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信达生物尾盘涨近3% 公司将递交玛仕度肽9mg用于成人体重控制的新药上市申请
Zhi Tong Cai Jing· 2025-11-20 07:55
消息面上,11月20日,信达生物宣布,玛仕度肽注射液(IBI362)在中国中重度肥胖人群中开展的III期临 床研究(GLORY-2)达成主要终点和所有关键次要终点,信达生物将于近期向监管机构递交玛仕度肽9mg 用于成人体重控制的新药上市申请。 公开资料显示,玛仕度肽是信达生物与礼来制药共同推进的一款胰高血糖素(GCG)/胰高血糖素样 肽-1(GLP-1)双受体激动剂,也是全球首个获批的GCG/GLP-1双受体激动剂。该药已在国内获批两项适 应症,分别用于成人肥胖或超重患者的长期体重控制以及成人2型糖尿病患者的血糖控制。 信达生物(01801)尾盘涨近3%,截至发稿,涨2.62%,报92港元,成交额7.47亿港元。 ...
港股异动 | 信达生物(01801)尾盘涨近3% 公司将递交玛仕度肽9mg用于成人体重控制的新药上市申请
智通财经网· 2025-11-20 07:54
智通财经APP获悉,信达生物(01801)尾盘涨近3%,截至发稿,涨2.62%,报92港元,成交额7.47亿港 元。 消息面上,11月20日,信达生物宣布,玛仕度肽注射液(IBI362)在中国中重度肥胖人群中开展的III期临 床研究(GLORY-2)达成主要终点和所有关键次要终点,信达生物将于近期向监管机构递交玛仕度肽9mg 用于成人体重控制的新药上市申请。 公开资料显示,玛仕度肽是信达生物与礼来制药共同推进的一款胰高血糖素(GCG)/胰高血糖素样 肽-1(GLP-1)双受体激动剂,也是全球首个获批的GCG/GLP-1双受体激动剂。该药已在国内获批两项适 应症,分别用于成人肥胖或超重患者的长期体重控制以及成人2型糖尿病患者的血糖控制。 ...
Mazdutide 9 mg Achieves Up to 20.1% Weight Loss in Chinese Adults with Obesity, GLORY-2 Study Meets Primary and All Key Secondary Endpoints
Prnewswire· 2025-11-20 00:00
Core Insights - Innovent Biologics announced that the Phase 3 clinical trial of mazdutide met its primary and key secondary endpoints, indicating its efficacy for weight management in Chinese adults with obesity [1][2][3] Clinical Trial Details - The GLORY-2 study involved 462 participants with a mean baseline weight of 94.0 kg and a mean BMI of 34.3 kg/m², randomized to receive either mazdutide 9 mg or placebo over a 60-week period [2] - Participants in the mazdutide group experienced a mean weight reduction of 18.55% at Week 60, compared to 3.02% in the placebo group, with 44.0% achieving a weight reduction of 20% or more [3][4] Secondary Endpoints and Safety - All key secondary endpoints were met, including improvements in waist circumference, blood pressure, and lipid levels, demonstrating the drug's superiority over placebo [4][5] - The treatment showed favorable tolerability, with a low discontinuation rate due to adverse events (2.9% in the mazdutide group) [6] Expert Commentary - Experts highlighted the significance of mazdutide in addressing obesity, particularly in a country with a high prevalence of obesity and related cardiometabolic diseases [7] - The drug is positioned as a viable alternative to metabolic surgery, with evidence supporting its effectiveness in weight management [7][8] Future Plans and Recognition - Innovent plans to submit a new drug application for mazdutide to the NMPA and is exploring further therapeutic potentials for the drug [8][10] - Mazdutide has received recognition in top-tier journals and was listed among the "Top 10 Most Anticipated Drug Launches of 2025" [8][9] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases and has launched 16 products to date [17]
速递|针对青少年肥胖!信达生物玛仕度肽启动第8项Ⅲ期临床
GLP1减重宝典· 2025-11-19 15:40
Core Viewpoint - The article discusses the ongoing clinical trials of IBI362 (Mastrutide), a dual receptor agonist for GLP-1 and GCG, aimed at treating overweight and obesity in adolescents, highlighting its potential efficacy and safety in this demographic [2][3]. Group 1: Clinical Trials Overview - A Phase III clinical trial (GLORY-YOUNG) is being conducted to evaluate the efficacy and safety of IBI362 in overweight or obese adolescents aged 12 to 18, with a target enrollment of 180 participants across 25 medical institutions [3]. - IBI362 is administered weekly at a dosage of 2 mg (0.5 ml) for a treatment period of 4 weeks [3]. - The drug has already received approval for two indications in adults: long-term weight management for overweight or obese individuals and blood glucose control for adults with type 2 diabetes [3]. Group 2: Ongoing and Completed Studies - IBI362 has completed or is currently involved in eight Phase III clinical studies, including trials for overweight or obese populations and comparisons with other treatments for type 2 diabetes [4][8]. - Notable completed studies include GLORY-1 and DREAMS-3, which have met their primary endpoints, while other studies are still ongoing [6]. - Additional research is being conducted on various conditions, including metabolic-associated fatty liver disease (MAFLD) and heart failure with preserved ejection fraction (HFpEF) [6]. Group 3: Industry Context - The article emphasizes the growing interest in GLP-1 receptor agonists as a new class of diabetes medications that enhance insulin secretion and suppress appetite, thereby aiding in weight loss and blood sugar control [16]. - The GLP-1 industry is supported by a network of professionals and experts, indicating a collaborative effort to advance research and development in this field [12][13].
信达生物(01801.HK)获摩根大通增持143.88万股
Ge Long Hui· 2025-11-17 23:21
增持后,JPMorgan Chase & Co.最新持好仓数目为8684.107万股,持好仓比例由4.98%上升至5.06%。 | 股份代號: | 01801 | | --- | --- | | 上市法國名稱: | 信建生物製藥 | | 日期(日 / 月 / 年): | 18/10/2025 - 18/11/2025 | 格隆汇11月18日丨根据联交所最新权益披露资料显示,2025年11月11日,信达生物(01801.HK)获JPMorgan Chase & Co.以每股均价84.7327港元增持好仓 143.88万股,涉资约1.22亿港元。 | Frida Barra | 大 股東/董事/最高行政人員名 作出披露的 買 入 / 賣出或涉及的 每股的平均價 | | | | 持有權益的股份數目 佔已發行的有關事件的日 相關法國 | | --- | --- | --- | --- | --- | --- | | | 版 分享 三 | | | 和人员上面落語 | 有投票樓股期(日/月/ 份權益 | | | | | | | 份自分比 年) | | CS20251114E00461 | JPMorgan Chase & ...
上半年创新药上市数量同比增长59% 创新药产业跑出加速度
Jing Ji Ri Bao· 2025-11-17 23:05
Core Insights - In 2024, China approved 48 innovative drugs for market entry, ranking second globally, just behind the United States with 50 approvals. In the first half of this year, the National Medical Products Administration approved 43 innovative drugs, marking a 59% year-on-year increase [1] Policy Guidance - Beijing has implemented a series of pioneering reforms in the pharmaceutical and health sector, including the establishment of green channels for rare disease drug approvals and optimizing clinical trial reviews. These measures aim to create a favorable environment for high-quality industry development [2] - The Beijing Municipal Science and Technology Commission has introduced 32 new measures to support the high-quality development of innovative pharmaceuticals and medical devices [2] - Chengdu has also rolled out specific policies to support the biopharmaceutical industry, focusing on drug and device R&D innovation and enhancing clinical research quality [2] Innovation Ecosystem - Chengdu's Tianfu International Biotech City is a key hub for the biopharmaceutical industry, housing 108 clinical research drugs, including 63 in clinical stages. The "Wutong Plan" launched by Chengdu High-tech Zone offers a comprehensive service list for the pharmaceutical health industry [3] - Jiangsu province has established a robust innovation ecosystem, exemplified by the production of the world's first dual-target weight-loss drug, which was approved in just 16 months [4] Comprehensive Innovation Efforts - Jiangsu has concentrated resources in policy, funding, and talent to strengthen its innovative platforms and tackle key technological challenges in the biopharmaceutical sector [5][6] - The National Biopharmaceutical Technology Innovation Center is focusing on critical technology R&D and public platform construction, with 66 projects already initiated [6] Capital Support - The capital market is increasingly supporting innovative drug development, with Beijing's Changping District establishing a multi-faceted investment framework, including a 200 billion yuan pharmaceutical investment fund [7] - The Zhongguancun Life Science Park in Changping has become a hub for cell and gene therapy, with over 20 companies advancing their products into clinical research [7] - Jiangsu's Shengsheng Biopharmaceutical Co. has committed to significant R&D investments, increasing its budget from 20 billion yuan in the first five years to nearly 80 billion yuan in the subsequent five years [7] Industry Layout - Under the dual support of policies and funding, various regions are accelerating their focus on cutting-edge fields, enhancing both the innovation and industrial chains [8] - The Suzhou Biopharmaceutical Industrial Park has gathered over 620 innovative pharmaceutical companies and more than 35,000 R&D talents, establishing a strong foundation for drug development and high-end medical devices [8]
小摩增持信达生物(01801)约143.88万股 每股作价约84.73港元
智通财经网· 2025-11-17 11:08
智通财经APP获悉,香港联交所最新资料显示,11月11日,小摩增持信达生物(01801)143.8757万股,每 股作价84.7327港元,总金额约为1.22亿港元。增持后最新持股数目约为8684.11万股,最新持股比例为 5.06%。 ...
小摩增持信达生物约143.88万股 每股作价约84.73港元
Zhi Tong Cai Jing· 2025-11-17 11:04
Group 1 - JPMorgan increased its stake in Innovent Biologics (01801) by acquiring 1,438,757 shares at a price of HKD 84.7327 per share, totaling approximately HKD 122 million [1] - Following the acquisition, JPMorgan's total shareholding in Innovent Biologics is approximately 86,841,100 shares, representing a stake of 5.06% [1]
创新药概念股走弱,相关ETF跌超2%
Sou Hu Cai Jing· 2025-11-17 06:28
Group 1 - The core viewpoint indicates a decline in innovative drug concept stocks, with notable drops in companies such as Kanglong Chemical, Kelun Pharmaceutical, and Xinlitai, among others [1] - The innovative drug-related ETFs have also experienced a decline, with an overall drop exceeding 2% [1] - Despite the downturn, there have been positive developments in China's biotechnology sector, including 35 research presentations at the ESMO 2025 conference and significant collaborations like the $11.4 billion partnership between Innovent Biologics and Takeda, highlighting global recognition of Chinese innovative drug value [2]
港股创新药ETF(159567)跌1.12%,成交额22.14亿元
Xin Lang Cai Jing· 2025-11-14 10:14
Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 1.12% with a trading volume of 2.214 billion yuan on November 14, 2024 [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of November 13, 2024, the fund's latest share count was 9.665 billion shares, with a total size of 8.579 billion yuan, reflecting a year-to-date increase of 2344.51% in shares and 2170.81% in size [1] Fund Performance - The current fund manager, Ma Jun, has achieved a return of 69.74% since taking over on January 3, 2024 [2] - The fund's top holdings include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant weightings in the portfolio [2] Trading Activity - Over the past 20 trading days, the ETF has accumulated a trading volume of 28.057 billion yuan, averaging 1.403 billion yuan per day [1] - Year-to-date, the ETF has recorded a total trading volume of 251.214 billion yuan, with an average daily trading volume of 1.196 billion yuan [1]