The POST-PRANDIAL HYPO-AVOID STUDY Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People with Type 1 Diabetes

开始日期2026-04-10

申办/合作机构

Steno Diabetes Center Copenhagen

NCT05454709

/ Withdrawn临床2期

A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study

The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®.
This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.

开始日期2023-12-29

申办/合作机构

Inreda Diabetic BV

NCT05378672

/ Completed临床3期

Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes (T1D)

This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.) into the buttocks.
Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

开始日期2023-05-09

申办/合作机构

Zealand Pharma U.S., Inc.

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100 项与达西格列酮相关的临床结果

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100 项与达西格列酮相关的转化医学

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100 项与达西格列酮相关的专利（医药）

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项与达西格列酮相关的文献（医药）

2026-03-01·Small science

Engineering a Glucose‐Responsive Glucagon Prodrug Through Arginine–Phenylboronic Acid Pendant Modification

Article

作者: DeWolf, Emily L. ; Webber, Matthew J. ; Kadu, Pradeep ; Power, Elizabeth M. ; Chen, Weike ; Xian, Sijie ; Kilmer, Rory ; Webber, Bernice

Activatable prodrug strategies offer powerful means to control therapeutic presentation in space and time. Here, we report a single‐molecule prodrug design that enables glucose‐responsive activation of a glucagon analog for hypoglycemia protection. The system conjugates dasiglucagon with a synthetic pendant comprised of alternating arginine and phenylboronic acid (PBA) units, designed to couple peptide solubility to glucose concentration. The pendant modulates net charge through glucose‐dependent PBA–diol complexation, driving aggregation under normoglycemia and solubilization under hypoglycemia. The lead pendant contains five arginine–PBA repeats and exhibits optimal glucose‐responsive solubility and charge modulation, forming aggregates at high glucose and dissolving as glucose levels decline. Despite a modest reduction in receptor potency relative to native dasiglucagon, this approach provides significant prophylactic protection in a streptozotocin‐induced diabetic mouse model of insulin overdose, rescuing mice from hypoglycemia and eliminating mortality events. This work demonstrates a proof‐of‐concept for molecularly engineered, metabolite‐responsive glucagon prodrugs that function as on‐demand therapeutic depots. More broadly, it establishes a modular design paradigm for dynamic, self‐regulating peptide therapeutics based on charge modulation rather than external carrier systems.

2025-07-15·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Dasiglucagon in Children With Congenital Hyperinsulinism Up to 1 Year of Age: Results From a Randomized Clinical Trial

Article

作者: Thornton, Paul S ; Birch, Sune ; Kendall, David M ; De Leon, Diva D ; Kummer, Sebastian ; Ivkovic, Jelena ; Banerjee, Indraneel ; Bøge, Eva

Abstract:

Context:

Congenital hyperinsulinism (CHI) is a cause of persistent hypoglycemia in childhood with a considerable risk of lifelong neurological sequelae. Available pharmacological therapies are limited. Dasiglucagon is a glucagon analog for the treatment of hypoglycemia.

Objective:

To assess the efficacy and safety of dasiglucagon in children with CHI up to 1 year of age.

Methods:

This study included a randomized, crossover, double-blind, placebo-controlled part 1 and an open-label, single-arm part 2 at 4 centers in Germany, the United Kingdom, and the United States. Participants comprised children with CHI aged 7 days to 12 months who were dependent on IV glucose. In part 1, participants were randomized to dasiglucagon or placebo for 48 hours, then crossed over to the other treatment for 48 hours. In part 2, all participants received dasiglucagon for 21 days. The primary outcome was mean IV glucose infusion rate (GIR) in the last 12 hours of part 1.

Results:

Between June 19, 2020, and February 9, 2022, 12 eligible participants were randomized to dasiglucagon–placebo (n = 7) or placebo–dasiglucagon (n = 5). The IV GIR was significantly reduced with dasiglucagon compared with placebo (least-squares mean 4.3 mg/kg/min [95% confidence interval [CI], 1.04 to 7.60 mg/kg/min] and 9.5 mg/kg/min [95% CI, 6.24 to 12.81 mg/kg/min], respectively; P = .004). The most frequent adverse events in both treatment groups were gastrointestinal, dermatological, and metabolism and nutritional disorders.

Conclusion:

In infants with CHI, dasiglucagon significantly reduced the amount of IV glucose needed to maintain euglycemia compared with placebo. Dasiglucagon represents a promising treatment for the management of CHI.

2025-04-22·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Letter to the Editor From He et al: “Dasiglucagon in Children With Congenital Hyperinsulinism up to 1 Year of Age: Results From a Randomized Clinical Trial”

Communications

作者: Wang, Chenxi ; Tian, Huichuan ; He, Ziyi

103

项与达西格列酮相关的新闻（医药）

2026-08-26

·动脉网

先天性高胰岛素血症市场在预测期（2026-2036年）将以12%的复合年增长率扩张，疾病认知度提升及新型疗法推动市场增长 DelveInsightCongenital Hyperinsulinism Market to Expand at a CAGR of 12% During the Forecast Period (2026-2036) as Rising Disease Recognition and Novel Therapies Fuel Market Growth

The congenital hyperinsulinism market is poised for steady growth, driven by increasing disease awareness, improved neonatal screening, and advances in genetic and molecular diagnostics. Growth is further supported by the continued need for effective therapies, as existing treatment options such as diazoxide and somatostatin analogs remain inadequate for many patients. 先天性高胰岛素血症市场有望实现稳步增长，这得益于疾病认知度的提高、新生儿筛查的改善以及遗传和分子诊断技术的进步。由于地塞米松和生长抑素类似物等现有治疗方案对许多患者而言仍显不足，对有效疗法的持续需求也进一步推动了市场增长。Meanwhile, emerging targeted therapies such as Dasiglucagon (Zealand Pharma), Ersodetug (RZ358; Rezolute), Avexitide (Amylyx Pharmaceuticals), Efpegerglucagon (HM15136; Hanmi Pharmaceutical), and others are expected to diversify the treatment landscape and create new commercial opportunities.. 与此同时，达西格列酮（Zealand Pharma）、Ersodetug（RZ358；Rezolute）、阿维西肽（Amylyx Pharmaceuticals）、Efpegerglucagon（HM15136；韩美制药）等新兴靶向疗法有望使治疗格局多样化，并创造新的商业机会。LAS VEGAS 拉斯维加斯, ，Aug. 26, 2026 2026年8月26日/PRNewswire/ -- Recently published Congenital Hyperinsulinism Market Insights report includes a comprehensive understanding of current treatment practices, congenital hyperinsulinismemerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].. /美通社/ -- 最近发布的《先天性高胰岛素血症市场洞察》报告全面分析了当前的治疗实践、先天性高胰岛素血症新兴药物、各疗法的市场份额，以及2022年至2036年的当前和预测市场规模，并按主要市场（美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本）进行了细分。Congenital Hyperinsulinism Market Summary 先天性高胰岛素血症市场概览The market size for congenital hyperinsulinismwas found to be 先天性高胰岛素血症的市场规模被发现为USD 110 million 1.1亿美元in the 7MM in 2025. 在2025年的7MM中。The United States accounted for the largest congenital hyperinsulinismtreatment market size, approximately 美国占据了最大的先天性高胰岛素血症治疗市场规模，约占41% 41%of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. 占2025年七大主要市场（7MM）总市场规模的比例，并与包括欧盟四国（德国、法国、意大利和西班牙）、英国和日本在内的其他主要市场进行比较。The total diagnosed prevalent cases of congenital hyperinsulinism in the 7MM were 在7MM中，先天性高胰岛素血症的总确诊患病病例数为15,700 15,700cases in 2025, which is expected to increase during the forecast period (2026–2036). 2025年的病例数，预计在预测期（2026–2036年）内将有所增加。Leading congenital hyperinsulinism companies, such as 先天性高胰岛素血症领域的领先企业，例如Zealand Pharma, Rezolute, Amylyx Pharmaceuticals, Hanmi Pharmaceutical, Zealand Pharma、Rezolute、Amylyx Pharmaceuticals、韩美制药，and others, are developing new congenital hyperinsulinism treatmentdrugs that can be available in the congenital hyperinsulinism market in the coming years. 以及其他公司，正在开发新的先天性高胰岛素血症治疗药物，这些药物有望在未来几年内进入先天性高胰岛素血症市场。The promising congenital hyperinsulinism therapies in clinical trials include 临床试验中前景良好的先天性高胰岛素血症疗法包括Dasiglucagon, Ersodetug (RZ358), Avexitide, Efpegerglucagon (HM15136), 达西格卢糖，Ersodetug（RZ358），Avexitide，Efpegerglucagon（HM15136），and others. 等等。Discover new treatment for congenital hyperinsulinism @ 发现先天性高胰岛素血症的新疗法 @https://www.delveinsight.com/report-store/congenital-hyperinsulinism-market https://www.delveinsight.com/report-store/congenital-hyperinsulinism-marketKey Factors Driving the Growth of the Congenital Hyperinsulinism Market 推动先天性高胰岛素血症市场增长的关键因素Rising Disease Awareness and Improved Diagnosis: 疾病认知度提升与诊断水平改善：Growing awareness of congenital hyperinsulinism (CHI) among clinicians and caregivers is supporting earlier recognition and diagnosis. Advances in genetic testing and molecular diagnostics are also enabling more accurate identification of disease subtypes. 临床医生和照护者对先天性高胰岛素血症（CHI）的认识不断提高，有助于更早地识别和诊断该病。基因检测和分子诊断技术的进步也使得疾病亚型的鉴定更加准确。Advancements in Genetic and Molecular Research: 遗传与分子研究的进展：Improved understanding of the genetic mechanisms underlying CHI is facilitating the development of targeted therapeutic strategies. Growing knowledge of mutations affecting insulin secretion may also support more personalized approaches to treatment. 对先天性高胰岛素血症（CHI）潜在遗传机制的深入理解，正在推动靶向治疗策略的开发。对影响胰岛素分泌突变的日益了解，也有助于实现更加个体化的治疗方案。Increasing Detection of Rare Genetic Disorders: 罕见遗传病检出率不断上升：Although congenital hyperinsulinism is a rare disorder, advancements in diagnostic techniques, patient registries, and disease reporting mechanisms are improving case identification worldwide. The growing number of diagnosed patients is, in turn, driving continued demand for effective treatment options.. 尽管先天性高胰岛素血症是一种罕见疾病，但诊断技术、患者登记系统以及疾病报告机制的进步正在改善全球范围内的病例识别。确诊患者数量的增加反过来又推动了对有效治疗方案的持续需求。Growing Pipeline of Novel Therapies: 不断增长的 novel 疗法管线：Increasing clinical research into innovative pharmacological and molecular approaches is expected to expand treatment options for patients with congenital hyperinsulinism. The emergence of therapies such as 预计对创新药理学和分子方法的临床研究不断增加，将为先天性高胰岛素血症患者扩大治疗选择。诸如以下疗法的出现Dasiglucagon 达西格卢卡肽(Zealand Pharma), （Zealand Pharma）Ersodetug 埃尔斯多图格(RZ358; Rezolute), (RZ358；Rezolute)Avexitide 阿维西肽(Amylyx Pharmaceuticals), （Amylyx Pharmaceuticals）Efpegerglucagon 依佩格胰高血糖素(HM15136; Hanmi Pharmaceutical), and others targeting the underlying mechanisms of inappropriate insulin secretion could significantly reshape the market. （HM15136；韩美制药），以及其他针对胰岛素分泌失调潜在机制的药物，可能会显著重塑市场格局。Download the report to understand the top emerging congenital hyperinsulinism drugs@ 下载报告以了解新兴的先天性高胰岛素血症主要药物Congenital Hyperinsulinism Clinical Trials 先天性高胰岛素血症临床试验As per Aparna Thakur, Project Manager of Forecasting at DelveInsight, novel strategies, including gene-based and other mechanism-driven interventions, are being explored to correct or modulate the underlying defects in insulin regulation. Although still in early stages, these therapies hold potential for disease-modifying outcomes but face challenges related to clinical validation, long-term efficacy, and safety.. 据DelveInsight预测项目经理Aparna Thakur表示，人们正在探索包括基因疗法和其他机制驱动干预在内的新型策略，以纠正或调节胰岛素调节中的根本缺陷。尽管这些疗法仍处于早期阶段，但它们具有改变疾病进程的潜力，但也面临着与临床验证、长期疗效和安全性相关的挑战。DelveInsight's Congenital Hyperinsulinism Market Report delivers executive-level intelligence on the evolving market landscape, integrating epidemiology, treatment practices, competitive dynamics, emerging therapies, and market forecasts across the major markets through 2036. Built on a rigorous methodology combining comprehensive secondary research, primary interviews with key opinion leaders and industry experts, and proprietary patient-based forecasting models, the report provides a reliable foundation for strategic planning. DelveInsight 的《先天性高胰岛素血症市场报告》提供关于不断演变的市场格局的高层战略情报，整合了主要市场直至 2036 年的流行病学、治疗实践、竞争动态、新兴疗法及市场预测。该报告基于严谨的方法论构建，结合了全面的二手研究、与关键意见领袖和行业专家的一手访谈，以及专有的基于患者的预测模型，为战略规划提供了可靠的基础。Designed for pharmaceutical and biotech executives, it enables informed decisions on portfolio strategy, business development, market entry, investment prioritization, and commercial planning.. 专为制药和生物技术高管设计，助力其在产品组合战略、业务发展、市场准入、投资优先级排序以及商业规划方面做出明智决策。Congenital Hyperinsulinism Market Analysis 先天性高胰岛素血症市场分析The treatment landscape for congenital hyperinsulinism remains primarily centered on symptom control and the prevention of hypoglycemic episodes. 先天性高胰岛素血症的治疗格局仍主要以控制症状和预防低血糖发作为中心。Current management strategies include frequent feeding, continuous glucose administration, and pharmacological therapy. 当前的管理策略包括频繁喂养、持续葡萄糖给药以及药物治疗。Diazoxide 二氮嗪is generally considered the first-line treatment, while somatostatin analogs may be used in patients who do not respond adequately. In severe cases, particularly those involving focal disease, surgical approaches such as partial pancreatectomy may be necessary. 通常被视为一线治疗，而对于反应不足的患者，可以使用生长抑素类似物。在严重病例中，尤其是涉及局灶性病变的情况下，可能需要采用手术方法，如部分胰腺切除术。However, treatment outcomes remain inconsistent, with many patients showing inadequate responses or resistance to established therapies. 然而，治疗结果仍然不一致，许多患者对现有疗法反应不足或产生耐药性。This persistent variability underscores the substantial unmet need for more effective and durable treatment options, particularly therapies capable of addressing the underlying pathophysiology rather than merely managing hypoglycemic symptoms. 这种持续存在的变异性凸显出对更有效且更持久的治疗方案的巨大未满足需求，尤其是那些能够解决潜在病理生理机制而不仅仅是控制低血糖症状的疗法。The therapeutic landscape is gradually shifting toward targeted, mechanism-based approaches. Among the notable investigational therapies is 治疗格局正逐渐向靶向、基于机制的方法转变。其中值得关注的在研疗法包括Ersodetug (RZ358) 埃索德图格（RZ358）, which is designed to modulate insulin receptor signaling and represents a novel therapeutic strategy for patients with severe or treatment-resistant congenital hyperinsulinism. Such approaches could mark a transition from conventional symptom management toward functional disease modification. ，其旨在调节胰岛素受体信号传导，并为重度或难治性先天性高胰岛素血症患者代表了一种新型治疗策略。此类方法可能标志着从传统的症状管理向功能性疾病修饰的转变。Pharmaceutical companies and research organizations are increasingly investing in the development of novel therapies for this rare disorder. 制药公司和研究机构正日益加大对这种罕见疾病新型疗法开发的投入。Ongoing research is aimed at deepening the understanding of congenital hyperinsulinism biology and identifying new therapeutic targets, with genetic and molecular insights playing an increasingly important role in guiding drug development. 正在进行的研究旨在深化对先天性高胰岛素血症生物学的理解，并识别新的治疗靶点，其中遗传学和分子生物学见解在指导药物开发方面发挥着日益重要的作用。The emerging congenital hyperinsulinism pipeline remains relatively limited but is gaining momentum, with several investigational candidates potentially capable of reshaping the competitive landscape and addressing long-standing treatment gaps. 先天性高胰岛素血症的新兴研发管线仍然相对有限，但正逐渐获得动力，几种在研候选药物有可能重塑竞争格局并解决长期存在的治疗空白。As development programs advance and competition increases, the market is expected to see greater innovation and potentially improved outcomes for patients with this challenging condition. 随着研发项目的推进和竞争的加剧，预计市场将出现更多创新，并为患有这种疑难疾病的患者带来潜在更好的治疗结果。Congenital Hyperinsulinism Competitive Landscape 先天性高胰岛素血症竞争格局Some of the congenital hyperinsulinism drugs under development include 正在研发中的先天性高胰岛素血症药物包括Dasiglucagon 达西格卢卡肽(Zealand Pharma), （Zealand Pharma）Ersodetug 埃索德图格(RZ358; Rezolute), (RZ358；Rezolute)Avexitide 阿维西肽(Amylyx Pharmaceuticals), （Amylyx Pharmaceuticals）Efpegerglucagon 艾芬格胰高血糖素(HM15136; Hanmi Pharmaceutical), and others. (HM15136；韩美制药)，以及其他。Zealand Pharma's ZEGALOGUE Zealand Pharma 的 ZEGALOGUEis a glucagon analog that elevates blood glucose by promoting glucose release from the liver. Although it is approved for the treatment of severe hypoglycemia in patients with diabetes, its mechanism may also offer therapeutic potential in congenital hyperinsulinism by counteracting hypoglycemia caused by excessive insulin secretion. 是一种胰高血糖素类似物，通过促进肝脏释放葡萄糖来升高血糖。尽管它已被批准用于治疗糖尿病患者的严重低血糖症，但其作用机制也可能通过对抗因胰岛素分泌过多引起的低血糖，为先天性高胰岛素血症提供治疗潜力。The drug is currently in the registration stage, with the sponsor planning to resubmit a New Drug Application (NDA) in the second half of 2026.. 该药物目前处于注册阶段，申办方计划在2026年下半年重新提交新药上市申请（NDA）。Rezolute's Ersodetug Rezolute 公司的 Ersodetugis an investigational monoclonal antibody that targets the insulin receptor to modulate insulin activity and help maintain stable blood glucose levels in patients with congenital hyperinsulinism. The therapy is currently being evaluated in Phase III clinical development. It has received multiple regulatory designations, including . 是一种研究性单克隆抗体，靶向胰岛素受体以调节胰岛素活性，帮助先天性高胰岛素血症患者维持稳定的血糖水平。该疗法目前正处于III期临床开发评估阶段。它已获得多项监管认定，包括。Breakthrough Therapy Designation (BTD) 突破性疗法认定（BTD）, the UK's ，英国的Innovative Licensing and Access Pathway (ILAP) designation, and Orphan Drug Designations (ODD) 创新许可和准入途径（ILAP）认定，以及孤儿药资格认定（ODD）from the US and European Union for congenital hyperinsulinism and insulinoma-associated hypoglycemia. However, in December 2025, Rezolute announced that the Phase III sunRIZE study of ersodetug in congenital hyperinsulinism did not achieve its primary endpoint of reducing weekly hypoglycemia events.. 用于美国和欧盟批准的先天性高胰岛素血症及胰岛素瘤相关低血糖症。然而，2025年12月，Rezolute公司宣布，ersodetug治疗先天性高胰岛素血症的III期sunRIZE研究未能达到其主要终点，即减少每周低血糖事件的发生次数。Hanmi Pharmaceutical's Efpegerglucagon 韩美药品的Efpegerglucagonis a long-acting glucagon analog currently being investigated in Phase II clinical development for congenital hyperinsulinism. The therapy is designed to increase blood glucose levels by stimulating hepatic glucose release. It has received 是一种长效胰高血糖素类似物，目前正处于针对先天性高胰岛素血症的II期临床研究阶段。该疗法旨在通过刺激肝脏释放葡萄糖来提高血糖水平。它已获得Orphan Drug Designation 孤儿药认定from both the FDA and EMA, as well as the FDA's 来自美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA），以及美国食品药品监督管理局（FDA）的Rare Pediatric Disease Designation (RPDD) 罕见儿科疾病认定（RPDD）. The global Phase II study is ongoing, with topline results anticipated in the second half of 2026. Earlier interim findings indicated a reduction in hypoglycemia events and demonstrated favorable tolerability. In November 2024, Hanmi presented interim Phase II data for efpegerglucagon in congenital hyperinsulinism at the European Society for Paediatric Endocrinology (ESPE) conference.. 全球II期研究正在进行中，预计将于2026年下半年公布主要结果。早期的中期分析结果显示低血糖事件减少，并表现出良好的耐受性。2024年11月，韩美制药在欧洲儿科内分泌学会（ESPE）会议上公布了efpegerglucagon治疗先天性高胰岛素血症的II期中期数据。The anticipated launch of these emerging therapies are poised to transform the congenital hyperinsulinismmarket landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the congenital hyperinsulinismmarket landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.. 这些新兴疗法的预期上市将在未来几年内改变先天性高胰岛素血症市场的格局。随着这些前沿疗法不断成熟并获得监管批准，预计它们将重塑先天性高胰岛素血症市场格局，提供新的护理标准，并为医疗创新和经济增长带来机遇。Discover more about which pipeline drugs could transform congenital hyperinsulinism treatment market @ 了解更多关于哪些在研药物可能改变先天性高胰岛素血症治疗市场的信息 @Congenital Hyperinsulinism Medications 先天性高胰岛素血症药物Congenital Hyperinsulinism Epidemiology Segmentation 先天性高胰岛素血症流行病学细分The congenital hyperinsulinismepidemiology section provides insights into the historical and current congenital hyperinsulinismpatient pool and forecasted trends for the leading markets. In 2025, the estimated number of diagnosed prevalent cases of congenital hyperinsulinism in the US were around . 先天性高胰岛素血症流行病学部分提供了对历史及当前先天性高胰岛素血症患者群体以及主要市场预测趋势的洞察。2025年，美国估计确诊的先天性高胰岛素血症现患病例数约为。3,500 3,500, and this figure is expected to rise by 2036. ，预计到2036年这一数字还将上升。The congenital hyperinsulinismtreatment market reportproffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into: 先天性高胰岛素血症治疗市场报告提供了2022年至2036年研究期间主要市场的流行病学分析，细分如下：Total Diagnosed Prevalent Cases of Congenital Hyperinsulinism 先天性高胰岛素血症的确诊总患病病例数Type-specific Diagnosed Prevalent Cases of Congenital Hyperinsulinism based on Histological Presentation 基于组织学表现的先天性高胰岛素血症各类型确诊患病病例Mutation-specific Diagnosed Prevalent Cases of Congenital Hyperinsulinism 突变特异性的先天性高胰岛素血症确诊现患病例Total Treated Cases of Congenital Hyperinsulinism 先天性高胰岛素血症的总治疗病例数Congenital Hyperinsulinism Market Report Metrics 先天性高胰岛素血症市场报告指标Details 详情Study Period 学习阶段2022–2036 2022–2036Coverage 覆盖范围7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. 7MM [美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本]。Congenital Hyperinsulinism Market CAGR 先天性高胰岛素血症市场复合年增长率12% 12%Congenital Hyperinsulinism Market Size in 2025 2025年先天性高胰岛素血症市场规模USD 110 Million 1.1亿美元Key Congenital Hyperinsulinism Companies 先天性高胰岛素血症的主要企业Zealand Pharma, Rezolute, Amylyx Pharmaceuticals, Hanmi Pharmaceutical, and others Zealand Pharma、Rezolute、Amylyx Pharmaceuticals、韩美制药等KeyCongenital HyperinsulinismTherapies 先天性高胰岛素血症的关键疗法Dasiglucagon, Ersodetug (RZ358), Avexitide, Efpegerglucagon (HM15136), and others 达西格鲁肽、Ersodetug（RZ358）、阿维西肽、Efpegerglucagon（HM15136）及其他Scope of the 范围Congenital Hyperinsulinism 先天性高胰岛素血症Market Report 市场报告Congenital Hyperinsulinism Patient Population Forecast 先天性高胰岛素血症患者人群预测Congenital Hyperinsulinism Therapeutics Market Size 先天性高胰岛素血症治疗药物市场规模Congenital Hyperinsulinism Pipeline Analysis 先天性高胰岛素血症研发管线分析Congenital Hyperinsulinism Market Size and Trends 先天性高胰岛素血症市场规模与趋势Congenital Hyperinsulinism Market Opportunity 先天性高胰岛素血症市场机遇Congenital Hyperinsulinism Market Unmet Needs 先天性高胰岛素血症市场的未满足需求KOL's Views on Congenital Hyperinsulinism 关键意见领袖对先天性高胰岛素血症的观点Congenital Hyperinsulinism Market Access and Reimbursement 先天性高胰岛素血症的市场准入与报销Table of Contents 目录1 1Congenital Hyperinsulinism Market Key Insights 先天性高胰岛素血症市场关键洞察2 2Congenital Hyperinsulinism Market Report Introduction 先天性高胰岛素血症市场报告简介3 3Executive Summary of Congenital Hyperinsulinism 先天性高胰岛素血症执行摘要4 4Key Events 关键事件5 五Epidemiology and Market Forecast Methodology 流行病学与市场预测方法论6 六Congenital HyperinsulinismMarket Overview at a Glance 先天性高胰岛素血症市场概览一览6.1 6.1Market Share (%) Distribution by Therapies in 2025 2025年按疗法划分的市场份额（%）分布6.2 6.2Market Share (%) Distribution by Therapies in 2036 2036年按疗法划分的市场份额（%）分布7 7Disease Background and Overview of Congenital Hyperinsulinism 先天性高胰岛素血症的疾病背景与概述7.1 7.1Introduction 引言7.2 7.2Causes of Congenital Hyperinsulinism 先天性高胰岛素血症的病因7.3 7.3Signs and Symptoms of Congenital Hyperinsulinism 先天性高胰岛素血症的体征与症状7.4 7.4Pathogenesis of Congenital Hyperinsulinism 先天性高胰岛素血症的发病机制7.5 7.5Pathophysiology of Itch in Congenital HyperinsulinismSkin 先天性高胰岛素血症中瘙痒的病理生理学皮肤7.6 7.6Classification of Congenital Hyperinsulinism 先天性高胰岛素血症的分类7.7 7.7Genetic Bases of Congenital Hyperinsulinism 先天性高胰岛素血症的遗传基础7.8 7.8Diagnosis of Congenital Hyperinsulinism 先天性高胰岛素血症的诊断8 8Treatment and Management of Congenital Hyperinsulinism 先天性高胰岛素血症的治疗与管理9 9Treatment Guidelines 治疗指南10 10Epidemiology and Patient Population of Congenital Hyperinsulinism 先天性高胰岛素血症的流行病学与患者人群10.1 10.1Key Findings 主要发现10.2 10.2Assumption and Rationale 假设与依据10.3 10.3Total Diagnosed Prevalent Cases of Congenital Hyperinsulinism in the 7MM 七大主要市场（7MM）中先天性高胰岛素血症的确诊患病总病例数10.4 10.4The United States 美国10.4.1 10.4.1Total Diagnosed Prevalent Cases of Congenital Hyperinsulinism in the United States 美国先天性高胰岛素血症的确诊患病总病例数10.4.2 10.4.2Type-specific Diagnosed Prevalent Cases of Congenital Hyperinsulinism based on Histological Presentation in the United States 美国基于组织学表现的先天性高胰岛素血症各类型确诊患病病例10.4.3 10.4.3Mutation-specific Diagnosed Prevalent Cases of Congenital Hyperinsulinism in the United States 美国按突变类型分类的先天性高胰岛素血症确诊现患病例10.4.4 10.4.4Total Treated Cases of Congenital Hyperinsulinism in the United States 美国先天性高胰岛素血症的总治疗病例数10.5 10.5EU4 and the UK 欧盟四国与英国10.6 10.6Japan 日本11 十一Patient Journey of Congenital Hyperinsulinism 先天性高胰岛素血症患者诊疗历程12 十二Emerging Congenital Hyperinsulinism Drugs 新兴的先天性高胰岛素血症药物12.1 12.1Emerging Competitive Landscape of Congenital Hyperinsulinism 先天性高胰岛素血症新兴的竞争格局12.2 12.2ZEGALOGUE (dasiglucagon): Zealand Pharma ZEGALOGUE（达胰高血糖素）：Zealand Pharma12.2.1 12.2.1Product Description 产品描述12.2.2 12.2.2Other Developmental Activities 其他发展活动12.2.3 12.2.3Clinical Developmental Activities 临床开发活动12.2.3.1 12.2.3.1Clinical Trial Information 临床试验信息12.2.4 12.2.4Safety and Efficacy 安全性和有效性12.2.5 12.2.5Analyst's View 分析师观点12.3 12.3Ersodetug (RZ358): Rezolute Ersodetug（RZ358）：RezoluteList to be continued in the report… 列表中将在报告中继续…13 13Congenital Hyperinsulinism Market: 7MM Analysis 先天性高胰岛素血症市场：七国市场分析13.1 13.1Key Findings 主要发现13.2 13.2Congenital Hyperinsulinism Market Outlook 先天性高胰岛素血症市场前景展望13.3 13.3Key Congenital Hyperinsulinism Market Forecast Assumptions 先天性高胰岛素血症市场预测的关键假设13.4 13.4Conjoint Analysis 联合分析13.5 13.5Total Market Size of Congenital Hyperinsulinism in the 7MM 七大主要市场（7MM）先天性高胰岛素血症的总体市场规模13.6 13.6United States Congenital Hyperinsulinism Market Size 美国先天性高胰岛素血症市场规模13.6.1 13.6.1Total Market Size of Congenital Hyperinsulinism in the United States 美国先天性高胰岛素血症的总体市场规模13.6.2 13.6.2Market Size of Congenital Hyperinsulinism by Therapies in the United States 美国按疗法划分的先天性高胰岛素血症市场规模13.7 13.7EU4 and the UK Congenital Hyperinsulinism Market Size 欧盟四国及英国先天性高胰岛素血症市场规模13.8 13.8Japan Congenital Hyperinsulinism Market Size 日本先天性高胰岛素血症市场规模14 十四Unmet Needs of Congenital Hyperinsulinism 先天性高胰岛素血症的未满足需求15 十五SWOT Analysis of Congenital Hyperinsulinism 先天性高胰岛素血症的SWOT分析16 十六KOL Views of Congenital Hyperinsulinism 先天性高胰岛素血症的关键意见领袖观点17 17Market Access and Reimbursement of Congenital Hyperinsulinism 先天性高胰岛素血症的市场准入与报销17.1 17.1United States 美国17.2 17.2EU4 and the UK 欧盟四国与英国17.3 17.3Japan 日本17.4 17.4Congenital Hyperinsulinism: Market Access and Reimbursement 先天性高胰岛素血症：市场准入与报销18 十八Bibliography 参考文献19 十九Congenital Hyperinsulinism Market Report Methodology 先天性高胰岛素血症市场报告方法论Related Reports 相关报告Congenital Hyperinsulinism Clinical Trial Analysis 先天性高胰岛素血症临床试验分析Congenital Hyperinsulinism 先天性高胰岛素血症Pipeline Insight 管道洞察– –2026 2026report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key congenital hyperinsulinism companies, including 本报告提供关于管线格局、管线药物概况（包括临床和非临床阶段产品）以及先天性高胰岛素血症领域关键企业的全面洞察，包括Zealand Pharma, Rezolute, Amylyx Pharmaceuticals, Hanmi Pharmaceutical, Zealand Pharma、Rezolute、Amylyx Pharmaceuticals、韩美制药，and others. 等等。Post-bariatric Hypoglycemia Market 减重术后低血糖市场Post-bariatric Hypoglycemia Market Insights, Epidemiology, and Market Forecast – 2036 减重术后低血糖市场洞察、流行病学及市场预测 – 2036report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key post-bariatric hypoglycemia companies, including 本报告深入解析了该疾病、历史及预测流行病学，以及市场趋势、市场驱动因素、市场壁垒和关键的减肥术后低血糖症企业，包括Amylyx Pharmaceuticals, Vogenx, Recordati Group, MBX Biosciences, Confo Therapeutics, Gubra, Hanmi, Amylyx Pharmaceuticals、Vogenix、Recordati集团、MBX Biosciences、Confo Therapeutics、Gubra、韩美制药and others. 以及其他。Hyperinsulinemic Hypoglycemia 高胰岛素性低血糖症Market 市场Hyperinsulinemic Hypoglycemia 高胰岛素性低血糖症Market Insights, Epidemiology, and Market Forecast 市场洞察、流行病学及市场预测– –2036 2036report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hyperinsulinemic hypoglycemia companies, including 本报告深入解析了该疾病、历史及预测流行病学，以及市场趋势、市场驱动因素、市场壁垒和关键的高胰岛素血症性低血糖症企业，包括Eli Lilly and Company, Novo Nordisk A/S, Sanofi S.A., Aton Pharma, Inc. (Mallinckrodt Pharmaceuticals), Ipsen Pharma (IPSEN S.A.), Teva Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., Wockhardt Limited, Baxter International Inc., Sandoz International GmbH (Novartis AG), Fresenius Kabi AG, Mylan N.V., Accord Healthcare Ltd., Oramed Pharmaceuticals Inc.. 礼来公司、诺和诺德公司、赛诺菲公司、阿顿制药公司（马林克罗特制药）、益普生制药（益普生公司）、梯瓦制药工业有限公司、雷迪博士实验室有限公司、沃克哈特有限公司、百特国际有限公司、山德士国际有限公司（诺华公司）、费森尤斯卡比公司、迈兰公司、Accord Healthcare Ltd.、奥拉梅德制药公司。, ，and others. 以及其他。Severe Hypoglycemia Market 重度低血糖市场Severe Hypoglycemia Market Insights, Epidemiology, and Market Forecast – 2036 重度低血糖市场洞察、流行病学及市场预测——2036年report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key severe hypoglycemia companies, including 本报告深入解析了该疾病、历史及预测流行病学，以及市场趋势、市场驱动因素、市场壁垒和关键的重度低血糖症企业，包括Xeris Pharmaceuticals, Fresenius Kabi, Eli Lilly, Novo Nordisk, Amphastar Pharmaceuticals, Eiger BioPharmaceuticals, Zeal Pharma, Xeris Pharmaceuticals，Fresenius Kabi，Eli Lilly，Novo Nordisk，Amphastar Pharmaceuticals，Eiger BioPharmaceuticals，Zeal Pharma，and others. 以及其他。About 关于DelveInsight DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platformPharmDelve. DelveInsight 是一家领先的商业咨询和市场研究公司，专注于生命科学领域。它通过提供全面的端到端解决方案，帮助制药公司提升业绩。通过我们的订阅制平台 PharmDelve，您可以轻松获取所有医疗保健和制药市场研究报告。. 。Contact Us: 联系我们：Shruti Thakur 什鲁蒂·塔库尔[emailprotected] [email protected]+14699457679 +14699457679www.delveinsight.com www.delveinsight.comSOURCE DelveInsight Business Research, LLP 来源：DelveInsight 商业研究有限责任公司21 二十一% %more press release views with 更多新闻稿浏览量，通过Request a Demo 申请演示

2026-08-13

·BioSpace

Zealand Pharma Announces Financial Results for the First Half of 2026

Company announcement – No. 39 / 2026 Zealand Pharma Announces Financial Results for the First Half of 2026 A landmark first half defined by key milestones delivered for leading obesity assets, and a continued momentum building across all fronts of our Metabolic Frontier 2030 strategy. Announced decision to advance petrelintide into Phase 3 trials in H2 2026 following positive Phase 2 results, demonstrating double-digit weight loss with a tolerability pro comparable to placebo, supporting its potential to redefine the weight management experience for people living with obesity or overweight. Boehringer Ingelheim presented positive results from the SYNCHRONIZE TM -1 and SYNCHRONIZE TM -MASLD Phase 3 trials with survodutide, supporting its potential as a differentiated treatment option for people living with obesity or overweight and metabolic dysfunction, with readouts of the remaining key Phase 3 obesity trials expected later in the year. Initiated a Phase 1b clinical trial with ZP9830, a novel Kv1.3 ion channel blocker, in people with psoriasis, marking the first step towards establishing proof-of-concept for ZP9830 with broad potential across autoimmune and inflammatory diseases. Continued active balance sheet management through launch of a USD 200 million share buyback program and USD 100 million royalty monetization of a non-core asset via agreement with Royalty Pharma for rusfertide. Copenhagen, Denmark, August 13, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced the interim report for the six months ended June 30, 2026, and provided a corporate update. A first half of defining moments “In 2026 to date, we have executed with pace and precision across our pipeline,” Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said. “We delivered on the key commitments we set out at the start of the year, while maintaining our sharp focus on the next wave of metabolic health innovation. What stands out this half is not just the depth and breadth of progress, but what it signals about where the field is heading. At ADA 2026, the consensus among key opinion leaders on unmet needs in chronic weight management was clear: tolerability, treatment persistence, and patient experience now define the conversation, and we believe amylin is emerging as the answer. The opportunity in front of us has never been clearer.” Key financial results for H1 2026 DKK million H1-26 H1-25 Revenue 4,525 9,096 Operating expenses, excl. OOI 1 -1,204 -968 Operating expenses 1 -1,204 -1,164 Operating profit 3,321 7,931 Net financial items 292 -157 Profit for the period 3,524 7,238 DKK million Jun-30, 2026 Dec-31, 2025 Cash position 2 14,457 15,109 Notes: 1. Operating expenses consist of R&D, S&M, G&A and Other operating items (OOI). 2. Cash position includes cash, cash equivalents and marketable securities. Q2 2026 Highlights and Recent Developments Obesity Petrelintide, amylin analog. Presented Phase 2 ZUPREME-1 data at the American Diabetes Association’s 2026 Scientific Sessions. Petrelintide demonstrated double-digit weight reduction and a tolerability pro comparable to placebo in people living with overweight or obesity, supporting its potential as a future first-choice therapy for chronic weight management. Petrelintide, amylin analog. Reached a key milestone with the announcement of decision to advance petrelintide monotherapy into Phase 3 registrational trials, planned for initiation later in 2026. Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim presented results from the SYNCHRONIZE TM- 1 Phase 3 trial in people living with overweight or obesity. The trial met its primary endpoints and showed up to 16.6% weight loss with survodutide. The proportion of lean mass loss reflected no more than 11.3% of change in total tissue mass at the highest dose. The lean loss ratio reported in this company announcement has been updated from 10.8% to 11.3% following a recalculation of the dataset. Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim presented positive results from the SYNCHRONIZE TM -MASLD Phase 3 trial in people with overweight or obesity and MASLD with evidence of inflammation and/or fibrosis. The trial met its primary endpoints and showed that 6 out of 10 survodutide-treated participants achieving liver fat normalization. Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim announced expansion of the development program for survodutide with four Phase 3(b) trials initiating in 2026 to address key unmet needs in people living with obesity and real-world care. ZP6590, GIP receptor agonist . Zealand Pharma initiated a first-in-human clinical trial with ZP6590. Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker . Zealand Pharma initiated a Phase 1b trial with efficacy endpoints, investigating ZP9830 in people with psoriasis. The trial was initiated on the back of positive topline results from the single ascending dose (SAD) part of the combined SAD/multiple ascending dose (MAD) Phase 1a clinical trial with ZP9830 announced earlier in the year. Corporate Camilla Sylvest and Iris Löw-Friedrich were elected to the Zealand Pharma Board of Directors, both bringing deep expertise in metabolic health. Two strategically vital additions as the company enters the next phase of scaling into a generational biotech. On May 7, 2026, Zealand Pharma launched a share buy-back program of up to USD 200 million / DKK 1.3 billion. For more information on the share buy-back program, refer to Zealand Pharma Company Announcement No. 13/2026, May 7, 2026. As of August 7, 2026, total accumulated transactions under the program amount to DKK 742 million. Zealand Pharma entered into a USD 100 million royalty purchase and sale agreement with Royalty Pharma for rusfertide. For more information, refer to Zealand Pharma Company Announcement No. 38/2026, August 12, 2026. Continued to attract top talent and experienced leaders, with several senior hires bringing vital experience in metabolic health. This momentum was underscored by Medwatch’s 2026 Image Report, in which Zealand Pharma took the number one spot as the most attractive employer in the Danish Life Science sector. Upcoming events in the second half of 2026 Obesity Petrelintide, amylin analog. In H2 2026, Zealand Pharma and Roche expect to initiate registrational Phase 3 trials with petrelintide monotherapy. Petrelintide, amylin analog. In H2 2026, Zealand Pharma expects to report topline results from the Phase 2 ZUPREME-2 trial in people with overweight or obesity and type 2 diabetes. Petrelintide/enicepatide (CT-388), amylin+GLP-1/GIP fixed-dose combination. Zealand Pharma and Roche expect to initiate the Phase 2 ZYNERGY trial in people with overweight or obesity in H2 2026. Survodutide, glucagon/GLP-1 receptor dual agonist. Results from the Phase 3 SYNCHRONIZE TM -2 trial will be presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD). Results from the SYNCHRONIZE TM -CVOT trial are expected to be reported and presented later in the year. Rare diseases Glepaglutide in SBS. Zealand Pharma expects to complete the EU marketing authorization application review in H2 2026. In parallel, the company is engaging in partnership discussions for future commercialization of glepaglutide for short bowel syndrome (SBS). Dasiglucagon in CHI. In H2 2026, Zealand Pharma expects to resubmit the New Drug Application (NDA) for congenital hyperinsulinism (CHI) to the U.S. FDA. The submission will encompass both the three weeks use of dasiglucagon (Part 1 of the original NDA) as well as the use beyond three weeks (Part 2 of the original NDA). Chronic inflammation ZP9830, Kv1.3 Ion Channel Blocker. ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma expects to report topline data from the MAD part of the Phase 1a clinical trial with ZP9830 in H2 2026. Financial guidance for 2026 The financial guidance for collaboration revenue and operating expenses for 2026 is unchanged, and is expected to be DKK 4.5 billion and DKK 2.7-3.3 billion, respectively. DKK billion 2026 Guidance 3 2025 Actual Collaboration revenue 4.5 9.2 Operating expenses, excl. OOI 2.7-3.3 2.1 Notes: 3. Financial guidance based on foreign exchange rates as of August 12, 2026. Conference call today at 2 PM CET / 8 AM ET Zealand Pharma’s management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results through the first half of 2026 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; and Chief Medical Officer, David Kendall. The conference call will be conducted in English. To receive telephone dial-in information and a unique personal access PIN, please register at . The live listen-only audio webcast of the call and accompanying slides presentation will be accessible at . Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand Pharma’s website at . Financial Calendar for 2026 Q3 2026 November 12, 2026 Q4/FY 2026 February 25, 2027 About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at . Forward-looking Statements This company announcement contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development, and commercialization of pharmaceutical products, the timing of the company’s clinical trials and the reporting of data therefrom and the company’s significant events and potential catalysts in 2026 and financial guidance for 2026. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would”, and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Zealand Pharma® is a registered trademark of Zealand Pharma A/S. Contacts Eric Rojas (Investors) Vice President, Head of Investor Relations erojas@zealandpharma.com Neshat Anis Ahmadi (Investors) Manager, Investor Relations neahmadi@zealandpharma.com Rachel James-Owens (Media) Vice President, Corporate Communications & Media Relations Zealand Pharma Email: RJamesOwens@zealandpharma.com Andreas Hylleberg (Media) Director, External Communications Zealand Pharma Email: AHylleberg@zealandpharma.com Amber Fennell, Jessica Hodgson, Sean Leous (Media) ICR Healthcare Email: ZealandPharma@icrhealthcare.com +44 (0) 7739 658 783 Attachment Zealand Pharma H1 2026 Interim Report

临床2期临床3期临床1期财报临床结果

2026-07-30

·药品圈

FDA临时发布17个多肽注射剂PSG，撤回旧指南

*题图仅作示意用 7月28日，FDA仿制药办公室（OGD）未遵循季度发布的惯例，临时发布了一批修订版产品特定指南（PSG），仅涉及注射用多肽产品，共计17个产品（9个分子），且均为第二或第三次修订。从FDA官方公告措辞看，这一系列PSG不应仅被视为个案，而是标志着FDA在多肽仿制药监管科学上的显著进展。这批PSG通常包括5个技术领域的内容：重组、合成或半合成多肽的ANDA申报建议；先天免疫应答检测；杂质限度；高级结构评估；以及生物学活性评估。其内容结构也大同小异，通常包括：支持活性成分相同性（sameness）及杂质评估的建议。 “如有任何关于使用非临床检测方法评估重组多肽仿制药风险的疑问，请提交ANDA前产品开发会议请求。” 若通过充分的体外理化表征证明与参比制剂高度相似，可依据21 CFR 320.22(b)(1)豁免体内生物等效性（BE）试验。行业人士分析这一监管逻辑借鉴了近来生物类似药的审评理念变革，即从依赖临床终点转向依靠分析手段。对于非Q1/Q2（定性/定量）制剂的考虑，允许注射制剂在处方上存在一定差异。器械相关考虑（必要时），包括用户交互评估。同时，FDA正式宣布撤回2021年5月发布的行业指南《参照rDNA来源的高纯度合成肽药品ANDA行业指南》，称该指南已不再反映FDA当前的科学认知。CDER 2026年指南议程显示，FDA计划于今年内修订这份指南。这些PSG可以作为修订内容预览，且FDA明确称其也适用于其他多肽仿制药。此次更新的17项PSG草案完整目录如下： Calcitonin salmon (鲑降钙素，CALCIMAR, NDA 017769) Calcitonin salmon (鲑降钙素，MIACALCIN, NDA 017808) Dasiglucagon hydrochloride (ZEGALOGUE, NDA 214231) Glucagon (胰高血糖素，BAQSIMI, NDA 210134) Glucagon (胰高血糖素，GLUCAGON, NDA 020928) Glucagon (胰高血糖素，GVOKE, NDA 212097) Liraglutide (利拉鲁肽，VICTOZA, NDA 022341) Liraglutide (利拉鲁肽，SAXENDA, NDA 206321) Pegcetacoplan (SYFOVRE, NDA 217171) Pegcetacoplan (EMPAVELI, NDA 215014) Semaglutide (司美格鲁肽，OZEMPIC, NDA 209637) Semaglutide (司美格鲁肽，WEGOVY, NDA 215256) Teriparatide (特立帕肽，FORTEO, NDA 021318) Teriparatide (特立帕肽，NDA 218771) Tirzepatide (替尔泊肽，MOUNJARO, NDA 215866) Tirzepatide (替尔泊肽，ZEPBOUND, NDA 217806) Vosoritide (伏索利肽，VOXZOGO, NDA 214938) 识林在将上述文件录入至BE指南数据库时，发现鲑降钙素和特立帕肽分别被合并在单个PSG中，因此文件共计15份。另外值得一提的是，不同于欧盟还在面对模糊的监管局面，中美“化仿生”的路径已经打通。我国药监在2026年3月16日更新的《CDE受理共性问题》中澄清，以生物发酵来源的多肽类制剂为对照药品研发、全化学合成法制备的多肽类制剂，可按化学药品路径申报。如境内外均无全化学合成法制备的同品种上市的，申请人可参照化学药品2.2类申报；如境内外已有全化学合成法制备的同品种上市的，境外已上市的仿制药参照化学药品5.2类申报，境内申请人生产的药品参照化学药品3类或4类申报。但CDE特别强调，“由于涉及的情形较复杂，此类产品可能要求开展必要的非临床和临床研究，为降低研发风险，申请人应当与药审中心就其对照药品选择及药学、非临床、临床专业其他技术问题沟通一致后再开展研发申报。”

100 项与达西格列酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11359	达西格列酮	A10BX H04AA02	DB15226

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
低血糖	美国	Zealand Pharma U.S., Inc.	2021-03-22

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
先天性高胰岛素血症	申请上市	美国	Zealand Pharma A/S	-
1型糖尿病	临床3期	美国	Zealand Pharma U.S., Inc.	2017-06-28
1型糖尿病	临床3期	奥地利	Zealand Pharma U.S., Inc.	2017-06-28
1型糖尿病	临床3期	加拿大	Zealand Pharma U.S., Inc.	2017-06-28
1型糖尿病	临床3期	德国	Zealand Pharma U.S., Inc.	2017-06-28

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临床结果

适应症

分期

评价

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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


NCT05378672 (CTgov)	临床3期	1型糖尿病 \| 低血糖	8	Dasiglucagon (Dasiglucagon 0.3 mg)	範選夢壓獵憲餘夢鏇醖(襯憲夢淵簾衊廠膚獵醖) = 鹽壓醖鏇築製範蓋鏇積鑰淵鹹鏇膚願顧鏇簾築 (範遞繭鑰範窪夢憲簾淵, 10.72) 更多	-	2025-07-20
				Dasiglucagon (Dasiglucagon 0.6 mg)	範選夢壓獵憲餘夢鏇醖(襯憲夢淵簾衊廠膚獵醖) = 鏇齋網簾鹽衊衊築製鏇鑰淵鹹鏇膚願顧鏇簾築 (範遞繭鑰範窪夢憲簾淵, 14.47) 更多
EUCTR2020-005241-16-DK (EASD2023)	临床2期	低血糖	24	Dasiglucagon 120 µg	願遞淵積憲襯襯膚憲醖(獵鬱膚鹽獵鹽顧範鹹鑰): P-Value = 0.002 更多	积极	2023-10-04
				Placebo
NCT03777176 \| NCT04172441 (Biospace) 人工标引	临床3期	先天性高胰岛素血症	44	Dasiglucagon (NCT04172441)	鑰壓鹹製鹹鏇淵淵糧鬱(齋襯壓範鬱膚築膚餘獵) = Skin reactions and gastrointestinal disturbances 齋顧構網廠獵鹽築鏇鹽 (壓繭鏇艱網糧齋網醖糧 ) 更多	积极	2023-08-30
				Dasiglucagon (NCT03777176)
NCT04764968 (Pubmed)	临床2期	低血糖 \| 1型糖尿病	24	Dasiglucagon intervention (DASI)	顧鹹廠鹽鏇遞選鏇獵獵(壓網願繭糧鏇餘觸願顧) = Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect 憲遞齋衊製壓夢壓遞鬱 (夢壓壓蓋壓襯製積製憲 )	-	2023-04-11
NCT04172441 (ESPE2022) 人工标引	临床2/3期	先天性高胰岛素血症	12	Dasiglucagon	鬱淵醖膚壓築網衊窪夢(淵選觸積壓簾簾製顧衊) = 壓蓋鏇壓鹽窪鹹製繭構鏇廠醖鹹選鬱蓋獵鏇範 (艱糧構醖鹹選顧範壓繭 )	积极	2022-09-15
				Placebo	-
NCT04172441 (ESPE 12022 \| ESPE 22022) 人工标引	临床2/3期	先天性高胰岛素血症	12	Dasiglucagon	選獵觸糧簾憲艱觸鹽醖(淵築簾鑰築鬱鹹艱鹽繭) = 夢壓選願鹹築顧積廠觸鑰憲鑰繭蓋衊淵窪繭繭 (廠壓觸蓋醖網蓋顧壓網, 4.9)	积极	2022-09-15
				Placebo	選獵觸糧簾憲艱觸鹽醖(淵築簾鑰築鬱鹹艱鹽繭) = 鬱範蓋願顧鑰壓鏇遞淵鑰憲鑰繭蓋衊淵窪繭繭 (廠壓觸蓋醖網蓋顧壓網, 5.6)
ADA2022	N/A	1型糖尿病 \| 低血糖	-	Dasiglucagon (Usual Care)	蓋鹹襯觸鏇膚廠齋憲獵(繭顧餘製鏇廠遞鑰獵鹹) = Dasiglucagon use was safe and well tolerated with nausea being the most frequent adverse effect (no. of participants: UC: 4, DASI: 8) 淵憲獵蓋蓋鬱鬱蓋簾鹽 (築餘餘鹽餘簾鏇糧範夢 )	-	2022-06-01
				Dasiglucagon
NCT04172441 (GlobeNewswire) 人工标引	临床3期	先天性高胰岛素血症	12	Dasiglucagon	願觸壓壓鹽壓廠構構願(築憲鹽膚積壓襯襯顧淵) = 築襯網衊鏇繭願憲糧繭鹽選糧鹹壓艱獵觸齋鑰 (夢繭餘衊衊願淵蓋淵齋 )	积极	2022-05-19
				Placebo	願觸壓壓鹽壓廠構構願(築憲鹽膚積壓襯襯顧淵) = 糧鏇壓齋襯齋襯膚鏇鹹鹽選糧鹹壓艱獵觸齋鑰 (夢繭餘衊衊願淵蓋淵齋 )
NCT04449692 (Pubmed)	临床2期	1型糖尿病	20	Oral glucose (CHO)	範選鬱網廠齋構壓夢網(鏇構鬱積獵繭顧餘艱製) = Episodes of nausea were numerically, but not significantly, higher after dasiglucagon administration. 繭鹽獵築網鬱鹽醖艱鏇 (觸獵壓餘顧簾淵範範鬱 ) 更多	积极	2022-04-27
				Dasiglucagon 80 µg (D80)
NCT03688711 (Pubmed) 人工标引	临床3期	低血糖	45	Dasiglucagon	襯鬱願構醖鏇憲鏇獵醖(繭襯構淵膚顧繭鹽選選) = 築夢簾鬱壓鬱鬱鹹網壓範積鏇製淵選鹽淵築範 (積醖壓願窪憲醖齋鏇製, 8.0 ~ 12.0) 更多	积极	2021-10-01
				Placebo	襯鬱願構醖鏇憲鏇獵醖(繭襯構淵膚顧繭鹽選選) = 艱鹹鏇蓋夢範選積衊衊範積鏇製淵選鹽淵築範 (積醖壓願窪憲醖齋鏇製, 20.0 ~ NR) 更多