Core Viewpoint - The company has selected ASC35, a dual-target GLP-1R/GIPR agonist, as a clinical development candidate, expected to submit an IND application to the FDA by Q2 2026 for obesity treatment [1] Group 1: Drug Development and Characteristics - ASC35 is developed using the company's AI-assisted structure-based drug discovery and ultra-long-acting drug development platforms, showing approximately 4 times stronger agonistic activity on GLP-1R and GIPR compared to Tirzepatide [2] - ASC35 has a longer apparent half-life and higher bioavailability per milligram compared to Tirzepatide, allowing for monthly subcutaneous administration with a volume not exceeding 1 milliliter [2] - In non-human primate studies, ASC35's observed half-life is about 14 days, which is 6 times longer than that of FDA-approved Tirzepatide, indicating a potential human half-life of at least 30 days [3] Group 2: Efficacy and Comparative Studies - In diet-induced obesity mouse studies, ASC35 achieved a weight reduction of 33.6%, compared to 19.6% for Tirzepatide, representing a 71% relative improvement in weight loss [4][5] - ASC35 demonstrates superior in vitro agonistic activity, apparent half-life, subcutaneous bioavailability, and weight loss effects compared to Tirzepatide, suggesting it may become a best-in-class obesity therapy [5] Group 3: Strategic Development Plans - The company plans to develop ASC35 as a monotherapy and in combination with other agents for treating metabolic diseases, including obesity and diabetes [6] - ASC35 is intended to be combined with ASC36, an amylin receptor agonist, and ASC47, a THRβ agonist, for treating obesity and metabolic dysfunction-related fatty liver disease [6][7] - The proprietary ULAP technology allows the company to design various release rates for subcutaneous peptides, enhancing clinical efficacy and patient compliance [7]

Core Viewpoint - The company has selected ASC35, a potential best-in-class monthly subcutaneous injection GLP-1R/GIPR dual agonist peptide, as a clinical development candidate, with plans to submit an IND to the FDA by Q2 2026 for obesity treatment [1]. Group 1: Product Development - ASC35 is developed using the company's AI-assisted structure-based drug discovery (AISBDD) and ultra-long-acting platform (ULAP) technologies, showing approximately 4 times stronger agonistic activity on GLP-1R and GIPR compared to Tirzepatide [2]. - ASC35 has a longer apparent half-life and higher bioavailability per milligram compared to Tirzepatide, enabling monthly subcutaneous administration with a volume not exceeding 1 milliliter, which also supports cost-effective large-scale production [2]. Group 2: Preclinical Data - In non-human primate studies, ASC35's depot formulation has an average observed half-life of about 14 days, which is 6 times longer than that of FDA-approved Tirzepatide [3]. - ASC35 demonstrated approximately 80% and 70% higher drug exposure compared to Tirzepatide via intravenous and subcutaneous administration, respectively, suggesting a potential human half-life of at least 30 days based on preclinical data [3]. - In diet-induced obesity (DIO) mouse studies, ASC35 resulted in a weight reduction of 33.6%, compared to 19.6% for Tirzepatide, indicating a relative improvement of 71% in weight loss efficacy [4][5]. Group 3: Strategic Vision - The development of ASC35 reflects the company's commitment to innovation and complements its small molecule drug pipeline for treating obesity and other metabolic diseases [6]. - ASC35 is being developed as both a monotherapy and in combination with other agents, including ASC36 and ASC47, for treating obesity, diabetes, and metabolic dysfunction-related fatty liver disease [6]. Group 4: Technological Advantages - The company's AISBDD and ULAP technologies allow for the design and optimization of multiple long-acting peptides for monthly subcutaneous injection, enhancing clinical efficacy by precisely controlling the release rates of the peptides [7].

Core Viewpoint - The company has selected ASC35, a potential best-in-class monthly subcutaneous injection GLP-1R/GIPR dual agonist peptide, as a clinical development candidate for obesity treatment, with plans to submit an IND application to the FDA in Q2 2026 [1] Group 1: Product Development - ASC35 is expected to demonstrate best-in-class efficacy and a monthly dosing frequency, which may lead to superior weight loss results and a more patient-friendly titration scheme [1] - The initiation of clinical development for ASC35 highlights the company's commitment to innovation and complements its small molecule drug pipeline targeting obesity and other metabolic diseases [1] Group 2: Strategic Vision - The founder and CEO of the company emphasized the strategic importance of ASC35 in enhancing the company's portfolio and addressing unmet needs in obesity treatment [1]

Core Viewpoint - The company, Gilead Sciences, has selected ASC35 as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection GLP-1R/GIPR dual agonist for treating obesity and related metabolic diseases [1] Group 1 - Gilead plans to submit an Investigational New Drug (IND) application to the FDA in the second quarter of 2026 for ASC35 [1] - ASC35 is being developed as both a monotherapy and in combination therapy for treating cardiovascular metabolic diseases, including obesity, diabetes, and metabolic dysfunction-associated steatotic liver disease (MASH) [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. 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 ...

歌礼制药-B(01672)发布公告，于2025年10月10日，该公司斥资98.24万港元回购10万股股份，每股回购 价格为9.47-10.99港元。 ...

智通财经APP讯，歌礼制药-B(01672)发布公告，于2025年10月10日，该公司斥资98.24万港元回购10万 股股份，每股回购价格为9.47-10.99港元。 ...

格隆汇10月10日丨歌礼制药-B(01672.HK)公告，10月10日耗资98万港元回购10万股。 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 歌禮製藥有限公司 呈交日期： 2025年10月10日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 第 1 頁 共 7 頁 v 1.3.0 | 1). | 購回股份擬註銷但尚未註銷 | | 150,000 | 0.0151 % | HKD | 6.4567 | | --- | --- | --- | --- | --- | --- | --- | | | 變動日期 | 2025年4月3日 | | | | | | 2). | 購回股份擬註銷但尚未註銷 | | 150,000 | 0.0151 % | HKD | 5.0924 | | | 變動日期 | 2025年4月7日 | | | | | | 3). | 購回股份擬註銷但尚未註銷 | | ...

Core Viewpoint - Pharmaceutical stocks have declined again, with significant drops in various companies' stock prices, indicating a challenging market environment for the sector [1] Group 1: Stock Performance - Nocera Health (09969) fell by 11.37%, trading at HKD 14.73 [1] - Saint Noble Pharmaceuticals-B (02257) decreased by 11.05%, trading at HKD 13.36 [1] - Rongchang Biopharmaceutical (09995) dropped by 10.4%, trading at HKD 95.15 [1] - Gilead Sciences-B (01672) declined by 8.57%, trading at HKD 9.6 [1] - Viatris (01873) fell by 8.14%, trading at HKD 2.82 [1] Group 2: Investment Trends - According to CMB International, domestic investors have increased their holdings in pharmaceutical stocks through the Hong Kong Stock Connect since September, while foreign investment has slightly decreased since mid-year [1] - The overall trend of increasing investment in innovative drugs remains unchanged for both domestic and foreign investors [1] Group 3: Future Outlook - The ESMO conference is scheduled for mid to late October, with a recommendation to focus on companies like CanSino Biologics, Kelun-Biotech, Rongchang Biopharmaceutical, and Hengrui Medicine (600276) that are expected to release significant data [1] - The pharmaceutical sector in Hong Kong has shown relatively flat performance in September, but with the increase in industry catalysts (various academic conferences and favorable policies), the market is expected to rebound in October [1] Group 4: Market Analysis - Dongguan Securities reports that the pharmaceutical and biotechnology sector has consistently underperformed compared to the CSI 300 index, with some previously high-performing innovative drug companies experiencing corrections [1] - The medical research outsourcing sector has been strengthening due to improved expectations of U.S. interest rate cuts and better financing data, entering a performance vacuum period [1] - Future investment opportunities are suggested in innovative drugs and sectors with expected business development catalysts [1]