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速递|礼来口服orforglipron,已向FDA提交上市申请!
GLP1减重宝典· 2025-12-18 15:59
整理 | GLP1减重宝典内容团队 礼来同时表示,已就这款GLP-1口服药orforglipron向美国食品药品监督管理局提交上市申请。FDA此前已授予该药物优先审评资格, 这意味着审批周期有望从常规流程压缩至数月。受消息影响,美股盘前礼来股价整体保持平稳,市场反应相对克制。 此次试验的核心意义,在于解决当前减重治疗中的一个现实难题:大量患者在停用每周注射型减肥药后,体重往往出现明显反弹。尽管 口服药在整体减重幅度上不及注射剂,但最新数据表明,它或可作为一种"过渡性方案",帮助患者在告别针剂的同时,尽量守住已经取 得的减重成果。 美国制药巨头礼来最新披露的一项后期临床试验结果,为火热的GLP-1减重市场带来了新的想象空间。数据显示,部分肥胖患者在停止 使用注射类减肥药、转而服用礼来研发的每日一次口服减肥药后,仍能在较长时间内维持大部分减重成果。这一结果被视为口服减肥药 在"维持治疗"场景中的关键突破。 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。部分文章推送时未能与原作者或公众号平台取得联系。若涉及版权问题,敬请原作者 ...
医药行业周报:ADA大会在即,GLP-1减重赛道有哪些新进展?-20250623
Hua Yuan Zheng Quan· 2025-06-23 02:14
Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical industry [4] Core Views - The pharmaceutical sector is experiencing a correction, particularly in the innovative drug segment, but core innovative drug stocks with strong fundamentals are showing resilience. The report continues to favor the innovative drug industry trend and suggests focusing on companies with significant breakthroughs or international expansion [5][33] - The upcoming ADA 2025 conference is expected to showcase numerous advancements in the GLP-1 weight loss sector, highlighting the industry's robust development trajectory. Key areas of focus include muscle gain, oral small molecules, and new targets like Amylin [9][33] Summary by Sections 1. ADA 2025: Anticipating Muscle Gain Validation and New Target Exploration - The global sales of Semaglutide are projected to reach $25.9 billion in 2024, making the GLP-1 sector highly competitive [9] - The report identifies a growing demand for weight loss solutions that also promote muscle gain, particularly among elderly populations suffering from obesity [10] 1.1. Muscle Gain/Non-Weight Loss: New Demand in Weight Loss - Muscle loss is a significant challenge for GLP-1 treatments, with up to 40% of weight loss attributed to muscle loss in patients. The report emphasizes the need for weight loss solutions that preserve muscle mass [10] 1.2. Oral Small Molecules: Orforglipron Expected to be First Approved - Orforglipron is anticipated to be the first approved oral GLP-1 small molecule, with significant upstream benefits expected for companies like Kelun Pharmaceutical and WuXi AppTec [15] 1.3. Amylin: Next-Generation Target with Potential Advantages - The report discusses the potential of Amylin as a complementary treatment to GLP-1, with improved safety profiles and efficacy in weight loss [20] 1.4. Long-Acting Formulations: Improved Patient Compliance - Long-acting formulations are expected to enhance patient adherence to treatment regimens, with several promising candidates in development [21] 1.5. GLP-1 Weight Loss Efficacy: Updated Insights - The report provides an updated overview of the efficacy of GLP-1 treatments in weight loss, highlighting their effectiveness and safety [22] 1.6. Domestic Investment Opportunities from ADA - The report suggests focusing on companies like LaiKai Pharmaceutical and Gree Pharmaceutical, which are well-positioned in the weight loss and muscle gain sectors [25][28][31] 2. Industry Perspective: Innovation, International Expansion, and Aging Population - The report emphasizes the importance of innovation, international expansion, and the aging population as key drivers for the pharmaceutical industry. It notes that the industry has completed a transition from old to new growth drivers [33] - The pharmaceutical index has shown a decline of 4.35% recently, but the long-term outlook remains positive due to ongoing innovation and market expansion [33][44]