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」）宣布，已於近期與中國國家藥品監督管理局 就地尼法司他（denifanstat，ASC40）治療中重度尋常性痤瘡完成新藥上市申請前 (Pre-NDA)溝通，並計劃於近日遞交新藥上市申請。該新藥上市申請前(Pre-NDA) 溝通自2025年6月開始，並於2025年10月結束。 歌禮已完成地尼法司他(ASC40)治療中重度尋常性痤瘡的II期(NCT05104125)和III 期研究(NCT06192264)。 在該III期研究中，地尼法司他(ASC40)達到所有主要、關鍵次要及次要療效終點 （意向治療集(ITT)分 ...

（文章来源：每日经济新闻） 每经AI快讯，10月14日，港股医药股连日来持续低迷，午后跌幅继续扩大。截至发稿，维亚生物 (01873.HK)跌7.53%，报2.58港元；歌礼制药-B(01672.HK)跌7.09%，报9.17港元；康诺亚-B(02162.HK) 跌5.74%，报64港元。 ...

Group 1 - Pharmaceutical stocks have been experiencing a continuous decline, with notable drops in companies such as Viatris (01873) down 7.53% to HKD 2.58, and Singlomics (01672) down 7.09% to HKD 9.17 [1] - Huaxin Securities indicates that the trend of going global will continue into Q3 2025, but there are fewer significant business developments (BD) from listed companies, and NewCo-style BDs have not met market expectations [1] - The escalation of Sino-US trade conflicts may raise concerns about future decoupling risks, but the shift of global innovative R&D towards more efficient Chinese solutions is an unstoppable trend [1] Group 2 - Cinda Securities believes that Chinese innovative pharmaceutical companies are gaining global competitiveness in various niche markets, and while there may be short-term policy impacts, the long-term industry trend remains unchanged [2] - The innovative drug sector is expected to be a key focus in the next 2-3 years, despite potential short-term pullbacks [2] - The CXO sector is currently in a recovery phase, with continuous growth in performance expected to restore market confidence, and the recent iterations of the Biodefense Act have had minimal impact on leading companies [2]

Group 1 - The pharmaceutical stocks have been experiencing a continuous decline, with notable drops in companies such as Viatris (down 7.53% to HKD 2.58), Genscript Biotech (down 7.09% to HKD 9.17), and CanSino Biologics (down 5.74% to HKD 64) [1] - Huaxin Securities indicates that the trend of going global will continue into Q3 2025, but there are fewer significant business developments (BD) from listed companies, and the NewCo format of BD has not met market expectations [1] - The escalation of Sino-US trade conflicts may raise concerns about future decoupling risks, but the shift of global innovative research and development towards more efficient Chinese solutions is an unstoppable trend [1] Group 2 - Cinda Securities believes that Chinese innovative pharmaceutical companies are gaining a foothold on the global stage, possessing global competitiveness in various niche areas, despite potential short-term policy impacts [2] - The innovative drug sector is expected to remain a key focus for the next 2-3 years, with the CXO industry playing a crucial role in the global innovative drug supply chain [2] - The revised version of the Biodefense Act has undergone multiple iterations, with minimal impact on leading companies, and the CXO sector is currently experiencing a recovery phase, with continuous growth in performance likely to restore market confidence [2]

Group 1 - Company Gilead Sciences-B (01672.HK) announced a share buyback on October 13, spending HKD 968,000 to repurchase 100,000 shares [1]

Core Viewpoint - Company Gilead Sciences-B (01672) announced a share buyback plan, spending approximately HKD 968,300 to repurchase 100,000 shares on October 13, 2025 [1] Summary by Category Company Actions - The company is engaging in a share repurchase, indicating a strategy to return value to shareholders [1] Financial Details - The total expenditure for the buyback is approximately HKD 968,300 [1] - The number of shares being repurchased is 100,000 [1]

歌礼制药-B(01672)公布，2025年10月13日耗资约96.83万港元回购10万股股份。 ...

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13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 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01672 | 說明 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | 事件 | | 已發行股份（不包括庫存股份）變動 佔有關事件前的現有已發 | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 | | | | 已發行股份（不包 ...

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].