香港恒生指数收涨0.24%，恒生科技指数跌0.37%。新能源汽车股下跌，蔚来跌超6%，小鹏汽车跌超 5%；医药股走弱，派格生物医药跌超10%，歌礼制药跌超6%；中兴通讯跌超5%，美团跌超3%，华虹 半导体跌近3%。珠峰黄金涨超7%，万科企业尾盘拉升涨超3%。 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致：香港交易及結算所有限公司 公司名稱: 歌禮製藥有限公司 呈交日期: 2025年12月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01672 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 7,000,000,000 | USD | | 0.0001 | USD | | 700,000 | | 增加 / 減少 (-) | | | | 0 | | | USD | | 0 | | 本月底結存 | | | 7,000,000,000 | USD | | 0.0001 | USD | | 700,000 | 本月底法定/註冊股本總額： USD 700,000 FF ...

Core Insights - The article highlights the clinical development of ASC37, a novel oral GLP-1R/GIPR/GCGR triagonist peptide by Gilead Sciences, showcasing its significant pharmacokinetic advantages over existing treatments [5][7]. Group 1: Drug Development - ASC37 has entered clinical development as of November 30, with a notable oral bioavailability of 4.2%, which is approximately 9 times, 30 times, and 60 times higher than semaglutide, tirzepatide, and retatrutide, respectively [5]. - The drug's development leverages Gilead's two core technology platforms: AI-assisted drug discovery and enhanced oral peptide delivery technology [5]. - In non-human primate studies, ASC37 demonstrated an average apparent half-life of about 56 hours, supporting once-daily or even less frequent dosing [7]. Group 2: Efficacy and Exposure - ASC37 exhibited a drug exposure level (measured by area under the curve) approximately 57 times greater than that of retatrutide, indicating a higher amount of active substance entering systemic circulation for enhanced efficacy [7]. - The drug's activity levels in activating GLP-1R, GIPR, and GCGR receptors were approximately 5 times, 4 times, and 4 times higher than retatrutide, respectively [5]. Group 3: Regulatory Plans - Gilead plans to submit a new drug clinical trial application for ASC37 to the FDA for obesity treatment in the second quarter of 2026 [7].

Investment Rating - The report maintains a "Buy" rating for several key companies in the pharmaceutical and medical device sectors, including Tianjin Pharmaceutical (天士力), Innovent Biologics (信达生物), and Mindray Medical (迈瑞医疗) [4][5]. Core Insights - The report emphasizes the potential for domestic substitution in the blood purification device sector, highlighting that over 70% of the high-value medical consumables market is currently dominated by imported products. The report suggests that advancements in domestic technology for dialysis machines and filters could enhance local competitiveness [2][21][25]. - The report identifies a long-term growth logic for the blood purification industry, driven by an increasing patient base, improved payment capabilities, technological advancements, and strong government support [25][28]. - The investment strategy focuses on the clinical value of pharmaceuticals, recommending investments in innovative drug chains and high-end medical devices [3][32]. Summary by Sections Market Review - The A-share pharmaceutical index rose by 2.67%, outperforming the CSI 300 index by 1.03 percentage points, while underperforming the ChiNext index by 2.00 percentage points [1][16]. - The Hong Kong Hang Seng Medical Health Index increased by 3.85%, surpassing the Hang Seng Index by 1.49 percentage points [1][16]. R&D Progress - Recent IND applications include ATG-022 by Deqi Pharmaceutical, CH006 by Gilead Sciences, and FXS887 by Fosun Pharma, indicating ongoing innovation in the sector [37]. Key Company Profit Forecasts and Valuation - The report provides detailed earnings per share (EPS) and price-to-earnings (PE) ratios for various companies, with several receiving a "Buy" rating based on their projected performance [4]. Focus on Blood Purification Devices - Blood purification is a primary treatment for acute and chronic renal failure, with dialysis being the most common method. The report notes that the domestic market for dialysis machines and filters is still largely foreign-dominated, but there is significant room for domestic products to gain market share [2][21][25]. Investment Strategy - The report outlines a three-stage investment strategy based on clinical value, focusing on breakthrough technologies, clinical validation, and operational efficiency in the pharmaceutical and medical device sectors [32][34]. Recommended Companies - The report suggests monitoring leading companies in the blood purification device sector, including Shanwaishan, Weigao Blood Purification, Baolai Te, Jianfan Biological, Sanxin Medical, and Tianyi Medical [2][31].

证 券 研 究 报 告 行业周报 关注吸入制剂在呼吸疾病领域的突破 医药行业周报 投资评级： 报告日期： 推荐 （ 维持 ） 2025年11月30日 分析师：胡博新 SAC编号：S1050522120002 分析师：吴景欢 SAC编号：S1050523070004 医 药 行 业 观 点 在呼吸疾病领域，如IPF、COPD等，吸入制剂+新靶点组合正取得更多积极的治疗效果。2025年6月10日，Insmed公布其 治疗PAH(肺动脉高压）新药TPIP（曲前列环素棕榈醇吸入粉剂）的临床2b期顶线数据，安慰剂校正的PVR较基线降低35%， LS均值比0.65（p＜0.001）。其冻干粉制剂的设计，不仅实现了用药的方便性，只需每日一次，而且治疗效果也优于曲前 列环素的口服品种。7月9日，默沙东宣布收购一家专注于呼吸系统疾病的生物制药公司Verona Pharma，总交易价值约为 100亿美元。通过此次收购，默沙东将获得一款用于治疗慢性阻塞性肺病（COPD）的重磅新药Ohtuvayre（恩司芬群）， 这是一种针对磷酸二酯酶3和4（PDE3和PDE4）的首创选择性双重抑制剂。FDA于2024年6月批准Ohtuvayre用 ...

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]

Core Insights - The company has selected ASC37 oral tablets as its first clinical development candidate for obesity treatment, expected to submit an IND to the FDA in Q2 2026 [1] - ASC37 is developed using the 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 diverse pipeline [2] Summary by Sections Drug Development - ASC37 oral tablets are the first candidate utilizing the company's POTENT technology for oral peptide delivery [1] - The drug was discovered and optimized using Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) technology [1] Efficacy and Bioavailability - In vitro studies show that ASC37 has approximately 5 times, 4 times, and 4 times stronger agonistic activity on GLP-1R, GIPR, and GCGR compared to retatrutide [1] - 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 greater than that of retatrutide in the same studies [2] - The average apparent half-life of ASC37 in non-human primates was approximately 56 hours, supporting once-daily or less frequent dosing [2] Strategic Vision - The selection of ASC37 for clinical development reflects the company's strong R&D capabilities and commitment to addressing obesity treatment needs [2] - The company aims to build a highly competitive and differentiated pipeline to meet various treatment demands 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. 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 歌禮選定其首款口服GLP-1R/GIPR/GCGR三靶點激動劑 多肽ASC37進行臨床開發 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」）宣布已選定其首款口服GLP-1R/GIPR/GCGR[1] 三靶點激動劑多肽ASC37口服片作為臨床開發候選藥物。歌禮預計將於2026年第 二季度向美國食品藥品監督管理局(FDA)遞交ASC37口服片治療肥胖症的新藥臨 床試驗申請(IND)。 1 － 在非人靈長類動物的頭對頭研究中，通過利用歌禮口服多肽遞送增強技術 (POTENT)，ASC37口服片的平均絕對口服生物利用度達4.2%，分別約為採 用口服SN ...

Group 1: Core Insights - The current wave of innovative drugs is driven by China's participation in new technologies, with advancements in ADC, bispecific antibodies, second-generation IO, and GLP-1 [1] - The global pharmaceutical transaction volume has steadily increased, with total transaction amounts rising from $56.9 billion to $187.4 billion over the past decade, while China's transaction amounts surged from $3.1 billion to $57.1 billion [1] - By 2024, China's transaction volume is expected to account for approximately 30% of global pharmaceutical transactions [1] Group 2: Sector Analysis - In oncology, the combination of IO and ADC therapies remains strong, with significant transactions in the PD-1 bispecific antibody space; the sales of Pembrolizumab are projected to reach $29.482 billion in 2024 [2] - The autoimmune disease sector is witnessing a shift as older drugs face patent expirations, with new opportunities emerging in Th2 and Th17 pathways; Dupilumab is expected to lead with $14.1 billion in sales in 2024 [2] - The cardiovascular and metabolic disease market continues to grow, with GLP-1 receptor agonists projected to exceed $50 billion in global sales in 2024 [3] Group 3: Future Technologies - New technologies such as next-generation ADCs, TCE therapies, universal/in vivo CART technologies, gene therapy, and small nucleic acid technologies are anticipated to lead future disease treatments [4]

Group 1 - The core point of the article highlights the significant acquisition by Pfizer of Metsera for approximately $9.2 billion, which includes key assets MET-097i and MET-233i [1] - The article mentions that Eli Lilly and Novo Nordisk are also actively developing long-acting platforms, with strategic collaborations established with Camurus and Ascendis by 2025 to utilize their FluidCrystal and TransCon subcutaneous depot technologies for developing long-acting weight loss and glucose-lowering products [1] - Open Source Securities reports that as more clinical data is disclosed, the value of long-acting pipelines and technology platforms will become increasingly evident, predicting that new long-acting therapies will represent the most differentiated competitive direction in the weight loss and glucose-lowering market [1] Group 2 - The article notes that various technologies such as antibody-drug conjugates, fatty acid end-group modifications, and subcutaneous depot controlled-release can achieve long-acting administration, with Singularity Pharmaceuticals having developed multiple long-acting weight loss drug pipelines using its subcutaneous depot ULAP technology platform [1]