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 ...

Core Viewpoint - The article highlights the remarkable rise of Baili Tianheng, a Chinese biopharmaceutical company, which has seen its stock price surge over 1,000% since its IPO, driven by significant licensing deals and a shift towards innovative drug development [3][9][13]. Company Overview - Baili Tianheng's stock reached a historical high of 38.8 yuan, with a market capitalization exceeding 150 billion yuan, marking a more than tenfold increase from its IPO price of 24.70 yuan [3][7]. - The company was founded by Zhu Yi, a Sichuan entrepreneur, who transitioned from traditional pharmaceuticals to innovative drug research, establishing a cash flow system for R&D through previous successes in generic drugs [5][6]. Key Developments - In June 2023, Baili Tianheng's clinical data for its ADC drug BL-B01D1 generated significant interest, leading to a landmark licensing deal with Bristol-Myers Squibb worth approximately 84 billion yuan [9][10]. - The company reported a revenue of 5.823 billion yuan in the previous year, a staggering increase of 936.31%, and turned a profit with a net income of 3.708 billion yuan, a 575.02% year-on-year growth [10]. Market Context - The Chinese biopharmaceutical sector is experiencing a resurgence after a period of downturn, with several companies successfully listing and achieving significant stock price increases [13][14]. - The market is witnessing a shift where innovative drug companies are gaining recognition and valuation, as evidenced by the performance of Baili Tianheng and other firms in the sector [14][15]. Future Outlook - Zhu Yi aims for Baili Tianheng to become a multinational pharmaceutical company within five years, focusing on global commercialization of its products [11]. - Despite the current success, the company faces challenges in sustaining growth due to the high costs and risks associated with innovative drug development [10][12].

Market Performance - The Hong Kong stock market experienced a strong upward trend, with the Hang Seng Index rising by 1.43% to close at 25,417.98 points, and the Hang Seng Tech Index increasing by 1.95% to 5,687.45 points [1] - Major technology stocks saw significant gains, including Alibaba up 1.54%, Tencent up 2.19%, and JD.com up 1.92% [1] - The metals sector performed well, with Tianqi Lithium rising over 13% and Ganfeng Lithium increasing over 12% [1] - Pharmaceutical stocks also saw substantial increases, with 3SBio up over 18% and CanSino Biologics up over 7% [1] - Solar energy stocks surged, with Kamda Solar rising over 52% [1] Company News - China Tobacco Hong Kong signed an exclusive global distribution agreement for "Huanghelou" cigars with Hubei Tobacco [1] - Fosun International's subsidiary Fidelidade sold a 40% stake for €310 million [2] - Xinyi International reported a net revenue of approximately HKD 11.01 billion for the first eight months, a decrease of 5.5% year-on-year [3] - New World Development projected a revenue of HKD 79.72 billion for the fiscal year 2025, an increase of 11.5% year-on-year, with a net profit of HKD 19.28 billion, up 1.2% [3] - China Overseas Land & Investment reported a contract sales amount of RMB 150.33 billion for the first eight months, down 16.5% year-on-year [4] - China Construction Bank's subsidiary plans to increase capital by HKD 3 billion [5] Clinical Trials and Approvals - Heng Rui Medicine received approval to conduct clinical trials for RSS0393 ointment, aimed at alleviating tissue damage and inflammation related to atopic dermatitis [6] - Heng Rui Medicine also received approval for HRS-4729 injection, a tri-agonist for GLP-1R, GIPR, and GCGR [6] Institutional Insights - According to招商国际, recent volatility in the Hong Kong market is influenced by fluctuating U.S. interest rate expectations and profit-taking by southbound funds, but conditions are improving [8] -浙商国际 noted that the Hong Kong market has shown a consistent upward trend for four consecutive months, driven by strong southbound fund inflows and improved external funding conditions [8] - Guosen Securities reported that the overall mid-year performance of the internet sector was stable, with AI significantly impacting revenue and profit growth for major companies [9] -浙商国际 expressed a cautious optimism regarding the market's future performance despite potential short-term fluctuations [9]

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Market Overview - The Hong Kong stock market experienced a broad decline on September 4, with the Hang Seng Index closing at 25,058.51 points, down 284.92 points, a decrease of 1.12% [1] - The Hang Seng Tech Index also fell, closing at 5,578.86 points, down 104.88 points, a decline of 1.85% [1] Sector Performance - The Wind Hong Kong secondary industry indices showed mixed results, with sectors like daily consumer retail and utilities seeing slight gains of 0.77% and 0.49% respectively [2] - Conversely, the pharmaceutical and semiconductor sectors faced significant declines, with the pharmaceutical sector dropping by 4.71% and semiconductors by 6.16% [2][4] Individual Stock Movements - In the banking sector, several banks such as Tianjin Bank and Agricultural Bank of China saw gains exceeding 2%, while other banks like Standard Chartered and China Everbright Bank rose over 1% [2] - The pharmaceutical sector saw notable declines, with stocks like Jiahua Bio-B and Singlomics falling over 10%, while WuXi Biologics also experienced a drop of over 9% [3] - In the tech sector, Baidu rose over 2%, while Alibaba fell over 3%, and other tech stocks like Xiaomi and Kuaishou also saw declines [5] Capital Flow - Southbound capital showed a net selling trend for most of the day, but there was a noticeable inflow towards the end, with a net buying amount of HKD 1.386 billion from the Shanghai-Hong Kong Stock Connect [5] Future Outlook - Analysts from Guotai Junan believe that the potential for foreign capital to return to Hong Kong stocks is high, especially in the technology and financial sectors, as negative factors affecting tech stocks show signs of improvement [7] - According to Everbright Securities, the anticipated Fed rate cut cycle could lead to continued upward movement in the Hong Kong market, with a focus on technology growth and high dividend strategies [9]

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]