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通化东宝:国际化拓展加快推进 门冬胰岛素注射液在印尼获批上市
Core Viewpoint - Tonghua Dongbao has received approval from the Indonesian Food and Drug Authority for the registration of its Aspart Insulin Injection, marking a significant step in the company's international expansion and addressing the growing diabetes treatment needs in Indonesia [1][2]. Group 1: Product Approval and Market Expansion - The approval of Aspart Insulin Injection allows Tonghua Dongbao to sell this product in Indonesia, a major market, following its previous success in Myanmar [1]. - The company has been accelerating its internationalization efforts, achieving important milestones in markets such as Uzbekistan, Nicaragua, Myanmar, and Indonesia this year [2]. - The approval signifies a shift from a focus on raw human insulin to a more diverse product portfolio, including both raw materials and formulations, establishing a robust overseas product system [2]. Group 2: Market Demand and Patient Needs - Indonesia has a rising demand for medical services, with the International Diabetes Federation reporting that the number of diabetes patients aged 20-79 is expected to reach 20.43 million in 2024, with a prevalence rate of 11.0% [1]. - There is a significant gap in diabetes diagnosis and treatment in Indonesia, with 73.2% of diabetes patients undiagnosed, highlighting the urgent need for effective treatment options [1]. Group 3: Future Strategy and Goals - Tonghua Dongbao plans to leverage its production advantages to provide safe, effective, and affordable medical products for endocrine patients globally, aiming to expand its overseas sales [3]. - The company intends to continue registering its insulin products in more countries, starting from Indonesia and Myanmar, and is also focused on advancing the regulatory processes for its products in the U.S. and Europe [3].
通化东宝:关于门冬胰岛素注射液获得境外药品注册证书的公告
Core Viewpoint - Tonghua Dongbao has received the drug registration certificate for insulin aspart injection from the Indonesian Food and Drug Authority, indicating a significant regulatory approval for the company’s product in the Indonesian market [1] Group 1 - The company announced the receipt of the drug registration certificate on October 24 [1] - The registration number for the insulin aspart injection is DKI2570600143A1 [1]
通化东宝:产品门冬胰岛素注射液取得注册证
Mei Ri Jing Ji Xin Wen· 2025-10-24 08:50
Group 1 - Tonghua Dongbao Pharmaceutical Co., Ltd. has recently received the drug registration certificate for insulin aspart injection from the Indonesian Food and Drug Authority [1] - The Chinese innovative drug sector has sold overseas authorizations worth $80 billion this year [1] - The secondary market for biopharmaceuticals is currently thriving, while the primary market is experiencing a cooling in fundraising [1]
通化东宝(600867) - 通化东宝关于门冬胰岛素注射液获得境外药品注册证书的公告
2025-10-24 08:00
证券代码:600867 证券简称:通化东宝 公告编号:2025-071 通化东宝药业股份有限公司 关于门冬胰岛素注射液 获得境外药品注册证书的公告 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"或"通化东宝")于近日 收到印度尼西亚共和国食品药品监督管理局核准签发的门冬胰岛素注射液的药 品注册证书(注册证号:DKI2570600143A1)。现将相关情况公告如下: 一、公司产品获得境外药品注册证书情况 1.药品名称:EZ RAPID 二、药品的其他相关情况 门冬胰岛素注射液是一种速效胰岛素类似物,皮下注射后 10-20 分钟起效, 作用持续时间 3-5 个小时,主要控制餐后血糖。门冬胰岛素通常在餐前即刻给药, 必要时也可在餐后立即给药。门冬胰岛素具有起效快,作用持续时间较短,通常 与长效胰岛素联合使用以实现患者的基础与餐后血糖控制。 印度尼西亚位于亚洲东南部,是"一带一路"沿线重要国家。印度尼西亚是 东南亚最大经济体,总人口 2.81 亿(2024 年),为世界第四人口大国。 近年来 ...
通化东宝:门冬胰岛素注射液获得境外药品注册证书
Xin Lang Cai Jing· 2025-10-24 07:57
Core Insights - The company, Tonghua Dongbao, has received approval from the Indonesian Food and Drug Authority for the registration of its insulin aspart injection [1] Group 1 - The insulin aspart injection is a rapid-acting insulin analog that begins to take effect 10-20 minutes after subcutaneous injection [1] - The duration of action for the insulin aspart injection is 3-5 hours, primarily used for controlling postprandial blood glucose levels [1]
通化东宝(600867.SH):门冬胰岛素注射液获得境外药品注册证书
智通财经网· 2025-10-24 07:49
Core Viewpoint - Tonghua Dongbao has received the drug registration certificate for insulin aspart injection from the Indonesian Food and Drug Authority, allowing the company to sell this product in Indonesia, which enhances its international market presence and competitiveness [1] Group 1: Product Information - Insulin aspart injection is a rapid-acting insulin analog that takes effect within 10-20 minutes after subcutaneous injection and lasts for 3-5 hours, primarily used to control postprandial blood sugar [1] - Insulin aspart is typically administered immediately before meals and can also be given right after meals if necessary, often in combination with long-acting insulin for comprehensive blood sugar management [1] Group 2: Strategic Implications - The approval of insulin aspart injection by the Indonesian authority signifies that Tonghua Dongbao is now permitted to market this product in Indonesia, which is beneficial for expanding the company's international product line [1] - This development is expected to enhance the company's brand image, facilitate the expansion of international business, accelerate its presence in emerging markets, and improve its competitiveness in the global market [1]
通化东宝(600867) - 通化东宝2025年第三次临时股东会会议资料
2025-10-24 07:45
通化东宝药业股份有限公司 2025 年第三次临时股东会会议资料 股票简称:通化东宝 股票代码:600867 二〇二五年十一月三日 1 通化东宝药业股份有限公司 2025 年第三次临时股东会会议资料 目 录 | 2025 | 年第三次临时股东会会议议程 | 3 | | --- | --- | --- | | 议案 | 1:关于取消监事会并修订《公司章程》的议案 | 5 | | 议案 | 2:关于修订和新增公司部分治理制度的议案 | 6 | | 议案 | 3:关于变更会计师事务所的议案 | 7 | 2 通化东宝药业股份有限公司 2025 年第三次临时股东会会议资料 2025 年第三次临时股东会 会议议程 一、会议时间: 现场会议时间:2025 年 11 月 3 日上午 10 时 网络投票时间:网络投票起止时间:自 2025 年 11 月 3 日 至 2025 年 11 月 3 日 (五)休会统计表决结果 统计各项议案的现场表决结果,将现场投票数据上传至上海证券交易所信息 3 (一)主持人宣布会议开始 (二)推选股东会监票人和计票人 通化东宝药业股份有限公司 2025 年第三次临时股东会会议资料 网络公司,下载网络 ...
通化东宝:门冬胰岛素注射液获印度尼西亚药品注册证书
Xin Lang Cai Jing· 2025-10-24 07:38
Core Viewpoint - The company has received approval from the Indonesian Food and Drug Authority for the registration of its rapid-acting insulin aspart injection, which will enhance its international product line and competitiveness in emerging markets [1] Group 1 - The company has been granted a drug registration certificate for insulin aspart injection (registration number: DKI2570600143A1) by the Indonesian Republic Food and Drug Authority [1] - Insulin aspart is a rapid-acting insulin analog that begins to take effect 10-20 minutes after subcutaneous injection and lasts for 3-5 hours, primarily used for controlling postprandial blood sugar [1] - This approval will help the company enrich its international product offerings, improve brand image, and expand its international business [1]
通化东宝药业股份有限公司关于回购股份事项前十大股东及 前十大无限售条件股东持股情况的公告
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。 注2:本公司股份全部为无限售条件流通股,因此本公司前10大股东与前10大无限售条件股东一致。 特此公告。 通化东宝药业股份有限公司董事会 2025年10月23日 通化东宝药业股份有限公司(以下简称"公司"、"通化东宝")于2025年10月17日召开第十一届董事会第 十八次会议,审议通过了《关于以集中竞价交易方式回购公司股份方案的议案》。具体内容详见2025年 10月18日在中国证券报、上海证券报和上海证券交易所网站(www.sse.com.cn)披露的《通化东宝关于 以集中竞价交易方式回购公司股份方案的公告》(公告编号:2025-067)、《通化东宝关于以集中竞价 交易方式回购公司股份的回购报告书》(公告编号:2025-068)。 根据《上市公司股份回购规则》《上海证券交易所上市公司自律监管指引第7号一回购股份》等有关规 定,现将公司董事会公告回购股份决议的前一个交易日(2025年10月17日)登记在册的前十大股东和前 十大无限售条件股东的名称及持股数量、比例情况公告如下: ■ ...
通化东宝:截至2025年10月17日前十大流通股东持股占比47.97%
Mei Ri Jing Ji Xin Wen· 2025-10-22 09:02
Group 1 - Company announced a share buyback plan to be approved at the board meeting on October 17, 2025 [1] - The top ten unrestricted shareholders hold approximately 9.4 billion shares, accounting for 47.97% of total shares [1] - Major shareholders include Dongbao Industrial Group with about 614 million shares (31.34%) and Tianjin Zhenyi Equity Investment Partnership with about 183 million shares (9.35%) [1] Group 2 - For the first half of 2025, the company's revenue composition shows that the pharmaceutical industry accounts for 98.59%, while other businesses and real estate account for 1.27% and 0.14% respectively [2] - The current market capitalization of the company is 17.2 billion yuan [2]