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替尔泊肽“含金量”再升级 开启睡眠呼吸疾病药物治疗新时代
Zheng Quan Ri Bao Wang· 2025-07-03 09:42
除了改善OSA症状外,接受替尔泊肽治疗的成人患者平均体重减轻了18.1%,同时接受替尔泊肽和PAP 治疗的成人患者平均体重减轻了20.1%;而安慰剂组的成人患者平均体重分别减轻了1.3%和2.3%。 此外,替尔泊肽的安全性和耐受性与此前试验中报告的替尔泊肽安全性一致。最常见的不良事件是胃肠 道不良事件,程度为轻至中度。 礼来全球高级副总裁、礼来中国药物开发及医学事务中心负责人王莉博士表示:"OSA是一种高发疾 病,其治疗主要集中在生活方式干预和器械治疗上,但这些方法可能无法解决OSA相关的部分致病风险 因素,如肥胖。替尔泊肽是首个且目前唯一治疗成人肥胖患者的中重度OSA的处方药,半数患者经治疗 后不再有OSA相关症状,为临床和患者提供了突破性的治疗选择,填补了该领域的药物治疗空白。" 据记者了解,此次获批主要基于SURMOUNT-OSA临床3期试验的结果。该试验为期一年,评估了替尔 泊肽(10mg或15mg)用于正在接受或不愿接受气道正压通气(PAP)的成人肥胖患者的中度至重度阻塞性睡 眠呼吸暂停的治疗有效性。对于未使用PAP治疗的成人患者中,替尔泊肽在减少呼吸暂停低通气的效果 是安慰剂的5倍,即替尔泊肽可使 ...
受打鼾困扰的人有救了:最强减肥药替尔泊肽,在中国获批治疗阻塞性睡眠呼吸暂停
生物世界· 2025-07-03 09:38
撰文丨王聪 编辑丨王多鱼 排版丨水成文 替尔泊肽 (Tizepatide) 是 礼来公司开发的一款 葡萄糖依赖性促胰岛素多肽 (GIP) 受体和胰高血糖素 样肽-1 (GLP-1) 受体的双重激动剂 ,于2023年11月获得FDA批准作为减肥药上市 (商品名 Zepbound™) ,此前还获批用于 2型糖尿病的降糖 (商品名为Mounjaro™) 。替尔泊肽是目前已上市的 效果最好的减肥药物,在临床试验中多次刷新减肥效果新纪录。 2025 年 7 月 3 日, 中国国家药监局 (NMPA) 官网公示显示, 替尔泊肽在中国获批新适应症 —— 成 人肥胖患者的中度至重度 阻塞性睡眠呼吸暂停 (OSA) ,这也是替尔泊肽在国内获批的第三个适应症, 去年,替尔泊肽先后获批用于成人 2 型糖尿病 和 肥胖症 的治疗。 此次获批新的适应症,基于替尔泊肽在 3 期临床试验 SURMOUNT-OSA 中 的积极结果,结果显示,替尔 泊肽在为期 52 周的治疗中,帮助患者平均减重 20%, 睡眠中呼吸暂停低通气次数至少减少 27次/小时, 半数以上患者已不再有 阻塞性睡眠呼吸暂停 (OSA) 相关症状。 2024年 4 月 1 ...
礼来:替尔泊肽注射液第三项适应症获批,改善阻塞性睡眠呼吸暂停肥胖成人患者的睡眠障碍
Cai Jing Wang· 2025-07-03 09:18
经过一年的治疗,在仅使用替尔泊肽的患者中,有43%的成人患者实现了OSA症状完全缓解或无症状的 轻度OSA状态,而在同时接受替尔泊肽和PAP治疗的患者中,这一比例为52%;安慰剂组则分别为15% 和14%。 除了改善OSA症状外,接受替尔泊肽治疗的成人患者平均体重减轻了18.1%,同时接受替尔泊肽和PAP 治疗的成人患者平均体重减轻了20.1%;而安慰剂组的成人患者平均体重分别减轻了1.3%和2.3%。 7月3日,礼来官方公众号发布穆峰达第三项适应症中国获批的消息。披露礼来穆峰达 (替尔泊肽注射 液)获得中国国家药品监督管理局(NMPA)批准,成为首个且目前唯一用于治疗成人肥胖患者的中度 至重度阻塞性睡眠呼吸暂停(OSA)的处方药。替尔泊肽可改善中度至重度阻塞性睡眠呼吸暂停肥胖成 人患者的睡眠障碍。该适应症的使用需在控制饮食和增加运动基础上进行。 礼来集团副总裁兼中国总经理德赫兰表示,近一年以来,NMPA批准了替尔泊肽用于治疗2型糖尿病和 长期体重管理两项适应症。该药物在中国迎来了第三项适应症的获批,不仅再次彰显了礼来在内分泌代 谢领域的卓越进展,更标志着拓展睡眠呼吸领域的全新里程(002219)碑。 另据推 ...
礼来减重药又一关键适应症在国内获批,中国约2亿人罹患这种疾病
Di Yi Cai Jing· 2025-07-03 08:28
近一年以来,国家药监局已经批准了替尔泊肽用于治疗2型糖尿病和长期体重管理两项适应症。这项最 新获批的OSA适应症的使用,需在控制饮食和增加运动基础上进行。 接受替尔泊肽治疗的成人患者平均减重20%,睡眠中每小时呼吸暂停低通气次数至少减少27次。在接受 替尔泊肽治疗一年后,半数以上患者已不再有OSA相关症状。 7月3日,礼来宣布GLP-1类减重药替尔泊肽注射液(商品名:穆峰达)已获得中国国家药品监督管理局 (NMPA)批准,用于治疗成人肥胖患者的中度至重度阻塞性睡眠呼吸暂停(OSA)。该药物也是全球 首个且目前唯一用于治疗OSA的处方药。 OSA还与各种不良心血管疾病事件(CVD)的发生密切相关。去年发布的一份《心血管疾病患者阻塞 性呼吸睡眠暂停评估与管理专家共识(2024 版)》为我国CVD患者中OSA的评估和管理提供规范性指 导。 然而,由于患者对OSA疾病严重性认识不足,目前患者就诊率偏低,面临着严重的健康风险。 去年12月,美国FDA已经批准了替尔泊肽OSA适应症。随着该适应症在全球更多国家获批,将使礼来在 激烈的减重药市场竞争中更具优势。 礼来临床数据显示,接受替尔泊肽治疗的成人患者平均减重20%,睡 ...
替尔泊肽新适应证在华获批
news flash· 2025-07-03 07:54
礼来宣布穆峰达(替尔泊肽注射液)获得中国国家药品监督管理局(NMPA)批准,成为首个且目前唯一用 于治疗成人肥胖患者的中度至重度阻塞性睡眠呼吸暂停(OSA)的处方药。替尔泊肽可改善中度至重度阻 塞性睡眠呼吸暂停肥胖成人患者的睡眠障碍。该适应症的使用需在控制饮食和增加运动基础上进行。 (21世纪经济报道) ...
Wall Street Bulls Look Optimistic About Lilly (LLY): Should You Buy?
ZACKS· 2025-07-02 14:30
When deciding whether to buy, sell, or hold a stock, investors often rely on analyst recommendations. Media reports about rating changes by these brokerage-firm-employed (or sell-side) analysts often influence a stock's price, but are they really important?Let's take a look at what these Wall Street heavyweights have to say about Eli Lilly (LLY) before we discuss the reliability of brokerage recommendations and how to use them to your advantage.Lilly currently has an average brokerage recommendation (ABR) o ...
2 Growth Stocks to Buy Hand Over Fist in July
The Motley Fool· 2025-07-02 08:01
GLP-1 agonists, a type of drug used to treat diabetes and weight loss, could be the hottest growth story in healthcare today. Experts at Morgan Stanley estimate that the market could grow to a $150 billion opportunity over the next decade, representing a tenfold increase from its sales last year. Eli Lilly (LLY -0.40%) has captured approximately 35% of the GLP-1 market, alongside arch-rival Novo Nordisk, the current market leader at 65%. However, Eli Lilly could gain on, perhaps even surpass, its rival over ...
CVS drops Lilly's Zepbound
CNBC Television· 2025-07-01 18:53
ground it's losing to Lilly. Of course, it also just had that kind of pull up pulled out of that hims partnership. To our former reporter.Reporter Angelica Peebles is here for more. So when we say CVS, we're talking about the pharmacy part of this. >> We're talking about the pharmacy benefit.>> The PBM. >> The PBM. So for example, we have Caremark as our PBM.>> Are we do we do. I'm pretending like but I thought we had you and whatever I don't know how all this works. Just explain to us why this shift is hap ...
司美格鲁肽再添新对手,减重赛道中国药企渐露身手
Xin Jing Bao· 2025-07-01 01:37
Core Viewpoint - The approval of Ma Shidu Peptide as the world's first GCG/GLP-1 dual receptor agonist for weight management marks a significant development in the obesity treatment market, potentially disrupting the current dominance of existing products like Semaglutide [1][2][4]. Group 1: Product Approval and Market Impact - Ma Shidu Peptide, developed by Innovent Biologics in collaboration with Eli Lilly, has been approved for long-term weight control in adults with obesity or overweight [2]. - The drug is expected to break the current duopoly in the GLP-1 market, which has been largely dominated by Semaglutide and Tirzepatide [1][4]. - The global market for GLP-1 drugs is projected to exceed $50 billion in 2024, with Semaglutide contributing approximately $25 billion [7]. Group 2: Clinical Research and Efficacy - The approval was based on the results of the Phase III clinical trial (GLORY-1), which demonstrated significant weight loss in participants, with a mean percentage change from baseline of -12.0% and -14.8% for the 4mg and 6mg doses, respectively [3]. - The trial also showed that Ma Shidu Peptide significantly reduced liver fat content and improved various cardiometabolic indicators [3]. Group 3: Competitive Landscape - The GLP-1 receptor agonist market is becoming increasingly competitive, with over ten domestic companies in China actively developing similar drugs [4][11]. - Semaglutide's sales reached approximately $8.4 billion in the first quarter of 2023, surpassing Merck's Keytruda, which generated $7.205 billion [5]. - Tirzepatide, a competitor, has also shown promising results in head-to-head studies against Semaglutide, indicating a rapidly evolving competitive environment [6]. Group 4: Future Prospects and Trends - The market for GLP-1 weight management drugs in China is expected to grow significantly, with projections indicating a market size exceeding 15 billion yuan by 2025 [7]. - The trend is shifting from single-target to multi-target GLP-1 drugs, with several new candidates showing potential in clinical trials [8][9]. - Domestic companies are increasingly pursuing overseas licensing agreements for their GLP-1 drugs, indicating a strategic move to expand their market presence [10].
医药生物行业周报(6月第4周):创新药出海持续进行中-20250630
Century Securities· 2025-06-30 01:05
Investment Rating - The report does not explicitly state an investment rating for the pharmaceutical and biotechnology industry, but it indicates a positive long-term outlook on the direction of innovative drug exports [2][3]. Core Insights - The innovative drug export trend continues to gain momentum, with significant transactions such as the $60.5 billion deal between 3SBio and Pfizer for SSG-707, reflecting a robust short-term sentiment in the market. The report highlights ongoing collaborations between various biotech companies and global pharmaceutical firms, indicating a diverse pipeline of both early-stage projects and mature products [3][5]. - Recent clinical data from Eli Lilly on Bimagrumab shows promising results for weight loss, with a 10.8% reduction in weight over 72 weeks, all from fat loss, while muscle mass increased by 2.5%. This positions Bimagrumab favorably compared to other treatments [3][13]. Summary by Sections Market Weekly Review - The pharmaceutical and biotechnology sector experienced a significant decline of 4.35% from June 16 to June 20, underperforming against the CSI 300 index, which fell by 0.45%. All sub-sectors within the industry saw declines, with other biological products down by 6.7% and medical research outsourcing down by 5.83% [3][8]. - In the following week (June 23 to June 27), the sector rebounded with a 1.6% increase, although it still lagged behind the CSI 300's 1.95% gain. Notable performers included Shenzhou Cell-U, which surged by 30.5% [8][11]. Industry News and Key Company Announcements - Significant events include the approval of the first GCG/GLP-1 dual receptor agonist for weight control by the National Medical Products Administration, developed by Innovent Biologics and Eli Lilly [13]. - Collaborations such as the one between Hengrui Medicine and Otsuka Pharmaceutical for the development of a BCMAxCD3 bispecific T-cell connector highlight the ongoing trend of strategic partnerships in the industry [13][15]. - The report also notes the submission of a new drug application for a CAR-T cell product by Kintor Pharmaceutical, aimed at treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma [13][15].