曾被吹成"躺瘦神器"的司美格鲁肽，现在翻车了。 43 名用过 Ozempic （司美格鲁肽注射液）或 Wegovy （司美格鲁肽减重版）的患者，集体因为一种叫 NAION 的眼病申请赔偿。 这病听起来绕口，后果却堪比晴天霹雳，直接攻击视神经前部，视力下降、视野缺损都是有可能发生。 它不仅能让你拉肚子、吐到怀疑人生，还可能直接夺走你的视力，让你一辈子活在模糊里。 01 视力风险爆发，4名患者赔偿金近90万 就在 11 月 21 日，丹麦患者赔偿协会官网突然爆出猛料。 首批 5 个案件已经宣判， 4 个都拿到了赔偿。 这可不是小打小闹， 4 个人的赔偿金加起来已经快 90 万人民币，要是因为失明丢了工作、没法开车走路，赔偿金额还可能往上涨。 要知道这药全球都卖疯了。 摩根士丹利测算到 2025 年底，全球用过的人都突破 5000 万了，其中近 2000 万人是冲着减肥来的，这背后藏着多少潜在风险？ 而根据丹麦患者赔偿协会的说法，司美格鲁肽每 1 万名使用者中约有 1 人会受 NAION 影响。 5000 万人的基数摆在这里，万分之一就是 5000 个受害者。 事实上，相关风险早有预警。 2025 年 6 月 6 ...

中国GLP-1行业调研简报 | 2025/09 www.leadleo.com 报告标签：GLP-1RA药物、双靶点创新药、减重药 2025年9月 作者：吕佳睿 报告提供的任何内容（包括但不限于数据、文字、图表、图像等）均系头豹研究院独有的高度机密性文件（在报告中另行标明出处者除外）。未经头豹 研究院事先书面许可，任何人不得以任何方式擅自复制、再造、传播、出版、引用、改编、汇编本报告内容，若有违反上述约定的行为发生，头豹研究 院保留采取法律措施、追究相关人员责任的权利。头豹研究院开展的所有商业活动均使用"头豹研究院"或"头豹"的商号、商标，头豹研究院无任何前述名 称之外的其他分支机构，也未授权或聘用其他任何第三方代表头豹研究院开展商业活动。 1 头豹调研简报 | 2025/09 GLP-1行业 Q1：GLP-1药物是什么？ 可以治疗哪些疾病？ 图表1：GLP-1药物分类 | 药物种类 | 分子结构类别 | 半衰期 | 代谢及消除方式 | | --- | --- | --- | --- | | 短效制剂 | | | | | 贝那鲁肽 | GLP-1 | 11min | 肾脏为主 | | 艾塞那肽 | Exend ...

The Danish pharma giant is looking beyond trial results that showed semaglutide, the key ingredient in its weight-loss drugs, was not effective in slowing the progression of Alzheimer’s disease https://t.co/6rdUdPRnj0 ...

丹麦患者赔偿协会称，NAION是一种影响视神经前部的疾病，可能导致视力下降和视野缺损。它可能是Wegovy、Ozempic等含有司美格鲁肽药物的一种 罕见的副作用。 丹麦跨国药企诺和诺德旗下"减肥神药"司美格鲁肽，被曝可能导致严重视力损伤，目前已有43名患者向丹麦患者赔偿协会（Patienterstatningens organisation）申请赔偿。 当地时间11月21日，丹麦患者赔偿协会官网发布信息称，43名患者在使用Ozempic（中国注册名"诺和泰"）或Wegovy（中国注册名"诺和盈"）后，出现了 严重的眼部疾病NAION（非动脉性前部缺血性视神经病变），患者赔偿协会现已对首批5起案件作出裁决，其中4起案件均获赔偿，另一起案件被驳回。 据丹麦患者赔偿协会官网介绍，该组织是一个官方机构，负责裁定患者在接受医疗治疗后受伤，或因药物引起严重副作用时是否有权获得赔偿。患者可以 将患者赔偿协会的决定上诉至患者赔偿上诉委员会，并最终将案件提交法院审理。 据该协会官网，丹麦患者赔偿协会负责人凯伦-英格·巴斯特（Karen-IngerBast）说："那些因副作用而受影响的患者令人同情。NAION是一种严重的疾病， ...

据丹麦患者赔偿协会官网介绍，该组织是一个官方机构，负责裁定患者在接受医疗治疗后受伤，或因药物引起严重副作用时是否有权获得赔偿。患者可以将 患者赔偿协会的决定上诉至患者赔偿上诉委员会，并最终将案件提交法院审理。 据该协会官网，丹麦患者赔偿协会负责人凯伦-英格.巴斯特(Karen-IngerBast)说："那些因副作用而受影响的患者令人同情。NAION是一种严重的疾病，会对 视力造成永久性且无法治愈的损害。这些案件的评估也极其复杂，因为涉及的是新药，而且患者本身就是NAION的高危人群。我们的职责是为患者提供一 个全面且经过深思熟虑的裁决，希望这能为患者的治疗过程带来明确的交代。 丹麦跨国药企诺和诺德旗下"减肥神药"司美格鲁肽，被曝可能导致严重视力损伤，目前已有43名患者向丹麦患者赔偿协会(Patienterstatningens organisation)申 请赔偿。 当地时间11月21日，丹麦患者赔偿协会官网发布信息称，43名患者在使用Ozempic(中国注册名"诺和泰")或Wegovy(中国注册名"诺和盈")后，出现了严重的眼 部疾病NAION(非动脉性前部缺血性视神经病变)，患者赔偿协会现已对首批5起案件 ...

Core Insights - Novo Nordisk (NVO) and Pfizer (PFE) are leading pharmaceutical companies in distinct therapeutic areas, with NVO dominating the GLP-1 market and PFE traditionally strong in oncology [1][2] - Pfizer's recent acquisition of Metsera marks its re-entry into the obesity market, intensifying competition with Novo Nordisk [2][3] Novo Nordisk (NVO) - NVO holds a 59% global market share in the GLP-1 space, driven by its semaglutide products: Ozempic, Rybelsus, and Wegovy [5] - The company is expanding its manufacturing capacity and pursuing new indications for semaglutide, including cardiovascular benefits [6][7] - NVO is facing challenges with weaker sales of Ozempic and Wegovy, leading to a guidance cut and a restructuring program aimed at saving DKK 8 billion annually by 2026 [12][30] Pfizer (PFE) - PFE's oncology revenues have increased by 7% year-to-date, bolstered by the acquisition of Seagen and strong performance from key products [13][14] - The Metsera acquisition adds four clinical obesity programs to PFE's pipeline, enhancing its position in the obesity treatment market [16] - PFE is implementing cost reduction initiatives expected to save $7.7 billion by 2027, alongside a strong late-stage pipeline and a dividend yield of around 7% [15][32] Financial Estimates - The Zacks Consensus Estimate for NVO's 2025 sales and EPS indicates a year-over-year increase of approximately 14% and 9%, respectively [20] - In contrast, PFE's 2025 sales are expected to decrease by 1.1%, while EPS is projected to increase by 1% [23] Stock Performance and Valuation - Year-to-date, NVO shares have declined by 43.4%, while PFE shares have lost 3.1%, against an industry gain of 19% [26] - NVO trades at a higher price/earnings ratio of 13.36 compared to PFE's 8.2, indicating a more expensive valuation for NVO [28]

Core Insights - Novo Nordisk has submitted a regulatory filing for a higher dose of its obesity drug Wegovy, seeking approval for a 7.2 mg dose which is claimed to offer greater weight loss potential compared to existing doses [1][6] - The company is utilizing the FDA's Commissioner's National Priority Voucher pilot program for an expedited review process, potentially reducing the review period to 1-2 months [2] - Data from the phase III STEP UP study supports the filing, showing an average weight loss of 20.7% for participants on the 7.2 mg dose over 72 weeks [3][6] Regulatory Developments - The filing for the 7.2 mg dose is also under review by the EMA, with a final decision expected in Q1 2026 [4] - Novo Nordisk's investigational oral obesity pill, amycretin, has shown significant weight loss and HbA1c reduction in type 2 diabetes, while two studies on Rybelsus did not show superiority in Alzheimer's disease [8] Market Context - The obesity market in the U.S. is projected to reach $100 billion by 2030, with Novo Nordisk and Eli Lilly currently leading the market [11] - Competition is intensifying as both companies are racing to introduce oral weight-loss pills, with Novo Nordisk having submitted a regulatory filing for an oral version of Wegovy [12] Competitive Landscape - Eli Lilly is also developing next-generation drugs, including orforglipron and retatrutide, and has secured a CNPV for orforglipron [13] - Other companies, such as Viking Therapeutics, are advancing their obesity candidates, with ongoing late-stage studies [14][15] - Pfizer has recently acquired Metsera for approximately $10 billion, re-entering the obesity market with new clinical-stage programs [16] Stock Performance - Year to date, Novo Nordisk's shares have decreased by over 43%, contrasting with the industry's growth of 19% [5]

Core Viewpoint - Novo Nordisk is seeking accelerated review for a higher dose version of its obesity drug Wegovy (semaglutide) through the FDA's CNPV program, which could lead to approval within one to two months, coinciding with the review of its 25 mg oral semaglutide in Q4 [2][6]. Group 1: Drug Efficacy and Approval Process - The new 7.2 mg dose of semaglutide is expected to provide a more effective weight loss option, with clinical trial results showing an average weight loss of 20.7% over 72 weeks compared to 17.5% for the 2.4 mg group and 2.4% for the placebo group [2][3]. - In the 7.2 mg trial group, 33.2% of participants achieved at least a 25% weight loss, compared to 16.7% in the 2.4 mg group and 0% in the placebo group [3]. - The FDA has issued 15 CNPV designations to date, with Wegovy being among the second batch of drugs selected for this expedited review process [5]. Group 2: CNPV Controversy - Concerns regarding the CNPV program have been raised by lawmakers, questioning its potential to benefit pharmaceutical companies with close ties to the Trump administration and demanding transparency on the beneficiaries and review details [7][10]. - There are fears that the accelerated review process may undermine public trust in FDA decisions, especially in light of staffing cuts within the government [9]. - Reports indicate that the initial CNPV review process excluded the FDA team responsible for evaluations, leading to concerns about the legitimacy and pace of the decision-making [10].

Core Insights - Novo Nordisk announced that its recent trials of semaglutide did not slow the progression of Alzheimer's disease [2][3] - Semaglutide, a GLP-1 analog, was initially approved for blood sugar reduction and later for weight management, gaining significant attention as a "weight loss miracle drug" [2] - The trials included over 3,800 adult patients receiving standard Alzheimer's treatment, aiming to evaluate semaglutide's efficacy compared to a placebo [2] Group 1 - The trials showed that while semaglutide was safe and effective in improving Alzheimer's-related biomarkers, it did not delay disease progression [2] - Novo Nordisk's Chief Scientific Officer stated that the likelihood of GLP-1 drugs being effective for Alzheimer's treatment was considered very low [3] - The company will terminate a one-year extension trial, with results pending peer review and set to be presented at an upcoming scientific conference [3] Group 2 - Ongoing research into the effects of GLP-1 drugs on Alzheimer's disease is expected, with experts suggesting these drugs may be more suitable for prevention rather than treatment of diagnosed cases [3] - The Alzheimer's Association in the U.S. has indicated it will continue research involving GLP-1 [3]

Core Insights - Novo Nordisk's oral semaglutide failed to show significant efficacy in treating early symptomatic Alzheimer's disease in its Phase III trials, leading to a stock drop of over 10% [1][3] - This marks the first setback for semaglutide, a drug that has gained significant attention for various indications including diabetes and weight management [1][3] Company Summary - Novo Nordisk's recent clinical trials aimed to reduce cognitive decline in Alzheimer's patients by at least 20%, but results showed no significant improvement in the primary endpoint, CDR-SB [3][4] - The company announced the termination of the one-year extension phase of the trials, with preliminary results to be presented at upcoming conferences in December 2025 and March 2026 [3][4] - Despite the failure in Alzheimer's treatment, semaglutide continues to benefit patients with type 2 diabetes and obesity, as highlighted by the company's Chief Scientific Officer [4][5] Industry Summary - The Alzheimer's disease (AD) treatment market is projected to exceed $60 billion globally by 2030, with significant growth expected in China [7] - Despite setbacks, many pharmaceutical companies are actively pursuing AD drug development, with over 140 drugs currently in clinical stages [8] - Notable approved therapies that have shown efficacy in slowing Alzheimer's progression include Lecanemab and Donanemab, which have demonstrated a 20-35% reduction in cognitive decline over 18 months [7][8]