贝那鲁肽

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美国心脏病学会重磅发布:这两款药物成减肥"黄金标准"!
GLP1减重宝典· 2025-10-05 10:57
以下文章来源于内分泌早知道 ,作者关注内分泌的 内分泌早知道 . 深度分享内分泌用药经验、病例剖析、指南专业解读并紧跟国内外内分泌领域前沿进展,「每医健」旗下内容平台。 内分泌早知道 solution for injection in pre-filled per semaglutide subcutaneous use 美国心脏病学会最新发布的指南 首次明确将司美格鲁肽和替尔泊肽 列为肥胖症治疗的优选药物 UNDERSTANDING OBESITY 添加小助手 商务合作/投稿/学术交流 备注「姓名+公司+职务+诉求」 美国心脏病学会(ACC)最新发布的《心血管健康体重管理专家共识》引发广泛关注。这份权威指南首次明确将司美格鲁肽和替尔泊 肽列为肥胖症治疗的优选药物,这两种新型营养刺激激素(NuSH)疗法正在重塑减肥治疗新格局。 ▍ 突破性疗法带来双重获益 研究证实,这类创新药物不仅能显著减轻体重,更能为心血管高风险人群提供额外保护。对于合并2型糖尿病或已有心血管疾病的患 者,NuSH疗法可有效降低心血管死亡、心梗及中风风险。其中,司美格鲁肽作为GLP- 1受体激动剂的代表,与双靶点激动剂替尔泊肽 共同构成了当 ...
为什么使用司美格鲁肽等GLP-1药物减肥期间一定要多喝水?
GLP1减重宝典· 2025-09-14 03:08
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].
速递|重磅!CDE发布《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)》
GLP1减重宝典· 2025-09-13 04:27
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、 ...
跳不出减重反弹怪圈?科学告诉你原因,GLP-1或许真能帮上忙
GLP1减重宝典· 2025-09-12 02:59
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].
会议预告|从共识走向行动:第四届中国肥胖大会(COC2025)即将开幕!
GLP1减重宝典· 2025-08-12 09:52
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]
国产减肥药加速突围:如何与进口药竞争?是否还有BD预期?
Xin Lang Cai Jing· 2025-08-11 23:50
Group 1 - Xinda Biologics announced the official launch of its dual receptor agonist, Masitide, for weight management, which is the first GCG/GLP-1 dual receptor agonist approved for long-term weight control in adults in China [1] - Clinical data shows that Masitide can achieve a weight reduction of 21%, over 80% reduction in liver fat content, and significant improvements in cardiovascular and metabolic indicators [1] - The GLP-1 weight loss drug market has seen significant growth, with Novo Nordisk's semaglutide generating $16.5 billion in revenue and Eli Lilly's tirzepatide generating $14.7 billion in the first half of 2025 [1] Group 2 - The trend in GLP-1 weight loss drug development is shifting towards multi-target, long-acting, and oral formulations, with many domestic innovative pharmaceutical companies actively participating [2] - The popularity of GLP-1 drugs has been fueled by endorsements from high-profile individuals, leading to increased public interest and demand for these medications [3] - The market for GLP-1 drugs in China is estimated to be between 40 billion to 50 billion yuan, with significant potential for generic drugs as original patents expire [5] Group 3 - The competitive landscape for GLP-1 weight loss drugs is evolving, with various products entering the market, and companies need to adapt their commercialization strategies to succeed [6][9] - Regulatory requirements for GLP-1 products in China are stringent, necessitating large-scale clinical trials, which poses challenges for many companies [7] - Partnerships and business development (BD) opportunities are emerging as companies seek to expand their market presence internationally, with notable agreements already in place [8]
国内药企积极布局减肥药领域,又一国产创新药加入对“减肥神药”司美格鲁肽的挑战
Hua Xia Shi Bao· 2025-06-26 05:53
Core Insights - The article discusses the emergence of Ecnoglutide, a new GLP-1 receptor agonist developed by a team led by Professor Ji Linong from Peking University People's Hospital, which poses a challenge to the market dominance of Novo Nordisk's Semaglutide in the weight loss drug sector [1][4]. Company Developments - Ecnoglutide has shown impressive results in its Phase III clinical trial (SLIMMER), with over 92.8% of participants achieving effective weight loss and an average weight reduction of 15.1% over 48 weeks [3][4]. - The trial involved 664 participants across 36 centers in China, making it the largest sample size for a weight loss drug trial in the country [3]. - The drug has entered the market application stage, indicating a potential for commercialization soon [4]. Market Landscape - The global GLP-1 weight loss drug market is projected to exceed $150 billion by 2025, with Novo Nordisk's Semaglutide leading the market, generating $8 billion in Q1 2025, a 31% year-on-year increase [5]. - Other companies, including Hengrui Medicine, East China Pharmaceutical, and others, are actively developing weight loss drugs, with some products already in Phase II or III clinical trials [2][6]. Competitive Dynamics - Ecnoglutide's clinical trial results suggest a significant competitive edge over existing products, with a higher effective weight loss rate compared to similar drugs [3][4]. - The article highlights the potential for domestic companies to challenge established players like Novo Nordisk and Eli Lilly, as several innovative drugs are in advanced clinical stages [6]. Future Outlook - The article emphasizes the commercial opportunity for domestic alternatives in the weight loss drug market, especially as imported drugs have already cultivated market demand [7].
银诺医药二战港交所:仅一款GLP-1药物进入临床 市场竞争日益激烈独木能否撑起46亿估值?
Xin Lang Zheng Quan· 2025-06-19 01:27
Core Viewpoint - Guangzhou Yinnuo Pharmaceutical Group Co., Ltd. has submitted a second listing application to the Hong Kong Stock Exchange after its previous application expired, with a focus on innovative therapies for diabetes and metabolic diseases [1][2] Company Overview - Yinnuo Pharmaceutical was established in 2014 and is dedicated to researching and developing innovative therapies for diabetes and other metabolic diseases [1] - The company has multiple research pipelines targeting diabetes, obesity, and non-alcoholic fatty liver disease [1] Product Pipeline - The core product, Isupatide α (brand name: Yinuo Qing), is set to be approved for treating type 2 diabetes in January 2025 and has entered the commercialization phase [1] - The product for obesity treatment has completed Phase IIa clinical trials and has initiated Phase IIb/III trials in March 2024 [1] - Other pipelines are still in the pre-clinical stage, with the fatty liver disease treatment expected to start Phase IIa trials in 2026 [1] Market Competition - The domestic GLP-1 product market is highly competitive, with around 40 companies developing GLP-1 drugs for weight loss, resulting in a total of 206 pipelines [2][3] - Yinnuo's reliance on Isupatide α raises concerns about its commercial prospects due to intense competition and the presence of multiple established products in the market [2][3] Financial Performance - Yinnuo Pharmaceutical has faced continuous losses, with losses of 301 million, 733 million, and 175 million yuan from 2022 to 2024, totaling 1.5 billion yuan [5] - The company has significantly reduced its R&D spending from 492 million yuan in 2023 to 103 million yuan in 2024, contributing to a narrower loss in 2024 [5] Investment and Valuation - The company has completed four rounds of financing, raising a total of 1.514 billion yuan, with a valuation of 4.65 billion yuan as of January 2024, a significant increase from previous valuations [5] - Prior to the IPO application, some investors transferred their shares at a discount, indicating potential concerns about the company's valuation [6]
速递|5600万美元!先为达GLP-1激动剂达成许可和合作韩国权益
GLP1减重宝典· 2025-05-08 04:16
整理 | GLP1减重宝典内容团队 Ecnoglutide是一款具备cAMP信号偏向性的长效GLP-1受体激动剂,设计上优化了药效并降低了生产成本,可实现每周一次的注射。该药物正被开发用于 2型糖尿病、肥胖症以及代谢紊乱相关的脂肪性肝炎(MASH)治疗。 在I期和II期临床试验中,Ecnoglutide展现出良好的安全性和耐受性,并在糖尿病与肥胖患者中均显示积极疗效。基于这些数据,先为达于2023年1月启动 了Ecnoglutide与度拉糖肽的III期对比研究(NCT05680129),用于控制经二甲双胍治疗后血糖仍难以达标的2型糖尿病患者。 同年3月,公司又在中国启动Ecnoglutide治疗超重与肥胖人群的III期注册试验,这是继贝那鲁肽后第二款进入此阶段的国产GLP-1激动剂。这些研究的主 要结果有望于今年揭晓。 5月7日,先为达宣布与韩国制药企业HK inno.N Corporation签署合作协议,授权对方在韩国地区开发和销售伊诺格鲁肽注射液(Ecnoglutide, XW003)。 根据协议条款, 先为达将获得首付款以及总额最高达5600万美元的研发、注册和商业化阶段的里程碑付款 ,并在产品上市后 ...