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中国首款双靶点玛仕度肽获批,诺和诺德减重新药紧随其后
Ge Long Hui· 2025-07-02 10:52
上周,全球减重药物市场迎来双重突破:中国国家药品监督管理局(NMPA)于6月27日正式批准信达生物与礼来制药联合研发的全球首款胰高血糖素 (GCG)/胰高血糖素样肽-1(GLP-1)双受体激动剂玛仕度肽上市。 | 索引号 | XZXK-2025-255 | 主题分类 | | --- | --- | --- | | 标题 | 国家药监局批准玛仕度肽注射液上市 | | | 发布日期 | 2025-06-27 | | 截图来源:NMPA官网 而诺和诺德则在6月26日举行的第85届美国糖尿病协会(ADA)科学年会上公布了其新型GLP-1/胰淀素受体双重激动剂「Amycretin」的Ⅲ期临床试验数据, 相关结果同步发表于《柳叶刀》。 两大创新药物的同期亮相,标志着全球减重治疗正式迈入"双靶点时代"。 一、玛仕度肽:全球首款GCG/GLP-1双靶点药物 4mg剂量组平均减重12.0%,体重降幅≥5%的患者比例达73.5%; 安慰剂组仅减重0.5%。 玛仕度肽的疗效不仅体现在体重数字上,更通过多维度代谢指标改善为患者带来长期健康获益: 肝脏脂肪代谢:6mg剂量组治疗48周后,肝脏脂肪含量(LFC)平均相对降幅达80.24% ...
减肥药巨头诺和诺德怒斩Hims&Hers:58天“闪婚闪离”背后的生死焦虑
Sou Hu Cai Jing· 2025-07-02 04:41
Core Viewpoint - The abrupt termination of the partnership between Novo Nordisk and Hims & Hers highlights the survival crisis faced by global weight loss drug giants amid the challenges posed by generic drugs and setbacks in innovative drug development [1][8]. Group 1: Partnership Breakdown - The collaboration between Novo Nordisk and Hims & Hers began on April 29, 2025, aiming to provide the authentic weight loss drug Wegovy through Hims & Hers' platform [2]. - The initial expectation was for Hims & Hers to guide patients from unregulated compounded drugs to the legitimate product, while Novo Nordisk sought to expand its digital channels [2][3]. - The partnership unraveled due to Hims & Hers' continued sale of compounded semaglutide, which violated compliance standards set by Novo Nordisk [2][3]. Group 2: Market Impact - Following the partnership's collapse, Hims & Hers' stock plummeted nearly 30%, resulting in a market value loss of approximately $5 billion, while Novo Nordisk's stock fell over 9%, erasing $9 billion in market capitalization [1]. - The incident reflects a broader crisis in the GLP-1 weight loss drug market, with Novo Nordisk facing intense competition from Eli Lilly's tirzepatide, which has outperformed semaglutide in weight loss efficacy [4][8]. Group 3: Regulatory and Compliance Issues - Novo Nordisk accused Hims & Hers of large-scale compounding and deceptive marketing practices that jeopardized patient safety, particularly concerning the use of "illegal foreign active pharmaceutical ingredients" [1][4]. - The FDA's resolution of the Wegovy shortage has significantly reduced the legal space for compounded drugs, leading to a survival crisis for compounding companies [5][8]. Group 4: Novo Nordisk's Strategic Response - In response to its challenges, Novo Nordisk is investing heavily in the development of new generation drugs, including a $2.2 billion prepayment to Septerna for oral weight loss drug development [7]. - The company is also building a digital healthcare ecosystem, having formed strategic partnerships with companies like Ping An Health to create a comprehensive obesity management system [7][8]. Group 5: Industry Dynamics - The global weight loss drug market is projected to exceed $50 billion in 2024, with the U.S. accounting for 80% of this market, indicating a highly lucrative yet competitive landscape [8]. - The rapid changes in the market, driven by both innovative competitors and generic drug proliferation, are forcing traditional pharmaceutical giants like Novo Nordisk to rethink their strategies in the face of compliance and channel challenges [8][9].
医药生物行业周报:全球首个双靶点减重药上市,持续关注GLP-1赛道机会-20250630
Donghai Securities· 2025-06-30 10:50
[Table_Reportdate] 2025年06月30日 超配 [证券分析师 Table_Authors] 杜永宏 S0630522040001 dyh@longone.com.cn 证券分析师 上周(06月23日-06月27日)医药生物板块整体上涨1.60%,在申万31个行业中排第 24位,跑输沪深300指数0.35个百分点。当前医药生物板块PE估值为27.67倍,处于历史 中低位水平,相对于沪深300的估值溢价为124%。子板块涨幅前三的为医疗服务(申万)、 医疗器械(申万)、医药商业(申万)、涨幅分别为2.92%、2.10%、2.08%。个股方面,上周 上涨的个股为397只(占比83.76%),下跌的个股70只(占比14.77%)。涨幅前五的个股分 别为神州细胞(30.45%)、浩欧博(27.08%)、华人健康(25.97%)、华强科技(22.94%)、 迈威生物-U(17.44%)。 ➢ 行业要闻: 2025年6月27日,信达生物发布公告,宣布信尔美®(玛仕度肽注射液)获NMPA批准 上市,用于成人肥胖或超重患者的长期体重控制。信尔美®(玛仕度肽注射液)是本公司 与礼来制药共同推进的一款胰高血糖素 ...
行业周报:多款减肥药亮相2025ADA,重点关注AMYR与ActRII靶点-20250629
KAIYUAN SECURITIES· 2025-06-29 06:45
Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [2] Core Insights - The report highlights the emergence of multiple promising weight loss drugs showcased at the 2025 ADA conference, focusing on AMYR and ActRII target drugs, which exhibit excellent clinical data and are expected to become core targets for future weight loss drug development [6][15] - The report emphasizes the potential of oral and ultra-long-acting drugs in the weight loss and glycemic control market, which are anticipated to open new incremental market opportunities [8][31] - The report recommends several pharmaceutical and biotechnology companies as investment targets, including Heng Rui Medicine, East China Medicine, and others across various segments such as CXO, research services, traditional Chinese medicine, raw materials, medical devices, and retail pharmacies [9] Summary by Sections 1. Weight Loss Drug Developments - The 2025 ADA conference showcased several potential pipeline drugs for weight loss, with a focus on AMYR and ActRII target drugs, which are expected to lead future developments in this area [15] - AMYR-targeted drugs, such as eloralintide from Eli Lilly, demonstrated superior efficacy and safety compared to GLP-1 drugs, indicating a promising future for this class of drugs [16][18] - ActRII-targeted drugs, particularly Bimagrumab, showed significant weight loss results, with 100% of weight loss coming from fat, suggesting a new standard for high-quality weight loss therapies [28][29] 2. Oral and Ultra-Long-Acting Drugs - The report identifies oral GLP-1RA drugs as a new trend in the weight loss and glycemic control market, with several companies presenting promising clinical data at the 2025 ADA conference [31][32] - The ultra-long-acting drug Maridebart cafraglutide demonstrated effective weight loss results with extended dosing intervals, enhancing patient compliance and treatment simplicity [33][34] 3. Recommended Investment Targets - The report lists various companies across different segments as recommended investment targets, including pharmaceutical and biotechnology firms, CXO companies, research service providers, traditional Chinese medicine manufacturers, raw material suppliers, medical device companies, and retail pharmacies [9]
Healthy Returns: New weight loss drug data show Eli Lilly is gaining ground
CNBC· 2025-06-25 17:33
In this articleNOVO.B-DKLLYA sign with the company logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.Scott Olson | Getty ImagesA version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.Competition in the blockbuster weight loss drug market is ramping up, as drugmakers share fresh data on new and existing treatments. The annual American D ...
减肥药“军备竞赛”升级!诺和诺德(NVO.US)启动“新药扫货模式”
智通财经网· 2025-06-24 13:15
Group 1 - Novo Nordisk is seeking early-stage deals to enhance its next-generation weight loss drug portfolio amid increasing competition in the booming weight loss market [1] - The company faces significant challenges following the global success of its diabetes drugs Ozempic and Wegovy, leading to a substantial decline in its stock price as competitors like Eli Lilly enter the market [1] - Following a series of setbacks, Novo Nordisk announced the dismissal of CEO Lars Fruergaard Jorgensen last month to realign its business strategy [1] Group 2 - The core strategy of Novo Nordisk involves searching for new weight loss therapies and applying them to more obesity-related diseases, highlighted by a recent $2.2 billion collaboration with Septerna to develop drugs for obesity and diabetes [2] - In March, Novo Nordisk committed to pay up to $2 billion to a Chinese biotech company for a drug license similar to Eli Lilly's next-generation weight loss drug retatrutide [2] - The company is exploring areas beyond incretin hormones, which are the basis for its existing blockbuster drugs Wegovy and Ozempic, as well as next-generation drugs CagriSema and amycretin [2] Group 3 - The responsibility of the new product and portfolio strategy head, Ludovic Helfgott, is to align Novo Nordisk's commercial strategy with its long-term goals [3] - The company is focusing on emerging new compounds, particularly amycretin, to assist patients with obesity-related conditions such as sleep apnea, a field previously unexplored by Novo Nordisk [3] - Helfgott emphasized that the company is not dismissing any new drugs and is closely monitoring market dynamics and emerging opportunities [3]
诺和诺德(NVO.US)Wegovy减肥药登陆印度,落后礼来数月进场
智通财经网· 2025-06-24 09:07
Group 1 - Novo Nordisk has entered the Indian market with its weight loss drug Wegovy, which has been approved for long-term chronic weight management and reducing the risk of major cardiovascular events [1][2] - Wegovy will be available in five dosages, with the starting dose of 0.25 mg priced at 4,336.25 INR (approximately 50.3 USD) and the highest dose of 2.4 mg priced at 6,503.75 INR, significantly lower than its US price of 337.25 USD [1] - The introduction of Wegovy follows a recommendation from the American College of Cardiology to use semaglutide as a first-line treatment for cardiovascular diseases, addressing a significant health issue in India where heart disease is a leading cause of death [2] Group 2 - Novo Nordisk aims to collaborate with insurance companies and financial institutions to enhance the affordability and accessibility of Wegovy, and is considering partnerships with local companies for further product promotion [3] - The market for weight loss therapies in India is growing, as evidenced by a 60% month-on-month increase in sales of Eli Lilly's Mounjaro since its launch, indicating strong consumer interest in such treatments [3] - Novo Nordisk plans to introduce its next-generation anti-obesity candidates, CagriSema and amycretin, which are currently in clinical trials, and is preparing for the market after the expiration of the semaglutide patent in Q2 2026 [3]
速递|体重减轻高达24%!诺和诺德实验减重药冲向三期临床
GLP1减重宝典· 2025-06-23 08:47
整理 | GLP1减重宝典内容团队 诺和诺德近日宣布,其实验性减重药物 Amycretin 在早期临床试验中显示出显著疗效,超重和肥胖成人的体重最高减轻达 24%。这一结果为计 划于明年启动的大型三期临床试验奠定了基础。 《柳叶刀》同期刊登的一篇评论指出,尽管减重幅度的提升令人鼓舞,但当前肥胖管理的重点正在转向降低心血管疾病及其他并发症的风险和 负担。 来自伦敦帝国理工学院的代谢医学教授 Tricia Tan 与内分泌学家 Bernard Khoo 博士评论称,要明确像司美格鲁肽(如诺和诺德的 Ozempic) 这类 GLP-1 药物与像 Amycretin 这类新药在肥胖治疗中的相对价值和定位,还需开展直接的对比研究。 *本文仅供医疗卫生专业人士参考 公司表示,Amycretin 以每周注射或每日口服的形式给药,其不良反应主要集中在胃肠道,发生率与其他近期推出的减重药物相似。 这项完整的试验结果已在芝加哥举行的美国糖尿病协会年会上公布,并同步发表于《柳叶刀》医学期刊。 诺和诺德开发负责人 Martin Holst Lange 表示,Amycretin 的三期临床试验将于 2026 年启动,预计持续数年,随后 ...
诺和诺德新一代减肥药Amycretin小型试验取得积极成果
news flash· 2025-06-21 12:32
Core Insights - Novo Nordisk's experimental drug Amycretin shows promising results in early trials, helping overweight and obese adults lose up to 24% of their body weight [1] - The company plans to initiate late-stage studies next year [1] - The primary side effects of the drug are gastrointestinal symptoms, with incidence rates comparable to other recent weight loss medications [1]
股价腰斩后,诺和诺德迎来翻盘希望?实验数据显示新药减重效果击败Zepbound
Hua Er Jie Jian Wen· 2025-06-21 10:11
Core Insights - Novo Nordisk's new injectable obesity drug, amycretin, shows significant weight loss potential, outperforming current market leaders [1][4] - In early trials, participants receiving the highest dose of amycretin lost an average of 24.3%, compared to 1.1% in the placebo group, surpassing Eli Lilly's Zepbound (22.5%) and Novo's own Wegovy (15%) [1][4] - The company is under pressure to demonstrate its drug pipeline can compete effectively against Eli Lilly, especially after a nearly 50% drop in stock price over the past year [1] Drug Development and Efficacy - Amycretin combines the active ingredients of Wegovy and Ozempic with the hormone incretin to enhance satiety [4] - An oral version of amycretin also showed promise, with participants in the highest dose group losing an average of 13.1%, compared to 1.2% in the placebo group [4] - The absence of a plateau in weight loss during the 12-week trial suggests potential for greater weight loss in longer trials or real-world applications [4] Competitive Landscape - The positive results for amycretin are crucial for Novo Nordisk, especially following disappointing results from another obesity drug, CagriSema, which led to a significant stock price drop [5] - Analysts remain optimistic about Eli Lilly's oral obesity drug, orforglipron, which achieved an average weight loss of 14.7% in a 36-week phase 2 study [5] - Novo Nordisk has submitted an approval application for the oral version of Wegovy, based on trial data showing an average weight loss of 16.6% over 64 weeks [5]