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速递|银诺医药最新!依苏帕格鲁肽α减重IIb期研究达主要终点
GLP1减重宝典· 2025-12-27 03:28
我国超重和肥胖人群的患病率持续攀升,作为独立慢性疾病及多种重要慢性病的致病因素,肥胖症已成为重大公共卫生问题。GLP-1受 体激动剂(GLP-1RA)已在超重/肥胖患者中证实确切疗效。银诺医药自主研发的依苏帕格鲁肽α在中国超重/肥胖患者中开展的IIb期 ENLIGHT研究顶线数据证实达到主要终点。 该研究采用随机双盲、安慰剂对照、多中心设计,共纳入200例不伴糖尿病的超重及肥胖成人受试者,评估依苏帕格鲁肽α 5~20 mg剂 量范围治疗18周的疗效与安全性。结果显示,各剂量组体重较基线均显著下降,优于安慰剂组(P<0.0001),此外,治疗期间依苏帕 格鲁肽α组患者体重呈现持续下降趋势。 强效减重:20 mg每周一次(QW)组体重降幅达10.58%。灵活方案:20 mg每2周一次(Q2W)减重效果与10 mg每周一次相当。改善 代谢:腰围、内脏脂肪及肝脏脂肪含量等较基线均显著改善。减脂护肌:脂肪实现了"优先燃烧",脂肌比显著提升。安全耐受:未发生 低血糖事件。胃肠道不良反应多为轻中度、呈一过性且可自行恢复。 整理 | GLP1减重宝典内容团队 在12月6日,依苏帕格鲁肽α减重ENLIGHT研究者会上,银诺医药 ...
银诺医药-B午前涨超5% 依苏帕格鲁肽ɑ获国家基层糖尿病防治指南推荐
Xin Lang Cai Jing· 2025-12-17 03:28
银诺医药-B(02591)午前股价上涨5.37%,现报32.60港元,成交额3325.27万港元。 据银诺医药官微消息,在《"健康中国2030"规划纲要》推动糖尿病防治关口前移、提升创新药物可及性 的战略部署下,中国原研首款超长效人源性GLP-1受体激动剂(GLP-1RA)依苏帕格鲁肽α(商品名: 怡诺轻®)正式纳入2025版国家医保药品目录,适用于"成人2型糖尿病患者的血糖控制",自2026年1月 1日起正式执行。此举标志着我国糖尿病创新治疗普惠化又迈出关键一步。 在《国家基层糖尿病防治管理指南(2025) 》中,依苏帕格鲁肽ɑ被列为注射类降糖药物的GLP-1RA周 制剂,为基层医疗机构配备和使用该药提供了直接的政策与规范依据。指南强调,对于合并动脉粥样硬 化性心血管疾病(ASCVD)或其风险因素、心力衰竭、慢性肾脏病(CKD)的成人2型糖尿病 (T2DM)患者,以及需要体重管理的超重肥胖患者,GLP-1RA是重要的治疗选择。 责任编辑:卢昱君 责任编辑:卢昱君 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 银诺医药-B( ...
生物医药行业:2025年医保及首版商保目录公布,中国药品价格登记系统上线,助力创新药发展
Ping An Securities· 2025-12-09 04:53
证券研究报告 2025年医保及首版商保目录公布,中国药品价格登记系 统上线,助力创新药发展 生物医药行业 强于大市(维持) 周观点 行业观点 12月7日,2025年《国家基本医疗保险、生育保险和工伤保险药品目录》和首版《商业健康保险创新药品目录》发布 12月7日,2025创新药高质量发展大会在广州召开,会议将发布2025年《国家基本医疗保险、生育保险和工伤保险药品目录》和首版 《商业健康保险创新药品目录》。据了解,2025年国家基本医疗保险、生育保险和工伤保险药品目录是国家医保局成立以来的第8次 调整。本次目录调整新增114种药品,其中50种为1类创新药。首版商保创新药目录共纳入19种药品,既有CAR-T等肿瘤治疗药品,也 有社会关注度较高的阿尔茨海默病治疗药品 12月2日,中国药品价格登记系统在北京正式上线。这一全新的系统将有利于中国创新药走出去,构建全球化价格体系,也有助于吸 引更多国外高质量新药进入中国市场,惠及中国患者。 资料来源:第一财经,国家医保局,财联社,平安证券研究所 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. ...
首版商保创新药目录推出,恒瑞医药、海思科等多家药企上榜
Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory, set to be implemented nationwide from January 1, 2026 [1][2] Summary by Sections National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 of them being new products launched within the last five years, representing 97.3% of the new additions [2] - Among the new drugs, 50 are classified as Category 1 innovative drugs, with a success rate of 88%, an increase from 76% in 2024 [2] - The total number of drugs in the directory has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2] Company Announcements - Several listed companies, including Heng Rui Medicine, Fosun Pharma, and Hai Si Ke, announced new drug inclusions or renewals in the updated National Medical Insurance Directory [3] - Heng Rui Medicine reported that 20 products/indications were included, with significant coverage across various diseases such as tumors and cardiovascular conditions [3][4] - Hai Si Ke's two Category 1 innovative drugs were included, with one being a new addition and the other a renewal [4] Commercial Health Insurance Innovative Drug Directory - The first Commercial Health Insurance Innovative Drug Directory includes 19 new drugs from 18 innovative pharmaceutical companies, with 9 being Category 1 innovative drugs [7] - Notably, five CAR-T products were included, representing over half of the CAR-T products available in China, which previously faced challenges in entering the insurance market due to high pricing [7][8] - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the complementarity with the basic medical insurance [7][10] Notable Drug Inclusions - The directory includes drugs for significant diseases such as triple-negative breast cancer and pancreatic cancer, as well as treatments for rare diseases like Gaucher disease [5][9] - In the diabetes sector, several domestic drugs were newly included, such as a long-acting GLP-1 receptor agonist [6] - Companies like Bei Hai Kang Cheng and Bai Ji Shen Zhou have also successfully included their innovative drugs in the Commercial Health Insurance Directory [9]
银诺医药-B核心产品纳入《国家医保药品目录》
Zhi Tong Cai Jing· 2025-12-07 11:44
银诺医药-B(02591)发布公告,集团核心产品(即依苏帕格鲁肽α)已成功纳入中国最新版《国家医保药品 目录》(2025年版),用于治疗2型糖尿病("T2D")适应症。最新版《国家医保药品目录》将于2026年1月1 日正式生效。 ...
银诺医药-B(02591.HK):核心产品(即依苏帕格鲁肽α)成功纳入中国最新版《国家医保药品目录》
Ge Long Hui· 2025-12-07 11:30
依苏帕格鲁肽α是集团研发的国内首款原研人源长效GLP-1受体激动剂,并于今年1月在中国获批用于单 药治疗及联合二甲双胍治疗T2D。依苏帕格鲁肽α用于治疗T2D和其他代谢性疾病。依苏帕格鲁肽α的临 床研究证明其起效快、疗效强且持久、半衰期长及安全性良好。 格隆汇12月7日丨银诺医药-B(02591.HK)公告,集团核心产品(即依苏帕格鲁肽α)已成功纳入中国最新版 《国家医保药品目录》(2025年版)("《国家医保药品目录》"),用于治疗2型糖尿病("T2D")适应症。最新 版《国家医保药品目录》将于2026年1月1日正式生效。 依苏帕格鲁肽α起效快、疗效强且持久。在III期临床试验中,经过前4周的治疗,接受依苏帕格鲁肽α单 药治疗(3.0mg)的T2D患者的糖化血红蛋白(HbA1c)水平降低了1.1%。依苏帕格鲁肽α亦展现出卓越的降 糖效果。在一项随机双盲安慰剂对照III期临床试验中,1.0mg和3.0mg剂量的依苏帕格鲁肽α单药治疗在 第24周时使HbA1c分别较基线显著降低1.7%和2.2%,具有统计学和临床意义。 依苏帕格鲁肽α表现出长达204小时的平均半衰期。依苏帕格鲁肽α延长的长效作用能够在长期疾病管 ...
银诺医药-B再涨超6% 昨日股价飙涨超30% 公司获纳入恒生综指
Zhi Tong Cai Jing· 2025-11-25 05:54
银诺医药-B(02591)再涨超6%,昨日股价飙涨超30%。截至发稿,涨6.11%,报40.3港元,成交额2313.13 万港元。 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, 银诺医药获纳入恒生综合指数成份股。上海证券此前研报指出,银诺医药依苏帕格鲁肽α具有良好的安 全性和降糖、减重效果,在治疗糖尿病、肥胖、脂肪肝等慢性代谢性疾病方面表现显著优势,公司登陆 港交所有望推进研发管线及商业化拓展。 ...
银诺医药-B涨近10% 获纳入恒生综合指数 12月8日起生效
Zhi Tong Cai Jing· 2025-11-24 06:48
Core Viewpoint - Silver诺医药-B (02591) has seen a nearly 10% increase in stock price following its inclusion in the Hang Seng Composite Index, effective December 8, 2025, which is expected to enhance its market visibility and support its research and commercialization efforts [1] Group 1: Stock Performance - As of the report, Silver诺医药-B's stock price rose by 9.81%, reaching 31.8 HKD, with a trading volume of 2.7693 million HKD [1] Group 2: Clinical Trials and Product Development - On November 21, it was announced that Silver诺医药 has completed the first patient dosing in a Phase III clinical trial for its core product, Isuparaglutide α, aimed at treating obesity and overweight conditions, with plans to recruit approximately 800 participants [1] - The company has demonstrated that Isuparaglutide α has good safety profiles and significant effects in reducing blood sugar and weight, showing advantages in treating chronic metabolic diseases such as diabetes, obesity, and fatty liver [1] Group 3: Market Outlook and Competition - The GLP-1 sector remains a focus, with ongoing competition intensifying; stakeholders are advised to monitor the expansion of indications, submission for market approval, and the commercialization process [1]
从指数调整看创新药机遇,银诺医药-B入选恒生综合指数背后的逻辑
Sou Hu Cai Jing· 2025-11-24 04:01
Core Viewpoint - The inclusion of SINO Pharmaceutical-B (2591.HK) in the Hang Seng Composite Index marks a significant recognition of its investment value and lays the groundwork for its future inclusion in the Hong Kong Stock Connect program [1] Group 1: Market Performance and Recognition - SINO Pharmaceutical has demonstrated strong market performance since its listing, achieving a subscription rate of 5340 times during its IPO, making it the second most oversubscribed new stock of the year [2] - The company's stock price surged over 285% on its first trading day and maintained high interest, closing with a 206% increase, reflecting strong market recognition of its core value [2] - Despite experiencing short-term price adjustments due to market sentiment, the company's operational progress aligns with the broader trend of quality stocks in the innovative drug sector recovering in value [2] Group 2: R&D and Competitive Edge - SINO Pharmaceutical's R&D capabilities are a core competitive advantage, particularly in the efficiency of pipeline advancement and source innovation [4] - The company has positioned itself as a leader in the GLP-1 drug market with its product, Isu-Paglutide α, being the first GLP-1 drug approved in Asia and the third globally, showcasing its competitive edge [5] - The drug's long half-life allows for bi-weekly dosing, addressing patient compliance issues, which strengthens its market position [5] Group 3: Commercialization and Market Strategy - The rapid commercialization of Isu-Paglutide α, which generated revenue of 56.446 million yuan by June 30, demonstrates the company's effective commercialization capabilities [6] - The drug has successfully passed the formal review for inclusion in the National Medical Insurance Drug List, which could enhance its market penetration [6][7] - The company has established a robust commercialization team to support market entry and growth following the drug's inclusion in insurance [7] Group 4: Global Expansion and Market Positioning - SINO Pharmaceutical is leveraging its experience in the Greater Bay Area to create a replicable commercialization model for international markets [16] - The company is targeting emerging markets in Southeast Asia and Latin America, where there is a high demand for GLP-1 drugs due to insufficient supply [17][18] - SINO Pharmaceutical is also preparing to enter mainstream markets like Europe and the U.S. by accumulating necessary clinical data through ongoing trials [19] Group 5: Future Outlook and Investment Potential - The global market for anti-obesity drugs is projected to exceed $100 billion by 2030, positioning SINO Pharmaceutical favorably with its differentiated product offerings [21] - The company is expected to benefit from upcoming catalysts such as the results of insurance negotiations, BLA approvals in Southeast Asia, and the completion of clinical trials for obesity indications [21] - Current market conditions may present an opportune moment for investors to consider SINO Pharmaceutical as a key player in the valuation recovery of the Hong Kong pharmaceutical sector [21]
从指数调整看创新药机遇,银诺医药-B(2591.HK)入选恒生综合指数背后的板块逻辑
Ge Long Hui· 2025-11-24 02:20
Core Viewpoint - The inclusion of SINO Pharmaceutical-B (2591.HK) in the Hang Seng Composite Index marks a significant recognition of its investment value and lays the foundation for its future inclusion in the Hong Kong Stock Connect [1][2]. Company Performance - SINO Pharmaceutical has demonstrated strong market performance since its listing, achieving a subscription rate of 5340 times during its IPO, making it the second most oversubscribed new stock of the year [2]. - The company's stock price surged over 285% on its first trading day and closed up 206%, reflecting high market recognition of its core value [2]. - Despite experiencing short-term price adjustments due to market sentiment, the company's core operational actions have remained steady, aligning with the logic of prioritizing quality stocks for recovery [2]. Research and Development - SINO Pharmaceutical's R&D capabilities are a key competitive advantage, particularly in pipeline advancement and source innovation [4]. - The company has successfully launched its GLP-1 drug, Isu-Paglutide α, becoming the first in Asia to do so and the third globally, showcasing its leading clinical advancement efficiency [5]. - The drug's long half-life supports bi-weekly dosing, addressing patient compliance issues, which strengthens its competitive position in the market [5]. Market Strategy - The rapid commercialization of Isu-Paglutide α in China, with revenues of 56.446 million yuan by June 30, demonstrates the company's effective commercialization capabilities [6]. - The drug has passed the formal review for inclusion in the National Medical Insurance Drug List, which could enhance its market penetration [6][7]. - The company is expanding its indications for Isu-Paglutide α, with ongoing clinical trials for obesity and metabolic dysfunction-related fatty liver disease (MASH), which broadens its growth potential [7]. Innovation Pipeline - SINO Pharmaceutical has a robust pipeline with five preclinical candidates targeting various diseases, indicating its commitment to true innovation rather than following existing treatments [8][10]. - The company’s new targets are designed to address unmet clinical needs, positioning it for potential industry disruption [10][11]. Global Expansion - The company is building a global presence with a focus on emerging markets, leveraging its clinical data from China to gain regulatory approvals [15][17]. - SINO Pharmaceutical has achieved commercial success in Macau and is applying for BLA in Southeast Asia and Latin America, aiming to capture market share in regions with high unmet medical needs [16][18]. - The company is also preparing for entry into mainstream markets like Europe and the U.S. by accumulating necessary clinical data through ongoing trials [19]. Industry Outlook - The global market for GLP-1 drugs is expected to expand significantly, with projections indicating it could exceed $100 billion by 2030 [21]. - SINO Pharmaceutical's differentiated product offerings and global strategy align with institutional expectations for innovation value pricing [21]. - The company is positioned to benefit from upcoming catalysts, including insurance negotiations and clinical trial milestones, which could enhance its fundamental value [21].