Core Insights - The company reported results from its ASC30 oral small molecule GLP-1 receptor agonist study at the 61st EASD Annual Meeting, indicating promising weight loss outcomes in obese subjects [1][5] Study Results - The Ib phase MAD study was randomized, double-blind, and placebo-controlled, assessing the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ASC30 in obese participants (BMI: 30-40 kg/m²) [1] - In MAD cohort 2, ASC30 showed a 6.5% average weight reduction after 28 days of treatment, while cohort 1 showed a 4.5% reduction, both adjusted for placebo [1] - No signs of weight loss plateau were observed by day 29 [1] Pharmacokinetics - ASC30 at 20 mg and 40 mg demonstrated superior oral PK characteristics at steady state, with a positive correlation between higher drug exposure (AUC) and significant weight loss [2] - Key PK metrics for MAD cohorts are summarized, showing differences in Tmax, Cmax, AUCo-24h, and half-life (T1/2) between the two cohorts [3] Safety and Tolerability - ASC30 exhibited good safety and tolerability, with only mild to moderate gastrointestinal adverse events reported [5] - No vomiting was reported in cohort 1, while cohort 2 experienced vomiting primarily during the 10 mg dose escalation week [5] - No serious adverse events (SAE) were reported, and liver enzymes remained stable throughout the study [5]

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 5% following the announcement of positive results from its ASC30 oral GLP-1R agonist study, indicating significant weight loss and good safety profile [1] Company Summary - Gilead Sciences reported a 5.02% increase in stock price, reaching HKD 10.88, with a trading volume of HKD 92.59 million [1] - The company announced results from a 28-day multiple ascending dose study of ASC30, showing a maximum average weight loss of 6.5% compared to baseline after treatment [1] - ASC30 demonstrated superior efficacy due to higher oral drug exposure, with good safety and tolerability, experiencing only mild to moderate gastrointestinal adverse events [1] Industry Summary - Dongwu Securities highlighted that Gilead Sciences has several catalysts in the second half of the year, with multiple important clinical data releases expected [1] - The firm anticipates that by Q4 2025, Gilead will report top-line data for ASC30 oral Phase II, ASC47 Phase I, and ASC50 Phase I trials, with ASC30 subcutaneous Phase II data expected in Q1 2026 [1] - The company plans to submit 2-3 new IND applications to the FDA within the next 6-9 months, including a dual-target peptide weight loss pipeline [1]

Core Viewpoint - The stock of Gilead Sciences-B (01672) increased by over 5%, currently trading at 10.88 HKD with a transaction volume of 92.59 million HKD, following the announcement of positive results from its ASC30 oral GLP-1R agonist study [1] Group 1: Clinical Trial Results - Gilead announced that at the 61st European Association for the Study of Diabetes (EASD) conference in Vienna, it reported results from its ASC30 oral GLP-1R agonist 28-day multiple dose escalation study [1] - The ASC30 oral tablet showed an average weight loss of up to 6.5% after 28 days of treatment, adjusted for placebo [1] - The efficacy of ASC30 is attributed to its higher oral drug exposure, with good safety and tolerability, experiencing only mild to moderate gastrointestinal adverse events [1] Group 2: Future Catalysts - Dongwu Securities noted that Gilead has several catalysts in the second half of the year, with multiple important clinical data expected to be disclosed [1] - The firm anticipates that by Q4 2025, Gilead will read out phase II topline data for ASC30 oral, phase I data for ASC47, and phase I data for ASC50, with phase II topline data for ASC30 subcutaneous expected in Q1 2026 [1] - The company plans to submit 2-3 new IND applications to the FDA for its pipeline, including a dual-target peptide weight loss program, within the next 6-9 months [1]

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） 自願性公告 歌禮在第61屆歐洲糖尿病研究協會(EASD) 年會上報告其ASC30口服小分子GLP-1R激動劑 28天多劑量遞增研究隊列1和隊列2的結果 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」）宣布，在2025年9月16日在奧地利維也納舉 行的第61屆歐洲糖尿病研究協會(EASD)年會上的簡短口頭討論專場會議A中報告 了其ASC30口服小分子GLP-1受體(GLP-1R)激動劑28天多劑量遞增(MAD)研究 (NCT06680440)隊列1和隊列2的結果。 該Ib期MAD研究是一項在美國開展的隨機、雙盲、安慰劑對照的研究，旨在評估 ASC30每日一次 ...

Core Viewpoint - The article highlights the positive market response to the announcement by Gilead Sciences-B (01672) regarding its long-acting subcutaneous formulation ASC30 for weight management, which shows a promising 75-day apparent half-life in obese subjects, indicating potential for quarterly dosing in the future [1] Company Developments - Gilead Sciences' stock rose over 4%, reaching HKD 11.63 with a trading volume of HKD 37.09 million following the announcement [1] - The ASC30 formulation is developed using Gilead's Ultra Long-Acting Pharmaceutical (ULAP) platform, showcasing the company's innovation in drug development for obesity management [1] Clinical Trials and Future Prospects - Gilead's major shareholder has committed to a voluntary lock-up, agreeing not to sell any shares before the release of three key clinical data points: 1. Topline data from the U.S. Phase I clinical study of ASC47 combined with semaglutide, expected by the end of September 2025 2. Topline data from the U.S. 13-week Phase IIa clinical study of ASC30 oral tablets in overweight or obese subjects, expected by December 2025 3. Topline data from the U.S. Phase I single ascending dose study of ASC50 in healthy subjects, expected by December 2025 [1]

Core Viewpoint - The company, Gilead Sciences-B (01672.HK), will present data on ASC30, an oral small molecule GLP-1 receptor agonist, at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria [1] Summary by Relevant Sections Clinical Data Presentation - The presentation will include findings from a 28-day multiple ascending dose study (NCT06680440) of ASC30, highlighting its superior weight loss effects in obese subjects [1] - The abstract title for the discussion is "ASC30, an oral GLP-1R biased small molecule agonist shows superior weight loss effects in obese subjects: a 28-day multiple ascending dose study" [1] Event Details - The discussion will take place on September 16, 2025, from 12:00 to 13:00 (Central European Summer Time) [1] - The report number for this presentation is 827 [1] Company Perspective - Dr. Wu Jinzi, founder, chairman, and CEO of the company, expressed anticipation for showcasing the clinical data at the EASD meeting, believing that the efficacy and safety data will position ASC30 as a differentiated treatment option for obesity [1]

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） 自願性公告 歌禮將在第61屆歐洲糖尿病研究協會(EASD)年會上報告ASC30 口服小分子GLP-1R激動劑28天多劑量遞增研究結果 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」）宣布，將在奧地利維也納舉行的第61屆歐洲 糖尿病研究協會(EASD)年會上的簡短口頭討論中報告ASC30口服小分子GLP-1受 體(GLP-1R)激動劑28天多劑量遞增研究(NCT06680440)數據。 簡短口頭討論細節 「我們期待在今年的EASD年會上向業界展示ASC30口服片的臨床數據，」歌禮創 始人、董事會主席兼首席執行官吳勁梓博士表示，「我們相信這些療效和安全性數 據 ...

Core Viewpoint - The article discusses the recent approval of IBI3032, a novel oral small molecule GLP-1 receptor agonist developed by Innovent Biologics, aimed at long-term weight management for overweight or obese adults [2][5]. Group 1: Product Development - IBI3032 has received clinical trial implicit approval from the China National Medical Products Administration (NMPA) and is set to undergo Phase 1 clinical trials in both China and the United States, starting in the second half of 2025 [2]. - The drug is designed to activate GLP-1 receptors, which can delay gastric emptying, suppress appetite, and promote insulin secretion, thereby addressing obesity and type 2 diabetes [3][5]. - IBI3032 is developed using structure-based drug design (SBDD) strategies, optimizing its physicochemical properties and pharmacokinetics [3][5]. Group 2: Strategic Positioning - Innovent Biologics is rapidly expanding its metabolic pipeline based on the foundation of the drug Masteglutide, with the initiation of IBI3032's clinical research marking a significant evolution in its metabolic product matrix [5]. - The drug has shown promising characteristics in preclinical animal models, including a longer elimination half-life and higher drug exposure levels at the same dosage, indicating potential for combination therapy with other small molecules in the metabolic field [5].

Core Viewpoint - The approval of IBI3032 for clinical trials by the FDA marks a significant advancement for the company in its metabolic product pipeline, potentially enhancing its market position and growth prospects [1] Company Summary - Company shares of Innovent Biologics (01801) rose by 3.12%, reaching HKD 95.8, with a trading volume of HKD 219 million [1] - The company announced on August 5 that its innovative oral small molecule GLP-1R agonist, IBI3032, received IND approval from the FDA [1] - IBI3032 is developed independently by the company and is designed to preferentially activate the cAMP signaling pathway, based on a globally validated molecular framework with complete independent intellectual property rights [1] - The Phase I clinical trial for IBI3032 will be conducted simultaneously in China and the U.S., starting in the second half of 2025, involving healthy subjects and overweight or obese populations [1] - The initiation of clinical research for IBI3032 is a crucial step in the evolution of the company's metabolic product matrix, leveraging the foundation of the drug Masitide [1] Industry Summary - The approval of IBI3032's IND by both the NMPA in China and the FDA in the U.S. indicates a positive regulatory environment for innovative drug development in the metabolic sector [1] - The company's strategic focus on expanding its metabolic pipeline through IBI3032 aligns with current trends in the pharmaceutical industry towards developing effective treatments for obesity and related metabolic disorders [1]