证券研究报告 创新药周报20251130： 口服FXIa抑制剂asundexian预防脑卒中复发III 期成功 本报告由华创证券有限责任公司编制 卖的出价或询价。本报告所载信息均为个人观点，并不构成对所涉及证券的个人投资建议。 请仔细阅读PPT后部分的分析师声明及免责声明。 2025-11-30 证券分析师 刘浩 执业编号：S0360520120002 邮箱：liuhao@hcyjs.com 联系人 段江瑶 邮箱：duanjiangyao@hcyjs.com 联系人 吴昱爽 邮箱：wuyushuang@hcyjs.com @2021 华创版权所有 第一部分 本周创新药重点关注 国内创新药回顾 02 全球新药速递 03 证券研究报告 ┃ 凝血通路：内源性、外源性以及下游共同通路 ┃ 抗凝药物的作用机制对比 资料来源：Omri Cohen, et al.，Novel horizons in anticoagulation: the emerging role of factor XI inhibitors across different settings，Davide Capodanno, et al.，Fac ...

Core Viewpoint - The article discusses the emerging risks associated with the weight-loss drug Semaglutide, particularly its potential to cause vision loss, which has led to compensation claims from affected patients [4][6][7]. Group 1: Vision Risk and Compensation - On November 21, a Danish patient compensation association reported that 43 patients who used Ozempic or Wegovy filed for compensation due to a condition called NAION, which can lead to vision loss [7][12]. - Four out of five initial cases have received compensation totaling nearly 900,000 RMB, highlighting the severity of the issue [11]. - The risk of NAION has been acknowledged, with estimates suggesting that approximately 1 in 10,000 users may be affected, potentially leading to 5,000 victims globally given the projected 50 million users by 2025 [12][13]. Group 2: Market Performance and Challenges - Despite ongoing controversies regarding side effects, Semaglutide remains a significant revenue generator for Novo Nordisk, with total sales reaching $25.462 billion in the first three quarters of 2025, a 24% year-on-year increase [25]. - The weight-loss version, Wegovy, has shown particularly strong performance, with sales of $8.609 billion, marking a 54% increase [25]. - However, the Chinese market has become a growth shortfall for Novo Nordisk, with revenues of approximately $2.237 billion and an 8% growth rate, lagging behind the company's overall double-digit growth [26]. Group 3: Competitive Landscape - Novo Nordisk is facing intensified competition in the Chinese GLP-1 market, with Eli Lilly's Tirzepatide emerging as a direct competitor, claiming similar weight-loss effects with potentially milder gastrointestinal side effects [29]. - The expiration of Semaglutide's patents post-2026 has prompted a surge in domestic pharmaceutical companies developing generic versions, with 27 companies currently pursuing market entry [30]. - The combination of emerging vision risks and fierce competition in the Chinese market poses significant challenges for Novo Nordisk, complicating its efforts to maintain its previous growth trajectory [31].

Core Insights - Novo Nordisk's share price has fallen to a four-year low, driven by a series of setbacks in drug trials and increasing competition in the GLP-1 market [1][5][6] Group 1: Drug Trials and Market Performance - The company's recent trial for semaglutide in treating Alzheimer's disease failed to show significant results, leading to the discontinuation of the trials [4][5] - Novo Nordisk's stock has dropped 48% in 2025, reflecting a broader trend of losing market share to competitors like Eli Lilly, which has captured 58% of the GLP-1 market [5][6] - The global GLP-1 market is projected to grow from $52 billion in 2024 to $187 billion by 2032, indicating a significant opportunity despite current challenges [2] Group 2: Competitive Landscape - Eli Lilly's stock has increased by 42% this year, significantly outperforming Novo Nordisk and the broader market, which is up 15.5% [7] - In a bid to regain competitive advantage, Novo Nordisk engaged in a bidding war for biotech start-up Metsera but ultimately lost to Pfizer [8][10] - The ongoing competition in the GLP-1 market remains intense, with obesity being a chronic disease that can lead to various health issues, ensuring continued interest in GLP-1 drugs [11]

Core Viewpoint - Novo Nordisk's Kyinsu® (IcoSema) has received EU approval, combining weekly insulin with GLP-1 receptor agonist for better management of type 2 diabetes in adults [4][6]. Group 1: Product Overview - Kyinsu® integrates Icodec insulin for sustained blood sugar control and Semaglutide for weight management [7]. - The product allows for a single weekly injection, simplifying treatment with a maximum dosage of 350 units of Icodec and 1.0 mg of Semaglutide [7]. - Clinical trials involving over 2,500 adult type 2 diabetes patients demonstrate Kyinsu®'s efficacy in reducing HbA1c levels and achieving significant weight loss with lower hypoglycemia rates compared to daily insulin regimens [7]. Group 2: Industry Impact - The weekly injection format of IcoSema addresses the common delay in insulin therapy initiation among type 2 diabetes patients, where about 50% delay treatment for over two years, increasing complication risks [6]. - The design of Kyinsu® aims to enhance patient adherence to treatment and offers a new option for personalized therapy [6].

Core Insights - Novo Nordisk has been under scrutiny as its stock price declines following disappointing earnings and drug trial results [1] - The focus is on identifying undervalued companies with strong fundamentals and cash flows, particularly in sectors like Oil & Gas and consumer goods [1] - The article emphasizes long-term value investing while acknowledging the potential for deal arbitrage in certain situations [1] Company Analysis - Novo Nordisk's stock is currently viewed as a bargain by investors due to its recent performance issues [1] - The company is part of a broader trend where investors are looking for opportunities in companies that are undervalued for unjustified reasons [1] Investment Strategy - The investment strategy highlighted includes a preference for long-term value investments while also exploring potential arbitrage opportunities [1] - The article suggests a cautious approach towards sectors that are difficult to understand, such as high-tech and certain consumer goods [1]

Group 1 - Novo Nordisk (NYSE: NVO) has been experiencing a decline in stock price due to recent earnings reports and drug trial failures, attracting the attention of bargain hunters [1] - The focus is on analyzing undervalued companies with strong fundamentals and cash flows, particularly in sectors like Oil & Gas and consumer goods [1] - Energy Transfer is highlighted as a company that was previously overlooked but has shown potential for long-term value investing [1] Group 2 - The article emphasizes a preference for long-term value investing while acknowledging the occasional interest in deal arbitrage opportunities [1] - There is a clear aversion to investing in high-tech businesses and certain consumer goods, with a specific mention of a lack of understanding regarding cryptocurrencies [1]

Core Viewpoint - The individual investor adopts a contrarian investment style, focusing on deep value opportunities, particularly in stocks that have recently experienced sell-offs due to non-recurrent events, while also considering insider buying as a positive signal [1] Investment Strategy - The investment portfolio is split approximately 50%-50% between shares and call options, indicating a balanced approach between equity and derivatives [1] - The investor's timeframe for holding positions typically ranges from 3 to 24 months, suggesting a medium-term investment horizon [1] - Fundamental analysis is employed to assess the health of companies, including their leverage and financial ratios compared to sector and industry averages [1] - Technical analysis is utilized to optimize entry and exit points, with a focus on support and resistance levels on weekly charts [1] Stock Selection Criteria - Preference is given to stocks that have undergone a recent sell-off, particularly when there is insider buying at the new lower price, indicating potential recovery [1] - The investor screens through thousands of stocks, primarily in the US, but is open to owning shares in less stable markets, referred to as "banana republics" [1] - Professional background checks are conducted on insiders who purchase shares post-sell-off to ensure credibility and alignment with shareholder interests [1]

Investors will want to see these key developments concerning Novo Nordisk's pipeline of new treatments.The company revealed critical information that investors will not want to miss. *Stock prices used were the afternoon prices of Nov. 23, 2025. The video was published on Nov. 25, 2025. ...

Core Viewpoint - The article discusses the emerging risks associated with the drug Semaglutide, previously marketed as a "weight loss miracle," highlighting serious side effects, including vision loss and gastrointestinal issues, which could undermine its popularity and market position [1][2][3]. Group 1: Vision Risks and Legal Implications - A recent report revealed that 43 patients who used Ozempic or Wegovy have filed for compensation due to a rare eye disease called NAION, which can lead to vision loss [5][9]. - The first five cases have resulted in compensation totaling nearly 900,000 RMB, indicating the potential for significant financial liabilities for the company [6][7]. - With an estimated 50 million users globally by the end of 2025, the risk translates to approximately 5,000 potential victims based on a 1 in 10,000 incidence rate [9][10]. Group 2: Sales Performance and Market Position - Despite the controversies, Semaglutide remains a significant revenue driver for Novo Nordisk, with total sales reaching $25.462 billion in the first three quarters of 2025, a 24% year-on-year increase [25]. - The weight loss version, Wegovy, has shown remarkable growth, with sales of $8.609 billion, marking a 54% increase year-on-year, making it the fastest-growing segment [26]. Group 3: Challenges in the Chinese Market - Novo Nordisk's revenue in China was approximately $2.237 billion, with an 8% growth rate, lagging behind the company's overall double-digit growth [27]. - The company aims to increase its growth rate in China to over 12% by 2026, implementing significant organizational changes and focusing on retail and online platforms [28][30]. - The competitive landscape in China's GLP-1 market has intensified, with Eli Lilly's Tirzepatide posing a direct threat due to its comparable weight loss effects and potentially milder side effects [32]. Group 4: Patent Expiry and Competition - As patents for Semaglutide's indications are set to expire post-2026, domestic companies are ramping up efforts to develop generic versions, with multiple applications already submitted for approval [34]. - A total of 27 companies are competing in this space, indicating an impending price war and market share battle [34][35].

Investment Rating - The report does not explicitly state an investment rating for the GLP-1RA drug industry Core Insights - The GLP-1 receptor agonists (GLP-1RA) are a class of drugs that mimic the action of GLP-1, promoting insulin secretion and reducing appetite, leading to blood sugar control and weight loss [2][3] - The global market for GLP-1 drugs is dominated by semaglutide and tirzepatide, with semaglutide achieving sales of $16.6 billion in the first half of 2025, making it the top-selling drug globally [8] - The expiration of patents for major drugs is expected to lead to a surge in generic versions, increasing market competition and reducing treatment costs [11] Summary by Sections GLP-1 Drug Classification and Mechanism - GLP-1RA drugs are categorized into short-acting, long-acting, and ultra-long-acting formulations, each with different pharmacokinetic profiles [2][3] - These drugs are effective in treating conditions such as obesity, type 2 diabetes, and metabolic disorders [4] Market Performance and Patent Expiration - The sales of GLP-1 drugs have shown significant growth, with semaglutide's weight management product Wegovy achieving $5.441 billion in sales, a 78% increase year-over-year [8] - Key patents for drugs like liraglutide have expired, while others like semaglutide will expire in 2026, paving the way for biosimilars [9][11] R&D Progress in China - Chinese companies are advancing in the development of dual-target and multi-target GLP-1 drugs, with significant progress in clinical trials [13][14] - The focus is shifting towards expanding indications for GLP-1 drugs beyond diabetes and obesity to include conditions like Alzheimer's and cardiovascular diseases [15] Future Market Potential - The Chinese GLP-1 market is projected to grow from 9.62 billion yuan in 2020 to 71.7 billion yuan by 2029, with a compound annual growth rate (CAGR) of 22.1% [22] - The inclusion of GLP-1 drugs in national health insurance is expected to enhance market penetration and accessibility [22] Innovation Trends - The industry is witnessing a trend towards multi-target drug development and the introduction of oral formulations to improve patient compliance [28][29] - The competitive landscape is intensifying as both original and generic drug manufacturers seek to establish a foothold in the market [30][31]