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礼来重磅口服减肥药试验取得新进展:针剂转口服后有效维持减重成果,已向FDA递交上市申请
Hua Er Jie Jian Wen· 2025-12-18 13:57
抢占诺和诺德存量市场 礼来公司旗下在研口服减肥药orforglipron在最新后期临床试验中取得关键进展,证明其能够有效帮助从 针剂转药的患者维持减重效果。鉴于该药物所展现的临床潜力,礼来周四宣布已向美国食品药品监督管 理局(FDA)提交了该每日一次GLP-1口服药的上市申请,旨在为肥胖症患者提供无需注射的长期体重 管理方案。 最新的临床数据显示,患者在从礼来的Zepbound或诺和诺德的Wegovy注射剂切换至orforglipron口服药 后,能够维持绝大部分减重成果。这一结果解决了肥胖治疗领域的一个核心痛点,即患者在停止每周一 次的针剂注射后往往会出现体重明显反弹。 受此便利性优势驱动,口服减重药物被视为该领域下一个突破点。FDA已在11月向礼来授予了优先审评 凭证,这意味着该药的审核周期可能缩短至数月内。尽管礼来的口服药在总体减重幅度上可能略逊于现 有的针剂,但其作为"无针化"维持治疗方案的潜力,正成为市场关注的焦点。 目前,全球减重药市场正演变为礼来与诺和诺德的两强争霸。虽然诺和诺德的口服版Wegovy预计将率 先上市并抢占先机,但礼来通过orforglipron展示了从竞争对手手中夺取维持期患者市 ...
速递|体重减轻7.7%,歌礼制药口服GLP-1美国二期临床试验数据发布
GLP1减重宝典· 2025-12-11 03:34
Core Viewpoint - The article discusses the latest clinical results of GLP-1 oral weight loss drug ASC30 by Gilead Sciences, highlighting its competitive position in the oral weight loss drug market and comparing it with other leading products [5][6][7]. Summary by Sections Clinical Results of ASC30 - Gilead Sciences announced that ASC30 achieved a weight loss of 7.7% at the highest dose in a Phase II study involving 125 participants with obesity or overweight and at least one weight-related comorbidity [5]. - The study evaluated three dosing regimens (20mg, 40mg, and 60mg) with average weight loss of 5.4%, 7%, and 7.7% respectively, all statistically significant [5]. - No plateau in weight loss was observed during the trial period [5]. Comparison with Competitors - Gilead's data positions ASC30 in the upper-middle range of performance among oral weight loss drugs, with intense competition in the market [5]. - Novo Nordisk is awaiting FDA approval for its oral version of Wegovy, which demonstrated a weight loss of 15.1% over 68 weeks at a 50mg daily dose [5]. - Eli Lilly's orforglipron achieved a 12.4% weight loss over 72 weeks, but analysts noted persistent gastrointestinal side effects [6]. Safety and Tolerability - Gilead reported that the incidence of vomiting with ASC30 was about half that of orforglipron, with all gastrointestinal adverse events classified as grade 1-2 and occurring mainly during the dose escalation phase [7]. - No grade 3 or more severe events were reported, nor any serious drug-related adverse events [7]. - The CEO of Gilead indicated that ASC30 shows potential best-in-class characteristics in terms of weight loss efficacy and gastrointestinal tolerability [7]. Strategic Focus - Gilead plans to submit data to the FDA and apply for a Phase II end-of-study meeting in Q1 2026, having shifted its strategic focus to metabolic diseases earlier this year [7]. - Other competitors in the oral weight loss drug space include Viking Therapeutics, which reported a maximum weight loss of 12.2% in a Phase II study, but faced a 38% dropout rate among participants at the most effective dose [7].
口服GLP-1减重药问世四年后,司美格鲁肽片仍在领跑赛道
GLP1减重宝典· 2025-08-31 03:37
Core Viewpoint - Recent clinical results have led to new considerations regarding the prospects of oral weight loss medications, with concerns raised about their effectiveness compared to injectable formulations [4][5]. Injectable Drugs Remain Dominant - By 2030, oral therapies are expected to capture about 25% of the global anti-obesity drug market, but injectable peptides are likely to maintain dominance in the U.S. market due to patient and physician preferences for maximum weight loss [5]. - William Blair predicts that 80-90% of Viking's VK2735 revenue will come from subcutaneous injections, with oral formulations contributing relatively little [5]. Advantages of Oral Small Molecules - In developing countries with inadequate infrastructure, oral small molecules may have advantages as they do not require cold chain storage, making them easier to distribute and consume [6]. Clinical Results and Benchmark Discrepancies - Novo Nordisk's Wegovy (semaglutide injection) has set a benchmark for weight loss at 12-13% placebo-adjusted weight loss, while Eli Lilly's orforglipron only achieved 9.1% after 72 weeks, leading to a significant stock price drop [7][10]. - VK2735 showed a 10.9% placebo-adjusted weight loss in 13 weeks, but high patient dropout rates raise concerns about tolerability [10]. Competition Between Small Molecules and Peptides - Key candidates include Novo Nordisk's high-dose oral semaglutide, Eli Lilly's orforglipron, and Viking's oral VK2735, with differences in manufacturing, storage, and usage impacting market performance [11]. - Novo Nordisk's high-dose oral semaglutide demonstrated an average weight loss of 16.6%, maintaining strong market interest [11]. Data Interpretation and Trial Duration Differences - Analysts caution against direct comparisons between trials due to varying durations; VK2735's data covers only 13 weeks, while others span longer periods [12]. - Early data should not be directly compared to long-term results, as weight loss efficacy often stabilizes after 30 weeks [12]. Market Dynamics and Future Competition - The industry is closely monitoring whether oral therapies can truly change market dynamics, with Novo Nordisk leading in efficacy and supply capabilities [14]. - Eli Lilly plans to submit a registration application for orforglipron within the year, while Viking is exploring further development paths [14]. Conclusion - The emergence of oral weight loss medications adds a new dimension to the anti-obesity market, but injectable formulations remain the core choice in developed markets [15]. - The ultimate market dynamics will depend on efficacy, tolerability, and patient adherence as more competitors enter the field [15].
礼来第二季度营收155.6亿美元,口服减重药临床数据未达预期
Huan Qiu Wang Zi Xun· 2025-08-08 02:44
Core Insights - Eli Lilly reported Q2 2025 revenue of $15.56 billion, exceeding Wall Street's expectation of $14.69 billion, with a net profit of $5.66 billion or $6.29 per share, compared to $2.97 billion or $3.28 per share in the same period last year [1][3] - The adjusted earnings per share, excluding one-time intangible asset-related items, were $6.31, surpassing the market expectation of $5.57 [1][3] Revenue Drivers - The diabetes treatment drug Mounjaro generated nearly $5.2 billion in revenue for the quarter, marking a 68% year-over-year increase [3] - The weight loss drug Zepbound achieved sales of $3.38 billion in the same quarter, a staggering 172% year-over-year growth [3] Revised Guidance - Based on strong performance, Eli Lilly raised its full-year earnings forecast to an adjusted earnings per share of $21.75 to $23, up from the previous estimate of $20.78 to $22.28 [3] - The company now expects annual sales to be between $60 billion and $62 billion, higher than the prior range of $58 billion to $61 billion [3] Market Reaction - Despite the positive earnings report, Eli Lilly's stock price fell by 14.14% on August 7 [3] - The decline was influenced by clinical trial results for the oral weight loss drug Orforglipron, which showed a maximum weight loss of 12.4 kg over 72 weeks, falling short of market expectations [3]
口服减重药数据不及预期 礼来股价重挫逾14%
Bei Jing Shang Bao· 2025-08-07 14:53
Core Viewpoint - Eli Lilly's stock experienced a significant drop of over 14% during intraday trading on August 7, following the release of clinical trial results that did not meet market expectations [2]. Group 1: Clinical Trial Results - Eli Lilly announced clinical data for its oral weight loss drug Orforglipron, which was tested on over 3,000 overweight adults with at least one weight-related comorbidity but without diabetes [2]. - In the highest dosage group, participants achieved an average weight loss of 12.4 kg over 72 weeks, translating to a weight reduction of 12.4% [2].
口服减重药数据不及预期,礼来股价重挫逾14%
Bei Jing Shang Bao· 2025-08-07 14:39
Core Viewpoint - Eli Lilly's stock experienced a significant drop of over 14% during intraday trading on August 7, following the release of clinical trial data that did not meet market expectations [1] Group 1: Clinical Trial Results - Eli Lilly announced clinical trial results for its oral weight loss drug Orforglipron, which was tested on over 3,000 overweight adults with at least one weight-related comorbidity and no diabetes [1] - In the highest dosage group, participants achieved an average weight loss of 12.4 kg over 72 weeks, corresponding to a weight reduction of 12.4% [1]