东吴证券指出，公司下半年催化剂较多，多个重要临床数据即将披露：根据临床试验进度和公司公告， 预计2025年Q4将读出ASC30口服II期、ASC47的I期及ASC50的I期顶线数据，2026年Q1将读出ASC30皮 下注射II期顶线数据。同时公司预计未来6-9个月将向FDA申报2-3个新管线的IND，包含双靶点多肽减 重管线。 智通财经APP获悉，歌礼制药-B(01672)早盘涨超5%，截至发稿，涨5.02%，报14.86港元，成交额 2036.04万港元。 消息面上，歌礼制药宣布，小分子GLP-1受体(GLP-1R)激动剂ASC30用于减重维持的超长效皮下储库型 (depot)制剂在美国Ib期临床研究的肥胖受试者中显示出75天的表观半衰期，该数据支持ASC30作为长期 体重管理的维持疗法，每季度给药一次。ASC30减重维持制剂利用歌礼超长效药物开发平台开发而成。 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The clinical data indicates an ultra-long half-life for ASC30, which is expected to be launched as a quarterly formulation [7] - ASC30 has shown a 75-day apparent half-life in obese subjects, suggesting the potential for a long-term weight management solution with quarterly dosing [7] - The safety data for ASC30 is excellent, with no serious adverse events reported, supporting the possibility of higher dosing [7] - The Ultra-Long-Acting Platform (ULAP) will facilitate the development of various subcutaneous injection formulations [7] - The company has multiple catalysts in the second half of the year, with important clinical data expected to be disclosed [7] - Revenue forecasts for 2025 are set at 0.02 billion, 0.64 billion, and 2.03 billion for 2025, 2026, and 2027 respectively, with a maintained "Buy" rating [7] Financial Summary - Total revenue for 2023 is projected at 56.69 million, with a significant increase expected in 2026 at 64.43 million and 203.23 million in 2027 [1][8] - The net profit attributable to the parent company is forecasted to be negative, with figures of (144.72) million in 2023 and (358.40) million in 2027 [1][8] - The earnings per share (EPS) is expected to improve from (0.15) in 2023 to (0.37) in 2027 [1][8] - The price-to-earnings (P/E) ratio is projected to decrease from (54.06) in 2023 to (21.83) in 2027 [1][8]

Core Insights - The announcement highlights the development of ASC30, a long-acting subcutaneous formulation of a small molecule GLP-1 receptor agonist, designed for weight maintenance therapy with a 75-day observed half-life, supporting quarterly dosing [1][2] Group 1: Clinical Research Findings - ASC30 demonstrated a median time to reach peak concentration (Cmax) of 17 days after a single 100 mg subcutaneous injection in obese subjects [1] - The drug showed a favorable gastrointestinal (GI) tolerance profile, with adverse events such as vomiting and nausea at 0.0%, and diarrhea and constipation at 12.5% in the ASC30 group, compared to higher rates in the placebo group [2] - No serious adverse events (SAE) or grade 3 and above adverse events (AE) were reported during the study, indicating a good safety profile [3] Group 2: Market Potential and Therapeutic Impact - ASC30 addresses a significant unmet medical need in long-term weight management, with the potential to improve patient adherence and quality of life through quarterly dosing [2] - The drug is positioned as a breakthrough in the field of weight maintenance therapy, being the fastest clinical advancement among quarterly dosing incretin medications [2] - ASC30 is the first and only small molecule GLP-1R agonist that can be administered orally daily or via subcutaneous injection monthly to quarterly, suitable for both weight loss and maintenance therapy [4]

Core Viewpoint - The announcement highlights the promising results of the small molecule GLP-1R agonist ASC30, which is being developed for weight maintenance therapy, showing a long apparent half-life of 75 days in obese subjects during a Phase Ib clinical trial [1] Group 1: Clinical Trial Results - ASC30 demonstrated an apparent half-life of 75 days in obese subjects, indicating its potential for long-term weight management [1] - After a single subcutaneous injection of 100 mg ASC30, the time to reach peak blood concentration (Cmax) was 17 days post-administration [1] - The blood concentration of ASC30 decreased to 50% of Cmax approximately 75 days after administration, supporting its quarterly dosing regimen [1] Group 2: Drug Development Potential - ASC30 is noted as the fastest progressing quarterly administered incretin drug in clinical development, suggesting a competitive edge in the market for weight management therapies [1] - The good tolerability of ASC30 supports its potential as a long-term maintenance therapy for weight management [1]

在Ib期研究中，未报告任何严重不良事件(SAE)，亦未观察到3级或以上不良事件(AE)。经100毫克 ASC30治疗的肥胖受试者中，GI相关AE较少且仅为1级。未出现肝酶(包括丙氨酸氨基转移酶(ALT)、天 冬氨酸氨基转移酶(AST)及总胆红素 (TBL))升高。实验室检查、生命体征、ECGs(心电图，包括按心率 校正的QT间期(QTc))和体格检查均未有异常。 ASC30超长效皮下注射储库型制剂展现出与剂量呈比例的药代动力学特征，可同时支持减重治疗和维持 疗法。同为利用歌礼ULAP开发的ASC30用于减重治疗的超长效皮下储库型制剂，作为每月一次减重治 疗疗法，目前正在美国开展IIa期研究 (NCT06679959)，受试者为肥胖人群(BMI ≥ 30 kg/m²)或伴有至少 一种体重相关合并症的超重人群(27 kg/m2 ≤ BMI < 30 kg/m2 )。预计于2026年第一季度获得 ASC30减重 治疗制剂IIa期研究的顶线数据。ASC30减重治疗制剂在肥胖受试者中表现出46天的表观半衰期，支持 每月给药一次治疗肥胖症。 基于小分子、多肽和蛋白质╱抗体的特性，歌礼可通过其专有的ULAP技术设计皮下储库 ...

ASC30是一款正在临床研究中的小分子GLP-1R偏向激动剂，具有独特和差异化性质，使得同一小分子 同时适用于口服片剂和皮下注射给药成为可能。ASC30是一种新化学实体(NCE)，拥有美国和全球化合 物专利保护，专利保护期至2044年(不含专利延期)。 8名肥胖受试者单次皮下注射ASC30减重维持制剂(100毫克)后，达到ASC30血药峰浓度(Cmax )的时间为 给药后17天(中位数)。给药约75天后，ASC30血药浓度降至Cmax值的百分五十(50%)，即表观半衰期为 75天。 格隆汇9月9日丨歌礼制药-B(01672.HK)公告，小分子GLP-1受体(GLP-1R)激动剂ASC30用于减重维持的 超长效皮下储库型(depot)制剂在美国Ib期临床研究(NCT06679959)的肥胖受试者(体重指数 (BMI)≥30kg/m)中显示出75天的表观半衰期(observedhalf-life)，该数据支持ASC30作为长期体重管理的维 持疗法，每季度给药一次。ASC30减重维持制剂利用歌礼超长效药物开发平台(Ultra-Long- ActingPlatform，ULAP)开发而成。 "减重维持疗法是长期体重管 ...

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。 8名肥胖受試者單次皮下注射ASC30減重維持製劑（100毫克）後，達到ASC30血藥 峰濃度(Cmax)的時間為給藥後17天（中位數）。給藥約75天後，ASC30血藥濃度降 至Cmax值的百分之五十(50%)，即表觀半衰期為75天。 「減重維持療法是長期體重管理中一個重大未滿足的醫療需求，」歌禮創始人、董 事會主席兼首席執行官吳勁梓博士表示，「例如，患者在使用每周一次腸促胰素 （incretin）藥物治療一段時間實現減重目標後，更傾向於轉換為每季度給藥一次 的療法以維持體重。基於包括超長半衰期在內的優越的藥代動力學參數以及良好 的安全性，我們相信ASC30每季度給藥一次的方案有望幫助患者維持體重且不反 1 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 歌禮宣佈小分子GLP-1R激動劑ASC30用於減重維持的超長效 皮下儲 ...

Group 1 - The Hong Kong Hang Seng Index closed down by 1.12% [1] - The Hang Seng Tech Index fell by 1.85% [1] - Semiconductor stocks experienced a broad decline, with SMIC and Shanghai Fudan dropping over 6%, and Hua Hong Semiconductor falling over 5% [1] Group 2 - Innovative drug concept stocks corrected, with Genscript Biotech falling over 10% and Hengrui Medicine dropping over 6% [1] - The gold sector also saw declines, with Lingbao Gold and China Gold International both falling over 7% [1]

Group 1 - The Hong Kong stock market for innovative drug concept stocks is experiencing a decline, with notable drops in various companies [1] - Gilead Sciences-B has fallen over 7%, while companies such as Kanglong Chemical, Innovent Biologics, and Kelaiying have decreased by more than 5% [1] - Other companies like Fosun Pharma, Tigermed, and Rongchang Biologics have also seen declines of over 4% [1]

Core Viewpoint - The article discusses the upcoming 2025 Shanghai Leading Industries and the 14th Pharmaceutical CEO Forum, highlighting the focus on innovation and global expansion of Chinese pharmaceutical companies [1]. Summary by Sections Event Overview - The event will take place on September 4-5, 2025, at the Mandarin Oriental Hotel in Pudong, Shanghai, featuring nearly a hundred executives from listed companies, including chairpersons, CEOs, and industry leaders [4]. Morning Sessions - The morning session on September 4 will include a keynote speech and several roundtable discussions focusing on topics such as the global expansion of Chinese pharmaceutical companies and the search for the next billion-dollar drug [4][5]. - Notable discussions will include: - "From Local Innovation to Global Leadership: The Era of Chinese Pharmaceutical Companies Going Abroad" [4]. - "The Birth of Big Drugs is the Future of Pharmaceuticals: Finding the Next Billion-Dollar Bomb" [4]. Afternoon Sessions - The afternoon will feature discussions on future disease areas and technologies worth exploring for pharmaceutical assets going abroad, as well as the new cycle of Chinese innovative drugs under global competition [5][6]. - Additional topics will cover advancements in drug development platforms and the emerging field of brain-machine interfaces [6]. TMT Forum - The TMT (Technology, Media, and Telecommunications) forum will also take place, discussing AI's impact on various industries, including gaming and healthcare [7][8]. - Key topics will include AI innovations in mobile internet ecosystems and the future of AI in healthcare [7]. Pharmaceutical Sub-Forum - The pharmaceutical sub-forum will address topics such as ADC technology exploration, probiotic delivery systems, and the future development paths of dual antibodies and XDC [8]. - Discussions will also focus on the integration of medical insurance and the innovative practices in building a multi-level medical security system in China [8].