Core Viewpoint - The stock of Gilead Sciences-B (01672) has increased over 30% in the month, with a current price of HKD 18.24 and a trading volume of HKD 17.99 million, following the announcement of its first oral glucagon-like peptide-1 receptor agonist, ASC36, entering clinical development [1] Group 1 - The company announced on February 11 that it has selected ASC36 oral tablets for clinical development, with plans to submit an Investigational New Drug (IND) application to the FDA in the second quarter of 2026 for obesity treatment [1] - ASC36 is expected to have superior oral bioavailability and efficacy compared to a recently FDA-approved GLP-1R agonist, potentially allowing for lower dosing [1] - The weight loss effect per milligram of ASC36 peptide is anticipated to be more effective, which may lead to lower manufacturing costs due to scalability advantages [1] Group 2 - ASC36 is developed using the company's proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) technology [1] - The oral tablet formulation of ASC36 has been optimized using the company's proprietary POTENT technology for effective oral peptide delivery [1]

Core Viewpoint - The stock of Gilead Sciences-B (01672) has increased by over 30% in the month, with a current rise of 6.42% to HKD 18.24, driven by the announcement of its first oral glucagon-like peptide-1 receptor agonist, ASC36, entering clinical development [1] Company Developments - On February 11, Gilead Sciences-B announced that its board has selected ASC36 oral tablets for clinical development [1] - The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC36 in the second quarter of 2026 for the treatment of obesity [1] Product Advantages - ASC36 is expected to have superior oral bioavailability and efficacy compared to a recently FDA-approved GLP-1R agonist, potentially allowing for lower dosing [1] - Each milligram of ASC36 peptide is anticipated to provide better weight loss effects, which may lead to lower manufacturing costs due to scalability advantages [1] Technology and Innovation - ASC36 is developed using Gilead's proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) technology [1] - The oral tablet formulation of ASC36 has been optimized using Gilead's proprietary POTENT technology for effective oral peptide delivery [1]

Core Viewpoint - The company, Gilead Sciences, has announced the selection of its first oral glucagon-like peptide-1 (GLP-1) receptor agonist, ASC36, for clinical development, with plans to submit an Investigational New Drug (IND) application to the FDA by Q2 2026 [1] Group 1: Drug Development and Clinical Trials - ASC36 oral tablets are developed using Gilead's proprietary oral peptide delivery enhancement technology (POTENT) [1] - The absolute oral bioavailability of ASC36 in non-human primates is 8% for the 10 mg dose and 6% for the 25 mg dose, with elimination half-lives of 116 hours and 167 hours respectively, supporting less frequent dosing [1][2] - The drug has shown significant weight loss effects in both non-human primates and diet-induced obesity (DIO) rat models, achieving up to a 13.2% reduction in average body weight relative to baseline after 7 days of treatment [2] Group 2: Comparative Efficacy and Manufacturing Advantages - ASC36 demonstrated approximately 32% and 91% greater weight loss compared to eloralintide and petrelintide, respectively, in head-to-head DIO rat models [2] - The potential for superior oral bioavailability and efficacy may allow for lower dosing compared to recently FDA-approved GLP-1R agonists, which could lead to cost advantages in large-scale production [2] - ASC36 is part of a broader pipeline of insulin candidates, including oral small molecule insulin and monthly subcutaneous insulin peptides, leveraging Gilead's three proprietary technology platforms: AI-assisted structure-based drug discovery (AISBDD), ultra-long-acting drug development platform (ULAP), and POTENT [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 ASC36口服片由歌禮利用其專有的口服多肽遞送增強技術(POTENT)開發而成。 在非人靈長類動物中，10毫克ASC36口服片在每只動物中每日一次給藥，給藥7 天後，穩態下的絕對口服生物利用度(absolute oral bioavailability)[1]為8%，消除半 衰期(elimination half-life)達116小時；25毫克ASC36口服片在每只動物中每日一 1 － 在非人靈長類動物研究中，通過利用歌禮口服多肽遞送增強技術(POTENT)， ASC36口服片在穩態下的絕對口服生物利用度達6%至8%。 － 在非人靈長類動物中，ASC36口服片每日一次給藥7天後，使相對基線的平 均體重下降高達13.2%。ASC36片亦顯著減少了食物攝入。 － 在一項頭對頭飲食誘導肥胖(DIO)大鼠模型中，與eloralintide和petre ...

Core Insights - The company has selected ASC37 oral tablets as its first clinical development candidate for obesity treatment, with plans to submit an IND application to the FDA in Q2 2026 [1] - ASC37 is developed using the company's proprietary Peptide Oral Transport Enhancement Technology (POTENT) and is a multi-target peptide agonist for GLP-1R, GIPR, and GCGR [1] - The CEO emphasized the company's commitment to addressing unmet needs in obesity treatment through its advanced research capabilities and differentiated pipeline [2] Summary by Sections - **Product Development** - ASC37 oral tablets are the first candidate utilizing the POTENT technology [1] - The drug shows approximately 5 times, 4 times, and 4 times stronger agonistic activity on GLP-1R, GIPR, and GCGR compared to retatrutide [1] - **Pharmacokinetics** - In non-human primate studies, ASC37 achieved an average absolute oral bioavailability of 4.2%, outperforming semaglutide, tirzepatide, and retatrutide by 9 times, 30 times, and 60 times respectively [2] - The drug exposure (AUC) of ASC37 was about 57 times that of retatrutide in the same studies [2] - The average apparent half-life of ASC37 was approximately 56 hours, supporting once-daily or less frequent dosing [2] - **Strategic Vision** - The selection of ASC37 reflects the company's strong R&D capabilities and commitment to addressing the unmet needs in obesity treatment [2] - The company aims to establish a highly competitive and diversified pipeline to meet various treatment needs for obesity and other metabolic diseases [2]

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. 1 － 在頭對頭非人靈長類動物研究中，ASC35 的平均表觀半衰期(observed half-life)約為14天，比替爾泊肽長6倍，支持在人體中每月一次皮下給藥。 － 在頭對頭非人靈長類動物研究中，ASC35靜脈注射和皮下注射後的藥物暴露 量比替爾泊肽靜脈注射和皮下注射分別高約80%和70%。 歌禮製藥有限公司 － 體外實驗顯示，ASC35對GLP-1受體(GLP-1R)和GIP受體(GIPR)的激動活性 比替爾泊肽強約4倍。 － 在頭對頭飲食誘導肥胖(DIO)小鼠研究中，ASC35的減重效果較替爾泊肽相對 提升約71%。 － 預計將於2026年第二季度向美國食品藥品監督管理局(FDA)遞交ASC35新藥 臨床試驗申請(IND)。 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮選定同類最佳每月一次皮下注射GLP-1R/GIPR雙靶 ...

Group 1: Financial Performance - The company achieved a revenue of 590 million yuan, representing a year-on-year growth of 4.87% [1] - The net profit attributable to shareholders reached 130 million yuan, with a cash balance of 600 million yuan [1] - The net cash flow from operating activities significantly improved to 84.14 million yuan, an increase of 149 million yuan compared to the same period last year [1] Group 2: R&D Investment and Pipeline - The company has established a robust R&D platform and formed collaborations with well-known domestic and international enterprises to accelerate the replacement of imported drugs [2] - Currently, the company has over 20 innovative drugs in its pipeline, covering various therapeutic areas including autoimmune diseases, pain management, cardiovascular diseases, and oncology [2] - The subsidiary, Nuohe Shengtai, is actively advancing multiple innovative drug projects in clinical research [2] Group 3: Clinical CRO Business Growth - The company has adopted an integrated service model combining preclinical and clinical research, enhancing its technological capabilities and talent pool [4] - Revenue from clinical trials and bioanalysis services reached 280 million yuan, reflecting a year-on-year growth of 29.05% [4] - The company is collaborating with Huawei Cloud to develop an AI-based platform for peptide drug discovery, which is expected to create new growth opportunities [4] Group 4: Clinical Trial Network - The company has established 19 permanent sites nationwide and formed long-term partnerships with over 300 hospitals, creating an extensive clinical trial network [5] - The company has accumulated rich experience in clinical research for innovative and modified new drugs across various therapeutic areas [5] - The comprehensive R&D service model enhances the probability of successful drug development and improves order acquisition capabilities [6]

Core Viewpoint - Sunshine Nuohuo reported a revenue of 590 million yuan for the first half of 2025, marking a year-on-year growth of 4.87%, with significant improvement in net cash flow from operating activities at 84.1375 million yuan, indicating enhanced operational capability and innovation strength [1] Group 1: Financial Performance - The company achieved an operating income of 590 million yuan, reflecting a year-on-year increase of 4.87% [1] - The net cash flow from operating activities was 84.1375 million yuan, showing substantial improvement compared to the same period last year [1] Group 2: R&D and Innovation - R&D expenses reached 76.269 million yuan, up 10.39% year-on-year, focusing on core drivers of innovation [1] - Significant advancements were made in the fields of small nucleic acid drugs and peptide drugs, with key progress in self-developed core product pipelines [1] Group 3: Technological Developments - The company established a drug delivery system development platform for small nucleic acid drugs, addressing industry challenges such as stability, targeting, and bioavailability [1] - In collaboration with Huawei Cloud, the company developed an AI peptide molecular discovery platform, enhancing molecular discovery and optimization capabilities [1] Group 4: Product Pipeline Progress - The subsidiary Nuohuo Shengtai's "STC007 injection" has shown significant progress in Phase II clinical trials for moderate to severe pain post-abdominal surgery, with Phase III trials underway [2] - "STC008 injection" is in Phase I clinical trials, targeting cachexia in advanced solid tumors, with a large market potential and urgent clinical need [2] - The ZM001 injection, developed in collaboration with Yimiao Shenzhou, has received clinical approval and is entering Phase I trials for systemic lupus erythematosus, demonstrating rapid B-cell clearance and excellent safety [2]