Icodec Insulin

Awiqli® offers adults with type 2 diabetes an alternative to daily basal insulin injections, reducing frequency of these weekly basal injections from seven to one per week1 Awiqli® will be available at over 70,000 pharmacies nationwide Affordability programs can be found through NovoCare.com, where eligible patients can pay as little as $35 per month PLAINSBORO, N.J., Aug. 11, 2026 /PRNewswire/ -- Novo Nordisk today announced the nationwide launch of Awiqli® (insulin icodec-abae) injection 700 units/mL, the first once-weekly basal insulin approved as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes,1 following the U.S. Food and Drug Administration (FDA) approval earlier this year. "Awiqli® represents meaningful progress in the options available for basal insulin therapy for the millions of adults with type 2 diabetes" said Tom Scales, Senior Vice President of Market Access & Public Affairs and Patient Support Solutions at Novo Nordisk. "As the only once-weekly basal insulin available in the US, Awiqli® reduces the frequency of daily basal injections from seven to one per week. Our focus is ensuring broad access so interested, eligible adults with type 2 diabetes have the support they need to talk to their doctor about starting Awiqli®." Clinical studies support simplifying treatment regimens for adults with type 2 diabetes.2 Daily basal insulin routines can be challenging for some patients, and less frequent basal dosing support may help reduce this common barrier to basal insulin therapy.2 By offering a once-weekly dosing profile delivered via the prefilled FlexTouch® pen, Awiqli® may help patients with a basal insulin routine that feels more manageable. The FDA approval was based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® injection which evaluated Awiqli® administered once-weekly in adult patients with type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonist, in three randomized, open-label, treat-to-target, active-controlled trials and one randomized, double-blind, treat-to-target, active-controlled trial. The clinical program evaluated once-weekly Awiqli® vs daily basal insulin and demonstrated efficacy in the primary endpoint of non-inferiority in mean change in HbA1c from baseline to trial end across the ONWARDS pivotal clinical trial program for adults with type 2 diabetes. Across five ONWARDS trials, the safety profile of Awiqli® was overall consistent with the daily basal insulin class used in each trial.3-6 Common adverse events include hypoglycemia (low blood sugar), serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.1 Awiqli® is now accessible to the millions of adults with type 2 diabetes who may benefit from it, and appropriate patients can access it at retail pharmacies nationwide. In addition, to support adults with type 2 diabetes, Novo Nordisk offers a Patient Education Center through NovoCare.com which includes patient educational resources and tools, healthy recipes, and affordability offerings for eligible patients to help lower out-of-pocket costs to as little as $35 per month for those who qualify. For more information on Awiqli®, clinical trial data, and prescribing information, please visit Awiqli.com. About Awiqli ® Awiqli® (insulin icodec-abae) injection 700 units/mL is a prescription medicine and is the first and only FDA-approved once-weekly basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1 Awiqli® is designed as an alternative to daily basal insulin and its approval is supported by the ONWARDS clinical program, which evaluated its efficacy and safety across diverse adult populations living with type 2 diabetes.3-6 Awiqli® is administered once-weekly on the same day each week using the Awiqli® FlexTouch® pen.1 Awiqli® is approved in the US, EU, and 13 additional countries, with market-specific indications for diabetes. What is Awiqli ® (insulin icodec-abae) injection 700 units/mL? Prescription Awiqli ® is a long-acting insulin (U-700) that is used to control high blood sugar in adults with type 2 diabetes mellitus It is not known if Awiqli® is safe and effective in children and adolescents Awiqli® is available in 1 concentration: U-700 Important Safety Information Do not share your Awiqli ® FlexTouch ® pen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli ® and other insulin products or injectable medicines used to treat diabetes. If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli ® dosage. The dosage of Awiqli ® is different from other injectable medicines used to treat diabetes. Always make sure that you select the correct dosage of your Awiqli® FlexTouch® pen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen. Do not dial the maximum single dosage (700 units) of your Awiqli® FlexTouch® pen, unless prescribed by your healthcare provider. Do not use a syringe to withdraw Awiqli® from your pen. Talk to your healthcare provider if you have any questions about how to correctly dose Awiqli® FlexTouch®. Who should not take Awiqli ® ? Do not take Awiqli ® if you: are having an episode of low blood sugar (hypoglycemia) have an allergy to Awiqli® or any of the ingredients in Awiqli®. See the full Patient Information for a complete listing of ingredients in Awiqli® Before taking Awiqli ® , tell your healthcare provider about all your medical conditions, including if you are: have liver or kidney problems take other medicines, especially ones called TZDs (thiazolidinediones) have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Awiqli ® pregnant, planning to become pregnant, or are breastfeeding taking new prescription or over-the-counter medicines, vitamins, or herbal supplements Talk to your health care provider about low blood sugar and how to manage it. How should I take Awiqli ® FlexTouch ® ? Read the Instructions for Use that come with your Awiqli® FlexTouch ® pen Your healthcare provider should show you how to use Awiqli ® FlexTouch ® pen before you use it for the first time Take Awiqli® exactly as your healthcare provider tells you to. Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Awiqli® FlexTouch ® pens are made to deliver your insulin dose in units Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to. The amount of insulin and best time for you to take your insulin may need to change if you take different types of insulin Inject Awiqli® FlexTouch ® 1 time each week on any day of the week on the same day each week If you need to change the day of the week, you may do so if your last dose has been at least 4 days If you have missed your dose, take your missed dose as soon as possible as long as it has been 4 days or less. Then continue the 1 time each week schedule 1 week from the day your missed dose was taken If more than 4 days has passed, skip the missed dose and take your next Awiqli® dose on your regularly scheduled day. Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them Never inject Awiqli® FlexTouch ® into a vein or muscle or use Awiqli® in an infusion pump Never use a syringe to remove Awiqli® from the FlexTouch® pen Do not dilute or mix Awiqli® with any other insulin or solution Awiqli® FlexTouch ® can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen) Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the exact same spot for each injection Do not inject where the skin has pits, is thickened, or has lumps Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin Keep Awiqli and all medicines out of the reach of children. What should I avoid while taking Awiqli ® ? Do not drive or operate heavy machinery, until you know how Awiqli® affects you Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol What are the possible side effects of Awiqli ® ? Awiqli ® may cause serious side effects that can be life-threatening, including: Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, fast heartbeat, blurred vision, slurred speech, shakiness, anxiety, irritability, mood changes, hunger and headache Severe allergic reactions (whole body reaction). Stop using Awiqli and get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over you whole body, trouble breathing, a fast heartbeat or sweating Low potassium in your blood (hypokalemia) Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Awiqli®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness Common side effects may include: hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain. Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion These are not all the possible side effects of Awiqli®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 Please click here for the full Prescribing Information. About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs approximately 10,000 people throughout the country across more than 10 manufacturing, R&D and corporate locations in seven states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X. _______________________ References Awiqli® (insulin icodec-abae) [package insert]. Plainsboro, NJ: Novo Nordisk Inc. Jude E, Malecki M, Huelgas R, et al. Expert panel guidance and narrative review of treatment simplification of complex insulin regimens to improve outcomes in type 2 diabetes. Diabetes Ther. 13, 619–634 (2022). Rosenstock J, Gowda A, Liang B. Weekly icodec versus daily glargine U100 in type 2 diabetes without previous insulin. N Engl J Med. 2023;389(16):1533. doi:10.1056/NEJMc2310221 Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 (23)00093-1 Lingvay I, Asong M, Desouza C, et al. Once-weekly insulin icodec vs once-daily insulin degludec in adults with insulin-naive type 2 diabetes: the ONWARDS 3 randomized clinical trial. JAMA. 2023;330(3):228–237. doi:10.1001/jama.2023.11313 Mathieu C, Ásbjörnsdóttir B, Bajaj H, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. 2023 (23)00520-2 Awiqli® and FlexTouch® Pen are registered trademarks of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2026 Novo Nordisk All rights reserved. US26AWQ00068 August 2026 SOURCE Novo Nordisk 21% more press release views with Request a Demo

产业定位与核心壁垒：胰岛素为1型糖尿病唯一用药，晚期2型糖尿病核心治疗药物，属于重组蛋白类生物药。其生产壁垒集中在 工程菌株、高密度发酵、蛋白复性、色谱纯化、无菌制剂五大环节，具备极高的技术门槛与准入壁垒。一、 行业规模与政策周期（集采深度复盘）1. 市场规模演变（触底反弹） 历史高点：2021年市场规模接近300亿元。 调整期：2022-2023年受首轮集采降价影响，市场规模大幅下滑，于2023年触底。 复苏期：2024年起恢复增长，2025年已突破200亿元。随着长效制剂与周制剂占比提升，未来市场规模有望持续扩容。2. 国家集采分析（量价平衡） 首轮集采（2022年Q2落地）：用量大幅提升（近40%），但价格大幅下降导致整体市场规模萎缩，企业利润承压。 第二轮集采（2024年Q2落地）：价格温和回升，品种间价差明显收窄，实现了监管、企业、患者三方利益平衡，存量品种价值趋于稳定。同时，诺和诺德豁免集采的品种（如德谷门冬双胰岛素、德谷利拉鲁肽）凭借创新优势成为大单品。 下一轮集采推演（预计2026-2027年）：预计将延续当前政策，价格体系整体稳定。需重点关注的变数是：双胰岛素届时将迎来较多类似药上市，竞争加剧；而周制剂及周制剂复方因竞争格局良好，大概率豁免集采，有望成为下一周期核心增量。二、 核心驱动力与竞争格局1. 长期需求确定性极高（人口与病理） 人口结构红利：未来十年，70后、80后逐步迈入50岁+阶段。该年龄段糖尿病发病率相比前代近乎翻倍，是未来胰岛素用药的核心增量群体。 疾病刚性需求：糖尿病不可逆，患者进展到需胰岛素阶段后需终身用药。目前爆火的GLP-1类药物在机理上仅能延缓病程，无法完全替代胰岛素。 行业商业特性：具备竞争格局优良、壁垒高、模式稳定、现金流充沛的特点，属于典型的长期稳步增长赛道。2. 中外竞争格局重塑 全球三巨头：诺和诺德、礼来、赛诺菲合计占据全球约70%的份额。 诺和诺德中国区产品结构变化（重点参考）：受集采影响，其集采品种规模缩减近60%，2023年触底后，2024-2025年依靠未纳入集采的创新大单品（德谷门冬双胰岛素、德谷利拉鲁肽、周制剂依柯胰岛素）重回增长，上述产品合计收入已超50亿元，是外资在国内市场的核心利润来源。 国内梯队：甘李药业、通化东宝、联邦制药、东阳光药等龙头企业，正凭借二代/三代胰岛素的集采中标，迅速抢占公立医院存量市场，并通过“出海”开辟新战场。三、 出海进展与全球市场机遇1. 全球空间与对手退场 市场空间：全球胰岛素市场约1000亿元，其中中美欧三地合计占比超80%，是兵家必争之地。 历史性机遇：近年来，礼来选择退出欧洲胰岛素业务，诺和诺德在欧洲的供应态度亦趋于消极，这为国内企业切入欧美市场留出了巨大的空白空间。 商业模式：欧美市场多采用利润分成合作模式；在新兴市场（如巴西等），通过技术转让+长协模式可实现利润最大化。2. 近期出海进展（2026年催化剂） 甘李药业：3款胰岛素已获欧洲上市许可。 东阳光药、通化东宝：甘精/门冬胰岛素已获美国市场准入，后续通化东宝的赖脯等产品亦有望获批，美国商业化落地有望贡献超预期业绩。四、 创新管线与第四代（周制剂）机遇1. 第四代周制剂胰岛素（核心成长曲线） 核心优势：每年可减少注射超300次，依从性与疗效双优，能显著缓解患者“注射抗拒”心理。 市场潜力：诺和诺德依柯（Icodec）2025年在国内销售已超3亿元，预计未来5年有望成为30亿级大单品。 竞争格局：全球核心玩家为诺和诺德与甘李药业（GDR4）。甘李药业GDR4的三期临床数据已达到优效，且头对头依柯的三期数据预计在2026年底或2027年初公布。若数据达到预期，将确认GDR4的 "me better" 定位，具备极高的出海及商业化价值。2. 复方制剂管线（协同增效） 优势：控糖效果优于单用，可抵消胰岛素带来的体重增加副作用，且定价灵活，利润空间更优。 布局代表：甘李药业布局了GZR102（双周GLP-1 + GDR4），进度国内靠前，有望成为BIC（同类最佳）品种。五、 核心标的投资逻辑梳理 基于上述行业背景，目前胰岛素赛道核心上市公司的投资亮点如下： 甘李药业（研发领跑与出海先锋） 研发领先：全面覆盖周制剂、复方等前沿方向，管线梯队丰富。 核心催化剂：GDR4三期数据完整，头对头依柯数据即将读出，若达预期，价值将迎来重估；同时欧洲上市许可已落地，海外增量明确。 通化东宝（美国商业化先发优势） 先发优势：门冬胰岛素已正式获得美国上市批准，是国内企业中美国商业化落地进度领先的企业。 后续催化：后续甘精、赖脯胰岛素有望在美国陆续获批，若商业化顺利推进，将大幅贡献业绩弹性。 联邦制药（管线授权价值重估） 技术差异化：公司已公布周制剂胰岛素IND，且具备技术差异化优势。 重大事件催化：其三靶点GLP-1分子已重磅授权给诺和诺德，创下国内创新药授权金额纪录。此事件有望带动市场对其管线估值进行向上重估，公司价值需重新审视。 【重要免责声明】 性质说明：本内容（含文字、图表及数据）系本人基于公开信息进行的个人学习笔记与观点整理，仅用于记录和分享个人的研究兴趣，绝不构成任何形式的投资建议、操作指导或收益承诺。 风险提示：金融市场存在极高风险，过往业绩不代表未来表现。文中提及的任何具体标的、行业或策略，均存在较大的价格波动甚至归零风险。 操作自主：请您务必独立判断，依据自身风险承受能力做出决策。凡因参考本文内容而导致的任何投资损益，均与本人及本发布平台无关。 版权合规：若文中引用资料涉及版权问题，请联系本人删除，本文仅供交流学习使用。