2025 年 10 月 9 日 证券研究报告 行业周报 weiyuqi@gwgsc.com 执业证书编号：S0200525060001 联系电话：010-68099389 公司地址：北京市丰台区凤凰嘴街 行业评级： | 报告期：2025.9.15-2025.10.8 | | | --- | --- | | 投资评级 | 看好 | | 评级变动 | 维持评级 | 分析师： huchenxi@gwgsc.com 执业证书编号：S0200518090001 联系电话：010-68085205 医药生物行业双周报 2025 年第 20 期总第 143 期 2025ESMO 大会召开在即 关注临床数据及基本面优异的公司 行业回顾 本报告期医药生物行业指数跌幅为 2.72%，在申万 31 个一级行业中 位居第 23，跑输沪深 300 指数（2.62%）。从子行业来看，医疗研发 外包、医疗设备涨幅居前，涨幅分别为 2.28%、0.59%；原料药、医 院跌幅居前，跌幅分别为 9.84%、5.78%。 行业走势： 估值方面，截至 2025 年 9 月 30 日，医药生物行业 PE（TTM 整体法， 剔除负值）为 31.23x（ ...

Core Viewpoint - The article emphasizes the importance of adhering to the recommended administration guidelines for oral semaglutide to achieve optimal therapeutic effects in weight loss and blood sugar control [2][13]. Administration Guidelines - The recommended way to take oral semaglutide is to consume it with no more than 4 ounces (approximately 120 milliliters) of water before breakfast, ensuring at least a 30-minute interval before eating or drinking anything else [2]. - Taking the medication before any meal or after any meal is less effective due to shorter fasting periods, which can lead to lower plasma concentrations of semaglutide [3]. - If a person only eats lunch and dinner, taking the medication before lunch is acceptable; similarly, if only breakfast and dinner are consumed, taking it before dinner is also permissible [4]. - Taking the medication after meals is not recommended as it significantly diminishes its effectiveness [5]. Timing Considerations - Taking the medication before bedtime is contingent on the fasting duration; if dinner is skipped, it can be taken before sleep, but it is not advisable if dinner is consumed due to insufficient fasting time [7][8]. - The amount of water used to take the medication should not exceed 120 mL, as excessive water can hinder the drug's absorption [9]. - It is crucial to wait at least 30 minutes after taking the medication before consuming breakfast or any other oral medications to avoid interference with absorption [10]. Impact of Non-compliance - Occasional deviations from the recommended administration (e.g., forgetting to take the medication or taking it with too much water) generally have a minimal impact on overall efficacy; however, consistent non-compliance can adversely affect therapeutic outcomes [11][12]. Efficacy Comparison - Oral semaglutide (Rybelsus) and injectable semaglutide (Ozempic) have been shown to have comparable efficacy in clinical trials, with similar reductions in A1C levels and weight loss observed in both [14].

Core Insights - Eli Lilly's orforglipron shows superior glycemic control compared to oral semaglutide in recent clinical trials [1][2] - The ACHIEVE-3 trial results indicate a significant reduction in HbA1c levels and weight loss for orforglipron users [2][3] - The oral GLP-1 drug market is expanding, with increasing interest from Chinese companies in developing oral formulations [4][5] Group 1: Clinical Trial Results - The ACHIEVE-3 trial demonstrated that the highest dose of orforglipron resulted in a 2.2% reduction in HbA1c, compared to a 1.4% reduction for oral semaglutide [2] - Participants using orforglipron lost an average of 8.9 kg (9.2%), while those on oral semaglutide lost 5.0 kg (5.3%), representing a relative improvement of 73.6% [2] - Orforglipron users showed clinical improvements in cardiovascular risk factors, including non-HDL cholesterol and triglycerides [2] Group 2: Market Dynamics - Oral semaglutide's revenue grew from $0.07 billion in 2019 to $3.38 billion in 2024, with a compound annual growth rate of 239.5% [4] - The preference for oral medications over injections is evident, with 39.7% of surveyed individuals favoring oral treatments [5] - Chinese companies are accelerating their development of oral GLP-1 drugs, with several candidates in late-stage clinical trials [5]

Core Viewpoint - Eli Lilly's orforglipron shows significantly better glycemic control compared to oral semaglutide in the phase III clinical trial "ACHIEVE-3" [2][3] Group 1: Clinical Trial Results - In the ACHIEVE-3 trial, the highest dose of orforglipron resulted in a 2.2% reduction in HbA1c, while the highest dose of oral semaglutide resulted in a 1.4% reduction [3] - Participants using the highest dose of orforglipron lost an average of 8.9 kg (9.2%), compared to a 5.0 kg (5.3%) loss for those on oral semaglutide, representing a relative improvement of 73.6% [3] - Orforglipron users showed clinically meaningful improvements in several cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure, and triglycerides [3] Group 2: Market Context and Competitors - Oral semaglutide is currently the only approved oral GLP-1 drug for type 2 diabetes, with revenue growth from $0.07 billion in 2019 to $3.383 billion in 2024, reflecting a compound annual growth rate of 239.5% [5] - Novo Nordisk has submitted a weight loss indication application for oral semaglutide, which has shown near-injection efficacy in late-stage trials [5] - The development of oral GLP-1 formulations is challenging, with two main directions: oral peptides and oral small molecules, each facing unique challenges [5][6] Group 3: Industry Trends - There is a growing preference for oral medications over injections, with 39.7% of surveyed individuals indicating a preference for oral treatments [6] - The complexity and unpredictability of side effects in oral small molecules present additional challenges, but the higher technical barriers in oral GLP-1 development may reduce competition [6] - Chinese companies are accelerating their development of oral GLP-1 drugs, with several candidates in late-stage clinical trials [6]

Core Viewpoint - Novo Nordisk's oral semaglutide has shown significant weight loss results comparable to its injectable counterpart Wegovy, with a 16.6% average weight reduction in a 64-week trial, leading to a stock price increase of 5.4% on the announcement day [4][5]. Group 1: Clinical Trial Results - In the Oasis 4 study, patients treated with oral semaglutide experienced an average weight loss of 16.6%, slightly better than the 15% reduction seen with Wegovy in similar populations [4]. - The oral formulation is expected to replicate the efficacy and safety of the injectable version, as confirmed by Novo Nordisk's Chief Scientific Officer [5]. Group 2: Market Competition - The oral GLP-1 market is becoming increasingly competitive, with Eli Lilly's candidate Orforglipron showing a 12.4% average weight loss in a recent trial [6]. - Novo Nordisk emphasizes that its oral semaglutide can achieve approximately 17% weight loss with a lower discontinuation rate due to adverse reactions, suggesting better safety and tolerability [6]. Group 3: Strategic Focus and Pipeline - Novo Nordisk is not only advancing oral semaglutide but also developing next-generation weight loss therapies, including long-acting amylin analog Cagrilintide [8]. - The company is undergoing a strategic transformation, including a workforce reduction of about 9,000 employees to concentrate resources on diabetes and obesity core areas [8].

Core Insights - Diabetes is a global public health challenge, with over 500 million patients worldwide, predominantly suffering from type 2 diabetes. China faces a significant burden in diabetes management [1] - Eli Lilly's ACHIEVE-3 study provides new insights into managing type 2 diabetes, comparing orforglipron and oral semaglutide, showing orforglipron's superior efficacy in reducing A1C levels and weight loss [1][2] - The study indicates that orforglipron leads to a 2.2% reduction in A1C levels compared to 1.4% for oral semaglutide, and participants on orforglipron lost an average of 8.9 kg (9.2%) versus 5.0 kg (5.3%) for semaglutide [1][2] Group 1 - Orforglipron shows significant improvements in cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure, and triglycerides, while maintaining safety and tolerability [2] - The research expands chronic disease management pathways, providing more tools for personalized treatment plans, which is crucial for long-term diabetes management [2] - The ATTAIN-1 study also demonstrated that orforglipron can aid in weight loss and improve cardiovascular risk factors in overweight or obese individuals without diabetes [2] Group 2 - Eli Lilly emphasizes the importance of convenient medication options for early management of metabolic disorders, shifting the focus from treatment to prevention [3] - The company is advancing orforglipron's application for obesity treatment globally, with regulatory approval expected soon, while the application for type 2 diabetes treatment is anticipated in 2026 [3] - The innovation in drug development is expected to translate into accessible health benefits for the public, contributing to overall health goals [3]

Core Viewpoint - Morgan Stanley maintains a positive outlook on Eli Lilly's oral GLP-1 receptor agonist Orforglipron (Orfor) for obesity treatment, following the release of Phase III clinical trial data, with a target price of $1028 and an "overweight" rating [1][2]. Group 1: Clinical Trial Results - The ATTAIN-1 trial demonstrated Orfor's effectiveness in weight loss, cardiovascular metabolic improvements, and safety across multiple dimensions [1]. - Weight loss plateaued between weeks 48 to 72 across all three dosage groups, with results comparable to the Phase II trial at 36 weeks, potentially due to trial design and population differences [1][2]. - In comparison, Novo Nordisk's oral semaglutide 25mg also showed a weight loss plateau between weeks 48 to 64, with a male population percentage of approximately 24% [1]. Group 2: Metabolic and Safety Improvements - Orfor significantly improved multiple cardiovascular metabolic risk factors, including waist circumference, systolic blood pressure, non-HDL cholesterol, and triglycerides, along with other metabolic indicators [2]. - In terms of body composition, 73.1% of weight loss was attributed to fat reduction, while 26.9% was from lean body mass loss [2]. - Safety assessments indicated that Orfor's adverse reactions were consistent with other GLP-1 medications, primarily mild to moderate gastrointestinal events, with no significant drug-related liver injury detected [2]. Group 3: Market Potential - Orfor is particularly suitable for individuals with a lower BMI (<35) and those preferring oral therapies or lacking access to injectable medications, including patients in low to middle-income countries [2]. - The successful market entry of Orfor, along with the expansion of another weight loss drug, tirzepatide, and accelerated supply of auto-injectors, could present upside risks [2].

Core Viewpoint - Novo Nordisk announced that the European Medicines Agency (EMA) has approved an update to the label of Rybelsus (oral semaglutide) to reflect cardiovascular benefits demonstrated in the SOUL trial [2][4]. Group 1: Cardiovascular Benefits - Oral semaglutide is now the first oral GLP-1 receptor agonist in the EU to have confirmed cardiovascular benefits in the treatment of type 2 diabetes [4]. - The SOUL trial is a Phase 3b study assessing the impact of oral semaglutide on cardiovascular outcomes in patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD) [2][6]. Group 2: Implications for Treatment - Cardiovascular complications are a leading cause of disability and death among type 2 diabetes patients, making treatments that protect the heart crucial for improving health outcomes and quality of life [6]. - With this approval, semaglutide becomes the only oral GLP-1 RA that can lower blood sugar and weight while providing cardiovascular benefits [6]. Group 3: Future Developments - In the U.S., a decision regarding the expansion of the label for oral semaglutide to include cardiovascular benefits is expected later this year [8]. - Novo Nordisk has also submitted an application for a daily 25 mg oral semaglutide (injection form marketed as Wegovy) for adults with obesity or overweight and cardiovascular disease, with results anticipated by the end of this year [8].

Core Viewpoint - The recent phase III clinical results of orforglipron for overweight or obese adults with type 2 diabetes have reignited market confidence, despite earlier disappointing data from Eli Lilly [2][10]. Group 1: Clinical Trial Results - The ATTAIN-2 trial (NCT05872620) showed that all dosage groups achieved both primary and secondary endpoints, with the highest dose of 36mg leading to an average weight loss of 10.5% (22.9 pounds) over 72 weeks [2][5]. - Weight loss effects were observed across all doses, with the 12mg group losing an average of 7.8%, the 6mg group losing 5.5%, and the placebo group losing 2.2% [6]. - Over 50% of patients in the 36mg group lost at least 10% of their body weight, compared to only 7% in the placebo group, and approximately 28.4% of patients lost more than 15% [7]. Group 2: Market Reaction and Analyst Insights - Following the announcement on August 26, Eli Lilly's stock price opened up 2.8% and closed up 2.7%, reaching a market capitalization of $659.8 billion [3]. - Analyst Andy Hsieh noted that orforglipron's performance in the overweight diabetic patient group exceeded investor expectations, highlighting the competitive advantage in the diabetes treatment market, which affects about 15% of U.S. adults [4][11]. Group 3: Safety and Regulatory Progress - The safety profile of orforglipron aligns with previous studies, with gastrointestinal symptoms being the most common adverse effects, mostly mild to moderate [8]. - Eli Lilly plans to present complete data at future medical conferences and has confirmed the submission of a "complete data package" for global regulatory approval [9].

Group 1 - The World Lung Cancer Conference (WCLC) is set to showcase numerous innovative drugs from Chinese pharmaceutical companies, highlighting the potential investment opportunities in the sector [1] - Several leading innovative drug companies will present significant new products during the WCLC, including key studies on anti-PD-1 monoclonal antibodies and other targeted therapies [1] - The Chinese innovative drug industry is entering a new phase of high-quality development, characterized by rapid advancements in research and development [3] Group 2 - Over 1,250 innovative drugs are currently in the research phase in China, a number that has nearly increased tenfold compared to a decade ago, indicating significant growth in the sector [3] - The total amount of innovative drug transactions abroad reached nearly $50 billion in the first half of 2025, with upfront payments exceeding $2 billion, suggesting a record-breaking year ahead [3] - More than 100 innovative drugs have been included in the preliminary list for commercial insurance coverage, signaling a potential second growth curve for the innovative drug market [5] Group 3 - The innovative drug industry is transitioning from policy-driven growth to value realization, with companies that possess global competitiveness expected to thrive through differentiated innovation and international expansion [7] - Investors are encouraged to track policy implementation, clinical trial progress, and overseas commercialization to seize medium to long-term structural opportunities in the innovative drug sector [7] - The innovative drug ETFs and related funds are recommended as effective tools for investors looking to gain exposure to the innovative drug industry [7]