A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Petrelintide Co-Administered With RO7795068 in Adults With Obesity or Overweight

The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.

开始日期2026-06-30

申办/合作机构

Zealand Pharma A/S

NCT07338214

/ Completed临床1期

Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations in Participants With a BMI ≥27.0 kg/m²

This clinical research study is testing the study compound petrelintide that is being developed for the weight management in people with obesity or overweight with co-morbidities or related diseases.
The goal is to learn how the same single dose of petrelintide, given using different concentrations, works in the body when given to participants with a BMI at, or above, 27kg/m2.
The main questions it aims to answer are:
1. Are there differences in how the body absorbs, distributes, metabolises and excretes petrelintide when same single dose petrelintide is given using different concentrations?
2. Are there differences in safety of petrelintide when same single dose petrelintide is given using different concentrations?
Participants will:
Visit the study center 10 times for tests and blood sampling (9 day ambulatory visits and 1 in-house visit of 4 consecutive days with sleeping 3 nights at the study center).
Petrelintide will be given once as a single injection in a skin fold of the abdomen on Day 1. The participants will be monitored until approximately Day 50.

开始日期2025-12-17

申办/合作机构

Zealand Pharma A/S

[+1]

NCT06926842

/ Active, not recruiting临床2期

A Randomized, Double-Blind, Phase 2 Trial of Once-Weekly Petrelintide Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes

The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.

开始日期2025-04-22

申办/合作机构

Zealand Pharma A/S

[+1]

100 项与 Petrelintide 相关的临床结果

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100 项与 Petrelintide 相关的转化医学

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100 项与 Petrelintide 相关的专利（医药）

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项与 Petrelintide 相关的文献（医药）

2026-07-01·DIABETES OBESITY & METABOLISM

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials

Article

作者: Macura, Stanislava ; Brændholt Olsen, Minna ; Heise, Tim ; Griffin, Jon ; Fredsted Hagen, Berith ; Hesse, Dan ; Hövelmann, Ulrike

ABSTRACT:

Aims:

Petrelintide is a long‐acting amylin analogue in development for weight management. The safety, tolerability, pharmacokinetics, and pharmacodynamics of petrelintide were evaluated in single ascending dose (SAD) and multiple ascending dose (MAD) trials.

Materials and Methods:

Both trials were randomized, placebo‐controlled, and double‐blind. The SAD trial assessed subcutaneous (SC) petrelintide doses of 0.04–2.4 mg and a 0.35 mg intravenous dose. The MAD trial evaluated 6 once‐weekly SC doses of 0.6 and 1.2 mg (part 1), and 16 once‐weekly doses escalated every 2 weeks to target doses of 2.4, 4.8, and 9.0 mg (part 2). The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.

Results:

Petrelintide was well tolerated, with no serious or severe treatment‐emergent adverse events (TEAEs). In both trials, the most common TEAEs included gastrointestinal (GI) disorders, most of which were mild. One participant discontinued treatment due to GI TEAEs. Nausea, the most common GI TEAE, occurred in 16.7%–33.3% of participants receiving petrelintide versus 16.7% for placebo in MAD part 2, while diarrhoea was rare and vomiting was only experienced by the participant who discontinued. Petrelintide was slowly absorbed, had a half‐life of ~10 days, showed steady‐state dose proportionality, and reduced body weight by up to 8.6% after 16 weeks.

Conclusion:

Petrelintide appeared safe, had a low incidence of GI TEAEs, and resulted in clinically relevant weight loss. These findings support further development of petrelintide as an effective weight‐management medication, with potential for improved GI tolerability over existing therapies.

2026-03-01·VASCULAR PHARMACOLOGY

Amylin receptors as therapeutic targets in obesity: Emerging peptide-based strategies

Review

作者: Rejili, Mokhtar ; Haouala, Faouzi ; Sahoo, Samir ; Khan, Yumna ; Pal, Amrita ; Arora, Vimal ; Ganesan, Subbulakshmi ; Hussain, Md Sadique

Obesity is a chronic, relapsing metabolic disorder driven by complex genetic and environmental factors, leading to an imbalance in energy regulation. Despite the presence of GLP-1 receptor agonists with induced mild weight loss, there are significant unmet clinical needs with poor efficacy and tolerability problems. Amylin, a neuroendocrine hormone co-released with insulin, controls hunger, gastric motility, glucagon secretion, and energy metabolism via divergent amylin receptor (AMYR) subtypes (1-3), namely the calcitonin receptor (CTR) and the receptor activity-modifying proteins (RAMPs). Novel insight into the molecular make-up of AMYRs and central signaling reinforces its key function in modulating homeostatic and hedonic feeding mechanisms. The article is a review of the emerging preclinical and clinical data regarding the application of peptide-based amylin receptor agonists (AMYRAs), including pramlintide and cagrilintide, KBP-series DACRAs, and investigational drugs, including ZP8396 and amycretin. The agents show enhanced pharmacokinetics, synergy with GLP-1 receptor agonist, and favorable impact on weight regulation and metabolic plasticity. Genetic CALCR and RAMP mutations, new delivery approaches, and dual therapy by digital health technologies and bariatric surgery are also discussed in this review. Of particular interest, amylin-derived medications can have advantages over weight loss but definite disease-modifying action remains to be determined. Taken together, AMYRAs represent a potential category of therapeutics with promising disease-modifying effects that goes beyond weight loss, providing fresh perspectives for precision obesity management by 2030.

2026-03-01·PEPTIDES

Long-acting amylin-related peptides as therapies for obesity and type 2 diabetes

Review

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

The first therapeutically useful amylin receptor (AMYR) agonist, pramlintide was based upon the structure of non-aggregating rat amylin and found limited application as an adjunct to insulin therapy. It acts centrally to induce satiety, promote weight loss, suppress prandial glucagon release and reduce prandial hyperglycaemia. Recent understanding of the heterodimeric structure of amylin-calcitonin receptor complexes and of amylin structure-function properties has assisted the design of a second generation of non-aggregating, long-acting amylin analogues. These are now advancing in clinical development and promise to provide an effective additional resource for the management of obesity and type 2 diabetes. Amongst these agents is the dual AMYR/ calcitonin-receptor (CTR) agonist, cagrilintide that has also been co-formulated into a once weekly subcutaneous injection with the long-acting glucagon-like peptide-1receptor (GLP-1R) agonist, semaglutide (CagriSema). In clinical trials, CagriSema has achieved greater effects than either component alone. A unimolecular AMYR/CTR/GLP-1R multi-agonist peptide, amycretin has been developed for weekly injection and as a once-daily tablet. Several recently developed long-acting amylin analogues have shown strong efficacy as monotherapy in clinical trials: these include eloralintide, petrelintide, Met-233 and AZD6234. Other analogues with marked efficacy in preclinical studies, including non-peptide AMYR agonists are under development. Gastrointestinal side effects, especially nausea, similar to those reported for GLP-1R agonists are commonplace during initiation and up-titration of amylin analogues but mostly resolve during continued use. Evidence is emerging that long-acting AMYR agonists may show potential therapeutic benefits in treatment of patients with fatty liver disease, diabetes-associated kidney complications and resistant hypertension.

233

项与 Petrelintide 相关的新闻（医药）

2026-07-06

·PRNewswire

Ascletis Submits Two IND Applications to the U.S. FDA for the Treatment of Obesity: ASC36 Once-Monthly Injection, a Peptide Amylin Receptor Agonist, and ASC36_35 FDC Once-Monthly Injection, a Co-Formulation of ASC36 Plus Peptide GLP-1R/GIPR Agonist ASC35

ASC36_35 FDC, a once-monthly subcutaneous (SQ) injection co-formulation of ASC36 and ASC35, is a potentially first-in-class drug candidate targeting three validated targets of amylin receptor, GLP-1R and GIPR. ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study. ASC36 is a potentially first-in-class once-monthly to once-quarterly SQ injection targeting amylin receptor. ASC36 monotherapy demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively, in head-to-head DIO rat studies. HONG KONG, July 5, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today recent submissions of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for ASC36, a once-monthly to once-quarterly next-generation peptide amylin receptor agonist and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 plus peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity. "Eloralintide in combination with tirzepatide recently demonstrated 29.0% weight loss at week 32[1]. However, two separate weekly injections are required; one for eloralintide and one for tirzepatide. In contrast, ASC36_35 FDC, a potentially first-in-class subcutaneous (SQ) injection co-formulation targeting amylin receptor, GLP-1R and GIPR, requires only one monthly injection," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "Equally exciting, ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study. These animal models are highly predictive of human efficacy." Both ASC36 and ASC35 were discovered in-house utilizing Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD). Both ASC36 once-monthly to once-quarterly formulation and ASC36_35 FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilizing Ascletis' Ultra-Long-Acting Platform (ULAP) technology. In head-to-head non-human primate (NHP) studies, ASC36 SALD formulation demonstrated approximately 6-fold longer observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration in humans. In NHP studies, ASC36_35 FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans. Preclinical studies have established the superior efficacy of ASC36 injection and ASC36_35 FDC injection co-formulation. In head-to-head DIO rat studies, which are highly predictive of human efficacy, ASC36 monotherapy, targeting amylin receptor, demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively. In head-to-head DIO rat studies, the ASC36_35 co-formulation, targeting three targets of amylin receptor, GLP-1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide. Both ASC36 injection formulation and ASC36_35 FDC injection co-formulation exhibit excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH. Two IND submissions for ASC36 once-monthly injection and ASC36_35 once-monthly injection co-formulation build upon the recent milestone achieved by ASC35 once-monthly SALD formulation. In June 2026, Ascletis announced U.S. FDA IND clearance to initiate a Phase I clinical trial for ASC35 as a once-monthly SQ treatment for obesity (Press Release), highlighting the Company's robust clinical execution and the potential of its ULAP technology. About Ascletis Pharma Inc. Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, ASC39, an eloralintide-like potent and amylin-selective oral small molecule amylin receptor agonist, and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1RA) and ASC39 (amylin RA), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK). For more information, please visit . Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR Teams +86-181-0650-9129 (China) [email protected] [email protected] SOURCE Ascletis Pharma Inc. 21% more press release views with Request a Demo

临床1期临床结果

2026-07-06

·歌礼

歌礼向FDA递交两项治疗肥胖症的IND：多肽胰淀素受体激动剂月注射剂ASC36以及ASC36联合多肽GLP-1R/GIPR激动剂ASC35的ASC36_35复方月注射剂

-ASC36_35 FDC是每月一次皮下注射的ASC36和ASC35的复方制剂，有望成为靶向胰淀素受体、GLP-1R和GIPR这三个已验证的靶点的同类首创(first-in-class)候选药物。 -在头对头饮食诱导肥胖(DIO)大鼠研究中，ASC36_35 FDC的减重效果较eloralintide联合替尔泊肽相对提升约51%。 -ASC36有望成为靶向胰淀素受体的同类首创、每月一次至每季度一次皮下注射剂。 -在头对头饮食诱导肥胖(DIO)大鼠研究中，ASC36单药的减重效果较petrelintide单药和eloralintide单药分别相对提升约91%和32%。香港，2026年7月6日 – 歌礼制药有限公司(香港联交所代码：1672，简称“歌礼”)今日宣布，近期已向美国食品药品监督管理局(FDA)递交了两项新药临床试验申请(IND)：每月一次至每季度一次新一代多肽胰淀素受体激动剂ASC36，以及ASC36_35 FDC，即ASC36联合多肽GLP-1R/GIPR激动剂ASC35的每月一次注射复方制剂，用于治疗肥胖症。吴劲梓博士歌礼创始人、董事会主席兼首席执行官 Eloralintide联合替尔泊肽近期数据显示，在第32周时体重下降为29.0%[1]。然而，该方案需要每周注射两针，一针eloralintide，另一针替尔泊肽。而有望成为同类首创、靶向胰淀素受体、GLP-1R和GIPR的皮下注射复方制剂ASC36_35 FDC，每月仅需注射一次，同样令人振奋的是，在头对头饮食诱导肥胖(DIO)大鼠研究中，ASC36_35 FDC的减重效果较eloralintide联合替尔泊肽相对提升约51%。这些动物模型对人体疗效具有高度预测性。 ASC36和ASC35均是歌礼利用其基于结构的AI辅助药物发现(AISBDD)技术自主研发的。ASC36每月一次至每季度一次制剂以及ASC36_35 FDC每月一次复方制剂均为自组装脂质储库型(SALD)制剂，利用歌礼专有的超长效药物开发平台(ULAP)技术开发而成。在头对头非人灵长类动物研究中，ASC36 SALD制剂的表观半衰期(observed half-life)约为eloralintide的6倍，支持在人体中每月一次至每季度一次皮下给药。在非人灵长类动物研究中，ASC36和ASC35两者在ASC36_35 FDC SALD制剂中均具有较长的表观半衰期，支持在人体中每月一次皮下给药。临床前研究已确立了ASC36注射剂及ASC36_35 FDC复方注射剂的优越疗效。在头对头DIO大鼠研究中(对人体疗效具有高度预测性)，靶向胰淀素受体的ASC36单药较petrelintide单药和eloralintide单药的减重效果分别相对提升约91%和32%。在头对头DIO大鼠研究中，ASC36_35复方制剂靶向胰淀素受体、GLP-1R和GIPR三个靶点，减重效果较eloralintide联合替尔泊肽相对提升约51%。 ASC36注射剂和ASC36_35 FDC复方注射剂具有优越的理化稳定性，在中性pH值附近没有纤维化导致的聚集沉淀。在ASC35 SALD月制剂近期取得的里程碑基础上，我们已递交ASC36月注射剂及ASC36_35复方月注射剂两项IND。2026年6月，歌礼宣布其每月一次皮下注射ASC35治疗肥胖症的I期临床试验已获美国FDA的IND批准(新闻发布)，彰显了公司强劲的临床开发执行力及其ULAP技术的潜力。 [1] Eli Lilly and Company. Safety, tolerability, pharmacokinetics and pharmacodynamics of eloralintide and tirzepatide co-administered as once-weekly subcutaneous injections [Abstract accepted for presentation at EASD 2026] 关于歌礼制药有限公司歌礼制药有限公司是一家全价值链整合型生物技术公司，聚焦有望成为治疗代谢疾病同类最佳(best-in-class)和同类首创(first-in-class)药物的开发和商业化。利用公司专有的基于结构的AI辅助药物发现(Artificial Intelligence-assisted Structure-Based Drug Discovery，AISBDD)、超长效药物开发平台(Ultra-Long-Acting Platform，ULAP)技术以及口服多肽递送增强技术(Peptide Oral Transport ENhancement Technology，POTENT)，歌礼已自主研发多款小分子和多肽候选药物，包括其核心项目ASC30，一款在研小分子GLP-1R激动剂，既可每日一次口服也可每月一次至每季度一次皮下注射作为减重治疗疗法和减重维持疗法，用于长期体重管理；ASC36，一款胰淀素受体激动剂多肽，ASC35，一款每月一次皮下注射GLP-1R/GIPR双靶点激动剂多肽，ASC37，一款GLP-1R/GIPR/GCGR三靶点激动剂多肽，ASC39，一款类似eloralintide、对胰淀素具有选择性的强效口服小分子胰淀素受体激动剂，和ASC30_39 FDC，ASC30(GLP-1RA)与ASC39(胰淀素受体激动剂)的固定剂量复方制剂(FDC)，用于长期体重管理。歌礼已在香港联交所上市(1672.HK)。欲了解更多信息，敬请登录网站：www.ascletis.com。关于“Abstract accepted for presentation at EASD 2026”，可点击“阅读原文”查看详细信息！

ASCO会议临床结果临床申请

2026-06-25

·MedChem早知道

罗氏：立足肿瘤与诊断业务，全面重塑研发管线

曾有一段时期，各项营收数据给罗氏描绘出不容乐观的前景。三款肿瘤重磅药物赫赛汀、安维汀、美罗华一度将罗氏推上全球最大抗癌药企的宝座，巅峰时期三款药物年销售额合计约 210 亿美元。然而生物类似药的问世打破了这一格局。德意志银行当时预警，罗氏有 220 亿美元营收将直面竞品冲击。2018 年，摩根大通分析师预测罗氏核心重磅产品销售额将出现两位数下滑。仿制药侵蚀带来的业绩下滑，实际幅度与速度均超出罗氏内部预期；公司原本测算 2018 至 2023 年间将产生 96 亿瑞士法郎销售缺口，结果这一缺口在 2021 年就提前兑现。但罗氏凭借新一代药物实现逆势增长：治疗多发性硬化的奥法木单抗、A 型血友病药物艾美赛珠单抗、眼底疾病双特异性抗体法瑞西单抗共同对冲了业绩下滑压力。至 2025 年，五大核心增长产品合计销售额突破 200 亿美元。如今罗氏又将走向何方？在巩固自身传统优势业务的基础上，公司开启第二轮战略转型：布局肥胖赛道、豪掷 71 亿美元押注全新炎症性肠病作用机制、收购异体细胞治疗技术平台，上述重大动作均集中在近两年落地。目录罗氏现有业务版图的奠基之路危机来袭：生物类似药冲击核心单抗营收填补业绩缺口的新一代重磅产品并购交易：罗氏核心增长引擎罗氏当前战略布局全貌罗氏第二轮全面转型一、罗氏现有业务版图的奠基之路罗氏如今的企业格局，源于相隔数十年的两笔关键收购。1990 年，罗氏收购加州生物技术企业基因泰克 60% 股权；2009 年完成全额收购，斥资 468 亿美元收购剩余流通股份，这笔交易在当时创下瑞士企业并购金额纪录。此次收购过程一波三折。2008 年 7 月罗氏发起对基因泰克少数股东的收购邀约，初始报价每股 89 美元立刻引发股东强烈反对，股东集体提起集体诉讼，指控罗氏违背受托责任。原告方认为，罗氏刻意选择市场动荡、美元走弱的窗口期发起收购，压低收购成本。双方最终达成和解，但罗氏不得不将收购报价上调至每股 95 美元。这笔收购带给罗氏的远不止丰富药物管线，更是孕育赫赛汀、安维汀、美罗华三款肿瘤王牌单抗的研发平台。此后二十年间，这三款产品奠定了罗氏全球肿瘤药企龙头的行业地位。赫赛汀彻底改写 HER2 阳性乳腺癌治疗方案；安维汀成为多瘤种标准治疗用药；美罗华独占血液肿瘤市场，后续拓展至自身免疫疾病领域。依托几乎全部出自基因泰克实验室的单抗产品，罗氏稳居全球肿瘤药企榜首多年。另一项奠定罗氏格局的关键收购发生在 1997 年，罗氏斥资 110 亿美元收购勃林格曼海姆，由此搭建起医药 + 诊断双业务体系，彼时绝大多数同行均将诊断业务视为附属板块。罗氏的核心逻辑在于：同步开发靶向治疗药物与配套伴随诊断试剂，精准筛选获益患者，从而完整掌控患者诊疗全流程。这套布局也成为罗氏 “个体化医疗” 战略的根基，数十年间始终贯穿公司整体发展思路。二、危机来袭：生物类似药冲击核心单抗营收 2019 年 9 月，时任罗氏制药事业部首席执行官比尔・安德森预估，赫赛汀、安维汀、美罗华三款药物销售额将整体缩水 60%~70%，他称这一预测仍偏保守。公司测算 2018 至 2023 年将产生 96 亿瑞士法郎（折合 118 亿美元）的销售额缺口。生物原研药面临的竞品冲击，与传统小分子专利悬崖存在本质区别。受医生用药习惯、换药成本、医保支付规则多重因素影响，生物类似药渗透速度更慢、竞争周期更长，对原研的业绩侵蚀幅度不及化学仿制药。即便如此，2022 年一季度数据显示，安维汀销售额同比下滑 32%，赫赛汀下滑 19%，美罗华下滑 21%。面对业绩承压，罗氏采取双线应对策略：其一，主动精简管线。2024 年初公司砍掉 8 款早中期在研候选药物，包含 5 款神经领域、3 款血液肿瘤与实体瘤管线项目。首席执行官托马斯・施奈克表示，此举意在将研发资源重新倾斜至差异化优势最突出的研发项目。其二，通过合作与并购引进临床风险已大幅降低的外部资产。施奈克明确提出，罗氏全研发阶段均有收购外部药物资产的布局规划。三、填补业绩缺口的新一代重磅产品 2025 年，罗氏五大核心增长产品 —— 奥法木单抗、艾美赛珠单抗、法瑞西单抗、帕捷特固定剂量复方、奥马珠单抗合计销售额达 214 亿瑞士法郎（折合 264 亿美元），较 2024 年新增 32 亿瑞士法郎（39 亿美元）。奥法木单抗：2017 年获批的抗 CD20 多发性硬化单抗，为罗氏当前营收最高单品，2025 年销售额 70.1 亿瑞士法郎（86 亿美元）；艾美赛珠单抗：A 型血友病双特异性抗体，销售额 48 亿瑞士法郎（59 亿美元），同比增长 11%；法瑞西单抗：双靶点眼底疾病抗体，2022 年初上市，是罗氏增速最快的产品之一。罗氏优先在自身具备技术积淀的领域谨慎布局新品：奥法木单抗依托成熟抗体技术拓展至神经领域；艾美赛珠单抗、法瑞西单抗均采用罗氏内部深耕多年的双特异性抗体技术平台；帕捷特复方制剂则属于 HER2 单抗产品线生命周期延长开发。四、并购交易：罗氏核心增长引擎 2023 年起，罗氏持续投入巨额资金开展并购。2025 年 1 月摩根大通医疗健康大会上，罗氏制药事业部总裁特蕾莎・格雷厄姆透露，公司每年可动用约 100 亿美元并购资金；只要能寻得与现有管线互补、或有望改写重大疾病治疗格局的变革性资产，就会果断出手。罗氏并购主要分为两大类型：第一类：大额收购临床后期、即将进入 III 期的成熟资产，大幅降低临床失败风险 2023 年 10 月收购 Telavant：预付 71 亿美元，另加 1.5 亿美元短期里程碑付款，获得抗 TL1A 单抗 afimkibart 美国、日本权益。该药物 IIb 期溃疡性结肠炎临床数据亮眼，作用机制可同时抑制炎症与纤维化，是全新炎症性肠病靶点。六周后收购 Carmot Therapeutics：预付 27 亿美元，最高额外支付 4 亿美元里程碑，拿下三款临床阶段肥胖候选药物，含一款即将进入 II 期的 GLP-1/GIP 双受体激动剂 CT-388。 2025 年 9 月收购 89bio：预付 24 亿美元，交易总金额最高可达 35 亿美元，引进处于 III 期的 MASH 治疗药物 FGF21 类似物 pegozafermin。第二类：中小型精准收购，补齐细分技术短板 2024 年 11 月收购 Poseida Therapeutics：交易总额最高 15 亿美元，获得非病毒、富含记忆 T 细胞的异体 CAR-T 平台。罗氏自 2022 年便与该公司开展技术合作。 2024 年 9 月通过基因泰克完成对 Regor Therapeutics 的资产收购，预付 8.5 亿美元，拿下两款新一代乳腺癌 CDK 抑制剂，有望接替现有 CDK4/6 抑制剂管线。 2025 年 3 月与 Zealand Pharma 达成合作：预付 16.5 亿美元，潜在总价值 53 亿美元，共同研发胰淀素类似物 petrelintide，计划与 CT-388 联用开发肥胖复方疗法。短短两年内，罗氏上述交易预付资金总额超 150 亿美元，布局赛道覆盖炎症性肠病、肥胖、代谢相关脂肪性肝炎（MASH）、细胞治疗、乳腺肿瘤。五、罗氏当前战略布局全貌过去数年罗氏扩张力度最大的赛道当属肥胖，同时公司在免疫、神经疾病领域也持续重金投入。1. 肥胖管线：罗氏最大胆的战略押注罗氏肥胖管线采取组合管线布局，瞄准未来 5 至 7 年市场格局。核心产品 CT-388 为每周一次注射 GLP-1/GIP 双受体激动剂，作用机制与礼来替尔泊肽一致。2026 年 1 月公布 II 期临床数据：最高剂量组校正安慰剂后 48 周减重幅度达 22.5%，且减重曲线未出现平台期。2026 年一季度已启动两项 III 期临床试验。从时间维度看，罗氏入局时机并不占优：诺和诺德 Wegovy、礼来 Zepbound 已上市多年，具备成熟商业化体系、医生用药认知与庞大患者群体。即便 III 期临床数据达标，罗氏也已落后竞争对手。罗氏的破局思路是复方联合疗法。当前肥胖市场以单药 GLP-1 为主，但该类药物存在明显短板：胃肠道恶心反应导致大量患者停药，长期用药还会造成肌肉流失。罗氏预判，待自家产品上市时，兼顾耐受性、保护肌肉量的复方方案将成为行业新标准。通过 16.5 亿美元合作引进的 petrelintide 胰淀素类似物，可与 GLP-1 药物协同，减轻恶心副作用、保留瘦体重；罗氏计划 2026 年上半年启动 petrelintide 联合 CT-388 临床试验。当然管线布局并非全部顺利：2026 年 3 月罗氏宣布终止肌抑素抗体 Emugrobart 开发，该药物原本用于联合 Mounjaro 保护肌肉量。2. 肠道炎症与免疫领域：70 亿美元押注 TL1A 靶点逻辑炎症性肠病（IBD）市场规模庞大、临床需求旺盛，但现有疗法远不能满足患者需求。尽管目前已有多款生物制剂上市，包括肿瘤坏死因子抑制剂、白介素 12/23 单抗、整合素阻断剂，绝大多数溃疡性结肠炎与克罗恩病患者仍无法实现长期病情缓解。 TL1A 是同时调控炎症与纤维化的细胞因子，也是近几年免疫领域最受关注的靶点之一。与现有 IBD 靶点不同，TL1A 既介导免疫激活，也会诱发肠道纤维化瘢痕，后者是克罗恩病长期并发症的核心诱因。同时靶向两条通路的单抗，疗效潜力有望超越当前所有在售药物，这也是罗氏豪掷重金收购 afimkibart（抗 TL1A 单抗）的底层逻辑。目前 afimkibart 溃疡性结肠炎 III 期试验正在推进，预计 2027 年递交上市申请；克罗恩病 II 期临床同步开展。但 TL1A 靶点赛道现已极度拥挤：默沙东、赛诺菲 / 梯瓦、艾伯维、Spyre Therapeutics、勃林格殷格翰均有同靶点管线。2026 年 6 月默沙东率先宣布其 TL1A 单抗 tulisokibart 取得溃疡性结肠炎 III 期阳性关键数据，临床里程碑进度反超罗氏。此前市场普遍看好 afimkibart 领跑赛道，如今罗氏丧失先发优势。公司预计 2027 年才会递交上市申请，大概率成为赛道第二、第三位上市产品，71 亿美元收购成本对应的商业化回报预期被削弱，产品差异化打造变得至关重要。3. 细胞治疗与神经领域：全新布局与未竟挑战收购 Poseida 补齐了罗氏此前空白的异体 CAR-T 技术平台。当前自体 CAR-T 需提取每位患者自身细胞定制生产，流程耗时、成本高昂、供应链复杂；而异体细胞治疗可提前批量制备供体细胞，大幅缩短给药周期、降低治疗费用。Poseida 核心候选药物 P-BCMA-ALLO1 靶向多发性骨髓瘤，I 期临床针对经多线治疗患者，客观缓解率达 91%。该平台技术同样可拓展至自身免疫疾病，也是罗氏重点布局方向。神经领域，罗氏阿尔茨海默管线屡遭挫折：2022 年甘特鲁单抗两项 III 期临床宣告失败，更早之前克伦鲁单抗等多款候选药物也接连折戟。在此背景下罗氏推进新一代阿尔茨海默单抗 trontinemab。该药物区别于甘特鲁单抗，搭载罗氏自有 Brainshuttle 转运技术，借助转铁蛋白受体穿透血脑屏障，清除大脑淀粉样蛋白的效率与深度优于前代抗体。II 期临床显示，给药 6 个月后 91% 受试者淀粉样蛋白 PET 检测转阴。目前两项 III 期试验已启动，但核心疑问仍未解决：淀粉样蛋白清除能否转化为认知功能改善，这也是此前所有阿尔茨海默管线共同面临的瓶颈。帕金森管线前景同样不明朗：治疗药物 prasinezumab 帕多瓦 II 期临床未达到主要临床终点，但罗氏仍决定推进 III 期。公司表示综合全部试验数据，该药物有望成为首款疾病修饰型帕金森药物。当前帕金森领域几乎无延缓病程药物，罗氏的决策具备合理依据，但最终仍需 III 期临床验证疗效。六、罗氏第二轮全面转型面对生物类似药带来的营收危机，罗氏依靠自身成熟优势完成突围：深耕双特异性抗体、优化老药生命周期、迭代成熟靶点新一代产品。而当下战略逻辑已然转变，公司走出传统肿瘤业务舒适区。肥胖、炎症性肠病、异体细胞治疗、神经退行性疾病均不属于原有成熟管线延伸，而是全新竞争赛道，部分领域行业发展速度甚至超出罗氏预判。罗氏根基稳固，具备稳健财务体系、完善商业化基础设施与成熟并购能力，拥有充足竞争底气。但转型前景仍存诸多不确定性：肥胖复方疗法能否实现对礼来、诺和诺德先发优势的弯道超车；TL1A 赛道默沙东抢先临床突破后 afimkibart 如何打造差异化；trontinemab 能否实现罗氏多年阿尔茨海默药物研发夙愿，均有待验证。如今的罗氏，这家以肿瘤与诊断业务起家的巨头，正同步在多个治疗领域完成全方位自我重塑。

100 项与 Petrelintide 相关的药物交易

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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
2型糖尿病	临床2期	美国	Zealand Pharma A/S	2025-04-22
肥胖	临床2期	美国	Zealand Pharma A/S	2024-12-09
肥胖	临床2期	波兰	Zealand Pharma A/S	2024-12-09
肥胖	临床2期	罗马尼亚	Zealand Pharma A/S	2024-12-09
超重	临床1期	德国	Zealand Pharma A/S	2025-12-17

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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


NCT06662539 (ZUPREME-1, Company pipeline) 人工标引	临床2期	超重 \| 肥胖	493	petrelintide	簾餘窪廠壓壓鏇範願艱(鏇簾窪鏇觸網醖齋淵選) = resulted in statistically significant and clinically meaningful weight loss. 鑰築製壓艱襯顧鹽鹽鬱 (遞襯醖蓋齋齋壓夢鹽遞 ) 达到更多	积极	2026-03-05
				Placebo
NCT05613387 (MAD, Biospace) 人工标引	临床1期	超重	48	Petrelintide	艱獵鏇齋壓憲顧製鹹構(選鬱淵廠憲蓋鹽膚蓋遞) = Petrelintide was assessed to be well tolerated in the trial, with no serious or severe adverse events (AEs). All gastrointestinal (GI) AEs were mild except for two moderate events (nausea and vomiting) reported by one participant who discontinued treatment after the third dose. 廠鹹鏇蓋齋壓觸鹽醖繭 (製鹽鏇範積醖選簾選鏇 ) 更多	积极	2024-06-20
				Placebo
NCT05613387 (MAD , GlobeNewswire) 人工标引	临床1期	肥胖	-	ZP8396 0.6mg (administered once-weekly)	齋淵構築遞築繭鹽壓遞(齋夢願遞顧構製網襯夢) = 廠醖顧壓壓糧鑰繭簾鹽選築鏇夢蓋鏇鬱衊衊鏇 (壓獵餘齋觸顧構鏇膚夢 )	积极	2023-07-03
				ZP8396 1.2mg (administered once-weekly)	齋淵構築遞築繭鹽壓遞(齋夢願遞顧構製網襯夢) = 簾餘廠網選積醖獵鏇齋選築鏇夢蓋鏇鬱衊衊鏇 (壓獵餘齋觸顧構鏇膚夢 )
NCT05096598 (ADA2023)	N/A	超重	56	ZP8396	願築築艱壓衊艱廠蓋衊(顧鹹選餘遞窪憲壓鹽餘) = most events were mild and transient 糧齋繭鹽憲廠廠願襯遞 (衊襯願遞齋淵窪顧積醖 ) 更多	积极	2023-06-20
				Placebo