医药生物 2025 年 11 月 23 日 投资评级：看好（维持） 行业走势图 数据来源：聚源 -19% -10% 0% 10% 19% 29% 2024-11 2025-03 2025-07 医药生物 沪深300 相关研究报告 《MNC 全面布局 FGF21 靶点，关注 国内投资机会—行业周报》-2025.11.16 《流感高发，关注相关投资机会—行 业周报》-2025.11.9 《集采+医保谈判稳步推进，关注相关 投资机会—行业周报》-2025.11.2 减肥赛道开启"长效革命" ，MNC 加速布局高价值平台 ——行业周报 | 余汝意（分析师） | 汪晋（分析师） | 石启正（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | wangjin3@kysec.cn | shiqizheng@kysec.cn | | 证书编号：S0790523070002 | 证书编号：S0790525060003 | 证书编号：S0790125020004 | 以辉瑞、礼来、诺和诺德为代表的 MNC 正积极布局超长效管线与技术平台 11 月 13 日，辉瑞宣布已成功完成对 Mets ...

Core Insights - The article highlights the transformative journey of Gilead Sciences (1672.HK) in the Chinese biotech industry, showcasing its resilience and strategic decision-making in the face of challenges [2][11] - Gilead's shift towards a differentiated pipeline in weight loss drugs has led to a significant market re-evaluation and recovery in its stock price [4][9] Group 1: Company Development - Gilead Sciences was listed on the Hong Kong Stock Exchange in August 2018 at an initial price of 14 HKD, reaching a market capitalization of 16 billion HKD, but faced a decline due to setbacks in its core hepatitis C drug [3][4] - By August 2024, the company's stock price had plummeted to 0.76 HKD, resulting in a market value reduction of over 95% [3][4] - The founder, Dr. Wu Jinzi, demonstrated strategic foresight by pivoting the company's focus to the metabolic disease sector, particularly the weight loss drug market, starting in 2022 [3][5] Group 2: Strategic Shift and Market Response - Following the strategic shift, Gilead's stock price surged from 0.76 HKD in August 2024 to 18.75 HKD by August 2025, representing an increase of over 20 times and restoring its market capitalization to the billion HKD level [4][9] - The market's positive response reflects recognition of Gilead's research team's capabilities and strategic execution [4][9] Group 3: R&D and Competitive Advantage - Gilead has adopted a differentiated approach in drug development, focusing on oral small molecule GLP-1 receptor agonists and ultra-long-acting formulations, rather than following mainstream peptide drug development paths [5][8] - The core pipeline, ASC30, has shown promising clinical results, with a maximum weight reduction of 6.5% in U.S. Phase Ib trials, and is expected to complete Phase IIa trials by the end of the year [5][6] - Gilead is also developing ASC35 and ASC36, which are expected to provide significant advantages in terms of dosing frequency and efficacy compared to existing treatments [6][7] Group 4: Global Competitiveness and Valuation - Despite the stock price recovery, Gilead's current market capitalization is still considered undervalued compared to global peers, as evidenced by recent acquisition bids for similar companies [9][10] - Gilead's diverse pipeline, including multiple formulations with the potential for monthly and quarterly dosing, positions it favorably in the competitive landscape [9][10] Group 5: Lessons and Implications for the Industry - Gilead's successful transformation underscores the importance of strong R&D leadership and strategic vision in navigating industry challenges [11] - The case of Gilead serves as a valuable reference for other Chinese biotech companies seeking to innovate and compete on a global scale [11]

Core Viewpoint - Gilead Sciences-B (01672) saw a stock increase of over 7%, currently trading at 10.11 HKD, following its inclusion in the MSCI Global Small Cap Index, effective after market close on November 24 [1] Group 1: Stock Performance - Gilead Sciences-B's stock rose by 6.98%, with a trading volume of 21.57 million HKD [1] Group 2: MSCI Inclusion - On November 6, MSCI announced the results of its November index review, which included Gilead Sciences-B in the MSCI Global Small Cap Index [1] Group 3: Clinical Research Updates - Gilead Sciences-B presented multiple reports at the 2025 ObesityWeek in Atlanta, Georgia, including a complete analysis of the ASC30 oral tablet Phase Ib study [1] - The ASC30 oral tablet study showed an average weight loss of up to 6.5% after placebo adjustment, demonstrating good safety and tolerability with only mild to moderate gastrointestinal adverse events [1] - The apparent half-lives of the ASC30 injection were 46 days and 75 days, supporting monthly and quarterly dosing regimens [1]

Core Insights - Ascletis Pharma Inc. presented promising data from Phase Ib studies of its obesity treatment candidates, ASC30 and the combination of ASC31 and ASC47, at ObesityWeek 2025, highlighting their efficacy and safety profiles [4][15]. Group 1: ASC30 Oral Tablet - The Phase Ib study of ASC30 oral tablet demonstrated a placebo-adjusted mean body weight reduction of up to 6.5% after 28 days of treatment, with the highest dose (60 mg) showing a maximum reduction of 9.3% [1][8]. - The study reported mild-to-moderate gastrointestinal adverse events (AEs), with no serious adverse events (SAEs) observed across all cohorts [7][8]. - The safety profile of ASC30 was consistent with or better than that of the GLP-1R agonist class, indicating it is safe and well tolerated [8]. Group 2: ASC30 Subcutaneous Injection - The Phase Ib study of ASC30 subcutaneous injection revealed an observed half-life of 46 days for the treatment formulation and 75 days for the maintenance formulation, supporting once-monthly and once-quarterly dosing [2][10]. - Similar to the oral tablet, the subcutaneous formulations were well tolerated, with only mild-to-moderate treatment-emergent adverse events reported [11][9]. - No serious adverse events or significant safety signals were detected, reinforcing the safety of ASC30 formulations [9][10]. Group 3: Combination of ASC31 and ASC47 - The combination of ASC31 and ASC47 significantly outperformed both tirzepatide and ASC31 monotherapy in weight loss, achieving a 44.8% reduction in weight compared to 19.1% for ASC31 alone, representing a 134% greater reduction [12][13]. - The combination also demonstrated superior results in body fat loss and muscle preservation, restoring the body composition of obese mice to that of healthy non-obese mice [13]. - ASC31 is a dual GLP-1R and GIPR peptide agonist, while ASC47 is designed for targeted delivery to adipose tissue, showcasing Ascletis' innovative approach in obesity treatment [12][13].

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。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 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®）以壁報形式進行多項報告，包括ASC30每日一次口服片Ib 期研究的完整分析、ASC30每月一次注射劑Ib期研究以及ASC31與ASC47聯合用 藥臨床前研究。 1 自願性公告 歌禮在2025年肥胖周（ObesityWeek®）報告ASC30口服片 Ib期研究的完整分析、ASC30注射劑Ib期研究 以及ASC31與ASC47聯合用藥臨床前研究 － ASC30口服片Ib期研究的積極數據顯示，安慰劑校準後的平均體重下降高達 6.5%；在所 ...

Core Viewpoint - The article highlights the rapid advancements in the development of GLP-1 receptor agonists (GLP-1RAs) in China, particularly focusing on innovative drugs like Ecnoglutide and their significant clinical trial results, indicating a shift from imitation to independent innovation in the pharmaceutical industry [7][12]. Group 1: Ecnoglutide's Clinical Results - Ecnoglutide demonstrated impressive results in its Phase III clinical trial, with patients losing an average of 13.8 kg after 48 weeks of treatment, compared to only 200g in the placebo group [8]. - The proportion of patients in the Ecnoglutide group who lost at least 5% of their body weight reached 92.8%, significantly higher than the 14% in the placebo group [8]. - Even after a 7-week cessation of the drug, patients only regained about 1% of their weight, indicating sustained weight loss effects [8]. Group 2: Mechanism and Benefits of Ecnoglutide - Ecnoglutide operates similarly to other GLP-1RAs like Semaglutide, regulating appetite, delaying gastric emptying, and optimizing insulin secretion while inhibiting glucagon secretion [9]. - The drug features an innovative molecular structure that enhances the activation of the cAMP signaling pathway, potentially improving glucose, weight, and lipid metabolism [9]. - Clinical data suggest that Ecnoglutide can reduce liver fat content and improve cardiovascular metabolic risks, making it a promising option for managing obesity and type 2 diabetes [9]. Group 3: Other Innovative GLP-1RAs - Bofanglutide, another single-target GLP-1RA, has begun Phase II clinical trials in the U.S., aiming to compare its weight loss effects against placebo and Tirzepatide [10]. - The dual receptor agonist Masitide has shown a 15% average weight reduction in a 36-week clinical trial and aims to address multiple conditions, including cardiovascular risks [10]. - UBT251, a triple receptor agonist, is in early clinical stages and targets obesity, chronic kidney disease, fatty liver, and type 2 diabetes, offering a more convenient bi-weekly injection option [10]. Group 4: Oral GLP-1RA Developments - The oral GLP-1RA ASC30 has shown positive early trial results, with patients losing an average of 6% more weight than those on placebo, and has submitted a Phase II clinical application to the FDA [11]. - The article emphasizes the importance of large-scale clinical trials in China to validate the safety and efficacy of GLP-1RAs in Asian populations, which have historically been underrepresented in such studies [11]. Group 5: Future Outlook for Chinese GLP-1RAs - The development of GLP-1RAs in China is entering a breakthrough phase, with a diverse pipeline that includes single, dual, and triple receptor agonists as well as oral formulations [12]. - The strong competitive edge of Chinese GLP-1RAs in managing various metabolic diseases is expected to enhance their position in the global market, particularly in personalized metabolic management for Asian populations [12].

Core Insights - Ascletis Pharma Inc. is presenting multiple posters on its obesity treatment programs, including ASC30, at ObesityWeek 2025 in Atlanta, Georgia, highlighting advancements in its obesity portfolio [1][2]. Group 1: Product Details - ASC30 is an investigational GLP-1 receptor biased small molecule agonist, designed for both oral and subcutaneous administration, with patent protection until 2044 [3]. - ASC31 is a novel peptide agonist targeting GLP-1R and GIPR, showing favorable pharmacokinetics and efficacy in diet-induced obese mice [4]. - ASC47 is a once-monthly subcutaneous injected small molecule agonist targeting thyroid hormone receptor beta, designed for adipose tissue targeting [5]. Group 2: Event Information - ObesityWeek 2025 will take place from November 4 to 7, 2025, featuring the latest developments in obesity research and treatment [7]. - Presentations at the event include a full analysis of a 28-day study of ASC30 and comparisons of ASC31 and ASC47 against existing treatments [2]. Group 3: Company Overview - Ascletis Pharma Inc. focuses on developing best-in-class therapeutics for metabolic diseases, utilizing proprietary technologies for drug discovery [8].

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]

Core Insights - Ascletis Pharma Inc. has completed enrollment in a U.S. Phase IIa study for its once-monthly subcutaneous (SQ) depot formulation of the small molecule GLP-1 receptor agonist ASC30, targeting obesity treatment [3][4] - The Phase IIa study is a 12-week, randomized, double-blind, placebo-controlled trial involving 65 participants with obesity or overweight, all having at least one weight-related comorbidity [4][3] - Topline data from the study is expected in the first quarter of 2026, marking a significant milestone in the development of ASC30 [2][7] Study Details - The Phase IIa study evaluates the efficacy, safety, and tolerability of ASC30 in participants with a body mass index (BMI) of 30 kg/m or higher, or 27 kg/m but less than 30 kg/m [4] - The study consists of three cohorts with different doses, totaling 65 participants [4] - The ultra-long-acting SQ depot formulation of ASC30 demonstrated a 46-day observed half-life in a Phase Ib study, supporting its once-monthly administration [2][5] Technology and Development - ASC30 is developed using Ascletis' Ultra-Long-Acting Platform (ULAP), which allows for a longer half-life compared to traditional albumin-dependent technologies [6][7] - The proprietary formulation shows a favorable peak-to-trough ratio of approximately 1.5 to 1, indicating its potential as a once-monthly treatment option for obesity [7][6] - ASC30 is a first and only investigational small molecule GLP-1R biased agonist designed for both oral and subcutaneous administration [9][10] Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing therapeutics for metabolic diseases, utilizing advanced technologies such as Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) [10] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [10]

Core Viewpoint - The completion of subject enrollment in the Phase IIa study for ASC30, a novel GLP-1 receptor agonist for obesity treatment, marks a significant milestone in the development of this innovative therapy [1] Company Summary - Songlei Pharmaceutical-B (01672.HK) has announced the completion of subject enrollment for its monthly subcutaneous depot formulation of the small molecule GLP-1 receptor agonist ASC30 in the United States [1] - The study involved 65 participants, all of whom are either obese or overweight individuals with at least one weight-related comorbidity [1] - The CEO of Songlei, Dr. Wu Jinzi, highlighted the importance of this milestone, indicating substantial progress in the development of ASC30 [1] Product Summary - ASC30 is the first and only small molecule GLP-1 receptor agonist that can be administered either orally once daily or via subcutaneous injection once a month to once a quarter [1] - The product is designed for both weight loss treatment and weight maintenance therapy, aimed at long-term weight management [1] - ASC30 features a prolonged apparent half-life of 46 days and a superior peak-to-trough ratio of approximately 1.5, positioning it as a promising monthly treatment option for obesity [1] - Topline data from the Phase IIa study is expected to be available in the first quarter of 2026 [1]