整理 | GLP1减重宝典内容团队 Viking Therapeutics 股价周二暴跌，此前公司公布的肥胖症口服药 中国国家药监局药品审评中心（CDE）官网近日公示，安进申报的1类新药AMG获得临床试验默示许可，拟用于 射血分数保留的或轻度降低 的心力衰竭合并肥胖。 | 44 | JXSL2500096 | AMG 133 | Amgen Inc. | 射血分数保留的或轻度 降低的心力衰竭合并肥 | 1 | | --- | --- | --- | --- | --- | --- | | | | | | 胖 | | | 45 | JXSL2500095 | AMG 133 | Amgen Inc. | 射血分数保留的或轻度 降低的心力衰竭合并肥 | 1 | | | | | | 胖 | | | 46 | JXSL2500094 | AMG 133 | Amgen Inc. | 射血分数保留的或轻度 降低的心力衰竭合并肥 胖 | 1 | | 47 | JXSL2500093 | AMG 133 | Amgen Inc. | 射血分数保留的或轻度 降低的心力衰竭合并肥 胖 | 1 | | 48 | JXSL2500 ...

整理 | GLP1减重宝典内容团队 "当使用 GLP-1 受体激动剂的患者体重减轻（甚至增加）时， 了解身体成分的潜在变化非常重要 ，包括内脏和皮下脂肪量、腹部肌肉 体积和质量、骨矿物质密度和器官特性（例如肝脏体积和衰减）"，通讯作者、威斯康星大学医学与公共卫生学院放射学和医学物理系 的医学博士 Perry J. Pickhardt 及其同事解释道。"这些身体成分测量无法从标准临床评估（例如体重、腰围和 BMI）中得出，可作为 心脏代谢疾病、虚弱和死亡风险的生物标志物。" 点击关注，追踪最新GLP-1资讯 ▍ 司美格鲁肽等GLP-1药物不仅能改变人体的外在外观，还能改变身体成分 衡量减肥效果的标准临床指标并不能全面反映减肥效果对整体健康的影响。另一方面，通过 CT 扫描得出的身体成分指标可以从心脏 代谢的角度更深入地了解减肥对身体的影响。研究人员最近在《美国放射学杂志》的新研究中详细描述了司美格鲁肽如何影响身体成 分。 ▍ 使用司美格鲁肽后， 身体成分的所有变化都是积极的，有利于心脏代谢健康 在这项研究中，研究人员分析了 241 名服用司美格鲁肽的患者的 腹部 CT 扫描 ，这些患者在服药前五年和服药后五年都 ...

整理 | GLP1减重宝典内容团队 基于这一突破性数据，Vivani Medical 宣布将优先推进 NPM-139 项目，计划于 2026 年正式启动临床试验，此举有望重塑全球肥胖及代谢疾 病治疗格局。 近期业务进展 Viking Therapeutics 股价周二暴跌，此前公司公布的肥胖症口服药 Vivani Medical于8月公布了截至2025年6月30日的第二季度财务业绩，并分享了业务更新，其中包括一项1000万美元的股权融资。 首席执行官Adam Mendelsohn博士表示："我们将战略重心放在司美格鲁肽植入剂NPM-139上，这使Vivani在技术可行性和商业潜力上都获得 了显著提升。随着司美格鲁肽类产品临床证据不断积累、市场接受度持续扩大，NPM-139的前景愈发明确。近期研发项目取得的两个成果支 撑了我们快速推进NPM-139临床开发的计划：其一是LIBERATE-1一期临床试验的积极结果，其二是NPM-139动物实验中令人鼓舞的减重数 据。" 他进一步说明："作为NanoPortal™植入技术的首次人体应用，LIBERATE-1证明了NPM-115具备良好的安全性与耐受性，并达成主要研究 ...

整理 | GLP1减重宝典内容团队 国家副主席韩正20号在北京会见丹麦诺和诺德公司董事会主席龙海歌。 韩正表示，今年5月，习近平主席复信中国丹麦商会负责人，勉励中国丹麦商会及会员企业为增进中丹、中欧友好和深化互利合作作出新贡 献。中丹、中欧经济互补性强，合作前景广阔。中国持续深化改革和扩大高水平对外开放，将为包括诺和诺德公司在内的各国企业提供巨大发 展机遇。中国始终把保障人民健康放在优先发展的战略位置，建成全世界最大、覆盖全民的基本医疗保障网，人均预期寿命不断提升，欢迎诺 和诺德公司等全球知名生物制药企业加强对华合作。 龙海歌高度评价近年来中国经济社会发展成就，表示诺和诺德公司将继续深耕中国市场，扩大对华投资，实现互利共赢。 诺和诺德全球高级副总裁兼大中国区总裁周霞萍表示， 做好慢性病防控对于提高国民健康水平、建设健康中国具有重大意义，一直受到国家的高度重视。诺和诺德深耕严重慢性疾病领域超过一个世 纪，也是肥胖症治疗的先行者和引领者。植根中国31年来，诺和诺德致力于成为中国政府及社会各界值得信赖的合作伙伴，与中国医药卫生事 业共生共赢。依托不断深化的全产业链布局，我们将持续发力，加速引入全球创新产品和治疗方案 ...

Core Insights - The FDA has approved Novo Nordisk's Wegovy (semaglutide) for the treatment of metabolic associated fatty liver disease (MASH) with moderate to severe liver fibrosis in non-cirrhotic adult patients, marking it as the first GLP-1 drug approved for this indication [1][2] - MASH is a serious progressive metabolic disease affecting the liver, with over one-third of overweight or obese patients also suffering from MASH, which can lead to delayed diagnosis and higher risks of advanced liver disease [1] Group 1 - The accelerated approval is based on the Phase 1 results of the ESSENCE trial, showing Wegovy can improve liver fibrosis without worsening fatty liver disease, demonstrating statistical significance and superiority [2] - Wegovy also shows improvement in fatty liver disease without worsening liver fibrosis [2] Group 2 - Novo Nordisk submitted a registration application in the EU in February 2025 and in Japan in May 2025 based on the Phase 1 results of the ESSENCE trial [3] - Results from Phase 2 of the ESSENCE trial are expected to be announced in 2029 [3]

诺和诺德的减肥药Wegovy近日获美国FDA批准新用途，可用于治疗代谢功能障碍相关脂肪性肝炎（MASH），消息推动公司股价一度上涨5%。这一突 破使诺和诺德在激烈的GLP-1药物市场竞争中，针对MASH领域抢占先发优势，以扭转年初以来的市值颓势。 诺和诺德的重磅药物Wegovy在一场关键的赛跑中击败竞争对手，其股价应声上涨。 据媒体18日报道，美国食品药品监督管理局（FDA）于上周五晚间批准了Wegovy的新用途。这一消息直接推动诺和诺德股价一度上涨高达5%，现已 回落至4.08%。 "在MASH领域获得批准，可能有助于改变诺和诺德在经历了一个较为艰难的开年后所面临的势头。" FDA批准Wegovy新用途——"肝病" Wegovy所属的GLP-1类药物因其显著的减重效果而广为人知，并由此催生了一个蓬勃发展的市场。将Wegovy的应用范围从单一的减肥领域拓展出去， 无疑将增强其市场竞争力。此次批准为诺和诺德在针对MASH（代谢功能障碍相关脂肪性肝炎）的治疗领域，赢得了对其主要竞争对手礼来的宝贵先发 优势。 对于诺和诺德而言，拓展新用途是支撑其旗舰产品需求的关键一步。 目前，Wegovy的销售增长正受到来自更便宜 ...

Core Viewpoint - Novo Nordisk's stock price has significantly declined, leading to an attractive valuation with a price-to-earnings ratio below its long-term average, despite a downward revision in 2025 earnings expectations and slowing growth. The core products Ozempic and Wegovy continue to show strong sales performance and global expansion potential, making it a "strong buy" for long-term investors [2][7]. Valuation Context - The company has increased capital expenditures significantly, approximately four times previous levels, which has compressed free cash flow in the short term. This investment is primarily directed towards production facilities rather than technology sectors, similar to trends seen in tech giants like Meta and Amazon [3]. Product Demand and Supply Issues - There is a warning that the shortage of Ozempic will persist until the fourth quarter, particularly in the EU, while the U.S. market has sufficient supply. This shortage reflects high market demand, and if production can be accelerated, revenue growth potential could be substantial. Capital expenditures are expected to remain high in the coming years, potentially reaching double-digit percentages of sales [5][6]. Earnings Guidance Adjustment - The management has revised the 2025 fiscal year outlook, lowering sales growth expectations from 13%-21% to 8%-14% and operating profit growth from 16%-24% to 10%-16%. The primary reasons for this adjustment are the slower growth of core products Wegovy and Ozempic, with demand for Wegovy in the U.S. obesity market falling short of expectations [6]. Financial Performance - Despite the guidance being lowered, Novo Nordisk's quarterly performance remains robust, with net sales for the first half of 2025 reaching 154.944 billion Danish Krone, a 16.1% year-over-year increase. Operating profit was 72.240 billion Danish Krone, up 25.0%, and diluted earnings per share increased by 22.8% to 12.49 Danish Krone [7]. Long-term Investment Perspective - The decline in stock price has brought Novo Nordisk's valuation back to an attractive range. While short-term performance may be under pressure, the strength of core products, global expansion potential, and patent barriers remain solid. As capital expenditures transition into production capacity, long-term profitability is expected to improve, making it a noteworthy consideration for long-term investors [2][7].

Core Viewpoint - Guangzhou Yinnuo Pharmaceutical Group Co., Ltd. successfully listed on the Hong Kong Stock Exchange, becoming another 18A biopharmaceutical company, with a significant market debut [1][3] Company Overview - Yinnuo Pharmaceutical, established in 2014, focuses on innovative therapies for diabetes and other metabolic diseases, with its core product being the human long-acting GLP-1 receptor agonist, Isu-Paglutide α, aimed at treating T2D, obesity, and other metabolic disorders [3][5] - The company received approval for Isu-Paglutide α for diabetes indications in January 2025, making it the first domestically produced human long-acting GLP-1 drug in Asia [3] IPO Details - The IPO was priced at HKD 18.68 per share, with a total of 36,556,400 H-shares issued, resulting in a market capitalization exceeding HKD 85 billion at the issuance price [1] - On its debut, the stock surged by 296.15%, reaching HKD 74 per share, and the market capitalization quickly surpassed HKD 338 billion [1] Financial Performance - As of May 31, 2025, Yinnuo Pharmaceutical generated revenue of RMB 0.381 billion from sales of Isu-Paglutide α in China [5] - The company's net loss increased from RMB 61.9 million for the five months ending May 31, 2024, to RMB 97.9 million for the five months ending May 31, 2025 [5] Market Strategy - Following the commercial launch in February 2025, Yinnuo Pharmaceutical rapidly penetrated the market through a dual-channel strategy of "hospitals + e-commerce," covering over 300 tertiary hospitals and ranking among the top in endocrine drug sales on platforms like JD and Alibaba [3] - The company is also developing additional indications for obesity and MASH (metabolic dysfunction-associated steatotic liver disease), with the obesity indication expected to complete Phase III clinical trials by Q4 2026 [3]

每经记者｜许立波 每经编辑｜张海妮 丨 2025年8月18日 星期一 丨 NO.1 司美格鲁肽获FDA批准用于治疗脂肪性肝炎 8月15日，诺和诺德宣布司美格鲁肽（Wegovy）的补充新药申请（sNDA）获FDA批准，用于结合减少 卡路里的饮食和增加体力活动，治疗伴有中晚期肝纤维化（F2期或F3期）的代谢功能障碍相关性脂肪 性肝炎（MASH）患者。诺和诺德执行副总裁、首席科学官兼研发主管Martin Holst Lange表 示："Wegovy是第一个也是目前唯一一个被批准用于治疗MASH的GLP-1药物，补充了已经证实的与司 美格鲁肽相关的减肥、心血管益处的大量证据。MASH有着沉重的健康负担，全世界三分之一的超重或 肥胖者受其影响。仅在美国，估计就有大约2200万例MASH患者。" 8月15日，云南白药公告，公司全资子公司云南白药集团中药资源有限公司拟以6.6亿元现金收购安国市 聚药堂药业有限公司（以下简称聚药堂）100%股权。此次收购旨在响应云南省提出的高质量发展云南 省中药材产业的要求，结合公司自身战略发展目标，更好地带动云南省内中药材的销售，更快地推动云 南白药相关业务布局全国，实现规模扩张，提升中药 ...

Core Viewpoint - Eli Lilly (LLY.N) announced a significant price increase for its weight loss drug Mounjaro in the UK, with a maximum increase of 170%, coinciding with the White House's push for pharmaceutical companies to raise prices in Europe to facilitate price reductions in the US [2][6]. Pricing Strategy - The new pricing also applies to the version of Mounjaro for type 2 diabetes, with the highest dosage monthly cost rising from £122 to £330 [3]. - This price increase only affects self-paying patients, as those receiving prescriptions through the National Health Service (NHS) in the UK are not impacted due to separate agreements covering costs [4]. - Eli Lilly stated that the initial pricing of Mounjaro in the UK was "significantly lower" than in three other European markets to avoid delays in entering the NHS channel, and the current adjustment aims to align UK pricing more closely with Europe [5]. Market Context - The decision highlights the pressure on global drug pricing, with the US being the largest pharmaceutical market where prescription drug costs are significantly higher than in other developed countries [6]. - The former administration under Trump aimed to reduce drug prices in the US while encouraging pharmaceutical companies to increase prices abroad [6]. - Eli Lilly's CEO, David Ricks, mentioned that narrowing the price gap between the US and Europe is a long-term goal, but European governments remain reluctant to accept higher drug prices [6]. Competitive Landscape - Mounjaro was launched in the UK in February 2024, while competitor Novo Nordisk's weight loss drug Wegovy entered the UK market in September 2023 [7].