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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
Core Viewpoint - The article discusses the recent developments regarding Eli Lilly's drug Tirzepatide, including its current status in the Chinese market and potential future approvals for additional indications [4][6]. Group 1: Drug Approval Status - On November 17, the National Medical Products Administration (NMPA) of China issued a notification regarding Eli Lilly's Tirzepatide injection, indicating that the application has not yet been approved but can still proceed with further data submission [4]. - The notification includes four application numbers: JXHS2400108, JXHS2400109, JXHS2400110, and JXHS2400111, with a date of issuance on November 14, 2025 [5]. Group 2: Current Indications - Tirzepatide has received approval in China for three indications: for adults with type 2 diabetes who have inadequate blood sugar control, for improving blood sugar control in adults with type 2 diabetes when used with insulin, and for long-term weight management in adults with obesity or overweight [6]. - Additionally, Tirzepatide is approved for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity [6]. Group 3: Speculated Future Indications - Industry insiders speculate that the application may be for the indication of "heart failure with preserved ejection fraction associated with obesity," which is still under registration approval in the United States [5].
第一波用上司美格鲁肽的人,已经开始用上了第二代的替尔泊肽了
GLP1减重宝典· 2025-11-15 11:22
1月2日,礼来中国宣布,其 GLP-1 类明星药替尔泊肽注射液(商品名:穆峰达)正式在中国上市。其在首发当晚 3 秒即告售罄,足见其受追 捧程度之高。据美团显示,在首发前,该药品的预约量日环比增长高达 300%,市场对其期待值持续攀升。替尔泊肽的热度大有超越其竞争对 手司美格鲁肽的态势。 2025年10月30日,礼来发布2025Q3业绩,第三季度营收176.01亿美元,同比增长54%。综合前两个季度的业绩来看,礼来在今年前九 个月的总营收为458.87亿美元(+46%)。从地区分布来看,2025年前9个月美国市场收入306.04亿美元(+43%),中国市场收入14.77 亿美元(+20%)。 整理 | GLP1减重宝典内容团队 值得一提的是,当家品种替尔泊肽(Mounjaro和Zepbound总计)第三季度总计销售101亿美元,前三季度总计248亿美元,预计全年有 望超过350亿美元。在美国市场,礼来的GLP-1市场份额早已超越诺和诺德。 然而, 不同的患者对药物的反应可能存在差异,有些患者可能对司美格鲁肽更为敏感,而有些患者则可能更适合使用替尔泊肽 。第一波用上司 美格鲁肽的人,有的人在使用司美格鲁肽不再那 ...
速递|替尔泊肽,新适应症申报上市!
GLP1减重宝典· 2025-11-13 10:41
Core Viewpoint - The article discusses the recent developments regarding the dual agonist Tirzepatide, highlighting its approval for new indications in China, which expands its market potential in the treatment of type 2 diabetes and obesity [2][4][8]. Group 1: Product Approval and Indications - Tirzepatide, developed by Eli Lilly, is a dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) [3][5]. - The drug was approved in the U.S. in May 2022 for the treatment of type 2 diabetes and received its first approval in China in May 2024 for adult patients with inadequate blood sugar control on diet and exercise, along with metformin and/or sulfonylureas [4][5]. - In July 2024, Tirzepatide was approved in China for long-term weight management in adults with obesity (BMI ≥ 28 kg/m²) or overweight (BMI ≥ 24 kg/m² with at least one weight-related comorbidity) [4][5]. Group 2: Market Implications - The approval of Tirzepatide strengthens Eli Lilly's position in the metabolic disease treatment landscape in China, where there is a large population of patients with obesity and type 2 diabetes, providing significant market opportunities [8]. - As the first GIP/GLP-1 dual agonist, Tirzepatide offers treatment options in both blood sugar control and weight management, which is expected to have a substantial impact on the market [8]. - The expansion of Tirzepatide's indications is a key strategic move for Eli Lilly, particularly in the obesity and metabolic disease sectors, potentially solidifying its market position in diabetes treatment and increasing its relevance in weight management [8].
礼来(LLY.US)替尔泊肽注射液新适应症在华申报获受理
智通财经网· 2025-11-13 07:05
2024年5月,替尔泊肽首次在我国获批上市,用于在饮食控制和运动基础上,接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病(T2DM) 患者。 2024年7月,替尔泊肽又在我国获批一项新适应症:用于在控制饮食和增加运动基础上,体重指数(BMI)符合以下要求的成人的长期体重管理:≥28 kg/m2(肥胖),或≥24 kg/m2(超重)并伴有至少一种体重相关合并症(如:高血压、血脂异常、高血糖、阻塞性睡眠呼吸暂停、心血管疾病等)。 今年6月,替尔泊肽又在华获批第三项适应症: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)。 智通财经APP获悉,11月13日,CDE官网显示,礼来(LLY.US)的葡萄糖依赖性促胰岛素多肽(GIP)和胰高血糖素样肽-1(GLP-1)受体双重激动剂替尔泊肽注 射液新适应症上市申请已获得受理。这是该药品在华第三项适应症获批后又一次申报。 | 序号 | 会睡着 | 药品名称 | 药品类型 | 申请类型 | 注册分类 | 企业名称 | 承办日期 | | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | JXHS ...
三季净赚49亿美元,医药巨头辉瑞,100亿美元收购Metsera
3 6 Ke· 2025-11-11 01:38
Core Insights - The surge in BD transactions has catalyzed the domestic innovative drug market, driven by multinational corporations (MNCs) eager to replenish their pipelines amid declining market performance post-2025 [1][2] - Major MNCs like Pfizer, Novo Nordisk, and Merck have experienced significant stock price declines, with Novo Nordisk's stock dropping over 65% in the past year [1] - Pfizer's acquisition of Metsera for $10 billion highlights the competitive landscape for blockbuster products, particularly in the weight loss drug sector [1][3] Group 1: MNC Market Dynamics - MNCs are facing a fundamental shift in pricing logic as single blockbuster products lose their competitive edge, leading to intensified competition for global best-selling products [1][2] - The U.S. price reductions for weight loss drugs, such as a drop from $1,350 to an average of $350 for Novo Nordisk's semaglutide, indicate a strategic "price for volume" trade-off [2] - The total value of BD transactions involving Chinese innovative drugs reached $75 billion by August 2023, accounting for 36% of global transactions, with projections of 18% for 2024 [2] Group 2: Pfizer's Strategic Moves - Pfizer's Q3 2025 earnings report showed a revenue of $16.65 billion, a 6% decline year-on-year, but better than analyst expectations, with adjusted net profit at $4.949 billion, down 18% [3] - The company has terminated 11 research projects across various therapeutic areas, indicating a strategic refocus [4] - Pfizer's successful acquisition of Metsera may position it favorably in the weight loss market, potentially revitalizing the global pharmaceutical industry and presenting opportunities for domestic innovative drug companies [5]
双11,处方药也能狂欢?
经济观察报· 2025-11-10 14:41
Core Viewpoint - The article highlights the significant rise in the promotion of prescription weight loss drugs during this year's Double 11 shopping festival, drawing comparisons to the popularity of the iPhone 17, and raises concerns about the compliance of such promotions with existing regulations [1][6]. Group 1: Promotion of Prescription Drugs - Major e-commerce platforms like JD.com, Alibaba, and Meituan have launched promotional activities that include prescription drugs, offering discounts of 10%-20% on various medications [3][4]. - The sales of weight loss drugs, particularly those like Tirzepatide, have surged, with sales growth exceeding 5.7 times compared to previous periods [6]. - The promotional strategies include common tactics such as "spend 300 yuan to get 50 yuan off" and "limited-time flash sales," which are typically seen in consumer goods [1][8]. Group 2: Regulatory Concerns - The promotion of prescription drugs may violate existing regulations, as certain promotional activities for prescription medications are explicitly prohibited [4][9]. - Legal experts indicate that while some promotional methods may not directly constitute illegal practices, they could still be interpreted as misleading advertising under current laws [10][14]. - The article discusses the potential for e-commerce platforms to face scrutiny for their promotional practices, especially if they lead to consumer misuse of prescription medications [12][18]. Group 3: Market Dynamics and Consumer Behavior - The article notes that the ease of obtaining prescriptions online has raised concerns about the potential for drug misuse, as consumers can quickly receive prescriptions without thorough medical evaluations [20][22]. - The introduction of "money-back guarantees" for weight loss drugs during promotions may encourage consumers to purchase these medications without proper medical guidance [16][21]. - The article emphasizes the importance of responsible marketing and the need for regulatory oversight to prevent potential health risks associated with the misuse of prescription drugs [23].
从每月1350美元降至350美元,特朗普宣布:减肥药大降价!发布会上药企高管晕倒,公司股价大跌
Mei Ri Jing Ji Xin Wen· 2025-11-07 06:29
Core Points - The U.S. government has reached a price control agreement with Eli Lilly and Novo Nordisk for obesity medications, which will be available through the TrumpRx direct drug sales channel [1][3] - Novo Nordisk's semaglutide injection price will drop from $1,350 to an average of $350 per month, while Eli Lilly's tirzepatide injection and the pending oral drug Orforglipron will decrease from $1,086 to an average of $346 per month [3] - Medicare and Medicaid will now reimburse obesity medications for patients, allowing Novo Nordisk and Eli Lilly to exchange price reductions for increased volume [4] Pricing and Investment Details - Under the agreement, all doses of GLP-1 injections from Novo Nordisk and Eli Lilly will be priced at $245, with Medicare beneficiaries only paying $50 per month after reimbursement [4] - The GLP-1 injections will also be reduced to $245 in the TrumpRx channel over the next two years [4] - Novo Nordisk has committed to invest an additional $10 billion in the U.S., including local production of oral semaglutide once approved [4] Market Reactions - Following the announcement, Novo Nordisk's stock fell by 4%, while Eli Lilly's stock rose by 1.26% [5]
累计在华投资超200亿元!礼来携重磅创新成果亮相2025进博会
Guo Ji Jin Rong Bao· 2025-11-07 04:18
Core Insights - The article highlights Eli Lilly's participation in the China International Import Expo, showcasing its innovative pharmaceutical products and commitment to the Chinese market [1][5][12] Product Innovations - Eli Lilly presented its new cardiovascular and metabolic health drug, Tirzepatide injection, approved for type 2 diabetes, long-term weight management, and obstructive sleep apnea [1] - The company also showcased its oral SERD Imlunestrant for breast cancer and the IL-23 inhibitor Mirikizumab for inflammatory bowel disease, both not yet approved in China [3] Public Health Initiatives - Eli Lilly created interactive experience zones, "Memory Café" and "Body Resistance Decoding Exhibition," to raise public awareness about Alzheimer's disease and obesity [3][6] - The "Body Resistance Decoding Exhibition" aims to educate the public on the physiological mechanisms behind weight management challenges, countering the stereotype that weight loss failures are due to lack of willpower [6] Strategic Collaborations - Eli Lilly announced a strategic partnership with the Shanghai Clinical Innovation and Transformation Research Institute to enhance clinical trial processes and accelerate drug development [8] - The company also established a strategic collaboration with Alibaba Health and upgraded its existing partnership with JD Health to promote digital transformation in chronic disease management [10] Investment and Market Commitment - Eli Lilly has invested over 20 billion RMB in China, emphasizing its strategic importance in the global market [11][12] - The company plans to open an innovation incubator in Shanghai and has committed to further investments, including a 1.5 billion RMB upgrade of its Suzhou factory to expand production of diabetes and obesity drugs [12]
特朗普官宣:减肥药降价
财联社· 2025-11-07 00:13
Core Viewpoint - The U.S. government has reached a drug price control agreement with Eli Lilly and Novo Nordisk, allowing discounted drugs to be sold through the "TrumpRx" direct sales channel [1] Group 1: Agreement Details - Novo Nordisk's semaglutide injection price will drop from $1,350 per month to an average of $350 [7] - Eli Lilly's tirzepatide injection and the pending oral drug (Orforglipron) will decrease from $1,086 per month to an average of $346 [7] - If the FDA approves the oral version of semaglutide or other oral drugs from both companies, pricing will start at $150 per month [7] Group 2: Insurance Coverage and Financial Implications - Medicare and Medicaid will reimburse obesity medications for the first time, representing a "price for volume" trade for both companies [8] - Under U.S. insurance coverage, all doses of Novo Nordisk and Eli Lilly's GLP-1 injections will be priced at $245, with beneficiaries paying only $50 per month after reimbursement [9] - The GLP-1 injections will also be priced at $245 in the "TrumpRx" channel over the next two years [10] Group 3: Additional Commitments and Investments - Novo Nordisk has committed to invest an additional $10 billion in the U.S., including local production of the oral semaglutide once approved [11] - The agreement is expected to have a "low single-digit" negative impact on global sales growth in 2026 [11] - Both companies will receive a three-year grace period from tariffs on drug imports following the agreement with the White House [12]
多款“全球首秀”药械亮相进博会,聚焦老龄化、减重庞大需求
Di Yi Cai Jing· 2025-11-05 11:19
Core Insights - The eighth China International Import Expo (CIIE) showcased several innovative medical devices and healthcare products, attracting significant attention from global trade delegations [1][2] Group 1: Medical Devices - Boston Scientific presented the ENROUTE Transcarotid Artery Revascularization (TCAR) device, the first and only approved device for TCAR procedures, aimed at reducing intraoperative risks associated with carotid artery stenosis [1] - Another product from Boston Scientific, the FARAWAVE NAV catheter, utilizes non-thermal electric fields for cardiac tissue ablation and has treated approximately 500,000 patients globally [1] - Medtronic introduced the Inceptiv closed-loop rechargeable spinal nerve stimulation system, designed to improve the quality of life for patients with chronic pain through weak electrical stimulation [4] - BD Medical showcased the M.R.I™ 4F Slim Implantable Port, the thinnest catheter in its category, designed for the Chinese population, which significantly reduces thrombosis rates by 40% [4] - The Venclose™ catheter, designed for treating lower limb varicose veins, features a flexible setup that minimizes patient trauma [5] Group 2: Innovative Treatments - Fosun Pharma presented the Exablate Neuro system, a high-intensity focused ultrasound (HIFU) device combined with MRI for treating drug-resistant essential tremors and Parkinson's disease [6] - Eli Lilly introduced innovative drugs targeting aging and obesity, including donanemab for Alzheimer's disease, which has shown to delay disease progression by approximately 30% in clinical trials [6]