通化东宝药业股份有限公司关于 甘精胰岛素注射液获得境外上市许可的公告 证券代码：600867 证券简称：通化东宝 公告编号：2025-061 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。现将相关情 况公告如下： 一、公司产品获得境外上市许可情况 3.规格：10ml:1000IU（每毫升 100 单位）（西林瓶） 3m1:300IU（每毫升 100 单位）（卡式瓶） 3ml:300IU（每毫升 100 单位）（预填充式注射笔） 4.适应症：糖尿病 5.上市许可号：3009EA11617 6.持有人：通化东宝药业股份有限公司 二、药品的其他相关情况 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。 1.产品名称：甘精胰岛素注射液（平舒霖） 2.剂型：注射剂 1 三、对公司的影响及风险提示 公司以药品上市许可持有人身份 ...

Core Viewpoint - Tonghua Dongbao (600867.SH) has received approval from the Ministry of Health of the Republic of the Union of Myanmar for the marketing license of its product, Insulin Glargine Injection [1] Company Summary - Insulin Glargine is a long-acting insulin analog that requires daily injection, with an onset of action that lasts for 24 hours [1] - The product is designed to provide a stable reduction in blood glucose levels without peak concentrations [1]

Core Viewpoint - Tonghua Dongbao (600867) has received approval from the Ministry of Health of the Republic of the Union of Myanmar for the marketing license of its product, Insulin Glargine Injection [1] Group 1: Product Information - Insulin Glargine is a long-acting insulin analog that requires daily injection [1] - The product has a 24-hour duration of action after injection, providing a stable reduction in blood glucose levels without peak concentration [1]

Core Viewpoint - Tonghua Dongbao (600867.SH) has received approval from the Ministry of Health of the Republic of the Union of Myanmar for the marketing of its product, Insulin Glargine Injection, which is a long-acting insulin analog that helps to stabilize blood sugar levels in patients [1] Group 1 - The product Insulin Glargine is designed to provide a steady reduction in blood sugar levels for patients [1] - In 2024, the average annual expenditure related to diabetes for patients in Myanmar is projected to be $164.1 [1]

Core Insights - Tonghua Dongbao focuses on the research and development of drugs for diabetes and other endocrine diseases, aiming to provide comprehensive solutions for patients in these areas [1][2] - The company reported a significant increase in revenue and profit for the first half of 2025, with a revenue of 1.373 billion yuan, representing an 85.6% year-on-year growth, and a net profit of 218 million yuan, compared to a loss of 23 million yuan in the same period last year [1] Financial Performance - In the first half of 2025, Tonghua Dongbao achieved operating revenue of 1.373 billion yuan, up 85.6% year-on-year [1] - The net profit attributable to shareholders was 218 million yuan, a turnaround from a loss of 23 million yuan in the previous year [1] - The basic earnings per share were reported at 0.11 yuan [1] Market Strategy - The company experienced over 200% year-on-year growth in the sales of insulin analogs in the domestic market and plans to leverage new procurement policies to expand market share [2] - Tonghua Dongbao is actively pursuing regulatory approvals for its insulin products in international markets, including the acceptance of its aspart insulin BLA by the FDA [2] Research and Development - The company emphasizes innovation and maintains a high level of investment in R&D, focusing on new product development such as ultra-rapid insulin and GLP-1/GIP dual receptor agonists [3] - Clinical trials for its injectable THDBH120 for weight loss are progressing well, with the first patient dosed in January 2025 [2] Future Outlook - The domestic insulin market is expected to continue stable growth over the next three years, with the company planning to explore new therapeutic areas such as weight loss and gout [3] - Tonghua Dongbao aims to enhance investor relations and improve transparency to better communicate its value and growth prospects to the market [3]

证券代码：600867 证券简称：通化东宝 公告编号：2025-060 通化东宝药业股份有限公司关于 2025 年员工持股计划完成股票非交易过户的公告 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"、"通化东宝"）于 2025 年 9 月 2 日召开了第十一届董事会第十七次会议、第十一届监事会第十一次会议、于 2025 年 9 月 18 日召开 2025 年第二次临时股东会，审议通过了《关于<通化东宝 2025 年员工持股计划（草案）>及其摘要的议案》等相关议案，同意公司实施 2025 年员工持股计划（以下简称"本员工持股计划"）。内容详见公司于 2025 年 9 月 3 日、2025 年 9 月 19 日在上海证券交易所网站（www.sse.com.cn）披露的相关 公告。 根据《关于上市公司实施员工持股计划试点的指导意见》及《上海证券交易 所上市公司自律监管指引第 1 号——规范运作》的相关规定，现将本员工持股计 划实施进展情况公告如下： 根据参与本员工持股计划实际认购和最终缴款 ...

Core Viewpoint - Tonghua Dongbao held a performance briefing for the first half of 2025, highlighting significant advancements in clinical trials and sales growth in insulin products [1] Group 1: Clinical Trials and Product Development - The injection THDBH120 for weight loss indications has completed its first patient dosing in a Phase II clinical trial as of January 2025, showing good safety, tolerability, and positive efficacy trends [1] - The company's insulin formulations are still in preclinical research, with future developments to be disclosed according to relevant regulations [1] Group 2: Domestic Market Performance - In the first half of 2025, the sales of insulin analogs in the domestic market achieved over 200% year-on-year growth [1] - The company plans to leverage the new round of centralized procurement to significantly boost the sales of insulin analogs and expand market share [1] Group 3: International Market Developments - The U.S. BLA for Aspart insulin has been accepted by the FDA, with ongoing efforts to advance the BLA submissions for Glargine and Lispro insulins [1] - Registration preparation and application work for insulin analogs in Europe and various developing countries are progressing in an orderly manner [1]

Core Insights - The acute gout medication market in China is projected to reach $100 million in 2024, contrasting sharply with the growing patient base of 19.4 million, which has increased by over 70% since 2019 [1][17] - The global acute gout medication market has seen a slight decline from $1.6 billion in 2019 to $1.5 billion in 2024, primarily due to rising prices of traditional drugs and their limitations, but is expected to rebound to $3.3 billion by 2030 with the introduction of new innovative treatments [13][14] Industry Overview - Acute gout medications are designed to quickly alleviate inflammation symptoms during acute attacks, focusing on suppressing inflammation rather than directly lowering uric acid levels [1][6] - The industry supply chain consists of upstream raw material suppliers, midstream manufacturers, and downstream distributors, with each segment's performance affecting the others [8][9] Market Dynamics - The global number of acute gout patients is expected to rise from 35.2 million in 2019 to 45.4 million in 2024, with a compound annual growth rate of 5.3%, driven by factors such as aging populations and dietary changes [11] - The current market is dominated by traditional drugs like allopurinol and febuxostat, which face challenges due to their toxicity, prompting a shift towards innovative drug development [17] Competitive Landscape - The acute gout medication market is characterized by a tiered competition structure, with major international players like Pfizer and Amgen leading the first tier, while domestic companies like Hengrui Medicine are emerging in the third tier with significant market shares [2][11] - The competition is shifting from price wars over traditional drugs to innovation-focused strategies, as companies invest in new drug development targeting specific mechanisms [2][11] Research and Analysis - The research team employs various analytical models such as SCP, SWOT, and PEST to comprehensively assess the market environment, industry policies, and competitive landscape [2][4] - A detailed report titled "2025-2031 China Acute Gout Medication Industry Market Research and Development Trend Forecast" has been compiled to guide investment decisions and strategic planning for stakeholders [23]

Core Viewpoint - Ganli Pharmaceutical has become the first Chinese pharmaceutical company to enter Brazil's PDP medical project, signing agreements with Fiocruz and BIOMM, with a total expected amount of no less than 3 billion yuan, which will positively impact the company's performance in 2025 and beyond [1][3]. Group 1: Project Details - The PDP model involves technology transfer, production line establishment, and national procurement, with Ganli Pharmaceutical responsible for delivering cell lines and process packages, and training for 168 technical tasks within 30 months [2]. - The total investment for the project is 130 million Brazilian Reais (approximately 160 million yuan), with a commitment from the SUS system to purchase 200 million units of insulin over 10 years, starting with a target of 20 million units in the first year, accounting for 58% of Brazil's total demand [2]. Group 2: Financial Implications - The contract's total amount is expected to contribute approximately 10% to the company's revenue over 10 years, averaging 300 million yuan annually, although the gross margin may be lower than domestic operations [3]. - In the first half of 2025, Ganli Pharmaceutical reported revenue of 2.067 billion yuan, a year-on-year increase of 57.18%, and a net profit of 604 million yuan, a year-on-year increase of 101.96% [6]. Group 3: Risks and Challenges - The project faces challenges such as exchange rate fluctuations, policy changes, and technical hurdles, with the Brazilian Real having fluctuated by 17% against the US dollar in the past 18 months [5]. - Ganli Pharmaceutical must deliver 160 key devices within 18 months, with 40% of these dependent on Chinese manufacturing, which could delay the construction plan if shipping routes are disrupted [5]. Group 4: Market Position and Strategy - Following the first round of centralized procurement, Ganli Pharmaceutical adjusted its business model, reducing its sales team by 37% and shifting its strategy towards digital marketing and grassroots penetration [6]. - The company has increased its R&D investment to 5.52 billion yuan in the first half of 2025, representing 26.7% of its revenue, indicating a focus on accelerating product development in response to market changes [7]. Group 5: International Expansion - Ganli Pharmaceutical has signed preliminary cooperation agreements with Egypt and Indonesia, which could potentially contribute over 1 billion yuan in revenue if similar terms to Brazil are replicated [10]. - The company's international revenue reached 222 million yuan in the first half of 2025, a year-on-year increase of 75.08%, accounting for 10.72% of total revenue, indicating significant growth potential in international markets [10].

Core Insights - The incidence of gout is increasing, particularly among younger populations, with approximately 2.53 million gout patients in China by 2024, representing 1-2 individuals per 100 people [2][12]. Company Overview - Hangzhou New Element Pharmaceutical Co., Ltd. is seeking an IPO on the Hong Kong Stock Exchange, focusing on innovative drugs for gout treatment, with unmet medical needs in this area [3][30]. - The company was founded in 2012 and has undergone five rounds of financing, raising approximately 1.078 billion RMB, with a current valuation of about 3.052 billion RMB [4][6]. - The founder, Dr. Shi Dongfang, has extensive experience in drug research and development, having worked in various pharmaceutical companies [7][8]. Product Pipeline - New Element Pharmaceutical is developing two clinical-stage products, ABP-671 and ABP-745, along with several preclinical projects targeting metabolic diseases, including gout and hyperuricemia [15][27]. - ABP-671 is a URAT1 inhibitor aimed at treating gout and hyperuricemia, currently in phase 2b/3 clinical trials in the US and China, showing promising safety and efficacy profiles [18][21]. - ABP-745 is a colchicine analog targeting acute gout, having successfully completed phase 1 trials and currently in phase 2 trials across multiple regions [27][28]. Market Landscape - The global market for hyperuricemia and gout treatment is approximately $3.2 billion, with a significant number of patients requiring long-term medication [11][12]. - The company faces competition from established players like Hengrui Medicine, Kangyuan Pharmaceutical, and others, which are also developing treatments in the gout space [3][24]. Financial Performance - New Element Pharmaceutical has not yet generated revenue from product sales, reporting losses of 697 million RMB over the past two and a half years [30][33]. - The company's R&D expenses have been substantial, accounting for a significant portion of total operating expenses, with cash reserves of approximately 55 million RMB as of mid-2025 [34][35].