肥胖症治疗
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歌礼制药-B:歌礼将携ASC30口服片、ASC30注射剂和ASC31与ASC47联合疗法的研究结果亮相2025年肥胖周
Zhi Tong Cai Jing· 2025-10-27 09:58
Core Insights - The company announced that it will present multiple obesity drug candidates, including ASC30 and the combination therapy of ASC31 and ASC47, at the 2025 ObesityWeek in Atlanta, Georgia [1] - The CEO expressed excitement about the progress of their small molecule and peptide obesity pipeline, highlighting the company's commitment to developing differentiated obesity treatment options [1] Company Developments - The company is actively advancing its obesity treatment pipeline, showcasing its candidates at a significant industry event [1] - The announcement reflects the company's strategic focus on addressing obesity through innovative therapies [1]
歌礼制药-B(01672.HK):将携ASC30口服片、ASC30注射剂和ASC31与ASC47联合疗法的研究结果亮相2025年肥胖周
Ge Long Hui· 2025-10-27 09:57
Core Viewpoint - The company, Gilead Sciences-B (01672.HK), announced its participation in the 2025 Obesity Week in Atlanta, Georgia, where it will present multiple obesity treatment candidates, including ASC30, ASC31, and ASC47 combination therapy [1] Group 1: Presentation Details - The company will report on the oral GLP-1 receptor biased small molecule agonist ASC30 in a 28-day multiple ascending dose study [1] - An Ib phase study on ASC30, a monthly subcutaneous injection small molecule GLP-1 receptor agonist in obese subjects, will also be presented [1] - The combination of GLP-1 receptor/GLP receptor agonist peptides ASC31 and ASC47 showed a relative weight loss improvement of 119.6% compared to tirzepatide in diet-induced obese mice [1] Group 2: Company Statements - The founder, chairman, and CEO of the company expressed excitement about the ongoing progress of their small molecule and peptide obesity pipeline, highlighting a strong commitment to developing differentiated obesity treatment solutions [1]
歌礼制药(01672) - 自愿性公告 - 歌礼将携ASC30口服片、ASC30注射剂和ASC31与...
2025-10-27 09:45
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 (於開曼群島註冊成立的有限公司) (股份代號:1672) 自願性公告 Ascletis Pharma Inc. 歌禮製藥有限公司 歌禮將攜ASC30口服片、ASC30注射劑和ASC31與ASC47聯合療法的 研究結果亮相2025年肥胖周(ObesityWeek®) 本公告乃歌禮製藥有限公司(「本公司」或「歌禮」,連同其附屬公司稱為「本集 團」)自願作出,以使本公司股東及潛在投資者了解本集團的最新業務發展。 本公司董事(「董事」)會(「董事會」)宣佈將在美國佐治亞州亞特蘭大舉行的2025 年肥胖周(ObesityWeek®)以壁報形式報告多款肥胖症候選藥物,包括ASC30以及 ASC31與ASC47聯合療法。 報告細節: ASC30是一款正在臨床研究中的小分子GLP-1R偏向激動劑,具有獨特和差異化性 質,使得同一小分子同時適用於口服片劑和皮下注射給藥成為可能。ASC30是一 種新化學實體(NCE),擁有 ...
歌礼制药-B(01672)完成小分子GLP-1R激动剂ASC30治疗肥胖症的每月一次皮下储库型治疗制剂的美国IIa期研究受试者入组
智通财经网· 2025-10-20 00:27
Core Viewpoint - The completion of subject enrollment in the Phase IIa study of ASC30, a small molecule GLP-1 receptor agonist for obesity treatment, marks a significant milestone in the development of this innovative therapy [1][2]. Group 1: Study Details - The Phase IIa study is a 12-week, randomized, double-blind, placebo-controlled, multi-center clinical trial conducted in the U.S. with 65 participants, all of whom are either obese or overweight with at least one weight-related comorbidity [1]. - The study aims to evaluate the safety, tolerability, and efficacy of ASC30 in subjects with a body mass index (BMI) of ≥ 30 kg/m² or those with a BMI between 27 kg/m² and 30 kg/m² [1]. - Top-line data from the study is expected in the first quarter of 2026 [1]. Group 2: Pharmacokinetics and Technology - The observed half-life of ASC30 in obese subjects is 46 days, supporting a once-monthly dosing regimen, while the terminal half-life is 36 days [1]. - The peak-to-trough ratio of the drug is approximately 1.5:1, indicating favorable pharmacokinetic properties [2]. - ASC30 is developed using the company's proprietary ultra-long-acting drug development platform (ULAP), which overcomes limitations of albumin-dependent half-life extension technologies [2]. Group 3: Product Characteristics - ASC30 is the first and only small molecule GLP-1 receptor agonist that can be administered both orally and via subcutaneous injection, suitable for both weight loss treatment and maintenance [2][3]. - The compound is a new chemical entity (NCE) with patent protection in the U.S. and globally until 2044, excluding any patent extensions [3].
来凯医药-B(02105):I期临床MAD研究取得积极初步结果 LAE102展现出令人鼓舞的增肌减脂趋势
智通财经网· 2025-09-29 00:20
Core Insights - The company, 来凯医药-B (02105), announced positive preliminary results from the Phase I Multiple Ascending Dose (MAD) study of LAE102 for obesity treatment in China [1][2] - The MAD study demonstrated safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered LAE102 in overweight/obese subjects [1] Group 1: Study Results - The MAD study included overweight/obese subjects with an average BMI of 29.4 kg/m² and involved three dosing groups (2 mg/kg, 4 mg/kg, and 6 mg/kg) administered weekly for four weeks [1] - In the 6 mg/kg dosing group, subjects showed an average lean body mass increase of 1.7% and a fat mass reduction of 2.2% by week 5 [1] - After adjusting for the placebo group, the average lean body mass increase reached 4.6%, while fat mass decreased by 3.6% [1] Group 2: Safety and Tolerability - The MAD study confirmed good tolerability and safety, with no serious adverse events reported [1] - Most adverse events during treatment were mild (Grade 1) laboratory abnormalities, with no cases of diarrhea, muscle cramps, or acne reported [1] - Safety results were consistent with previous findings from the single ascending dose (SAD) study, with no new safety signals observed [1] Group 3: Future Development and Partnerships - The positive results from the MAD study support the continued clinical development of LAE102 for obesity treatment [2] - The company is actively negotiating with potential partners who have serious commitments and financial strength to prioritize this project, aiming to accelerate clinical development and commercialization [2] - The company maintains a robust financial position, allowing for selective evaluation of potential partnership structures to maximize global asset potential [2]
Fractyl Health (NasdaqGM:GUTS) Update / Briefing Transcript
2025-09-26 13:02
Summary of Fractyl Health's REMAIN1 Midpoint Cohort Data Call Company Overview - **Company**: Fractyl Health (NasdaqGM: GUTS) - **Industry**: Obesity treatment and metabolic disease management Key Points and Arguments 1. **Milestone Presentation**: Fractyl Health presented the first prospective randomized double-blind control data from the REMAIN1 midpoint cohort, demonstrating that Revita prevented weight regain three months after discontinuation of GLP-1 drugs [5][6] 2. **Therapeutic Category**: The results indicate a new potential therapeutic category in obesity post-GLP-1 weight maintenance, positioning Fractyl to lead in this area [5][6] 3. **Future Milestones**: The company anticipates four weight maintenance data readouts in the next year, with pivotal data and potential PMA filing expected in the second half of 2026 [5][18] 4. **Cash Flow**: Fractyl expects to have sufficient cash to fund operations into early 2027 [5] 5. **Revita's Mechanism**: Revita targets duodenal dysfunction as a root cause of obesity, aiming to restore normal signaling and create a durable metabolic reset [6][15] 6. **Clinical Efficacy**: In the REMAIN1 midpoint cohort, Revita patients lost 2.5% more body weight compared to sham patients, who regained 10% of their weight, resulting in a clinically significant treatment difference of 12.5% [9][14] 7. **Safety Profile**: Revita demonstrated an excellent safety and tolerability profile, with no serious device-related adverse events reported [10][15] 8. **Patient Demographics**: The study included 45 adults with obesity, mirroring the real-world GLP-1 population, with an average BMI of 37.1 kg/m² [13] 9. **Weight Loss Maintenance**: Revita patients lost an additional 2 kg after stopping tirzepatide, while sham patients regained 8 kg, highlighting Revita's effectiveness in maintaining weight loss [14][15] 10. **Market Demand**: There is significant demand for a durable alternative to GLP-1 drugs, with many patients eager to find solutions for weight maintenance after stopping medications [19][20] Additional Important Content 1. **Regulatory Designation**: Revita received FDA Breakthrough Device designation for post-GLP-1 weight maintenance, emphasizing its potential in a hard-to-treat patient population [7][10] 2. **Commercial Strategy**: If approved, Revita could fit seamlessly into existing endoscopy practices, with a sales model targeting hospitals and endoscopy centers [20][21] 3. **Payer Interest**: Early feedback from health plans indicates interest in a sustainable solution for long-term weight maintenance, which Revita could provide [20] 4. **Clinical Trial Design**: The REMAIN-1 program was designed to replicate pivotal cohort protocols, ensuring consistency in patient selection and treatment [10][18] 5. **Future Data Expectations**: Upcoming data releases include six-month results from the midpoint cohort and open-label data from the REVEAL-1 cohort, which will further validate Revita's efficacy [22][36] This summary encapsulates the critical insights from Fractyl Health's recent conference call, highlighting the company's innovative approach to obesity treatment and the promising data surrounding its product, Revita.
BMO's Seigerman on Pfizer-Metsera deal: Bullish as we've waited on Pfizer's foray into obesity
Youtube· 2025-09-22 18:01
Core Viewpoint - Fizer's acquisition of experimental obesity drugs positions the company as a credible competitor in the obesity treatment market, enhancing its growth potential and market presence [1][2]. Company Insights - Fizer's entry into the obesity market has been anticipated, with the potential to make a significant impact, especially with their once-monthly treatment options that differ from competitors like Lily and Novo [2][4]. - The oral peptide developed by Fizer does not require fasting, which could improve patient compliance compared to existing treatments [3]. - The obesity drug market is expected to be large enough to accommodate multiple competitors, suggesting that Fizer's new offerings could find a place alongside established players [4][6]. Market Dynamics - The obesity treatment market is projected to be driven by volume rather than price, with existing competitors facing pricing pressures [5]. - Fizer's once-monthly and oral treatment options may provide a competitive edge against established products from Lily and Novo [5]. - The infrastructure required for successful market entry includes a large sales force and complex contracts with payers, indicating significant investment needs for new entrants [7]. Investor Sentiment - Recent data from diabetes meetings has shifted investor sentiment positively towards Novo, highlighting a valuation disconnect between Novo and Lily, which may influence market dynamics [8][9]. - Investors are particularly interested in new trials, such as the Evoke trial examining oral simaglletide for Alzheimer's disease, indicating a broader interest in innovative treatments [9][10].
港股异动 | 歌礼制药-B(01672)涨超8% ASC47联合司美格鲁肽肥胖研究减重效果提升达56.2%
Zhi Tong Cai Jing· 2025-09-22 01:51
Core Viewpoint - The stock of Gilead Sciences-B (01672) increased by over 8%, reaching HKD 11.57 with a trading volume of HKD 23.73 million, following the announcement of significant clinical trial results for its weight loss drug ASC47 combined with semaglutide [1] Group 1: Clinical Trial Results - Gilead announced that in a study conducted on obese participants (BMI ≥ 30 kg/m²), the combination of ASC47 and semaglutide showed a weight loss effect that was 56.2% greater compared to the placebo combined with semaglutide [1] Group 2: Future Research Implications - The CEO of Gilead, Wu Jinzi, stated that this research provides important concept validation data, which will serve as a critical basis for the design of subsequent Phase IIb combination therapy studies targeting various metabolic diseases, including obesity and metabolic-associated fatty liver disease (MASH) [1]
歌礼制药-B涨超8% ASC47联合司美格鲁肽肥胖研究减重效果提升达56.2%
Zhi Tong Cai Jing· 2025-09-22 01:44
Core Viewpoint - The stock of Gilead Sciences-B (01672) increased by over 8%, reaching HKD 11.57, with a trading volume of HKD 23.73 million, following the announcement of significant weight loss results from its candidate drug ASC47 in combination with semaglutide [1] Group 1: Company Announcement - Gilead Sciences announced that, on day 29, the weight loss effect of ASC47 combined with semaglutide in obese subjects (BMI ≥ 30 kg/m²) was enhanced by up to 56.2% compared to the placebo combined with semaglutide [1] - The founder, chairman, and CEO of Gilead Sciences, Wu Jinzi, stated that this study provides important proof-of-concept data, which will serve as a critical basis for the design of subsequent Phase IIb combination therapy studies for various metabolic diseases, including obesity and metabolic-associated fatty liver disease (MASH) [1]
诺和诺德(NVO.US)计划为高剂量Wegovy申请美国监管批准
智通财经网· 2025-09-16 12:19
Group 1 - Novo Nordisk plans to apply for U.S. regulatory approval for a high-dose version of its weight loss therapy "Wegovy," aiming to compete against Eli Lilly's Zepbound in the growing obesity treatment market [1] - The company's Chief Scientific Officer, Martin Holst Lange, stated that the high-dose Wegovy has comparable weight loss potential to Eli Lilly's offering, providing new treatment options for patients [1] - Novo Nordisk is building a diversified product portfolio around the active ingredient semaglutide, which includes both high-dose injections and an oral tablet version of Wegovy [1] Group 2 - Earlier this year, Novo Nordisk submitted an application for the high-dose Wegovy in Europe [2] - The company reiterated plans to conduct late-stage clinical trials for the experimental compound cagrilintide, which operates through a different mechanism than semaglutide [2] - Novo Nordisk is adjusting its R&D strategy following underwhelming results from its next-generation obesity therapy CagriSema, planning to test cagrilintide's efficacy separately and optimize CagriSema's positioning through new clinical trials [2]