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速递|礼来替尔泊肽新适应症突发!市场推测或未被批准
GLP1减重宝典· 2025-11-20 14:44
整理 | GLP1减重宝典内容团队 11月17日,国家药品监督管理局(NMPA)发布的药品通知件送达信息中,显示礼来公司的替尔泊肽注射液包含在内,涉及的四个受 理号分别是JXHS2400108、JXHS2400109、JXHS2400110和JXHS2400111,信息的签发日期为2025年11月14日。 根据国内现行的新药审批流程,若药物顺利通过审核,通常会收到"药品批准证明文件送达信息";而若收到的是"药品通知件",则表 示此次申请尚未获得批准。然而,收到"药品通知件"并不意味着药物最终无法上市,理论上只要补充相关数据并完成进一步申请,药 物仍有可能继续进入审批流程。 | 72 | JXHS2400108 | 替尔泊肽注射液 | Eli Lilly Nederland B.V. (注册代理 机构:礼来苏州制药有限公司) | 2025年11月14日 | | --- | --- | --- | --- | --- | | 73 | JXHS2400109 | 替尔泊肽注射液 | Eli Lilly Nederland B.V. (注册代理 机构:礼来苏州制药有限公司) | 2025年11月14日 | | 74 ...
海外制药企业2025Q3业绩回顾:MNC的产品在美国市场放量有多快?
Guoxin Securities· 2025-11-20 14:34
证券研究报告 | 2025年11月20日 海外制药企业2025Q3业绩回顾 ——MNC的产品在美国市场放量有多快? 行业研究 · 行业专题 医药生物 投资评级:优于大市(维持评级) 证券分析师:马千里 010-88005445 maqianli@guosen.com.cn S0980521070001 证券分析师:陈曦炳 0755-81982939 chenxibing@guosen.com.cn S0980521120001 证券分析师:彭思宇 0755-81982723 pengsiyu@guosen.com.cn S0980521060003 请务必阅读正文之后的免责声明及其项下所有内容 摘要 ◼ 2025Q3业绩回顾: 请务必阅读正文之后的免责声明及其项下所有内容 2 • Eli Lilly在GLP-1类药物驱动下,收入端同比+52%,其中Tirzepatide单季度营收首次超过100亿美元,同比+131%、环比+18%。与美国政府达成GLP-1价格协 议,降价及减少保险受益人自付金额从而获得Medicare及各州Medicaid扩大减重药物覆盖,同时对DTC渠道减重产品降价50美元/4支装,未来Or ...
Beyond GLP-1: Eli Lilly's Expanding Drug Portfolio Lifts Sales
ZACKS· 2025-11-20 13:06
Core Insights - Eli Lilly and Company's stock reached $1000 per share for the first time on November 12, indicating strong market performance and nearing a $1 trillion market cap, primarily driven by the success of GLP-1 drugs like Mounjaro and Zepbound [1][8] Drug Approvals and Revenue Contributions - Lilly has received approvals for several new drugs, including Omvoh, Jaypirca, Ebglyss, and Kisunla, which are contributing to revenue growth alongside GLP-1 drugs [2][5] - In the first nine months of 2025, Omvoh generated $176.9 million, while Ebglyss, Kisunla, and Jaypirca contributed $274.1 million, $140.6 million, and $358.2 million, respectively, totaling $950 million from these new drugs [3][10] Ongoing Studies and Future Potential - New drugs are being evaluated for additional indications, with Ebglyss in phase III trials for chronic rhinosinusitis and Jaypirca being studied for broader use in CLL and MCL [4][8] - Lilly anticipates launching new drugs in the fourth quarter of 2025 and throughout 2026, which will further enhance revenue [5][8] M&A Strategy - To diversify its portfolio beyond GLP-1 drugs, Lilly is pursuing M&A opportunities in cardiovascular, oncology, and neuroscience sectors, including the acquisition of Verve Therapeutics and Adverum Biotechnologies [6][7] Competitive Landscape - Omvoh faces competition from AbbVie’s and J&J’s products, while Kisunla competes with Eisai/Biogen's Leqembi, and Jaypirca competes with older BTK inhibitors [9][11] Stock Performance and Valuation - Lilly's stock has increased by 35.8% this year, outperforming the industry average of 14.4% [12] - The stock trades at a price/earnings ratio of 33.83, significantly higher than the industry average of 16.84, but below its 5-year mean of 34.54 [14] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has risen from $22.94 to $23.78, and for 2026 from $30.79 to $32.06 over the past 30 days [16]
使用减重药后体重下降为何不明显?人工智能试图筛出“超级应答者”
Di Yi Cai Jing· 2025-11-20 11:23
临床医生都迫切想知道如何才能为患者匹配最合适自己的减重药。 随着越来越多厂商加入GLP-1减重药的开发,这给医生和患者带来新的困惑,如何推荐或选择最适合自 己的减重药? 随着使用减重药患者的临床数据积累越来越多,未来患者的个性化疗法也有望更加精准。研究人员表 示,他们下一步的目标是开发一种算法,能够给出评分,以提示每种减重药在不同情况下的潜在益处和 风险,并在前瞻性研究中对其进行验证。 根据近日在线发表的一份研究报告,通过分析超过13.5万名患者的1400万份就医记录和1500万条临床数 据,美国研究人员发现,约有12.5%的患者属于"超级应答者",他们在开始接受减重治疗后一年内体重 减轻超过15%;另有35%的患者被认为是"中度应答者",他们在第一年体重减轻了5%至15%;而更多的 群体为"轻度应答者",占比47%,他们在用药第一年的体重减轻不到5%。 研究人员还发现,使用礼来替尔泊肽减重药的患者中,体重减轻不到5%的比例为23%-28%;而使用诺 和诺德司美格鲁肽减重药的患者中,这一比例为30%-43%。 这些研究数据表明,并非所有的患者都对减重药敏感。临床医生要知道哪种药物最有利于患者,就需要 考虑每个 ...
Novo Nordisk Just Made a Big Move in the Weight Loss Drug Market. Should You Worry About Rival Eli Lilly?
The Motley Fool· 2025-11-20 08:40
Novo Nordisk just addressed a problem that has prevented some from taking these drugs.Investors generally buy pharmaceutical stocks to add an element of safety to their portfolios. People need their medicines regardless of the economic environment, and this fact ensures a level of stability and growth for pharma companies' earnings.In recent years, though, certain drugmakers also have delivered a significant amount of growth. And this is thanks to one particular product portfolio: weight loss drugs. Novo No ...
实现更广领域更深层次更高质量互利共赢
Xin Hua Ri Bao· 2025-11-20 06:40
Core Insights - The 2025 Industry Chain Supply Chain International Cooperation Exchange Conference and Entrepreneurs Taihu Forum was held in Wuxi, focusing on enhancing international cooperation and collaboration mechanisms with global enterprises [1] - Jiangsu aims to strengthen its industrial chain and supply chain by fostering deep cooperation in emerging and characteristic industries, ensuring mutual benefits and high-quality development for various enterprises [1] Group 1 - The forum introduced industry chain matching activities, emphasizing the establishment of supply-demand bridges in key areas [1] - Jiangsu's Governor Liu Xiaotao engaged with leaders from multinational companies and research institutions, discussing their needs in research innovation, market expansion, and financing [1] - The government is committed to providing essential support, ensuring legal rights for enterprises, and enhancing the industrial chain and supply chain [1] Group 2 - During a meeting with Pfizer's global senior vice president, Liu Xiaotao highlighted Jiangsu's position as a core hub for the biopharmaceutical industry in China, with significant advantages in industry, talent, and funding [2] - Jiangsu plans to promote open innovation across the entire biopharmaceutical industry chain and create a top-tier business environment [2] - Pfizer expressed intentions to increase its presence in Jiangsu, collaborating with local enterprises and research teams for joint research and development [2]
Why big pharma is teaming up with AI giants to speed up drug discovery and make work easier for health care workers
Fortune· 2025-11-19 17:36
Core Insights - Nvidia's partnerships with Eli Lilly and Johnson & Johnson highlight a growing trend in the pharmaceutical industry to leverage AI for accelerating drug discovery and enhancing healthcare operations [1][4]. Group 1: AI in Drug Discovery - Eli Lilly aims to expedite drug discovery processes by creating a new Nvidia-chip powered "supercomputer" and "AI factory" set to launch by early 2026, utilizing AI models trained on extensive experimental data [3]. - The average cost and time for new drug discovery exceed $2 billion and over a decade, respectively, indicating a significant opportunity for AI to streamline these processes [2]. Group 2: Applications in Healthcare - Johnson & Johnson's partnership with Nvidia focuses on using AI to create simulated environments for surgical teams, enhancing training and improving clinical outcomes [4]. - The potential for generative AI in the pharmaceutical and medical products sectors could unlock tens of billions in value by improving drug discovery, clinical trials, and treatment administration [5]. Group 3: Customization and Specificity - There is a growing demand for AI solutions tailored to specific business needs within the pharmaceutical industry, moving away from generic platforms [7][8]. - Eli Lilly's Chief AI Officer emphasizes the importance of proprietary data and customized AI models to drive significant advancements in drug discovery [8]. Group 4: Future of AI in Surgery - The integration of physical AI in surgical settings could lead to a hybrid model where human surgeons collaborate with robots and digital agents, potentially transforming surgical techniques [10][11]. - The World Health Organization projects a global shortfall of 11 million health workers by 2030, underscoring the need for AI to assist in healthcare delivery [10].
口服GLP-1减重药问世四年后,司美格鲁肽片仍在领跑口服减重药赛道
GLP1减重宝典· 2025-11-19 15:40
整理 | GLP1减重宝典内容团队 近期公布的临床结果让市场对口服减重药物的前景产生了新的思考。 礼来的orforglipron与Viking Therapeutics的VK2735未能达到投资人期 待的减重效果,引发股价剧烈震荡 ,也让外界重新评估口服疗法的市场潜力。William Blair的分析师Andy Hsieh指出,口服减重药在美国可 能难以取代注射制剂的主导地位,但在低收入和中等收入国家或许能发挥更大作用。 ▍注射药仍占主导地位 根据预测, 到2030年口服疗法或将占据全球抗肥胖药物市场的四分之一。 但在美国市场,Hsieh认为注射型肽类仍会保持主导。"在美国,患 者和医生更倾向于选择能带来最大体重下降的方案,"他说。William Blair预计,Viking的VK2735未来八到九成的收入将来自皮下注射版本, 口服剂型的贡献相对有限。 VK2735的表现略显不同。在II期研究中,口服版本在13周内实现了10.9%的安慰剂校正减重,接近理想值。但不容忽视的是,其试验中患者 退出率较高,耐受性成为潜在隐患。Hsieh强调,口服药物的理想目标是既能达到注射剂同等的体重下降,又能保证较好的耐受性,但 ...
礼来创历史新高
Ge Long Hui A P P· 2025-11-19 15:20
格隆汇11月19日|礼来(LLY.US)涨1.6%报1047.44美元,创下历史新高,市值接近1万亿美元。 ...
礼来涨超1.6%,市值接近1万亿美元
Xin Lang Cai Jing· 2025-11-19 15:13
来源:滚动播报 礼来涨超1.6%,15个交易日13天上涨,续刷历史新高,市值接近1万亿美元。 ...