岛素分泌外，还具有保护与修复胰岛β细胞的功能，促进其增殖、抑制凋亡，从而维持长期血糖调节能力。 Part 2 / 技术迭代：从注射到口服，从单靶点到多靶点尽管司美格鲁肽、替尔泊肽等“明星”GLP-1类药物广为人知，技术迭代仍在持续。新一代GLP-1药物正朝着“更优效、更便捷、更安全”的方向升级，核心趋势体现在：从单靶点转向多靶点协同、从注射给药转向口服给药、从每周一次延长至每月一次，并且努力让减掉的主要是脂肪，而非珍贵的肌肉。技术迭代一览： 1.多靶点药物：疗效革命——从“单兵作战”到“多路协同” （1）第一代（单靶点）：如利拉鲁肽、司美格鲁肽，主要模拟GLP-1激活大脑受体抑制食欲。但肥胖成因复杂，单一路径存在疗效瓶颈。（2）第二代（多靶点）：通过协同激活或抑制多个代谢相关受体，突破单一靶点限制，实现“抑制食欲+加速代谢+器官保护”的协同机制。 lGIP & GLP-1组合（如替尔泊肽）：曾被视为“促肥胖”激素的GIP，与GLP-1联用可增强能量消耗，并可能减轻GLP-1胃肠道副作用，使减重过程更耐受，实现了降糖减重的“超级协同效应”。胰高血糖素 & GLP-1组合：胰高血糖素能强力促进肝脏能量消耗和脂肪分解，与GLP-1联用形成“抑制食欲”+“加速代谢”双重作用。三重乃至多重激动剂：未来药物可能同时靶向GLP-1、GIP和胰高血糖素受体，甚至整合其他靶点，多维度协同增效，实现更显著、更健康的减重效果。 2.口服制剂：用药体验革新——从“注射”到“口服” 尽管注射装置已优化，针头恐惧或抵触仍普遍存在。口服药片更具隐私性和便利性，尤其适合流动人群，显著提升患者的用药依从性。技术挑战与突破：多肽口服面临胃酸降解和肠道吸收差难题。科学家通过特殊制剂技术保护药物分子，使其能安全通过胃肠道并被吸收。小分子GLP-1RA（如Orforglipron ）：这是另一突破方向。非肽类化学小分子规避了吸收问题。礼来、恒瑞、信达等企业的布局，预示未来口服GLP-1药物可能更经济、生产更便捷，“服药如维生素”的体验将成为常态。 3.超长效制剂：给药频率降低——从“每周一次”到“每月一次” 长效GLP-1RAs将逐步取代短效制剂，目前以司美格鲁肽、替尔泊肽等周制剂为主。 ▶ 未来方向：双周制剂/月制剂：通过Fc融合蛋白、高分子聚合物微球等先进递送技术延长半衰期。安进的MariTide进度较快，初步数据支持每月甚至更长间隔给药。基因疗法“一次注射，管用半年”：利用病毒载体将GLP-1的基因导入人体，使细胞长期、稳定生产治疗性激素。 4. 减脂保肌：从“重量”到“体成分”的健康理念快速减重常伴随肌肉流失，导致基础代谢下降、乏力及骨折风险增加等。 ▶ 解决方案：靶向减脂增肌（ActRII）信号通路：负向调控肌肉生长抑制，同时促进肌肉生长并减少脂肪，实现“增肌减脂”。靶向肌肉生长抑制素（MSTN）：抑制MSTN可解除其对肌肉生长的抑制作用。靶向成纤维细胞生长因子21（FGF21）：该激素在调节能量代谢和改善胰岛素敏感性的同时，也可能优化身体成分。 Part3 / 应用拓展：从糖尿病到多疾病领域 GLP-1药物的应用领域持续扩展，从最初的降糖、减重，延伸至代谢功能障碍相关的脂肪性肝炎（MASH）、阿尔茨海默病等领域，其应用场景正从内分泌科向体检中心、心血管内科、神经内科快速渗透。心血管保护：GLP-1 RAs在临床试验中显著降低死亡率，并降低心血管和肾脏结局。研究表明，GLP-1RAs能够降低中风、心肌梗死、心力衰竭等风险。代谢相关脂肪性肝病（MAFLD）：全球约三分之二的2型糖尿病患者受此影响。多项研究表明，GLP-1RAs对MAFLD具有治疗潜力，无论患者是否患有糖尿病。阻塞性睡眠呼吸暂停（OSA）：GLP-1RAs可降低OSA患者的呼吸暂停低通气指数。2025年7月，中国NMPA正式批准替尔泊肽用于OSA治疗，成为国内该领域首个创新疗法。神经退行性疾病：新兴研究表明，GLP-1RAs可能对神经退行性疾病具有保护作用，包括阿尔茨海默病和帕金森病，并且对认知功能有积极影响。 Part 4 / 市场格局：双雄争霸，中国市场快速崛起全球GLP-1药物市场由诺和诺德和礼来主导，2024年全球GLP-1多肽类药物销售额达518亿美元，同比增长42%。预计到2030年，GLP-1类药物年销售额将超过1000亿美元，成为潜在的千亿美元市场。中国GLP-1市场规模从2016年的2.6亿元快速增长至2023年的87亿元，2025年预计达到233亿元，2030年有望达到400-500亿元。 2025年上半年，全球GLP-1类药物市场规模达352亿美元。诺和诺德的司美格鲁肽凭借Ozempic（降糖注射版）、Rybelsus（降糖口服版）与Wegovy（减重版）的“三驾马车”，以166.32亿美元销售额正式超越K药，登顶2025上半年全球“药王”。礼来的替尔泊肽以121.3%的同比增速斩获147.34亿美元销售额，与司美格鲁肽的差距仅缩至20亿美元。除现有产品外，两家企业持续推动新适应症申报、剂型优化和联合用药开发，巩固领先地位。在巨头激烈竞争的背后，是医学届对肥胖认知的根本转变——从早期的“代谢异常”到“慢性疾病”，再升级为“全身系统性风险”，这一观念革新极大拓展了GLP-1药物的临床价值和市场边界。 Part 5 / 中国药企崛起：从跟跑到并跑中国拥有超1.4亿糖尿病患者和超2亿肥胖人群，为GLP-1类药物提供了广阔的市场。国内药企正通过快速跟进和差异化创新，多维度切入这一赛道。中国GLP-1研发代表企业布局情况仿制药布局：司美格鲁肽国内专利预计2026年到期，GLP-1仿制药竞争升温。截至2025年8月，已有7家中国药企正式申报司美格鲁肽生物类似药上市申请，包括惠升生物、石药集团、九源基因、丽珠集团、华东医药、齐鲁制药、联邦制药。创新药进展：恒瑞医药HRS9531取得Ⅲ期临床试验积极顶线结果；众生药业RAY1225完成减重Ⅲ期入组；民为生物自主研发全球首创GLP-1/GIP/FGF21三靶点药物MWN105注射液进入临床阶段。跨境合作突破：2025年7月，石药集团将其口服小分子GLP-1RA SYH2086以最高20.75亿美元交易额授权给MASH赛道先锋Madrigal Pharmaceuticals，创中国代谢病领域授权新纪录。联邦制药将其三靶点药物UBT251以20亿美元授权给诺和诺德。 GLP-1药物市场的崛起，为全球数亿糖尿病和肥胖症患者带来新希望，也为全球医药市场注入强劲活力。预计到2030年，GLP-1类药物年销售额将突破1000亿美元，成为潜在的千亿美元市场。随着适应症的不断拓展与技术迭代加速，GLP-1赛道将持续高速发展。中国市场正成为全球GLP-1药物最重要的增量市场，凭借在细分领域的差异化布局与合作，中国药企有望实现国际化突破，在这条黄金赛道中分享更多增长红利。 GLP-1的故事才刚刚开始，从糖尿病到减肥，从MASH到阿尔茨海默病，这条关乎全球数亿代谢疾病患者健康的创新赛道还在不断拓宽。下一个十年，GLP-1将继续引领生物医药行业的创新浪潮。本文核心数据源自市场公开研究报告，仅作信息分享，不构成任何投资建议。若存在版权异议或内容侵权，请通过后台提交反馈，我们将及时处理。

上市批准临床结果

2025-09-10

·BioSpace

Beyond MariTide: Amgen Makes Portfolio Play Amid Scrutiny of Obesity Prospect

iStock, pishit Suddenly one obesity asset has come to define Amgen but executives see a fuller portfolio that will bring the big biotech into the future. Amgen went into 2025 on the back of 22% revenue growth driven by a portfolio of 14 products that could generate blockbuster sales. Yet, one investigational drug candidate, MariTide, dominates chatter about the company, with shifts in sentiment about the obesity prospect adding or wiping billions of dollars from the biotech’s value. The wild swings raise a question: Is one drug really going to be Amgen’s future? BMO Capital Markets analysts characterized the attention investors pay to the Amgen obesity program as a “hyper focus on MariTide” in a note to investors. This focus may reflect MariTide’s unusually high sales ceiling. Evaluate Pharma has tipped MariTide sales to hit $3.7 billion in 2030, a forecast that suggests it will be an important but not company-defining product. Yet, with Evaluate predicting GLP-1s will account for 9% of all prescription drug sales by 2030, there is scope for MariTide sales to go much higher if Amgen gains an edge over incumbents Eli Lilly and Novo Nordisk. After mixed data raised questions about MariTide’s tolerability, TD Cowen analysts said in a note to investors that expectations for MariTide are “relatively guarded.” These expectations, which are informed by questions about whether the drug can hit the right balance between efficacy and tolerability, put the onus on the rest of Amgen’s pipeline and portfolio to show the company has a bright future. Amgen’s Catalysts for 2025 BMO analysts flagged readouts from trials of dermatitis candidate rocatinlimab as two of Amgen’s big clinical updates for the second half of 2025. Amgen paid Kyowa Kirin $400 million upfront to partner on the development of the anti-OX40 antibody in 2021. The partners went on to start eight Phase III studies to assess the drug candidate in more than 3,300 patients with moderate-to-severe atopic dermatitis. Data from the ASCEND and ASTRO trials are due by the end of the year. The readouts will show how the antibody performs as a maintenance therapy and in adolescent patients. Analysts are looking to the data for insights into how the drug candidate compares to rival drugs such as Regeneron and Sanofi’s Dupixent. After seeing data from another Phase III trial, TD Cowen analysts wrote that the antibody “showed good efficacy and better than expected tolerability.” However, the analysts added that rocatinlimab is “unlikely to unseat Dupixent and will likely face stiff competition from [Sanofi’s] amlitelimab.” BMO analysts said rocatinlimab “could see use behind Dupixent” in atopic dermatitis. A readout is also expected for approved cholesterol drug Repatha in 2025. BMO analysts named the cardiovascular outcomes data as another key catalyst for the company in the second half of the year. Positive data could support further growth of the PCSK9 inhibitor, which has recovered from a slow start to become a key product for Amgen. Sales increased 31% to $696 million in the second quarter. Phase III data on bemarituzumab in gastric cancer are due around the end of the year. TD Cowen analysts said the data on the anti-FGFR2b antibody “ought to add another growth driver right after Uplizna is approved for generalized myasthenia gravis (gMG).” The FDA is set to decide whether to greenlight Uplizna in gMG in December. The anti-CD19 antibody won FDA approval in the fibro-inflammatory condition IgG4-RD this year, adding to an earlier authorization in neuromyelitis optica spectrum disorder. TD Cowen analysts anticipate “a solid launch” in IgG4-RD and gMG and see peak sales of $2 billion to $3 billion for the Uplizna franchise. The Tortoise and the Hare Biosimilars are another piece of the portfolio. Amgen said in January that it is on track to grow biosimilar sales to more than $4 billion by 2030. The company is developing a copy of the intravenous form of Merck’s Keytruda, which is set to lose patent protection in 2028. The biosimilar could help Amgen toward the sales target, but the company is also encouraging investors to look beyond any one product. “What’s maybe underappreciated is the portfolio effect. It’s true that any individual biosimilar will launch and then you can face further competition and price erosion,” Justin Claeys, VP of investor relations at Amgen, said at a BofA Securities event in May. “On the other hand, with these waves of launches that build on each other, in aggregate it’s actually quite a healthy business.” The steady biosimilar business contrasts with the potentially explosive growth of MariTide. Amgen is betting big on the obesity prospect, starting five Phase III studies in the first seven months of 2025. The trials are evaluating the effect of MariTide on weight loss and cardiovascular outcomes in patients with overweight or obesity and various comorbidities. MariTide targets the GLP-1 and GIP receptors. Both MariTide and Eli Lilly’s Zepbound are agonists of GLP-1, but Zepbound activates GIP, potentially lessening nausea and suppressing appetite, whereas MariTide blocks the receptor to try to reduce fat accumulation. Any release of obesity data has been sparking a frenzy at the markets of late, with even bigwigs like Lilly and Novo suffering share declines when their readouts didn’t meet analysts’ sky high expectations. Amgen found this, too, in November 2024, when Phase II results for MariTide showed weight loss of up to 20%—compared to expectations as high as 25%. Amgen’s shares declined 11% on the news. Analysts have also flagged potential tolerability issues with Amgen’s candidate. In response, the company has proposed a three-step dose escalation strategy. Amgen is planning to publish additional Phase II results on MariTide in the fourth quarter. Recent history suggests the data could spark movements in the biotech’s share price, but analysts are factoring a wider set of programs into their assessments. After Amgen posted second-quarter results in August, TD Cowen analysts highlighted the attractiveness of the company’s “broad growth portfolio.”

临床结果临床3期临床2期上市批准

100 项与抗GIPR 抗体（安进）相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
动脉粥样硬化	临床3期	中国	Amgen, Inc.	2025-07-16
动脉粥样硬化	临床3期	阿根廷	Amgen, Inc.	2025-07-16
动脉粥样硬化	临床3期	德国	Amgen, Inc.	2025-07-16
动脉粥样硬化	临床3期	波兰	Amgen, Inc.	2025-07-16
动脉粥样硬化	临床3期	新加坡	Amgen, Inc.	2025-07-16
间歇性跛行	临床3期	中国	Amgen, Inc.	2025-07-16
间歇性跛行	临床3期	阿根廷	Amgen, Inc.	2025-07-16
间歇性跛行	临床3期	德国	Amgen, Inc.	2025-07-16
间歇性跛行	临床3期	波兰	Amgen, Inc.	2025-07-16
间歇性跛行	临床3期	新加坡	Amgen, Inc.	2025-07-16

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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


NCT05669599 (Pubmed) 人工标引	临床2期	肥胖	592	Maridebart Cafraglutide 140mg/280mg/420mg	鹽顧鹽觸鏇築鬱壓艱鹹(網窪網鑰蓋繭憲網衊壓) = 鹽鏇蓋觸網壓鬱積繭襯憲選繭網鏇壓簾齋獵鬱 (積願觸觸廠壓顧襯衊獵 ) 更多	积极	2025-06-23
				Placebo	鹽顧鹽觸鏇築鬱壓艱鹹(網窪網鑰蓋繭憲網衊壓) = 齋獵鏇顧糧範蓋艱網獵憲選繭網鏇壓簾齋獵鬱 (積願觸觸廠壓顧襯衊獵, -4.2 ~ -0.7) 更多
NCT05056246 (CTgov)	临床1期	-	34	AMG 133 (Japanese Participants: AMG 133 Low Dose)	鑰襯蓋選簾齋繭鏇壓膚(淵網衊鏇築糧遞簾鹹範) = 淵鹹醖繭廠積構獵遞襯衊鑰簾糧選選壓夢構網 (繭淵遞鹹鏇廠製選醖繭, 57.3) 更多	-	2025-02-25
				AMG 133 (Japanese Participants: AMG 133 Medium Dose)	鑰襯蓋選簾齋繭鏇壓膚(淵網衊鏇築糧遞簾鹹範) = 獵窪夢窪膚憲膚膚網窪衊鑰簾糧選選壓夢構網 (繭淵遞鹹鏇廠製選醖繭, 24.1) 更多
NCT05669599 (Corporate Publications) 人工标引	临床2期	肥胖	592	AMG 133 420 mg (Without Type 2 Diabetes)	廠簾糧積淵繭觸築築網(壓窪簾膚獵窪艱觸壓網) = Without Type 2 Diabetes: MariTide Demonstrated up to ~20% Average Weight Loss at 52 Weeks Without a Weight Loss Plateau; With Type 2 Diabetes: MariTide Delivered an Impressive up to ~17% Average Weight Loss at 52 Weeks Without a Weight Loss Plateau 衊製範壓構構襯齋繭積 (淵襯觸鑰願壓網餘糧願 ) 更多	积极	2024-11-26
				Placebo (Without Type 2 Diabetes)
NCT04478708 (Corporate Publications) 人工标引	临床1期	肥胖	75	AMG 133	齋鹽積糧憲廠餘廠築鹽(範願簾窪鹽鏇餘選鏇餘) = 衊襯範鏇壓窪齋膚蓋獵鏇夢襯鏇獵蓋衊願獵顧 (繭獵糧積觸選繭鬱蓋衊 )	积极	2022-11-07
				Placebo	齋鹽積糧憲廠餘廠築鹽(範願簾窪鹽鏇餘選鏇餘) = 繭襯艱糧積繭襯壓淵鏇鏇夢襯鏇獵蓋衊願獵顧 (繭獵糧積觸選繭鬱蓋衊 )