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化学制药:创新药动态更新:GLP-1 小分子:口服 GLP-1 小分子受体激动剂达到三期临床终点,国产潜在 BIC 管线在美国临床展示减重潜力
Shanxi Securities· 2025-08-13 09:15
Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the chemical pharmaceutical industry [1]. Core Insights - The oral GLP-1 small molecule receptor agonists are positioned as effective treatments for type 2 diabetes and obesity, with advantages such as no dietary restrictions and low chemical synthesis supply difficulties. The oral small molecule GLP-1 RA Orforglipron has reached phase III clinical endpoints and is set to apply for market approval [1][2]. - The potential BIC pipeline from Geely Pharmaceutical shows promising weight loss potential in the U.S. clinical trials, demonstrating superior half-life, drug exposure, and activity compared to Orforglipron [1][3]. - In clinical trials, Orforglipron has shown significant reductions in A1C levels and weight loss, with 65% of patients achieving A1C values ≤6.5% and a weight reduction of -7.9% after 40 weeks of treatment [2]. - In a separate obesity trial, Orforglipron demonstrated a weight loss of -12.4% after 72 weeks, with 59.6% of patients losing ≥10% of their body weight [3]. - ASC30, another oral GLP-1 RA, has shown superior pharmacokinetic and pharmacodynamic characteristics, with a drug exposure 2.2 times higher than Orforglipron and a faster dose titration, which may enhance long-term efficacy [3]. Summary by Sections Market Performance - The chemical pharmaceutical industry has shown a strong market performance over the past year, particularly in the area of innovative drugs [1]. Drug Evaluation - The report highlights the successful clinical outcomes of Orforglipron and ASC30, emphasizing their potential in treating type 2 diabetes and obesity, with favorable safety profiles and tolerability [1][2][3]. Clinical Trial Results - Orforglipron's phase III trials have demonstrated significant efficacy in reducing A1C levels and body weight, while ASC30's early clinical results indicate its potential for superior performance compared to existing treatments [2][3].
异动盘点0813| 阅文集团涨超15%,北海康成-B再涨超31%;柯达夜盘跌超19%,小牛电动涨超11%
贝塔投资智库· 2025-08-13 04:00
Group 1 - Kangji Medical (09997) resumed trading with a nearly 1% increase, announcing a privatization agreement with Knight Bidco Limited, which will make Kangji a wholly-owned subsidiary and delist from the Hong Kong Stock Exchange after completion [1] - Tencent Music (01698) opened high with over a 15% increase, reporting a 30% year-on-year increase in adjusted net profit for Q2 ending June 30, 2025, driven by high-quality growth in its online music business [1] - Mingyuan Cloud (00909) opened over 2% higher, announcing a cash acquisition of 100% equity in ASIOT Co., Ltd. for 700 million yen by its subsidiary MytePro Japan [1] Group 2 - Yuedu Group (00772) surged over 15%, reporting a 68.5% year-on-year increase in net profit for the first half of the year, with strong performance in IP for premium films and animations, and significant growth in the emerging short drama sector [2] - Minmetals Resources (01208) rose over 9%, with net profit increasing 15 times year-on-year, attributed to higher copper production and rising prices of copper, gold, silver, and zinc [2] - Beihai Kangcheng-B (01228) increased over 31%, announcing a strategic cooperation agreement with Baiyang Pharmaceutical for exclusive commercial services in promoting several products in mainland China, Hong Kong, and Macau [2] Group 3 - Zhonghui Biotech-B (02627) surged over 25%, as its vaccine product was included in the preliminary review list of the national commercial health insurance innovative drug catalog [2] - Gilead Sciences-B (01672) rose over 5%, announcing promising efficacy results for its candidate drug ASC47 in combination with teriparatide for obesity treatment in diet-induced obesity mouse studies [3] - Dongying Travel (06882) fell over 9%, issuing a profit warning with expected net profit of approximately 6 million HKD for the first half of 2025, down about 82% from 34 million HKD in the same period last year [3] Group 4 - Kodak (KODK.US) dropped 19.91% after reporting a shift from profit to loss in Q2, raising concerns about its ability to execute critical financing measures [4] - Niu Technologies (NIU.US) rose 11.69%, reporting a turnaround to profitability in Q2 and projecting Q3 revenue between 1.433 billion to 1.638 billion CNY, a year-on-year increase of 40% to 60% [4] - Huya (HUYA.US) increased by 4.53%, preparing to release its financial report, with a strong growth trajectory in gaming-related services [4] Group 5 - ON Running (ONON.US) rose 8.95%, reporting a 32% year-on-year increase in Q2 sales and projecting annual net sales of at least 2.91 billion Swiss francs, exceeding previous expectations [6] - Micron Technology (MU.US) increased by 3.26%, significantly raising its Q4 fiscal year 2025 revenue guidance to between 11.1 billion to 11.3 billion USD, with gross margin guidance improved to 44% to 45% [6]
歌礼制药-B:治疗肥胖症的减重不减肌候选药物ASC47在临床前模型中显示与替尔泊肽联用的疗效胜过与司美格鲁肽联用
Zhi Tong Cai Jing· 2025-08-13 02:26
ASC47是一款由歌礼自主研发的、脂肪靶向、每月一次皮下注射的甲状腺激素受体β(THRβ)选择性小分 子激动剂。ASC47具有独特的差异化特性,能够靶向脂肪,从而在脂肪组织中产生剂量依赖性的高药物 浓度。 该DIO小鼠研究旨在对比低剂量ASC47(9mg/kg,单次给药)联合替尔泊肽(3nmol/kg,皮下,每日一次)与 替尔泊肽单药疗法(3nmol/kg,皮下,每日一次)的疗效。DIO小鼠的治疗期为14天。结果显示,低剂量 ASC47联合替尔泊肽的疗效优于替尔泊肽单药疗法,联合用药的小鼠平均总体重下降38.1%,替尔泊肽 单药治疗的小鼠则为20.4%,ASC47联合替尔泊肽比替尔泊肽单药疗法多减重87%(表1)。相比之下,在 DIO小鼠研究中,联合司美格鲁肽与司美格鲁肽单药疗法相比多减重55%,即低剂量ASC47联合司美格 鲁肽的疗效弱于联合替尔泊肽的疗效,具有统计学显著性(p=0.006)。 歌礼制药-B(01672)发布公告,同类首创的治疗肥胖症的减重不减肌候选药物ASC47与替尔泊肽联用在 饮食诱导肥胖(DIO)小鼠研究中显示出令人鼓舞的疗效结果。 低剂量ASC47与替尔泊肽联用使肥胖小鼠身体成分恢复 ...
歌礼制药-B涨超6% ASC47与替尔泊肽联用在临床前模型中显示积极疗效结果
Zhi Tong Cai Jing· 2025-08-13 01:56
Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 6%, reaching 15.46 HKD, following the announcement of promising results from a study on its obesity treatment candidate ASC47 combined with teriparatide [1] Group 1: Drug Development - ASC47 is a novel, fat-targeting, once-monthly subcutaneous thyroid hormone receptor β (THRβ) selective small molecule agonist developed by the company [1] - The study involved DIO mice and compared the efficacy of low-dose ASC47 (9 mg/kg, single dose) combined with teriparatide (3 nmol/kg, subcutaneous, daily) against teriparatide monotherapy [1] - Results showed that the combination therapy led to an average weight loss of 38.1% in mice, compared to 20.4% for the teriparatide monotherapy, indicating an 87% greater weight reduction with the combination [1] Group 2: Comparative Efficacy - In comparison, the combination of low-dose ASC47 with semaglutide resulted in a weight loss that was 55% greater than semaglutide monotherapy, indicating that the efficacy of ASC47 combined with teriparatide is superior [2] - The statistical significance of the difference in efficacy between ASC47 combined with semaglutide and teriparatide was noted (p=0.006) [2]
歌礼制药:ASC47在临床前模型中显示与替尔泊肽联用的疗效胜过与司美格鲁肽联用
Core Viewpoint - The announcement by the company regarding the promising efficacy results of ASC47 in combination with Tirzepatide for obesity treatment in diet-induced obesity (DIO) mouse models highlights a significant advancement in obesity therapeutics [1] Group 1: Drug Efficacy - The combination of low-dose ASC47 with Tirzepatide resulted in an 87% greater weight reduction compared to Tirzepatide alone in DIO mouse models [1] - ASC47 combined with Semaglutide showed a 55% greater weight reduction compared to Semaglutide alone, indicating that ASC47 enhances the efficacy of existing obesity treatments [1] - The treatment with low-dose ASC47 and Tirzepatide restored the body composition of obese mice to levels comparable to healthy non-obese mice [1] Group 2: Muscle Mass Preservation - At the end of the treatment, the total muscle mass percentage of obese mice treated with low-dose ASC47 and Tirzepatide (60.4%) was similar to that of healthy non-obese mice (62.0%), suggesting that the treatment preserves muscle mass while promoting weight loss [1]
歌礼制药-B(01672):治疗肥胖症的减重不减肌候选药物ASC47在临床前模型中显示与替尔泊肽联用的疗效胜过与司美格鲁肽联用
智通财经网· 2025-08-12 23:25
智通财经APP讯,歌礼制药-B(01672)发布公告,同类首创的治疗肥胖症的减重不减肌候选药物ASC47与 替尔泊肽联用在饮食诱导肥胖(DIO)小鼠研究中显示出令人鼓舞的疗效结果。 该DIO小鼠研究旨在对比低剂量ASC47(9mg/kg,单次给药)联合替尔泊肽(3nmol/kg,皮下,每日一次)与 替尔泊肽单药疗法(3nmol/kg,皮下,每日一次)的疗效。DIO小鼠的治疗期为14天。结果显示,低剂量 ASC47联合替尔泊肽的疗效优于替尔泊肽单药疗法,联合用药的小鼠平均总体重下降38.1%,替尔泊肽 单药治疗的小鼠则为20.4%,ASC47联合替尔泊肽比替尔泊肽单药疗法多减重87%(表1)。相比之下,在 DIO小鼠研究中,联合司美格鲁肽与司美格鲁肽单药疗法相比多减重55%,即低剂量ASC47联合司美格 鲁肽的疗效弱于联合替尔泊肽的疗效,具有统计学显著性(p=0.006)。 低剂量ASC47与替尔泊肽联用使肥胖小鼠身体成分恢复至健康非肥胖小鼠的水平。治疗结束时,经低剂 量ASC47与替尔泊肽联用治疗的肥胖小鼠的总肌肉量占总体重的百分比(60.4%)与健康非肥胖小鼠 (62.0%)相当,意味着实现健康减重。替尔泊 ...
歌礼制药(01672) - 自愿性公告 - 歌礼宣布治疗肥胖症的减重不减肌候选药物ASC47在临床前...
2025-08-12 22:45
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) 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。 | 表1. 低劑量ASC47與替爾泊肽聯用療效勝過與司美格魯肽聯用 | | --- | | | | 總體重 | 聯用與單藥相比, | | --- | --- | --- | --- | | 組別 | 給藥 | 相對基線的變化 | 增加的減重效果 | | 經替爾泊肽治療的 | 替爾泊肽, | | | | 肥胖小鼠 | 3 nmol/kg, | -20.4% | – | | | SQ,QD | | | | 經低劑量ASC47與 | ASC47, | | | | 替爾泊肽聯用治 | 9 mg/kg, | | | | 療的肥胖小鼠 | SQ,單次給藥 | -38.1% | | | | + | ( <0.0001 vs替爾 p | 87% | | | 替爾泊肽, | 泊肽單藥療法) | | | | 3 nmol/kg, ...
歌礼制药20250812
2025-08-12 15:05
Summary of the Conference Call for歌礼制药 Company Overview - **Company**: 歌礼制药 (Galephar Pharmaceuticals) - **Key Products**: ASC30, ASC47, and 地尼法司他 (Dinihufang) Industry Insights - **Market Segment**: GLP-1 market and acne treatment market - **Competitive Landscape**: Intense competition in the GLP-1 sector with notable players like 礼来 (Eli Lilly) and 辉瑞 (Pfizer) Key Points and Arguments ASC30 (GLP-1 Small Molecule Drug) - ASC30 is a small molecule GLP-1 drug with both injection and oral formulations, featuring a half-life of 25 days, which is longer than competitors, enhancing its efficacy and safety [2][6] - Early clinical trials show significant weight loss effects, with a maximum dose group achieving a 6.5% weight reduction in 28 days, indicating strong market competitiveness [2][8] - The drug's pharmacological properties are superior to those of similar products, with better activation of targets at lower concentrations [6] ASC47 (THR Beta Agonist) - ASC47 is the only drug in development globally targeting the THR beta receptor for muscle gain and fat loss, showing promising preclinical results in muscle protection and fat reduction [2][11] - The unique technology applied to ASC47 allows it to target fat cells effectively, which is a significant advantage over existing treatments [11] Dinihufang (Acne Treatment) - Dinihufang has shown a 20% reduction in skin lesions in phase III clinical trials, outperforming current topical treatments [12] - The oral formulation offers convenience and maintains good safety profiles, expected to apply for market approval in 2025, potentially generating substantial revenue [12] Competitive Advantages - The choice to develop small molecule GLP-1 drugs is aimed at differentiation, leveraging advantages such as easier scalability, stable storage, and dual formulation options [7] - ASC30's early clinical data positions it favorably against competitors, with expectations for strong topline data in late 2025 [9] Risks and Considerations - The GLP-1 pipeline faces significant competition, and there is a risk of revenues falling short of expectations, necessitating caution from investors [4][13] - The overall timeline for monetization is lengthy, which may affect long-term investment returns [4][13] Market Outlook - ASC30 is anticipated to become a key player in the market, with its unique design and dual formulation likely to drive significant revenue as clinical trials progress [8] - The combination of GLP-1 weight loss and self-developed oral muscle gain inhibitors is expected to enhance business development prospects [9] Additional Noteworthy Information - The early-stage small molecule oral drug 白芥 17 has attracted attention from multinational companies, indicating its potential in the market [5]
港股午评 恒生指数早盘跌0.66% 加密货币ETF及概念股走高
Jin Rong Jie· 2025-08-08 05:07
Group 1 - The Hang Seng Index fell by 0.66%, down 165 points, closing at 24,916 points, while the Hang Seng Tech Index dropped by 0.99% [1] - The early trading volume in Hong Kong stocks reached HKD 112.6 billion [1] - President Trump signed an executive order allowing alternative assets like private equity, real estate, and cryptocurrencies to enter 401K retirement savings plans, potentially opening up about USD 12.5 trillion in retirement account funds [1] Group 2 - Cryptocurrency-related stocks surged, with notable increases in prices: 嘉实以太币 (03179) up 6.48%, 博时以太币 (03009) up 6.24%, 华夏以太币 (03046) up 6.13%, and 博雅互动 (00434) up 6.46% [1] - 阜博集团 (03738) saw a significant rise of over 16%, with its stock price increasing by over 50% this week as the company expands into content industry RWA business [1] - 歌礼制药-B (01672) increased by 7.65% as ASC30 completed patient enrollment in Phase IIa, with strong business development expectations [1] - 君实生物 (01877) rose by 6.5% due to improved market conditions in the PD-(L)1/VEGF sector [1] Group 3 - RAFFLESINTERIOR (01376) resumed trading with an 80% surge after a change in controlling interest and a 43.1% discount on a full acquisition offer [2] - 老铺黄金 (06181) increased by 2.96% after being included in the MSCI China Index, with changes effective at the end of the month [2] Group 4 - 北海康成-B (01228) rose by over 30%, with a cumulative increase of nearly 9 times since early June, driven by the potential of the drug维拉苷酶β for significant business development opportunities [3] - 东风集团股份 (00489) saw an early morning increase of over 8%, despite a more than 90% year-on-year decline in net profit for the first half, managing to turn a profit compared to the previous quarter [4] - 和黄医药 (00013) dropped over 15% in early trading, with a 9.2% year-on-year decline in mid-term revenue, although selling joint venture equity led to a more than 16-fold increase in net profit [4]
港股异动 歌礼制药-B(01672)再涨超7% ASC30完成IIa期患者入组 机构称该管线具有较强BD预期
Jin Rong Jie· 2025-08-08 04:00
东吴证券指出,ASC30作为歌礼制药的核心管线,此前在美国开展的口服剂型Ia期临床读出了优秀的疗 效数据,4周最高减重6.5%,而与礼来同赛道的口服小分子GLP-1管线Orforglipron的4周最高减重3.4%相 比效果更佳,具有较高的全球BIC潜力。该行指出,歌礼制药对于ASC30的临床推进速度很快,整体效 率更高,且临床在美国开展,数据更受海外MNC认可。综合以上优势,认为该管线具有很强的BD预 期,随着25年Q4的临床数据读出,BD预计有望推进加快。 本文源自:智通财经网 智通财经获悉,歌礼制药-B(01672)再涨超7%,截至发稿,涨7.14%,报12.76港元,成交额1.28亿港 元。 消息面上,8月5日,歌礼制药宣布,其小分子GLP-1管线ASC30在美国进行的每日口服剂型减重适应症 13周IIa期研究已经完成入组,总计125名患者,预计将在2025年Q4读出顶线数据。ASC30拥有美国和全 球化合物专利保护,专利保护期至2044年。 ...