整理 | GLP1减重宝典内容团队 这些言论是周三在JAMA的一篇评论文章中发表的，由世卫组织官员Jeremy Farrar、Francesco Branca和Francesca Celletti撰写。 在文章中，专家们称肥胖是一个"大流行"的公共卫生问题， 影响全球10多亿人，几乎每个国家的病例都在增加。2019年，肥胖相关的非传染性 疾病夺走了500万人的生命。到 2030 年，全球肥胖相关成本可能达到 3 万亿美元 。 据世界卫生组织称，GLP-1受体激动剂目前正以高度医疗化的方式使用。 医疗保健系统需要制定更全面的解决方案，重点关注健康促进、疾病 预防和政策干预。 世界卫生组织官员认为， GLP-1 肥胖疗法的迅速崛起为该行业和医疗保健系统提供了对抗肥胖大流行的有力武器，但目前 的部署方式有可能无法实现这一目标。 在此背景下，GLP-1 受体激动剂的兴起和日益普及可能会对肥胖护理产生"变革性"影响，为各国卫生系统提供有效的药物治疗选择。 "然而，单独的药物治疗不足以解决肥胖危机，"世卫组织官员写道，并补充说，医疗保健系统必须采取整体应对措施，"确保普遍提供预防、治 疗和管理疾病的服务，使之易于获得、负 ...

智通财经APP获悉，据港交所6月9日披露，广州银诺医药集团股份有限公司(银诺医药)递表港交所主板，中信证券、中金公 司为其联席保荐人。此前该公司曾在2024年12月3日向港交所主板申请上市。 GLP-1疗法已显示出其具有多种治疗益处，包括降低血糖水平、促进体重减轻、减少食物摄入、调节脂质代谢和减少脂肪积 累。因此，GLP-1疗法在解决体重管理和改善代谢健康方面具有巨大潜力。 根据弗若斯特沙利文的资料，在治疗肥胖或超重领域，全球GLP-1药物市场预期将从2024年的147亿美元增加至2028年的338 亿美元，年复合增长率为23.2%，而在治疗肥胖或超重领域，中国GLP-1药物市场预期将从2024年的人民币4亿元增加至2028 年的人民币207亿元，年复合增长率为171.2%。 财务方面，于2023年度及2024年度，银诺医药研发开支分别约为人民币4.92亿元、1.03亿元;同期，该公司年内亏损分别约为 7.33亿元、1.75亿元。自2025年起，银诺医药开启首个产品商业化运营的发展新阶段。 | | 截至12月31日止年度 | | | --- | --- | --- | | | 2023年 | 2024年 | ...

整理 | GLP1减重宝典内容团队 CG-0416 的肝脏特异性激活使肝内活性代谢物浓度比外周组织高 20 倍，从而最大限度地降低全身 THR-β 激活，并提高长期安全性。 2. 肌肉保存突破 在26周饮食诱导肥胖 (DIO) 小鼠模型中，CG-0416 与低剂量 司美格鲁肽联合使用表现出： 脂肪量减少 66%（与司美格鲁肽 单药治疗相比） 肌肉脂肪减少比为 0.18 kg/kg（现有疗法为 0.35-0.63 kg/kg） 临床转化优势 在欧洲肝病研究协会 (EASL) 年会上，柯君医药 公布了其在研的肝脏靶向甲状腺激素β受体 (THR-β) 前药 CG-0416 的最新临床前研究结果。 该研究数据在"最新海报"环节中展示，突显了 CG-0416 在代谢功能障碍相关脂肪性肝炎 (MASH) 和体重管理方面的三重治疗潜力：与标准疗 法相比，肝脏脂质蓄积减少 58%；减重效果提高 66%；肌肉流失率降低 50%。这些研究结果使 CG-0416 成为同时治疗 MASH 和肥胖症的新 型双机制候选药物。 突破当前治疗局限性 GLP-1 受体激动剂（例如司美格鲁肽、替泽帕肽）在持续控制体重和保持肌肉质量方面面临挑战， ...

Financial Data and Key Metrics Changes - First quarter revenue was $5.6 million, a decrease from $9.4 million in the same period in 2024, primarily due to the temporary suspension of sales in France and lower investments in sales and marketing [22][5] - Adjusted net operating loss narrowed by 48% to $5.9 million compared to the prior year, with gross margin expanding to 75% from 73% in the prior year and 45% in the previous quarter [5][22] - Cash and cash equivalents at the end of the first quarter were $20.4 million, providing a runway for achieving FDA approval and profitability [25][12] Business Line Data and Key Metrics Changes - Sales and marketing expenses decreased to $3.6 million from $6.1 million in the same period in 2024, driven by increased operating efficiency [23] - Research and development expenses were reduced to $2.6 million from $5.7 million, primarily due to cost reductions related to the IDISSIPPI trial [23] - General and administrative expenses decreased to $5.2 million from $6.4 million, with adjusted expenses at $3.8 million excluding one-time financing costs [24] Market Data and Key Metrics Changes - The company observed over 40% growth quarter over quarter and year over year in its B2B2C model pilot in clinics in Europe [7] - The company expects revenues to ramp as the year progresses with the expansion of the B2B2C model and enhanced sales team onboarding [8] Company Strategy and Development Direction - The company’s 2025 plan focuses on five pillars: a new commercial plan, gaining FDA approval for the Allurion balloon, achieving profitability for the ex-U.S. business, scaling the AI product platform, and resuming commercialization in France [6][7] - The company aims to combine its program with low doses of GLP-1s to create a new standard of care for obesity, targeting a sustained weight reduction of over 20% while maintaining muscle mass [16][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficiency of the new B2B2C model and the potential for significant shareholder value as millions of patients could be treated with the Elerion program [26][27] - The company is optimistic about completing its PMA submission to the FDA by June and is encouraged by the FDA's feedback during the pre-PMA meeting [12][39] Other Important Information - The company has resumed treating patients in France and is in the final phases of updating marketing collateral to reactivate placements [15] - The company does not expect any impact on gross margin from tariffs for the remainder of the year, as most components are manufactured in the U.S. [12][13] Q&A Session Summary Question: Trends in regional markets, especially with the new marketing strategy - Management noted that mature markets for GLP-1s are creating tailwinds, with patients seeking alternatives and the expansion of the direct sales force expected to drive revenue growth [29][30] Question: Timeline and patient enrollment for the GLP-1 trial - Enrollment is expected to begin in the latter half of this year, with a one-year follow-up and a target of at least 75 subjects across multiple sites in Europe [31][32] Question: Design of the trial arms - The trial will focus on validating previous retrospective work with a single arm prospective trial design, leveraging historical data for comparison [33][34] Question: Future gross margin expectations - Management expects margins to remain in the same range as the first quarter, with potential increases as revenues ramp up [35][36] Question: Details on the pre-PMA meeting and next steps - The FDA was receptive to alternative analyses for the control group data, which could strengthen the overall application [39][40] Question: Current adoption of the Elerion program and GLP-1s - There is organic adoption of the combination therapy in the field, with physicians integrating GLP-1s with the Allurion balloon [45][46] Question: Revenue performance cadence for 2025 - Management anticipates steady revenue increases driven by the onboarding of new sales team members and recovery in France [49][50] Question: Expected costs for the prospective study - The prospective trial is not expected to have a material impact on the budget, as existing patient flow and lower costs overseas will be leveraged [51][52] Question: Regulatory strategy regarding expanded labeling - The focus is on the commercial implications of the study, with potential long-term benefits for discussions with regulators and payers [53][54] Question: Procedure growth trends - Procedure volume is stable, with some growth in certain territories, and management expects a recovery in France in the second half of the year [57][58]

整理 | GLP1减重宝典内容团队 诺和诺德今日公布了其2025年第一季度的财务业绩，报告显示，由于战略投资组合决策， 公司已于4月停止开发每周服用一次的口服司美格鲁 肽片剂。 今年早些时候，多家媒体报道称，诺和诺德已向美国食品药品监督管理局（FDA）提交了一份新的申请，申请25毫克口服司美格鲁肽，用于治 疗超重和肥胖。这使其成为全球首个寻求监管批准的专门用于减肥的口服GLP-1疗法。 然而，该版本采用每日一次的口服给药方式，并在早期临床试验中显示出良好的效果。根据诺和诺德分享的试验数据，参与者的平均起始体重 为105.4公斤。在每日服用50毫克口服司美格鲁肽的组中，68周后平均体重减轻了17.4%，而安慰剂组仅为1.8%，差异具有统计学意义。此外， 治疗组89.2%的患者体重减轻至少5%，而安慰剂组仅有24.5%的患者达到这一阈值。 尽管停用了每周一次的版本，诺和诺德仍继续通过针对代谢疾病和肥胖症的其他给药方案来推进口服司美格鲁肽的开发。 *本文仅供医疗卫生专业人士参考 版权声明：所有「GLP1减重宝典」的原创文章，转载须联系授权，并在文首/文末注明来源、作者、微信ID，否则减重宝典将向其追究法律责 任。部 ...