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通化东宝:利拉鲁肽注射液获巴西GMP证书
Zhong Zheng Wang· 2026-02-28 03:24
通化东宝与科兴制药达成出海合作以来,双方发挥各自优势,高效协同,积极推进利拉鲁肽注射液海外 注册、GMP审计等工作。2025年4月,产品获得哥伦比亚GMP证书;2025年11月,产品在秘鲁获批上 市。此次,该产品再获巴西GMP证书,通化东宝产品已在拉美市场形成多点突破的良好格局,国际化 步伐持续提速。 拉美等新兴市场糖尿病患病率高、患者数量增长迅速,对高品质、高可及性的生物药需求日益迫切。在 此背景下,通化东宝利拉鲁肽注射液产品将为当地患者提供更丰富的治疗选择。 中证报中证网讯(记者宋维东)日前,通化东宝(600867)与合作伙伴科兴制药携手的出海产品利拉鲁肽 注射液获得巴西国家卫生监督局(ANVISA)颁发的药品生产质量管理规范(GMP)证书。此举标志着通化 东宝利拉鲁肽注射液在拉美核心市场的合规化进程迈入新阶段,为产品登陆巴西市场筑牢核心资质基 础,这也是公司GLP-1类产品国际化布局的又一重要进展。 作为全球医药领域公认的高标准药品质量管理体系,PIC/S成员国的GMP认证以严苛、规范、互认度高 著称。巴西作为拉美地区核心的医药市场与PIC/S(国际药品认证合作组织)重要成员国,ANVISA监管体 系与 ...
通化东宝:与惠升生物合作 有望丰富内分泌代谢领域产品矩阵
Zhong Zheng Wang· 2026-02-27 03:05
中证报中证网讯(记者 宋维东)记者2月27日从通化东宝(600867)获悉,公司日前与港股上市公司四 环医药控股子公司惠升生物签署《商业化合作协议》。双方携手布局糖尿病治疗领域,实现资源互补、 协同发展。本次合作,将进一步丰富通化东宝在内分泌代谢领域的产品矩阵,持续巩固其在糖尿病治疗 领域的综合竞争力,为长期、可持续发展增添动能;惠升生物也有望借此次合作快速提升相关产品的市 场渗透率,进一步释放产品市场价值。双方将以此次合作为契机,共同推动优质国产胰岛素产品惠及更 广泛患者群体,实现互利共赢与高质量发展。 作为国产胰岛素龙头企业,通化东宝深耕糖尿病用药领域多年,拥有深厚的市场基础、成熟的商业化体 系及良好的品牌影响力,产品市场占有率长期位居国内同类产品前列。公司构建的覆盖全国的成熟商业 化网络,深入各级医疗机构与基层市场,具备高效推进产品准入、学术推广及终端放量的综合能力,能 为产品实现快速、广泛市场覆盖提供坚实支撑。此次合作,立足于通化东宝与惠升生物在各自领域的深 厚积淀,双方均对合作前景高度认可。未来,通化东宝将发挥内分泌代谢领域的商业化优势,加速惠优 加、惠优达市场推广与临床应用;惠升生物将持续增强研发 ...
通化东宝出海迎新进展,利拉鲁肽获巴西GMP证书
Quan Jing Wang· 2026-02-26 12:49
资料显示,2025年巴西人口约2.1亿,拥有庞大且不断增长的糖尿病患者群体,对于GLP-1这类降糖和减 重效果显著的产品,市场需求非常旺盛。 2025年以来,通化东宝国际化战略全面发力,海外收入延续高速增长势头,多款产品斩获国际注册重要 进展,海外产品矩阵与市场布局不断完善。在GLP-1类产品方面,2025年4月产品获得哥伦比亚GMP证 书,同年11月在秘鲁获批上市,此次再获巴西市场突破,标志着公司在拉美市场的系统性布局已见成 效,也为后续进入其他PIC/S成员国奠定基础,提供了有力的资质背书。 2月26日,通化东宝宣布,其与科兴制药携手出海的产品——利拉鲁肽注射液,正式获得 PIC/S(国际 药品认证合作组织)成员国巴西国家卫生监督局(ANVISA)颁发的药品生产质量管理规范(GMP)证 书,此项进展标志着通化东宝利拉鲁肽注射液在拉美核心市场的合规化进程迈入新阶段,也为产品正式 登陆巴西市场筑牢核心资质基础,是公司 GLP-1 类产品国际化布局的又一关键进展。 根据公开信息,利拉鲁肽作为一种人胰高血糖素样肽-1(GLP-1)类似物,可激活人GLP-1受体,促进 胰腺分泌胰岛素,可单独使用或与其他降糖药联合使 ...
通化东宝完成治理整改并预盈,股价震荡下行
Jing Ji Guan Cha Wang· 2026-02-14 08:02
Group 1 - The core viewpoint of the news is that Tonghua Dongbao has completed its governance rectification and is expected to achieve a profit in 2025, with a projected net profit of approximately 1.242 billion yuan, driven by the rapid growth of insulin analog products and international expansion [1] - The company emphasizes adherence to the "Code of Corporate Governance for Listed Companies" to ensure operational independence across various aspects [1] - Recent industry analysis indicates that the disruptions from centralized procurement have largely cleared, with innovation and international expansion becoming new growth points for the company [1] Group 2 - In the recent stock performance, Tonghua Dongbao's share price has shown a downward trend, closing at 8.70 yuan on February 13, down 4.19% from the previous week [2] - The stock's trading range has been 10.02%, with a net outflow of 6.6366 million yuan from major investors on February 13, reflecting cautious market sentiment [2] - The pharmaceutical and biotechnology sector has seen a decline of 5.30% during the same period, with Tonghua Dongbao's performance slightly better than the industry average [2] Group 3 - Institutional views indicate a neutral sentiment towards Tonghua Dongbao, with a target price of 10.92 yuan, suggesting a potential upside of 25.52% from the current price [3] - Profit forecasts from 21 institutions estimate a net profit of 1.242 billion yuan for 2025, representing a year-on-year growth of 3007.39%, although a decline to 815 million yuan is expected in 2026 due to reduced non-recurring income [3] - Analysts note that the company's revenue from insulin analogs has surpassed that of second-generation insulin, and internationalization is progressing steadily, though competition and R&D risks should be monitored [3]
通化东宝药业股份有限公司 关于对吉林证监局监督管理措施决定的整改报告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-02-10 23:11
Core Viewpoint - The company has received a regulatory decision from the Jilin Securities Regulatory Bureau, requiring it to rectify issues related to its governance and independence, particularly concerning its relationship with its controlling shareholder, Dongbao Group [1][2]. Group 1: Regulatory Decision and Company Response - The company has acknowledged the regulatory decision and has communicated it to relevant stakeholders, including its controlling shareholder and management [2]. - A board meeting was held to review and approve a rectification report in response to the regulatory decision [2]. Group 2: Identified Issues and Rectification Measures - The company and its controlling shareholder have been found to have overlapping property usage without formal rental agreements, indicating a lack of independence [3]. - To address this, the company signed a property lease agreement with Dongbao Group, specifying the rental terms for shared properties, ensuring market-based pricing for rent [4][5]. - The company will enhance training for its management and board members on compliance with relevant laws and regulations to improve operational standards [6]. Group 3: Rectification Status and Future Plans - The company has appointed specific individuals and departments responsible for the rectification process, and the measures have been completed [7]. - The company plans to maintain a focus on standardized governance and independence management in the long term [7]. - The regulatory inspection has provided valuable guidance for improving the company's governance level, and the company aims to strengthen its compliance and risk management systems [8].
通化东宝(600867) - 通化东宝关于对吉林证监局行政监管措施决定的整改报告
2026-02-10 08:00
证券代码:600867 证券简称:通化东宝 公告编号:2026-013 通化东宝药业股份有限公司 关于对吉林证监局监督管理措施决定的整改报告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 通化东宝药业股份有限公司(以下简称"公司")于近日收到中国证券监督管理委 员会吉林监管局(以下简称"吉林证监局")出具的《关于对通化东宝药业股份有限公 司采取责令改正并对李佳鸿采取出具警示函监督管理措施的决定》(吉证监决[2026]3 号)(以下简称"《决定书》"),要求公司就《决定书》中所提出的问题进行整改。 内容详见公司于2026年1月31日在上海证券交易所网站(www.sse.com.cn)披露的《关 于收到吉林证监局行政监管措施决定书的公告》(公告编号:2026-011)。 收到《决定书》后,公司及董事长高度重视,立即向控股股东东宝实业集团股份有 限公司(以下简称"东宝集团")、公司董事、高级管理人员及相关部门负责人进行 通报和传达,对《决定书》中涉及的事项进行全面梳理和深入分析,严格遵照《公司 法》《证券法》《上市公司治理准则》《 ...
GLP-1类药物成全球新药“销冠” 国内多家上市公司已“跃跃欲试”
Zheng Quan Ri Bao Wang· 2026-02-05 11:11
Group 1: Market Overview - The global sales of GLP-1 drugs have surpassed Merck's Keytruda, with Eli Lilly's Tirzepatide generating $36.5 billion and Novo Nordisk's Semaglutide achieving $36.1 billion in 2025 [1] - The sales of Tirzepatide's weight loss indication increased by 175% year-on-year, while the diabetes indication grew by 99% [1] - The potential patient market for weight loss is significantly large, indicating a strong demand for GLP-1 drugs [1] Group 2: Company Developments - Several domestic companies, including Innovent Biologics, Jiangsu Hengrui Medicine, Tonghua Dongbao, and East China Pharmaceutical, are actively developing GLP-1 drugs to meet weight loss market demands [2] - Innovent Biologics' GLP-1 weight loss drug, Sema, has been approved for sale in China, contributing to the company's revenue growth, which is expected to exceed 10 billion yuan in 2025 [3] - Hengrui Medicine is developing HRS9531, which shows promising results in weight loss and blood sugar control, while also improving cardiovascular and renal risk factors [4] Group 3: Competitive Strategies - Companies are adopting differentiated strategies in drug development, such as creating oral formulations, extending drug half-lives, and innovating sales models [5] - Hengrui Medicine is focusing on developing a GLP-1/GIP dual receptor agonist, which aims to enhance efficacy and safety [5] - Tonghua Dongbao is also working on a GLP-1/GIP dual receptor agonist, with clinical trials progressing smoothly [5] Group 4: Research and Development Focus - Innovent Biologics is expanding its research pipeline to include long-acting, oral, and multi-target projects, aiming to provide more effective treatment options [6] - East China Pharmaceutical is developing an oral small molecule GLP-1 drug, with successful completion of all subject enrollments for its clinical phase III study in weight management [6]
A股退税商店板块持续走高,茂业商业直线拉升触达涨停
Mei Ri Jing Ji Xin Wen· 2026-02-05 06:44
Group 1 - The A-share tax refund store sector has shown a continuous rise, with Maoye Commercial reaching the daily limit increase [2] - Hangzhou Xie Bai previously hit the daily limit, while Bai Da Group increased by over 5% [2] - Other stocks such as Guangbai Co., Hebai Group, Yuyuan, Bailian Group, and New World also experienced gains [2]
通化东宝股价涨5.17%,南方基金旗下1只基金位居十大流通股东,持有1705.39万股浮盈赚取767.43万元
Xin Lang Cai Jing· 2026-02-05 02:07
Group 1 - Tsinghua Dongbao's stock price increased by 5.17% to 9.15 CNY per share, with a trading volume of 269 million CNY and a turnover rate of 1.53%, resulting in a total market capitalization of 17.921 billion CNY [1] - Tsinghua Dongbao Pharmaceutical Co., Ltd. was established on December 28, 1992, and went public on August 24, 1994. The company specializes in hard capsule preparations, tablets (including hormone types), granules, small-volume injections, raw materials (recombinant human insulin), and biopharmaceutical products (recombinant human insulin injection) [1] - The main business revenue composition includes: biopharmaceuticals (raw materials and formulations) at 90.29%, medical devices such as injection pens and blood glucose test strips at 6.07%, traditional Chinese medicine and chemical drugs at 2.24%, and others at 1.27% [1] Group 2 - Among Tsinghua Dongbao's top ten circulating shareholders, a fund under Southern Fund holds a significant position. The Southern CSI 500 ETF (510500) reduced its holdings by 352,900 shares in the third quarter, now holding 17.0539 million shares, which accounts for 0.87% of circulating shares [2] - The Southern CSI 500 ETF (510500) was established on February 6, 2013, with a latest scale of 144.69 billion CNY. Year-to-date returns are 11.19%, ranking 482 out of 5566 in its category, while the one-year return is 51.04%, ranking 1152 out of 4285 [2]
2026年全球及中国糖尿病用药行业发展历程、产业链、发展现状、竞争格局及趋势研判:糖尿病患者人数持续增加,推动糖尿病用药需求显著增长[图]
Chan Ye Xin Xi Wang· 2026-02-05 01:20
Core Viewpoint - The diabetes medication market in China is experiencing rapid growth due to the increasing prevalence of diabetes driven by an aging population and rising obesity rates, alongside improvements in healthcare infrastructure and public awareness [1][8]. Industry Overview - Diabetes is characterized by chronic hyperglycemia due to insulin secretion and/or utilization defects, classified into Type 1, Type 2, gestational diabetes, and other specific types [2]. - Diabetes medications are categorized into eight classes, including insulin secretagogues, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, DPP-4 inhibitors, SGLT-2 inhibitors, insulin, and GLP-1 receptor agonists [2]. Market Growth - The market size for diabetes medications in China is projected to grow from 47 billion yuan in 2016 to 80.2 billion yuan in 2024, with a compound annual growth rate (CAGR) of 6.91% [1][8]. - By 2025, the market size is expected to reach approximately 85.7 billion yuan [1]. Patient Demographics - The number of diabetes patients in China is expected to increase from 118 million in 2016 to 148 million by 2024, with a CAGR of 2.87% [6][8]. - The adult diabetes prevalence rate in China is currently at 13.79%, which is significantly higher than the global average [6]. Competitive Landscape - The diabetes medication industry in China features a tiered competitive structure, with multinational companies like Novo Nordisk, Sanofi, Eli Lilly, and AstraZeneca leading the first tier due to their innovative drug development capabilities [8]. - Domestic companies such as Tonghua Dongbao, Gan & Lee Pharmaceuticals, and Huadong Medicine are emerging as strong competitors in the second tier, particularly in insulin and oral hypoglycemic agents [8]. Industry Trends - Future research and development in diabetes medications will focus on precision and individualized treatment, targeting specific mechanisms of Type 2 diabetes [12]. - The industry is expected to prioritize long-acting, multi-target drugs that modify disease progression, moving beyond mere blood sugar control [13]. - Companies will shift from being mere drug providers to comprehensive health management partners for diabetes patients, utilizing digital health technologies for continuous monitoring and personalized care [14].