整理 | GLP1减重宝典内容团队 一项研究显示，专家使用了一种基于模型的模拟方法，来评估在2型糖尿病患者身上，从GLP-1受体激动剂（司美格鲁肽和度拉糖肽） 转换至GIP/GLP1受体激动剂替尔泊肽所带来的疗效影响。 研究团队根据临床试验数据开发了一个模型，用于预测不同治疗方案的血糖控制和体重减轻效果。该模型预测了从司美格鲁肽 （SUSTAIN 1-10）或度拉肽（AWARD-11）转换至替尔泊肽（SURPASS 1-5，全球III期T2D项目）对血糖和体重的影响。通过模拟药 效时间进程，可以观察到从每周一次的GLP-1受体激动剂转换至替尔泊肽对疗效的影响。根据各自的标签，司美格鲁肽和度拉糖肽的剂 量会逐步增加。 根据模型预测，司美格鲁肽的 0.5mg、1.0mg 和 2.0mg 剂量在第 26 周时的 HbA1c 基线均值降低范围为 1.22% 至 1.79%，体重降低范 围为 3.62kg 至 6.87kg;而度拉糖肽的 1.5mg、3.0mg和 4.5mg 剂量在第 26 周时的 HbA1c 基线均值降低范围为 1.53% 至 1.84%，体重 降低范围为 2.55kg 至 3.71kg。 研究结果显 ...

整理 | GLP1减重宝典内容团队 如果您怀孕了或者正准备怀孕，您需要了解以下关于使用 GLP-1 药物治疗 2 型糖尿病或肥胖症的信息。 研究人员发现，与母亲在怀孕期间注射胰岛素控制糖尿病相比，母亲使用 GLP-1 药物所生的孩子患先天性缺陷的风险并没有增加。 虽然研究结 果令人鼓舞，但研究人员指出，还需要更多的证据才能排除 GLP-1 对胎儿的潜在风险，而且他们的研究只是迈出了了解这些药物如何影响儿童 发育的第一步。 胰高血糖素样肽 1 (GLP-1) 受体激动剂，如 Ozempic (semaglutide) 和 Trulicity (dulaglutide)，越来越多地用于治疗 2 型糖尿病，在某些情况 下，还用于减肥。如果您患有 2 型糖尿病，您的医生甚至可能提到过尝试其中一种较新的药物。 但是，如果您怀孕或试图怀孕，这些药物可以 安全使用吗？ 现有研究结果并不一致，因此专家建议女性在这种情况下暂时停止或推迟开始使用 GLP-1 药物。 "需要进行更多研究来确定在怀孕期间服用司美格鲁肽或其他 GLP-1 是否安全，"凤凰城亚利桑那州妇女健康中心的妇产科医生Monte Swarup 医 学博士说。"因 ...

Core Viewpoint - The article emphasizes the importance of hydration for individuals using GLP-1 medications, highlighting that adequate water intake can enhance the effectiveness of these weight loss drugs and mitigate potential side effects [4][6][7]. Group 1: Importance of Hydration - Water constitutes about 20% of daily total water intake, and using GLP-1 medications may lead to reduced food and water consumption, increasing the risk of dehydration [4]. - Proper hydration is crucial for digestion and drug metabolism, ensuring sufficient digestive fluids are available to aid in food breakdown and nutrient absorption [6]. - Insufficient water intake can lead to constipation and bloating, which may hinder weight loss efforts [6]. Group 2: Symptoms of Dehydration - Users of GLP-1 medications may experience mild dehydration, leading to symptoms such as headaches, muscle cramps, nausea, constipation, fatigue, and dizziness [7]. - Dehydration can exacerbate gastrointestinal side effects like nausea and constipation, making it essential for users to maintain adequate hydration [7]. Group 3: Detoxification and Fat Metabolism - Water aids in the elimination of toxins released during fat breakdown, preventing their accumulation and ensuring effective metabolism [8]. - Sufficient hydration is necessary for the body to metabolize fat efficiently, as dehydration can slow down weight loss progress [9]. Group 4: Energy Levels and Exercise Performance - Fatigue is a common side effect of dehydration and weight loss medications; drinking water can help restore energy levels [11]. - Hydration is vital for muscle function, endurance, and recovery, especially when exercise is part of a weight loss plan [11]. Group 5: Hydration Guidelines - There are no specific guidelines for water intake for GLP-1 users, but general recommendations suggest women should consume about 91 ounces and men about 125 ounces of water daily [12]. - Individual hydration needs may vary based on factors such as body size, other medications, outdoor temperature, and physical activity [12]. Group 6: Monitoring Hydration - A simple method to check hydration levels is by observing urine color; pale yellow indicates adequate hydration, while dark yellow suggests a need for increased intake [13]. - Keeping track of fluid intake and ensuring regular hydration throughout the day can help meet daily liquid goals [13].

整理 | GLP1减重宝典内容团队 为规范和指导重组胰高血糖素样肽-1受体激动剂的药学研究，在国家药品监督管理局的部署下，我中心组织制定了《重组胰高血糖素样肽-1受 体激动剂药学研究与评价技术指导原则（试行）》（见附件）。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监 综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。 特此通告。 附件：重组胰高血糖素样肽-1受体激动剂药学研究与评价技术指导原则（试行） 国家药监局药审中心 2025年9月3日 重组胰高血糖素样肽–1 受体激动剂 药学研究与评价技术指导原则(试行) 国家药品监督管理局药品审评中心 2025 年 9 月 | 一、前言 . | | --- | | 二、适用范围 . | | 三、一般原则 . | | (一)研发策略 | | (二)全生命周期管理 . | | (三)杂质研究 | | 四、原液生产工艺 . | | (一)生产用原材料 3 | | (二)化学分子修饰剂 . | | (三)重组 GLP-1 短肽的表达和修饰 6 | | (四)与其他蛋白融合的 GLP-1 受体激动剂 8 | | 五、 ...

Core Viewpoint - The article emphasizes that effective weight loss requires a scientific approach rather than extreme dieting or excessive exercise, highlighting the importance of maintaining muscle mass and a balanced lifestyle to avoid rebound weight gain [6][10][15]. Group 1: Weight Loss Challenges - Many individuals experience weight fluctuations, often losing weight only to regain it quickly, which may be due to ineffective weight loss methods [6]. - The concept of "false weight" is introduced, indicating that weight loss on the scale may not reflect actual fat loss, as it could be water or muscle loss instead [7]. - Extreme dieting and excessive exercise can lead to muscle loss and a decrease in metabolic rate, making it harder to maintain weight loss and leading to a cycle of rebound weight gain [8][10]. Group 2: Scientific Weight Loss Strategies - A healthy weight loss rate is suggested to be about 0.5% to 1% of body weight per week, equating to approximately four to ten pounds per month [12]. - Combining diet and exercise is crucial; a balanced intake of quality proteins and regular physical activity, including both aerobic and strength training, is recommended to preserve muscle and enhance metabolism [12]. - After achieving weight loss goals, a consolidation period of 1 to 3 months is necessary to maintain new weight levels by continuing healthy habits [12]. Group 3: GLP-1 Weight Loss Method - The GLP-1 weight loss method is introduced as a new approach for those struggling with weight loss or experiencing rebound effects [13]. - GLP-1, a hormone secreted by the intestines, helps control appetite and prolongs gastric emptying, leading to reduced caloric intake [13][14]. - Compared to traditional dieting and exercise, GLP-1 has the advantage of promoting fat loss rather than just water or muscle loss, resulting in more sustainable weight loss [14]. - It is emphasized that GLP-1 usage should be under medical supervision, and it should be combined with healthy lifestyle changes for long-term effectiveness [14].

Group 1 - The core issue raised by investors concerns the patent status of Dulaglutide and the delay in its submission for approval [2] - The company, Donglu Pharmaceutical, clarified on September 1 that there are no patent issues with its GLP-1 long-acting formulation and that it is currently preparing the necessary documentation for submission [2] - The specific timeline for the submission remains uncertain as the company is still in the process of gathering materials [2]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Views - The report highlights the release of the preliminary list of innovative drugs for commercial insurance, focusing on companies with leading clinical value and commercialization capabilities [4] - The pharmaceutical and biotechnology industry index increased by 2.21%, ranking 21st among 31 primary industries, underperforming the CSI 300 index which rose by 3.64% [5][16] - The report suggests a focus on companies in the oncology, metabolic diseases, and rare diseases treatment sectors, particularly those with strong clinical pipelines and commercialization capabilities [8] Industry Overview - The pharmaceutical and biotechnology industry PE (TTM, excluding negative values) as of August 15, 2025, is 31.38x, up from 30.97x in the previous period, indicating an upward valuation trend but still below the average [5][21] - The top three sub-industries by PE are vaccines (62.98x), hospitals (40.19x), and medical consumables (39.11x), while the lowest is pharmaceutical distribution (15.85x) [21] Important Industry News - The National Healthcare Security Administration (NHSA) has published the preliminary list of innovative drugs for commercial insurance, with over 100 innovative drugs included, covering areas such as oncology and rare diseases [8][26] - The NHSA is also advancing the reform of medical insurance payment methods, emphasizing a disease-based payment model to enhance the quality of healthcare services [30] Company Dynamics - Insmed's "Brensocatib" has received FDA approval for treating non-cystic fibrosis bronchiectasis, marking a significant advancement in targeted therapies for this condition [42][44] - Precigen's "Papzimeos" has been approved by the FDA as the first-in-class gene therapy for recurrent respiratory papillomatosis, providing a new treatment option for patients [48] - The approval of "博优平" (Dulaglutide injection) by 博安生物 marks it as the first domestically produced biosimilar of its kind, aiming to compete in the diabetes treatment market [49][50]

Core Insights - The GLP-1 class of drugs has evolved from a diabetes treatment tool to a strategic asset reshaping the global pharmaceutical landscape, with Novo Nordisk's semaglutide and Eli Lilly's tirzepatide achieving significant sales figures of $29.3 billion and $16.5 billion respectively in 2024 [1] - The Chinese market is experiencing a shift as domestic innovation breaks through, exemplified by the launch of the first domestically produced human-derived long-acting GLP-1 receptor agonist, Isupatide α, by the biotech company Yino Pharma [1][8] - The metabolic disease sector is becoming a critical focus due to its large patient base and treatment needs, with diabetes, obesity, and metabolic dysfunction-related non-alcoholic steatohepatitis (MASH) accounting for 65% of the market share in China and 82.3% globally [3][5] Market Dynamics - The global market for metabolic disease drugs is projected to grow from $145.4 billion in 2024 to $191.6 billion by 2028, with a compound annual growth rate (CAGR) of 7.1% [6] - The Chinese market for metabolic disease drugs is expected to increase from $16.4 billion to $24.5 billion during the same period, with a CAGR of 10.6% [6] - Long-acting GLP-1 therapies are anticipated to dominate the market, with their share rising from 1.2% in 2018 to 86.9% in 2024, and projected to reach 98.7% by 2034 [6] Company Overview - Yino Pharma is positioned as a leader in the industry with its first-mover advantage in the domestic market, aiming to disrupt the existing import monopoly with Isupatide α [10][21] - The company has a robust pipeline with five additional clinical candidates targeting major diseases, including diabetes, obesity, MASH, and Alzheimer's disease, all with global commercial rights [11] - Isupatide α has been approved for treating Type 2 diabetes (T2D) and has already generated revenue of approximately 38.14 million RMB within four months of its launch [17][19] Financial Performance - Yino Pharma has demonstrated a unique advantage by achieving commercialization with its core product while maintaining stable other income streams, with revenues recorded at 16.84 million RMB and 20.06 million RMB in 2023 and 2024 respectively [19] - The company's research and development (R&D) expenditures have significantly decreased from 492.1 million RMB in 2023 to 102.5 million RMB in 2024, reflecting the transition of Isupatide α to the commercialization phase [18] - As of May 31, 2025, Yino Pharma had over 600 million RMB in cash and cash equivalents, providing a solid financial foundation for future pipeline development and market expansion [20][22]

Core Insights - The global pharmaceutical sales ranking for the top 50 drugs has been revealed, with Novo Nordisk's semaglutide surpassing Merck's Keytruda to become the new sales champion, achieving over $16.6 billion in sales [1][3] - Eli Lilly's tirzepatide shows significant growth potential with a sales increase of 121.3%, reaching nearly $15 billion [1][2] - The entry of domestic innovative drugs into the ranking marks a notable shift in the competitive landscape [1] Group 1: Top Selling Drugs - Semaglutide, including Ozempic, Rybelsus, and Wegovy, generated sales of $16.632 billion, with a year-on-year growth of 29.8% [3][4] - Tirzepatide achieved sales of $14.734 billion, with a remarkable growth rate of 121.3% [3][8] - Dulaglutide, another Eli Lilly product, saw a decline in sales, highlighting the competitive pressures in the market [3][4] Group 2: Vaccine Sales Decline - Three vaccine products in the top 50 experienced sales declines, despite a favorable competitive landscape [4][5] - Gardasil 9, a nine-valent HPV vaccine, saw a nearly 50% drop in revenue [5][6] - The decline in vaccine sales is attributed to reduced government subsidies and market saturation [6][7] Group 3: Emerging Drugs and Growth - Over 70% of drugs in the ranking maintained positive sales growth, with only seven drugs exceeding a 30% growth rate [8] - Enzalutamide, approved for 13 years, continues to show over 30% growth, with sales projected to reach $4.6 billion in 2022 [9][10] - The competitive landscape for enzalutamide is expected to intensify as its core patent expires in 2026 [10]

Core Viewpoint - Obesity has become a global public health challenge, with China having the highest number of obese patients in the world, leading to various chronic diseases such as diabetes and cardiovascular diseases [2] Group 1: Conference Information - The 2025 China Obesity Conference (COC) will be held from August 15 to 17, 2025, at the National Conference Center in Beijing [3] - The conference will gather over 400 global experts from significant academic organizations to discuss the latest advancements in obesity prevention and treatment [5] Group 2: Training and Collaboration - A series of training programs will be launched, including the SCOPE School China, aimed at promoting standardized treatment for obesity in China [6] - The conference will feature 60 forums led by scholars from 16 countries, focusing on the integration of clinical and basic research [7] Group 3: Technological Advancements - The conference will address seven key topics, including surgical and pharmacological treatments for weight loss, endoscopic techniques, gut microbiota, immune regulation, drug development, corrective surgery, and artificial intelligence [8] Group 4: Publications and Community Engagement - The publication of the "National Health Management" series and the initiation of the "Obesity Studies" project mark significant milestones in obesity prevention and treatment in China [9] - The "Blue Dragonfly Action" initiative encourages public participation in scientific weight loss practices [10] Group 5: Industry and Academic Collaboration - Discussions on the development of weight loss drugs, new technology transfer, and the construction of an industrial ecosystem will be held [11] - Practical discussions on digital healthcare and AI's role in weight management will reshape the management paradigm [12] Group 6: Guidelines and Youth Involvement - The conference will analyze the latest clinical guidelines for obesity, facilitating the application of cutting-edge research data in clinical practice [13] - A youth forum will showcase innovative research and clinical achievements in obesity prevention and treatment [14]