Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 4% in the afternoon, currently up 3.85% at HKD 13.76, with a trading volume of HKD 12.1855 million. The company announced the completion of the first patient dosing in a Phase II clinical trial in the U.S. for its oral GLP-1 receptor agonist ASC30, aimed at treating type 2 diabetes, with plans to recruit approximately 100 patients across multiple centers in the U.S. The primary data from this 13-week study is expected to be released in Q3 2026 [1]. Group 1 - Gilead Sciences has initiated a Phase II clinical trial for ASC30, targeting type 2 diabetes treatment [1]. - The trial will involve around 100 patients and is set to take place in multiple centers across the U.S. [1]. - The company plans to announce the primary data from the trial in Q3 2026 [1]. Group 2 - The CEO of Gilead Sciences, Dr. Wu Jinzi, emphasized the strategic expansion into the diabetes treatment market with ASC30 [1]. - The company aims to showcase ASC30 as a potential best-in-class oral treatment option, administered once daily [1]. - The upcoming trial results are anticipated to provide significant insights into the efficacy of ASC30 for diabetes patients [1].

Core Viewpoint - The announcement of the completion of the first patient dosing in the Phase II clinical trial of ASC30 for type 2 diabetes treatment has positively impacted the stock price of the company, leading to a rise of over 4% [1] Company Developments - The company, Songlei Pharmaceutical, has initiated a Phase II clinical trial in the United States for its oral small molecule GLP-1 receptor agonist ASC30, targeting approximately 100 type 2 diabetes patients across multiple centers [1] - The primary data from this 13-week Phase II study is expected to be released in the third quarter of 2026 [1] - The founder and CEO, Dr. Wu Jinzi, emphasized the strategic importance of expanding ASC30's clinical development into the large diabetes treatment market, highlighting its potential as a best-in-class oral treatment option [1]

Summary of Key Points from Conference Call Records Industry Overview - The pharmaceutical industry is experiencing mixed performance in the A-share market, with the Shanghai Composite Index closing at 4132.61 points, down 0.09%, and the Shenzhen Component Index at 14316.64 points, down 0.85% [1][1] - The Shenwan Pharmaceutical Industry Index closed at 8648.35 points, up 0.29%, while the Hang Seng Healthcare Index in Hong Kong closed at 4032.36 points, down 1.58% [1][1] Company-Specific Insights Performance Forecasts - **Guangji Pharmaceutical**: Expected net loss for 2025 is between 518 million to 399 million yuan, a significant increase from the previous year's loss of 295 million yuan [2][2] - **Yixin Pharmacy**: Projected net profit for 2025 is between 260 million to 330 million yuan, a substantial increase of 127.79% to 189.12% year-on-year [2][3] - **International Medicine**: Anticipated revenue drop to 4.06 billion to 4.08 billion yuan, a 15.7% decline, with net loss expected to widen to between 315 million to 295 million yuan [3][3] - **Weichip Bio**: Expected revenue of 910 million yuan, a 38.32% increase, with net profit turning positive at 53.46 million yuan, a significant improvement from a loss of 115 million yuan [3][3] - **Tonghua Dongbao**: Forecasted net profit of 1.242 billion yuan, recovering from a loss of 42.72 million yuan in the previous year [4][4] - **Meinuo Pharma**: Expected net profit between 100 million to 123 million yuan, a growth of 49.69% to 84.11% year-on-year [4][4] - **Sangfor Biopharma**: Projected revenue of 4.2 billion yuan, a significant increase of 251.76%, with net profit expected to reach 2.9 billion yuan, a 311.35% increase [4][5] - **Huahai Pharmaceutical**: Expected net profit to decline by 70% to 80%, with projections between 224 million to 335 million yuan [5][5] - **Dabo Medical**: Anticipated net profit between 580 million to 610 million yuan, a growth of 62.55% to 70.96% [5][5] Regulatory Approvals - **Hengrui Medicine**: Received clinical trial approval for SHR-1049 injection [2][2] - **Qianjin Pharmaceutical**: Obtained drug registration for aluminum magnesium carbonate chewable tablets [2][2] - **Wantai Bio**: Two-valent HPV vaccine passed WHO PQ periodic review [2][2] Market Trends - The A-share market shows volatility with significant fluctuations in stock performance, particularly in the pharmaceutical sector, indicating potential investment opportunities and risks [1][1] - The performance of individual companies varies widely, with some showing strong growth while others face significant losses, highlighting the need for careful analysis when considering investments in this sector [2][3][4][5]

在肥胖或超重受试者中开展的13周研究显示，ASC30的经安慰剂校正后的体重下降高达7.7%，且胃肠 道耐受性更佳，未观察到肝脏安全性信号。该研究共入组125例肥胖受试者或伴有至少一种体重相关合 并症的超重受试者。 在第13周的主要终点上，ASC30片的每日一次20毫克、40毫克和60毫克分别实现了5.4%、7.0%和7.7% 的体重下降，且体重下降具有统计学显著性和临床意义。因不良事件导致的总停药率为4.8%。 1月26日，歌礼制药发布公告称，公司完成了口服小分子GLP-1R激动剂ASC30治疗糖尿病的美国II期研 究首批受试者给药。预计将于2026年第三季度获得该项研究的顶线数据。 ...

Group 1 - The company announced that its oral small molecule GLP-1 receptor agonist ASC30 for the treatment of type 2 diabetes has completed the first dosing of participants in a 13-week Phase II study in the U.S., with top-line data expected in Q3 2026 [1] - The company recently completed a 13-week Phase II study evaluating ASC30 for obesity treatment, enrolling 125 obese or overweight participants with at least one weight-related comorbidity across multiple centers in the U.S. [2] - At the primary endpoint of the 13-week study, ASC30 doses of 20 mg, 40 mg, and 60 mg achieved statistically significant and clinically meaningful weight reductions of 5.4%, 7.0%, and 7.7% respectively, with a dose-dependent effect observed [2] Group 2 - The overall discontinuation rate due to adverse events in the Phase II study for ASC30 was 4.8%, indicating a favorable safety profile [2] - ASC30 is the first and only small molecule GLP-1 receptor agonist in clinical research that can be administered both orally once daily and via subcutaneous injection once monthly to quarterly, targeting obesity, diabetes, and other metabolic diseases [2] - The company's strategy to expand ASC30's clinical development into the large diabetes treatment market is seen as a logical next step, providing an opportunity to showcase ASC30 as a best-in-class oral therapy option for patients [3]

Core Viewpoint - The company has initiated clinical trials for its oral small molecule GLP-1 receptor agonist ASC30, targeting type 2 diabetes and obesity, with significant data expected by Q3 2026 [1][3]. Group 1: Clinical Trials and Results - The company announced the completion of the first dosing of ASC30 in a 13-week Phase II study for type 2 diabetes in the U.S., with top-line data anticipated in Q3 2026 [1]. - A recent 13-week Phase II study for ASC30 in treating obesity involved 125 participants, showing statistically significant and clinically meaningful weight loss of 5.4%, 7.0%, and 7.7% for daily doses of 20 mg, 40 mg, and 60 mg respectively [2]. - The overall discontinuation rate due to adverse events in the obesity study was reported at 4.8%, indicating a favorable safety profile [2]. Group 2: Strategic Implications - The expansion of ASC30's clinical development into the diabetes treatment market is viewed as a logical strategic move, providing an opportunity to establish ASC30 as a best-in-class oral therapy option for patients [3].

Group 1 - The core focus of the news is the progress of Ascletis Pharma's oral small molecule GLP-1 receptor agonist ASC30, which is undergoing clinical trials for the treatment of type 2 diabetes and obesity [1][2][3] - The Phase II study for ASC30 in treating type 2 diabetes has commenced dosing the first batch of participants, with top-line data expected in Q3 2026 [1] - A recent Phase II study for ASC30 in treating obesity involved 125 participants and demonstrated statistically significant weight loss of 5.4%, 7.0%, and 7.7% for doses of 20mg, 40mg, and 60mg respectively, with a dose-dependent effect [2] Group 2 - ASC30 is the first and only small molecule GLP-1 receptor agonist in clinical research that can be administered both orally once daily and via subcutaneous injection monthly to quarterly [2] - The overall discontinuation rate due to adverse events in the obesity study was 4.8%, indicating a favorable safety profile [2] - The CEO of Ascletis Pharma highlighted the strategic expansion of ASC30's clinical development into the large diabetes treatment market, emphasizing the potential for ASC30 to offer a best-in-class oral therapy option [3]

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） 歌禮已於近期完成一項評估ASC30治療肥胖症的13周II期研究(NCT07002905)。 該研究在美國多個中心開展，共入組125例肥胖受試者或伴有至少一種體重相關 合併症的超重受試者。在第13周的主要終點上，每日一次20毫克、40毫克和60毫 克ASC30片分別實現了5.4%、7.0%和7.7%的經安慰劑校正後平均體重下降，體 重下降具有統計學顯著性、臨床意義且呈劑量依賴性。未觀察到減重平台期。每 周滴定直至目標劑量的ASC30的嘔吐發生率約為已公布的每周滴定的orforglipron 中觀察到的嘔吐發生率的一半。每周滴定的ASC30的胃腸道耐受性與已公布的 orforglipron在III期ATTAIN-1研究中每四周滴定(titrated every four weeks)的結果 相當。在ASC30用於治 ...

Core Viewpoint - The article discusses significant developments in the GLP-1 receptor agonist market, highlighting recent financing events and advancements in drug development aimed at obesity and type 2 diabetes treatment [4][6]. Group 1: Company Developments - On January 20, 2026, Gilead Sciences announced the selection of a new generation of monthly subcutaneous GLP-1R/GIPR/GCGR triple receptor agonists [4]. - On January 22, 2026, Jixing Pharmaceuticals completed a $287 million Series D financing round, focusing on the clinical development of its oral small molecule GLP-1 receptor agonist CX11 for obesity, overweight, and type 2 diabetes [4]. - The funds raised will support ongoing Phase II clinical trials for obesity and type 2 diabetes in the U.S. and prepare for subsequent Phase III trials [4]. Group 2: Product Insights - CX11 is an oral small molecule GLP-1 receptor agonist designed to provide a more convenient alternative to current injectable GLP-1 therapies [6]. - In December 2024, Jixing Pharmaceuticals acquired global rights (excluding China) to the CX11 project from Wenta Pharmaceutical, integrating it into their core pipeline [6]. - The CEO of Jixing Pharmaceuticals stated that this financing marks a significant milestone for the company, accelerating innovation in cardiovascular metabolic disease drug development and indicating a new phase of global growth [6]. Group 3: Investment Landscape - The financing round attracted notable international biopharmaceutical investors, including RTW Investments and Hengdian Capital, along with new investors such as SR One, TCGX, RA Capital Management, and others [6]. - This reflects a sustained interest from top-tier investors in the oral GLP-1 space, indicating confidence in the potential of these therapies [6].

Core Viewpoint - The article highlights the significant advancement of Goli Pharma in the development of ASC37, a next-generation GLP-1R/GIPR/GCGR tri-agonist peptide, which is set to enter clinical trials for obesity treatment in 2026, marking a key milestone in multi-target metabolic drug development [4][6]. Group 1: Drug Development and Characteristics - ASC37 has been developed using Goli's AI-assisted drug discovery platform and ultra-long-acting drug development platform, showing enhanced agonistic activity at GLP-1R, GIPR, and GCGR receptors, approximately 5 times, 4 times, and 4 times stronger than the leading candidate retatrutide, respectively [6]. - The drug's design allows for a significant extension of its apparent half-life, supporting monthly subcutaneous administration with a single injection volume of less than 1 mL, which is expected to improve patient compliance and reduce manufacturing costs [6][7]. - In non-human primate studies, ASC37 demonstrated an average apparent half-life of about 17 days, which is 7 times longer than that of retatrutide, indicating superior in vivo exposure maintenance capabilities [7]. Group 2: Therapeutic Applications and Combination Strategies - ASC37 is being developed for single-agent and combination therapies targeting obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH), addressing high-burden chronic diseases [7]. - Goli plans to explore the synergistic effects of ASC37 in combination with another monthly subcutaneous amylin receptor agonist peptide, ASC36, aligning with the global trend of integrating multiple pathways in metabolic drug development [7]. Group 3: Technological Platforms and Industry Position - The AISBDD and ULAP platforms are foundational to Goli's continuous output of peptide pipelines, allowing for the design of various release rates for subcutaneous depot peptides, achieving a better balance between efficacy, safety, and patient experience [8]. - The advancement of ASC37 reflects the shift of Chinese innovative pharmaceutical companies from imitation to competitive participation in global markets, particularly in drug frequency, pharmacokinetics, and system engineering [8].