玛仕度肽注射液
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强生口服IL-23拮抗剂申报上市,启动与乌司奴单抗的头对头研究
Ping An Securities· 2025-11-24 05:09
证券研究报告 强生口服IL-23拮抗剂申报上市,启动与乌司奴单抗的头 对头研究 生物医药行业 强于大市(维持) 平安证券研究所生物医药团队 分析师: 叶寅投资咨询资格编号:S1060514100001邮箱:YEYIN757@PINGAN.COM.CN 倪亦道投资咨询资格编号:S1060518070001邮箱:NIYIDAO242@PINGAN.COM.CN 韩盟盟投资咨询资格编号:S1060519060002邮箱:HANMENGMENG005@PINGAN.COM.CN 裴晓鹏投资咨询资格编号:S1060523090002邮箱:PEIXIAOPENG719@PINGAN.COM.CN 何敏秀投资咨询资格编号:S1060524030001邮箱:HEMINXIU894@PINGAN.COM.CN 王钰畅投资咨询资格编号:S1060524090001邮箱:WANGYUCHANG804@PINGAN.COM.CN 曹艳凯投资咨询资格编号:S1060524120001邮箱:CAOYANKAI947@PINGAN.COM.CN 张梦鸽投资咨询资格编号:S1060525070003邮箱:ZHANGMENGGE752@PIN ...
信达生物一度涨近5% 将于12月8日起正式染蓝
Zhi Tong Cai Jing· 2025-11-24 01:46
消息面上,11月21日,恒生指数系列季度检讨结果出炉,所有变动将于2025年12月8日起生效。其中, 信达生物将被纳入恒生指数成份股,成份股数目将由88只增加至89只。 信达生物(01801)一度涨近5%,截至发稿,涨3.9%,报90.65港元,成交额1.77亿港元。 值得一提的是,11月20日,信达生物宣布,玛仕度肽注射液(胰高血糖素[GCG]/胰高血糖素样肽-1[GLP- 1]双受体激动剂,研发代号: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。 ...
港股异动 | 信达生物(01801)一度涨近5% 将于12月8日起正式染蓝
智通财经网· 2025-11-24 01:44
智通财经APP获悉,信达生物(01801)一度涨近5%,截至发稿,涨3.9%,报90.65港元,成交额1.77亿港 元。 消息面上,11月21日,恒生指数系列季度检讨结果出炉,所有变动将于2025年12月8日起生效。其中, 信达生物将被纳入恒生指数成份股,成份股数目将由 88 只增加至 89 只。 值得一提的是,11月20日,信达生物宣布,玛仕度肽注射液(胰高血糖素[GCG] /胰高血糖素样 肽-1[GLP-1] 双受体激动剂,研发代号: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。 ...
新药周观点:小核酸药物治疗乙肝取得突破性数据-20251123
Guotou Securities· 2025-11-23 10:05
2025 年 11 月 23 日 生物医药Ⅱ 新药周观点:小核酸药物治疗乙肝取 得突破性数据 本周新药行情回顾: 2025 年 11 月 17 日-2025 年 11 月 23 日,新药板块涨幅前 5:来凯医 药(+13.34%)、北海康成(+2.67%)、嘉和生物(+2.19%)、永泰生 物 ( +1.94% )、 友 芝 友 ( +1.14% ); 跌 幅 前 5 : 药 明 巨 诺 ( - 15.75%)、艾迪药业(-14.56%)、盟科药业(-14.34%)、宜明昂科 (-13.40%)、凯因科技(-13.04%)。 本周建议关注标的: 考虑板块后续仍有多个催化值得期待,包括学术会议、数据读出、 多个 BD 兑现等,仍建议关注: 1)已获 MNC 认证未来海外放量确定性高的品种:三生制药、联邦制 药、科伦博泰等; 2)存在海外数据催化的品种:贝达药业、和黄医药、映恩生物等; 3)下一个可能海外授权 MNC 的重磅品种:复宏汉霖、石药集团、益 方生物等; 4)新的创新药技术突破领域:小核酸、体内 CAR-T、减脂增肌、自 免 CAR-T/双抗、基因疗法等。 本周新药行业重点分析: 小核酸药物治疗乙肝取得 ...
中泰国际每日晨讯-20251121
ZHONGTAI INTERNATIONAL SECURITIES· 2025-11-21 02:28
2025 年 11 月 21 日 星期五 ➢ 每日大市点评 11 月 20 日,港股缺乏向上推动力。除美国 12 月减息的不确定性外,中日关系紧张亦增加市场风险情绪,加上近期迎来 多达 28 只股份将陆续解禁,为港股带来调整压力。周四恒生指数最终收报 25,835 点,微涨 4 点(0.02%);恒生科技指 数下跌 32 点(0.6%),收报 5,574 点;全天大市成交额稍稍扩大至 2,451 亿元。港股通净流入增长至接近 160 亿元,是 近一个月以来单日净流入金额最高。盘面上,市场传闻政府将推出新一轮房地产刺激措施,消息导致内房股周四造好, 碧桂园(2007 HK)涨 3.1%;万科(2202 HK)涨 3.7%;中海外(688 HK)涨 2.5%。11 月 19 日宁德时代(3750 HK)有 7,000 多万股 H 股解禁,周四股价下挫 5.7%。除了宁德时代,年底前还有曹操出行(2643 HK)、英诺赛科(2577 HK) 和药捷安康(2617 HK)等较大规模股份解禁。投资者警惕基金在假期前减持股份。 美股方面,英伟达季度业绩强劲,令市场对人工智能前景重启乐观情绪;加上延迟发布的美国 9 月非农 ...
港股概念追踪|信达生物减肥药三期临床达终点 创新药板块趋势企稳(附概念股)
智通财经网· 2025-11-21 00:34
智通财经APP获悉,三款创新药发布公告取得有效进展,或引领恒生生物科技指数+恒生创新药指数企 稳。 1、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。 2、2025年11月20日,复宏汉霖(02696)宣布,创新型PD-1抑制剂H药 汉斯状®(斯鲁利单抗,欧洲商品 名:Hetronifly®)被国家药品监督管理局(NMPA)药品审评中心(CDE)正式纳入突破性治疗品种名单,联 合化疗用于新辅助/辅助治疗胃癌,成为首个获CDE突破性疗法认定的胃癌围手术期治疗药物。 此次获得突破性疗法认定,标志着H药在胃癌围手术期治疗中的潜力与临床价值获得权威认可,有望 ...
黄某云行贿案曝光;玛仕度肽GLORY-2研究达成终点
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-20 10:49
Group 1: Legal and Regulatory Issues - The National Healthcare Security Administration disclosed a bribery case involving Huang Mouyun, who was found guilty of bribing multiple healthcare professionals to increase sales of a traditional Chinese medicine product [1][2] - Huang Mouyun paid a total of 1.9263 million yuan in bribes to 15 doctors at a local hospital to secure sales, with the product achieving over 10 million yuan in sales since December 2018 [1][2] - The court ruled that Huang Mouyun's actions constituted bribery of non-state personnel, and he may receive a lighter sentence due to his confession [2] Group 2: Pharmaceutical Developments - Huason Pharmaceutical announced that its product, Amlodipine Besylate Tablets, has completed domestic production registration, aimed at enhancing market competitiveness amid an aging population [1] - Fosun Pharma's subsidiary has had its PD-1 monoclonal antibody, used for gastric cancer treatment, included in the breakthrough therapy designation, marking a significant advancement in cancer treatment options [3] - Tianyi Medical received a medical device registration certificate for its blood dialysis concentrate, which is intended for patients with acute and chronic renal failure [4] Group 3: Clinical Research and Results - Innovent Biologics reported that its drug, Ma Shidu Peptide, achieved a weight reduction of up to 20.1% in obese patients during a Phase III clinical trial, with significant improvements in various health metrics compared to the placebo group [5][6] - The trial involved 462 participants, with the Ma Shidu Peptide group showing an average weight loss of 18.55% after 60 weeks, while the placebo group only lost 3.02% [6] Group 4: Corporate Governance - Changchun High-tech announced a change in the shareholding structure of its controlling shareholder, which will not affect the company's operations or control [4][5] - Guangji Pharmaceutical's independent director, Guo Wei, resigned due to personal reasons, which may impact the board's composition and the presence of accounting professionals [8]
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。 ...
中国糖尿病药物行业调研简报:行业洞察:重磅新品获批不断,市场格局如何变化?-20251110
Tou Bao Yan Jiu Yuan· 2025-11-10 12:57
Investment Rating - The report does not explicitly state an investment rating for the diabetes drug industry Core Insights - The diabetes drug market is experiencing significant innovation, particularly with GLP-1 receptor agonists, which have seen advancements in long-acting and humanized formulations [3] - The global diabetes-related healthcare expenditure has surpassed $1 trillion, indicating a growing financial burden on healthcare systems [16] - China is facing a severe diabetes crisis, with 148 million adults diagnosed and a significant number of pre-diabetic individuals [12] Summary by Sections New Drug Approvals - In 2025, several innovative diabetes drugs were approved in China, including: - Eysuparaglutide α (怡诺轻), a long-acting GLP-1 receptor agonist [2] - Ploglitin tablets (善泽平), a new oral DPP-4 inhibitor [2] - Masitide injection (信尔美), the first dual receptor agonist for GCGR/GLP-1R globally [2][3] Drug Mechanisms and Innovations - The report highlights the importance of dual receptor agonism in metabolic disease treatment, with Masitide providing both appetite suppression and liver fat metabolism benefits [3] - Combination formulations, such as Dapagliflozin and Metformin, enhance treatment adherence by optimizing drug release and minimizing gastrointestinal side effects [4] Market Trends - Traditional diabetes medications like Metformin and Sulfonylureas are experiencing declining sales, while newer drugs like GLP-1 agonists and SGLT-2 inhibitors are seeing significant growth [8] - The retail market for diabetes medications in China exceeded 13 billion yuan in 2024, with a nearly 9% year-on-year growth in Q1 2025 [22] Global Diabetes Statistics - The number of diabetes patients aged 20-79 is projected to rise from 588.7 million in 2024 to 852.5 million by 2050 [11] - In 2024, China had 148 million adults with diabetes, highlighting the urgent need for effective management strategies [12] Healthcare Expenditure - The United States leads in diabetes-related healthcare spending at $404.5 billion, followed by China at $168.9 billion [15] - China's per capita diabetes-related healthcare expenditure is only $236, indicating a disparity in healthcare resource allocation [18]
苏州市327个创新联合体激活产业升级新动能
Su Zhou Ri Bao· 2025-11-08 00:37
Core Insights - Suzhou's innovation consortiums have achieved significant breakthroughs in high-temperature superconducting materials and dual-target weight loss drugs, marking a strong step towards technological self-reliance and innovation [1][4] - The city has established 327 innovation consortiums, leading the province in quantity, which includes collaborations with 1,268 leading enterprises and 264 research institutions [2][3] Group 1: Innovation Achievements - The innovation consortiums have developed AI-driven mass production processes for high-temperature superconducting materials, achieving full-chain autonomy in nuclear magnetic resonance magnets [1] - The consortiums have also created the world's first dual-target weight loss drug, marking a significant milestone in the pharmaceutical industry [1] - Notable projects include the development of domestically produced high-temperature superconducting materials and the discovery of new treatment targets for colorectal cancer [4] Group 2: Collaborative Ecosystem - Suzhou's innovation consortiums operate under a "group army" model, integrating leading enterprises, research institutions, and universities to tackle key technological challenges [2] - The city has established a comprehensive internal circulation system that spans from technology research to project incubation and industrial cultivation [2] - Eight benchmark innovation consortiums have been recognized for their collaborative efforts, serving as models for industry-wide innovation [2] Group 3: Economic Impact - The innovation consortiums are expected to drive over 10 billion yuan in R&D investments and facilitate the application of over 1,000 core technologies [4] - Specific consortiums have reported significant economic benefits, such as a semiconductor laser consortium generating 2 billion yuan in R&D investments and a projected 50 billion yuan in revenue from a robotics consortium [5] Group 4: Future Development - Suzhou aims to deepen the development of innovation consortiums by enhancing collaboration, resource sharing, and establishing platforms for concept validation and pilot testing [6] - The city plans to support the consortiums in undertaking major national scientific tasks and promoting successful experiences to foster new productive forces [6]