Workflow
度拉糖肽
icon
Search documents
速递|最大、最长CVOT出炉,替尔泊肽改写糖尿病心血管证据链
GLP1减重宝典· 2025-12-28 15:17
SURPASS-CVOT 是一项严格设计的心血管结局试验,采用事件驱动、随机、双盲、平行对照、非劣效性Ⅲ期研究设计,是首个直接头 对头比较两种基于肠促胰素机制药物的CVOT研究。该试验共纳入来自30个国家和地区的13299名2型糖尿病合并ASCVD患者,患者平 均年龄为64.1岁,近三分之一为女性,整体人群心血管风险水平较高。基线数据显示,65.0%的患者合并冠状动脉疾病,19.2%有卒中 史,25.3%合并外周动脉疾病,20.3%存在心力衰竭病史;患者平均糖尿病病程接近15年,平均HbA1C为8.4%,体重指数均值达32.6 kg/m²。 入组患者按照1:1比例,接受每周一次皮下注射最大耐受剂量的替尔泊肽(5 mg、10 mg或15 mg)或度拉糖肽治疗。研究的主要终点为 心血管死亡、非致死性心肌梗死或非致死性卒中的复合终点,中位随访时间约4年。 研究结果显示,在主要终点方面,替尔泊肽成功达成非劣效性目标。替尔泊肽组共有801名患者(12.2%)发生主要心血管事件,而度 拉 糖 肽 组 为 862 名 患 者 ( 13.1% ) , 主 要 终 点 风 险 降 低 8% ( HR 0.92;95.3% CI ...
背靠背两篇Nature:国产新药玛仕度肽,安全有效降糖、减肥,为糖尿病合并肥胖等代谢疾病的治疗带来新方案
生物世界· 2025-12-26 04:22
Core Viewpoint - Mazdutide, developed by Innovent Biologics, is a dual receptor agonist targeting GCG and GLP-1, showing promising results in weight loss and liver fat metabolism improvement for obese and overweight adults in China [1][2]. Group 1: Clinical Trial Results - The Phase 3 clinical trial GLORY-1 published in NEJM demonstrated that weekly injections of Mazdutide resulted in significant weight loss and safety in obese or overweight Chinese adults [1]. - In the trial, participants receiving Mazdutide showed a reduction in HbA1c of 1.57% for the 4 mg group and 2.15% for the 6 mg group, compared to a 0.14% reduction in the placebo group [5]. - The weight loss observed was 5.61% for the 4 mg group and 7.81% for the 6 mg group, while the placebo group lost only 1.26% [5]. Group 2: Regulatory Approval - Based on the successful clinical trial results, the National Medical Products Administration (NMPA) approved Mazdutide for long-term weight management in adults with obesity or overweight on June 27, 2025 [2]. Group 3: Additional Research Findings - Two additional Phase 3 studies on Mazdutide for treating type 2 diabetes were published back-to-back in Nature, marking a significant achievement for Chinese drug development in the metabolic and endocrine disease field [2][10]. - In a separate study comparing Mazdutide to Dulaglutide, both doses of Mazdutide showed non-inferiority and superiority in reducing HbA1c compared to Dulaglutide, with treatment differences of -0.24% and -0.30% respectively [9]. - The weight loss was significantly greater in the Mazdutide groups, with differences of -3.78% for the 4 mg group and -5.76% for the 6 mg group compared to Dulaglutide [9].
《自然》网站刊发两项研究证实降糖新药疗效和安全性
第一财经· 2025-12-18 09:31
据新华社,英国《自然》杂志网站日前刊发两篇来自中国研究人员的论文,验证了中美药企联合开发 的一款降糖新药作为单药治疗和联合口服降糖药治疗的疗效和安全性。这是两项以中国2型糖尿病患 者为对象的Ⅲ期临床研究。相关结果证明,玛仕度肽在血糖控制和减重方面效果均优于安慰剂或度拉 糖肽,同时可改善多项心血管代谢、肝脏和肾脏相关指标。据介绍,玛仕度肽是中国信达生物制药集 团与美国礼来制药共同推进的一款胰高血糖素(GCG)/胰高血糖素样肽-1(GLP-1)双受体激动 剂。 ...
《自然》网站刊发两项研究证实降糖新药疗效和安全性
Xin Hua Wang· 2025-12-18 09:09
英国《自然》杂志网站日前刊发两篇来自中国研究人员的论文,验证了中美药企联合开发的一款降糖新 药作为单药治疗和联合口服降糖药治疗的疗效和安全性。 据介绍,玛仕度肽是中国信达生物制药集团与美国礼来制药共同推进的一款胰高血糖素(GCG)/胰高 血糖素样肽-1(GLP-1)双受体激动剂。 参与相关研究的信达生物制药集团综合管线首席研发官钱镭说,上述研究成果为超重、肥胖和糖尿病患 者提供了高质量的循证医学证据,也显示了中国在相关领域的科研能力。 糖尿病与肥胖密切相关,超重会加重胰岛素抵抗,是导致2型糖尿病发生、进展和并发症增加的主要因 素之一。相关并发症可累及血管、眼睛、肾脏、足部等。 (文章来源:新华网) 这是两项以中国2型糖尿病患者为对象的Ⅲ期临床研究。相关结果证明,玛仕度肽在血糖控制和减重方 面效果均优于安慰剂或度拉糖肽,同时可改善多项心血管代谢、肝脏和肾脏相关指标。 ...
我国新药Ⅲ期临床研究成果首登《自然》
Ren Min Ri Bao· 2025-12-18 06:51
由我国多家研发单位联合完成的两项关于降糖减重药物的Ⅲ期临床研究成果,北京时间今日凌晨在线发表于国际科学 顶级学术期刊《自然》(《Nature》)。据了解,这是我国新药Ⅲ期临床研究成果首次登上《自然》,也是该杂志创 刊以来首次在代谢和内分泌疾病领域背靠背同步发表两项Ⅲ期临床研究成果。 玛仕度肽是信达生物自主开发的全球首个且唯一获批上市的GCG/GLP-1天然双靶减重降糖药物。"GLP-1是胰高血糖素 样肽-1的英文简称,它在餐后分泌,可促进胰岛素分泌、降低进食后的血糖,并减缓胃肠道蠕动,造成饱腹感。"据钱 镭博士介绍,GLP-1类药物可通过激活GLP-1的受体,增加胰岛素分泌,从而达到降低血糖和减轻体重的治疗效果。 GCG是胰高血糖素的英文缩写,由胰腺中的胰岛α细胞分泌,其受体主要在肝脏中表达。激活GCG受体可增强脂肪氧 化、促进能量消耗、改善肝脏脂肪代谢。"GCG与GLP-1靶点联合,通过'抑制食欲+加速代谢'的双重作用机制,可更 好解决肥胖患者内脏脂肪堆积、胰岛素抵抗等复杂代谢问题。" 据介绍,玛仕度肽已在中国获批用于糖尿病和减重两项适应症,并已开展7项Ⅲ期研究,涵盖糖尿病、肥胖及相关并 发症领域。该药在青 ...
华人学者一天发表了9篇Nature论文
生物世界· 2025-12-18 04:30
撰文丨王聪 编辑丨王多鱼 排版丨水成文 12 月 17 日, 国际顶尖学术期刊 Nature 上线了 19 篇论文,其中, 9 篇来自华人学者 (包括作为通讯 作者和第一作者的论文) 。 12 月 17 日, 中日友好医院 杨文英 教授 作为通讯作者 ( 北京医院·国家老年医学中心 郭立新 教授、中 日友好医院 张波 主任医师为共同第一作者 ) ,在 Nature 期刊发表了题为: Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes (玛 仕度肽与度拉糖肽在中国 2 型糖尿病成人患者 中的对比研究 ) 的研究论文 【1】 。 12 月 17 日, 信达生物 钱镭 博士作为通讯作者, 南京大学医学院附属鼓楼医院 朱大龙 教授和 山东第一 医科大学附属省立医院 赵家军 教授作为共同第一作者兼共同通讯作者,在 Nature 期刊发表了题为: Mazdutide versus placebo in Chinese adults with type 2 diabetes ( 玛 仕度肽 与安慰剂在中国 2 型糖 尿病成人患者中的对比研究 ...
靠减肥药狂卖1700亿,礼来登顶万亿美元药企
21世纪经济报道· 2025-11-24 10:20
Core Viewpoint - Eli Lilly has achieved a market capitalization exceeding $1 trillion, driven by the strong performance of its flagship product, tirzepatide, amidst challenges such as patent expirations, increasing market competition, and pricing pressures [1][2][4]. Financial Performance - Eli Lilly's Q3 revenue reached $17.6 billion, a 54% year-over-year increase, with tirzepatide's sales contributing significantly [1]. - Tirzepatide's diabetes version, Mounjaro, generated $6.515 billion in Q3 sales, while the weight loss version, Zepbound, achieved $3.588 billion [1]. - Combined, these products accounted for $10.103 billion in Q3 sales and $24.837 billion year-to-date, representing 49% of Eli Lilly's total revenue, with a 125% year-over-year growth [2]. Market Position and Competition - Eli Lilly's market share for its products among new patients in the U.S. has risen to 70%-75% [4]. - Tirzepatide has surpassed its competitor, semaglutide, in prescription volume, holding a 57.9% share compared to semaglutide's 41.7% as of Q3 2025 [4]. Industry Dynamics - The GLP-1 drug class is expected to become one of the largest pharmaceutical categories globally within the next three to five years [2]. - The market for obesity and metabolic drugs is projected to exceed $100 billion by 2030, with GLP-1 drugs being a key driver [6]. Competitive Landscape - Novo Nordisk remains a dominant player in the weight loss drug market, with its GLP-1 products generating significant revenue [5][6]. - Eli Lilly faces increasing competition from various domestic pharmaceutical companies developing next-generation GLP-1 drugs [7][8]. Challenges Ahead - Eli Lilly's reliance on a single product, patent expiration risks, and intensifying competition are significant concerns [9]. - Pricing pressures are mounting, with agreements to lower drug prices starting in 2026, which may impact Eli Lilly's market revenue [8]. Strategic Initiatives - To address these challenges, Eli Lilly is pursuing external acquisitions and technological advancements to create new growth avenues [10]. - The company has made significant investments in gene therapy and AI drug development, including partnerships and acquisitions aimed at expanding its portfolio [10][11]. Future Outlook - Eli Lilly's leadership emphasizes the importance of data-driven decision-making in navigating future challenges and opportunities [11]. - The company must explore new growth paths beyond GLP-1 drugs to sustain its market position and develop the next milestone product following tirzepatide [11].
礼来登顶万亿美元药企,“神话”背后暗藏隐忧
Core Insights - Eli Lilly has achieved a market capitalization exceeding $1 trillion, becoming the first pharmaceutical company to reach this milestone, driven by the strong performance of its flagship product, tirzepatide [2][4] - The sales of tirzepatide's diabetes version, Mounjaro, reached $6.515 billion in Q3, contributing significantly to Eli Lilly's overall revenue growth [2] - The competitive landscape for GLP-1 drugs is intensifying, with Eli Lilly facing challenges from patent expirations, market competition, and pricing pressures [2][8] Financial Performance - Eli Lilly's Q3 revenue reached $17.6 billion, a 54% year-over-year increase, with tirzepatide accounting for 49% of total revenue [2] - The combined sales of tirzepatide's two versions in Q3 amounted to $10.103 billion, with a total of $24.837 billion for the first three quarters, indicating a 125% year-over-year growth [2] Market Dynamics - The GLP-1 drug class is expected to become one of the largest pharmaceutical categories globally within the next three to five years, highlighting the potential for significant market growth [3][6] - Eli Lilly's market share among new patients in the U.S. has risen to between 70% and 75%, surpassing its main competitor, semaglutide [4] Competitive Landscape - Novo Nordisk remains a strong competitor in the weight loss drug market, with its product semaglutide generating substantial revenue [5] - The GLP-1 market is characterized by a "dual oligopoly" competition, with many domestic pharmaceutical companies actively developing next-generation GLP-1 drugs [6][7] Strategic Initiatives - Eli Lilly is pursuing aggressive acquisition strategies and business development plans to expand its market presence and explore new growth avenues [10] - The company has made significant investments in gene therapy and AI drug development, indicating a strategic shift towards innovative treatment options [10] Challenges Ahead - Despite current success, Eli Lilly faces significant challenges, including reliance on a single product, patent expiration risks, and increasing competition [9] - The company must accelerate efforts to diversify its product portfolio and develop new growth drivers to sustain its market position [9][10]
创新药的天花板又被捅破了
Xin Lang Cai Jing· 2025-11-22 12:23
Core Insights - Eli Lilly has become the first pharmaceutical company to reach a market capitalization of $1 trillion, marking a significant shift in the industry landscape traditionally dominated by tech giants [1][2] - The rise of Eli Lilly reflects a redefinition of value logic in the innovative drug sector, suggesting that the ceiling for drug company valuations is fundamentally tied to market potential rather than traditional metrics [1][3] Company Performance - Eli Lilly's journey to a $1 trillion valuation was driven by the success of its GLP-1 dual-target drug, tirzepatide, with sales of its diabetes version, Mounjaro, increasing by 970% year-over-year, and the obesity version, Zepbound, generating $176 million in its first month [3][4] - By Q3 2025, combined sales of these drugs are projected to exceed $10.1 billion, surpassing Merck's Keytruda to become the new "king of drugs" [4] - Eli Lilly's CEO reported a market share of 70% to 75% among new patients in the U.S., indicating that tirzepatide has become a dominant force in the GLP-1 market [4] Market Strategy - Despite some disappointing clinical data, Eli Lilly is expected to secure approval for the first oral small-molecule GLP-1 drug, orforglipron, which analysts believe will enhance its global market presence [5] - The company is adopting a strategy of price reduction for its obesity drugs, with expected monthly costs dropping from $350 to $245, and potentially to $149 for the oral version, aiming to increase patient access and market size [6][7] - Analysts have raised Eli Lilly's target stock price, with Citigroup projecting a target of $1,500 per share, corresponding to a market cap of $1.4 trillion, driven by the anticipated market expansion from Medicare agreements [7][8] Long-term Challenges - Eli Lilly's success is tempered by the looming challenge of patent expiration, particularly for tirzepatide, which is set to expire in 2036, raising concerns about potential market share erosion from biosimilars and generics [13][14] - The company is expected to generate $187 billion in free cash flow from its obesity drug business by 2030, providing resources for future innovations [14][15] - Eli Lilly is focusing on early-stage research investments rather than large-scale acquisitions, aiming to develop groundbreaking treatments, including a drug for early Alzheimer's disease [14][15] Future Outlook - Eli Lilly's strategy involves leveraging profits from its metabolic drugs to invest in cutting-edge areas such as gene therapy, with recent acquisitions aimed at expanding its portfolio [15] - The company's ability to maintain its $1 trillion valuation will depend on its success in developing new, competitive products beyond the GLP-1 drugs [15]
速递|史上首个!礼来市值突破万亿美元
GLP1减重宝典· 2025-11-22 03:28
Core Insights - Eli Lilly's market capitalization reached $1 trillion, making it the first pharmaceutical company to achieve this milestone [2] - Over the past two years, Eli Lilly's market value has significantly outpaced major competitors like Johnson & Johnson and Novo Nordisk [3] Market Comparison - Eli Lilly's market value of approximately 71,116 billion RMB is equivalent to 4.18 times the total market capitalization of all A-share pharmaceutical companies valued over 1 billion RMB [7][9] - This valuation is roughly equal to the combined market capitalizations of 17.63 Heng Rui Medicine, 22.76 BeiGene, 25.37 WuXi AppTec, 46 Bai Li Tian Heng, or 67 Pian Zai Huang [9]