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通化东宝甘精胰岛素注射液获得缅甸上市许可
Zheng Quan Shi Bao· 2025-10-10 19:35
据通化东宝10月10日晚最新公告,甘精胰岛素是长效胰岛素类似物产品,每天注射一次,注射起效后作 用时间可持续24小时,具有血药浓度无峰值、平稳地降低患者血糖的作用。截至2025年8月,缅甸总人 口约5130万人。近年来,人口老龄化、城市化、生活方式改变等趋势和慢性病患者数量的增加推动缅甸 医疗需求持续提升。国际糖尿病联盟(IDF)发布的全球糖尿病概览第11版(2024)数据显示,2024年 缅甸20—79岁的糖尿病患者规模上升至236.58万人,20—79岁的成年人糖尿病患病率为6.4%,未被确诊 的糖尿病患者人数占糖尿病总患病人数的比例达49.7%,患者人均糖尿病相关年度支出金额为164.1美 元。 通化东宝表示,公司以药品上市许可持有人身份获得缅甸联邦共和国政府卫生部下发的甘精胰岛素注射 液的上市许可,有利于丰富公司国际市场产品线,提升品牌形象,拓展国际业务,并为后续海外市场准 入申报提供可复制的经验路径,助力加速新兴市场布局,提高公司国际市场竞争力。公司已开展产品上 市销售的前期准备工作,但产品的具体销售情况可能受到市场需求变化、政策环境变化、市场竞争等因 素影响,具有不确定性。 (文章来源:证券时报) ...
通化东宝甘精胰岛素注射液 获得缅甸上市许可
Zheng Quan Shi Bao· 2025-10-10 18:16
通化东宝(600867)10月10日晚公告,公司于近日收到缅甸联邦共和国政府卫生部核准并签发的公司产 品甘精胰岛素注射液的上市许可。 据通化东宝10月10日晚最新公告,甘精胰岛素是长效胰岛素类似物产品,每天注射一次,注射起效后作 用时间可持续24小时,具有血药浓度无峰值、平稳地降低患者血糖的作用。截至2025年8月,缅甸总人 口约5130万人。近年来,人口老龄化、城市化、生活方式改变等趋势和慢性病患者数量的增加推动缅甸 医疗需求持续提升。国际糖尿病联盟(IDF)发布的全球糖尿病概览第11版(2024)数据显示,2024年缅甸20 —79岁的糖尿病患者规模上升至236.58万人,20—79岁的成年人糖尿病患病率为6.4%,未被确诊的糖尿 病患者人数占糖尿病总患病人数的比例达49.7%,患者人均糖尿病相关年度支出金额为164.1美元。 通化东宝表示,公司以药品上市许可持有人身份获得缅甸联邦共和国政府卫生部下发的甘精胰岛素注射 液的上市许可,有利于丰富公司国际市场产品线,提升品牌形象,拓展国际业务,并为后续海外市场准 入申报提供可复制的经验路径,助力加速新兴市场布局,提高公司国际市场竞争力。公司已开展产品上 市销售 ...
通化东宝:甘精胰岛素注射液获得缅甸上市许可
Xin Lang Cai Jing· 2025-10-10 09:01
通化东宝(600867.SH)公告称,公司于近日收到缅甸联邦共和国政府卫生部核准签发的公司产品甘精胰 岛素注射液的上市许可。该产品为长效胰岛素类似物,具有平稳降低患者血糖的作用。2024年缅甸患者 人均糖尿病相关年度支出金额为164.1美元。 ...
替尔泊肽显著改善糖尿病患者肌肉质量!基于英国生物库MRI数据验证的肌肉健康新证据
GLP1减重宝典· 2025-10-08 06:54
以下文章来源于内分泌早知道 ,作者关注内分泌的 内分泌早知道 . 深度分享内分泌用药经验、病例剖析、指南专业解读并紧跟国内外内分泌领域前沿进展,「每医健」旗下内容平台。 核心发现: 1. 全球首次证实:GLP- 1 /GIP双受体激动剂Tir z e pa ti de能有效减少2型糖尿病患者肌肉脂肪沉积,同时保持肌肉量合理变化 2. 5 2周治疗数据显示:患者体重显著降低同时,肌肉脂肪浸润程度明显改善,肌肉量变化与体重下降呈科学匹配 3. 创新研究方法:结合UK Bi oba nk近3000例真实世界数据,为临床结果提供精准参照系 研究价值与发表背景 这项具有里程碑意义的研究源自SURPASS- 3临床试验的MRI亚组分析,最新发表于《柳叶刀·糖尿病与内分泌学》2025年6月刊。研究 团队采用高精度MRI技术,系统对比了Tir z e pa ti de与德谷胰岛素治疗5 2周后,2型糖尿病患者大腿肌肉体积、脂肪浸润程度及标准化Z 分数的动态变化。 研究突破性地引入英国生物库大规模人群数据,首次建立了糖尿病药物治疗与肌肉健康变化的科学评价体系。这不仅为Tir z e p a ti de的 临床优势提供了影像学证 ...
诺和诺德(NVO.US)两款新药在美递交上市申请 依柯胰岛素已在欧盟和中国获批
智通财经网· 2025-09-30 13:32
智通财经APP获悉,9月29日,诺和诺德(NVO.US)宣布已向FDA递交依柯胰岛素(icodec)和Mim8的上市 申请,前者用于治疗2型糖尿病,后者用于治疗A型血友病。目前,依柯胰岛素已在欧盟和中国获批用 于治疗2型糖尿病。 依柯胰岛素是诺和诺德在口服胰岛素OI338的基础上设计的一款超长效胰岛素制剂,人体内半衰期长达 196h。其核心设计在于:①将18C长链脂肪酸替换为20C长链脂肪酸,提高分子与人血清白蛋白的结合 亲和力;②将B链16位Tyr(酪氨酸)替换为His(组氨酸),降低分子对人胰岛素受体的亲和力。 诺和诺德曾在2023年4月第一次向FDA提交依柯胰岛素的生物制品许可申请(BLA),当时申请的适应症 为1型糖尿病和2型糖尿病。2024年5月,FDA内分泌和代谢药物咨询委员会召开会议讨论了依柯胰岛素 治疗1型糖尿病的获益与风险。最终,委员会认为现有数据不足以得出依柯胰岛素治疗1型糖尿病的获 益-风险情况呈积极的结论。此次重新递交BLA,诺和诺德将依柯胰岛素的适应症缩小至2型糖尿病,申 请依据包括5项III期ONWARDS研究。 血友病是一种罕见的遗传性出血性疾病,会损害人体形成血栓的能力,而血栓 ...
两年叫停2款降糖1类新药研发 亚宝药业为何在热门赛道“栽跟头”?
Mei Ri Jing Ji Xin Wen· 2025-09-25 13:16
Group 1 - The core point of the article is that Yabao Pharmaceutical has halted the clinical research of SY-009, an SGLT-1 inhibitor, due to unsatisfactory results from its Phase II clinical trial, marking the second failure in diabetes drug development for the company [1][2][3] - Yabao Pharmaceutical, originally focused on pediatric drugs, aims to transition towards innovative drugs, reducing the proportion of generic drugs from 90% to 40% and increasing investment in innovative drug development [2][3] - The decision to terminate SY-009's clinical research was based on a careful assessment of the investment risks and future market value, leading to a significant write-off of previous R&D investments totaling approximately 87.87 million yuan [3] Group 2 - The global diabetes market is projected to approach $80 billion by 2024, with China's market exceeding 70 billion yuan, indicating a vast potential for diabetes treatment [4] - The competition in diabetes treatment is intense, with ten classes of oral medications available for Type 2 diabetes, but SGLT-1 inhibitors are rarely pursued by companies [4][5] - The focus of major pharmaceutical companies has shifted towards GLP-1 class drugs due to their proven efficacy and market potential, which has led to a changing competitive landscape in diabetes medications since 2019 [6]
Arecor announces Co-development Agreement with US Insulin Pump Device Company for AT278 & Sale of Royalty Rights and Technology Access Fees for AT220 and AT292
Globenewswire· 2025-09-25 06:30
Core Viewpoint - Arecor Therapeutics has entered a co-development agreement with Sequel Med Tech for AT278, an ultra-concentrated insulin, and secured up to $11 million in non-dilutive funding through a royalty financing agreement with Ligand Pharmaceuticals, enhancing its strategic position in the diabetes management market [2][3][19]. Co-Development Agreement - Arecor and Sequel will co-fund development activities for the AT278-AID System, with each company committing up to $1.3 million to prepare for Phase 2 clinical trials [5][6]. - The collaboration aims to leverage Sequel's advanced AID technology, which offers superior dosing accuracy and faster occlusion detection, making it a suitable partner for AT278 [4][10]. Financial Aspects - The royalty financing agreement with Ligand includes a $7 million upfront payment and an additional $4 million contingent on achieving commercial milestones, extending Arecor's cash runway to the first half of 2027 [15][19]. - Arecor has monetized royalty rights related to AT220 and technology access fees for AT292, providing immediate capital for ongoing development [14][18]. Market Opportunity - The total addressable US insulin revenue market for AT278 is estimated at approximately $2.9 billion, targeting high-need segments such as patients requiring high daily insulin doses and those seeking extended-wear devices [11][12]. - The partnership with Sequel is expected to address unmet needs in diabetes management, potentially leading to significant growth opportunities for Arecor [7][11]. Strategic Intent - Both companies intend to establish a broader co-development and commercialization partnership for AT278, aiming to meet the needs of patients with Type 1 and Type 2 diabetes [7][13]. - Arecor's focus on high-value R&D opportunities is exemplified by the development of AT278 and a novel oral delivery platform for peptides, which are seen as key to generating shareholder value [13][18].
微泰医疗-B涨超4% Equil贴敷式胰岛素泵儿童及青少年适应症获批
Zhi Tong Cai Jing· 2025-09-25 03:04
Core Viewpoint - MicroTech Medical-B (02235) has seen a stock increase of over 4%, currently trading at 8.06 HKD, following the approval of its core product, the Equil patch insulin pump, for use in children and adolescents aged 3-17 years with diabetes, expanding its market reach significantly [1][1][1] Group 1: Product Approval and Market Expansion - The National Medical Products Administration (NMPA) has approved the Equil patch insulin pump for pediatric use, which previously was only available for adult diabetes patients [1][1] - This approval provides a new treatment option for millions of children and adolescents with diabetes in China [1][1] Group 2: Clinical Trials and Efficacy - The clinical trials for this indication were led by the Children's Hospital affiliated with Zhejiang University School of Medicine, in collaboration with six top children's hospitals across the country [1][1] - The trials demonstrated the effectiveness and safety of Continuous Subcutaneous Insulin Infusion (CSII) in treating diabetes in children and adolescents [1][1] Group 3: Product Advantages - The patch insulin pump offers several advantages over traditional tube-based insulin pumps, including more precise and safe insulin delivery, ease of use, cost-effectiveness, enhanced privacy, and elimination of issues such as tube blockage and tangling [1][1][1]
两年叫停2款降糖1类新药研发 亚宝药业为何在热门赛道栽跟头?
Mei Ri Jing Ji Xin Wen· 2025-09-24 14:03
Core Viewpoint - A domestic pharmaceutical company, Yabao Pharmaceutical, has halted the clinical research of its oral drug SY-009, an SGLT1 inhibitor, due to unsatisfactory results from its Phase II clinical trial, marking the second failure in diabetes drug development for the company [1][2]. Group 1: Company Overview - Yabao Pharmaceutical, originally focused on pediatric drugs, is transitioning towards innovative drugs, aiming to reduce its reliance on generic drugs from 90% to 40% by 2024 [1]. - The company has invested a total of 87.87 million yuan in the development of SY-009, which will be written off as a loss due to the termination of the project [2]. Group 2: Drug Development Details - SY-009 was approved for clinical trials in July 2018 and underwent three Phase I and one Phase II clinical trials over nearly six years [2]. - The Phase II trial results indicated a lack of achievement in primary efficacy endpoints, leading to the decision to terminate further development [2][3]. Group 3: Market Context - The global diabetes treatment market is projected to reach nearly $80 billion by 2024, with China's market exceeding 70 billion yuan [3]. - The competition in diabetes treatment is intense, with various classes of oral medications available, but SGLT1 inhibitors have limited presence in the market [3][4]. - The rise of GLP-1 class drugs has shifted the competitive landscape in diabetes treatment, with significant market potential and ongoing exploration of new indications [5].
诺和诺德(NVO.US)每周注射糖尿病药物Kyinsu于欧盟获批
Zhi Tong Cai Jing· 2025-09-19 11:53
Core Viewpoint - Novo Nordisk's weekly injectable diabetes drug has received EU approval, providing patients with an additional treatment option [1] Group 1: Drug Approval and Composition - The European Medicines Agency's drug review panel recommended the approval of Kyinsu for treating type 2 diabetes patients [1] - The drug is a combination of insulin and semaglutide, the active ingredient in Novo Nordisk's popular weight loss drug Ozempic, and is also known as IcoSema [1] Group 2: Clinical Efficacy - Clinical trials indicate that the drug helps type 2 diabetes patients better control their weight and lower blood sugar levels, outperforming daily insulin injections [1] - The drug is particularly beneficial for patients who struggle to manage diabetes through daily insulin injections [1] Group 3: Regulatory Challenges - The long-acting insulin component of the drug was previously rejected by the U.S. Food and Drug Administration due to the need for more detailed information regarding the manufacturing process and indications for type 1 diabetes [1]