Company Overview - Zhuhai Rundu Pharmaceutical Co., Ltd. is a modern pharmaceutical enterprise established in 1999, located in Zhuhai, Guangdong Province. The company went public on January 5, 2018, on the Shenzhen Stock Exchange [2][3]. - The company specializes in drug research and development, production, and sales, focusing on chemical drug formulations, raw materials, and intermediates, with applications in cardiovascular, anti-infection, digestive, analgesic, and anesthetic treatments [2][3]. Product Development and Sales - The Class 1 innovative drug, Dexmedetomidine Hydrochloride Injection, submitted for registration in March 2024, is currently in the CDE drug approval sequence [4]. - The company’s subsidiary, Rundu Pharmaceutical (Jingmen) Co., Ltd., received a tobacco production license valid until June 30, 2028, enhancing its nicotine production capabilities. Sales of nicotine have significantly increased in the first three quarters of 2025 compared to the previous year, although this has not yet impacted overall performance [5]. - Sales of Rabeprazole Sodium Enteric-Coated Capsules have significantly declined due to inclusion in the national centralized procurement directory, affecting the company's performance in 2024 and the first half of 2025 [6][8]. Financial Performance - The decline in 2025 performance is attributed to changes in pharmaceutical industry policies and market conditions, particularly the national centralized procurement policy, leading to decreased sales and profit margins [8]. - The company aims to enhance profitability and competitiveness through cost reduction, efficiency improvements, and the implementation of ESG governance [8]. Production Capacity - The company has achieved a high capacity utilization rate, with a newly built oral solid dosage workshop designed for an annual capacity of 6 billion tablets, marking a significant upgrade in production capabilities [9][10]. - The subsidiary's designed annual capacity is 4,000 tons, currently in a ramp-up phase, with significant improvements compared to the previous year [10]. Future Directions - The company is focusing on the development of cardiovascular, digestive, anti-infection, and analgesic treatments, with plans to evaluate the expansion into new areas based on clinical needs and technological trends [10].

每经AI快讯，有投资者在投资者互动平台提问：董秘您好！CDE官网显示，药品评审暂停，是何种原 因，是发补材料还是其他原因？ 润都股份（002923.SZ）11月10日在投资者互动平台表示，尊敬的投资者，您好！公司1类创新药盐酸去 甲乌药碱注射液，目前仍在中国国家药品监督管理局的药品注册审评阶段，正常推进中。如有重大进 展，公司将严格遵循信息披露规定，及时履行信息披露义务。感谢您的关注！ （文章来源：每日经济新闻） ...

格隆汇11月10日丨润都股份(002923.SZ)在投资者互动平台表示，公司1类创新药盐酸去甲乌药碱注射 液，目前仍在中国国家药品监督管理局的药品注册审评阶段，正常推进中；未来公司将根据国内市场开 发和销售情况，不排除拓展海外市场的可能。 ...

| 投资者关系活动 | □特定对象调研 □ 分析师会议 | | --- | --- | | 类别 □ | 媒体采访 业绩说明会 □ | | □ | 新闻发布会 路演活动 □ | | ☑ | 现场参观 | | □ | 其他 | | 参与单位名称及 | 中信建投证券、景瑞私募、中国银行珠海分行、华夏银行珠海分 | | 人员姓名 | 行、浦发银行、广东恒誉融企、鑫丰物流 | | 时间 2025 | 年 10 月 23 日 下午 14:30~17:00 | | 地点 | 珠海市金湾区三灶镇机场北路 号 6 | | 上市公司接待人 | 副总经理、财务负责人：石深华先生 | | 员姓名 | 董事会秘书：苏军先生 | | | 证券事务代表：叶洁云女士 | | | 证券事务专员：都伊琦女士 | | | 一、行业政策分享 | | | 二、公司介绍 | | | 珠海润都制药股份有限公司位于广东省珠海市金湾区，成立于 | | 1999 | 年。2018 年 1 月 5 日，公司在深圳证券交易所成功上市。 | | | 公司扎根于风景秀丽的珠海，是一家集药物研发、生产、销售为 | | 投资者关系活动 | 一体的现代化科技型医药企业，主 ...

Group 1: Company Performance and Financials - The company reported a significant decline in net profit due to changes in national procurement policies, with major products like Rabeprazole Sodium Enteric-coated Capsules experiencing a substantial drop in sales volume [4] - The overall revenue and product profitability decreased compared to the previous year, influenced by market competition and pricing pressures on raw materials [4] - As of September 10, 2025, the total number of shareholders is 24,743 [6] Group 2: Product Development and Regulatory Status - The company has submitted a registration application for its innovative drug, Dexmedetomidine Hydrochloride Injection, to the National Medical Products Administration, which is currently in the review queue [3][4] - There is one Class 1 innovative drug under development, aimed at assisting in the diagnosis and evaluation of myocardial ischemia [4] Group 3: Strategic Initiatives and Future Outlook - The company plans to focus on core business areas, emphasizing innovation and the application of new technologies to enhance competitiveness [5] - Efforts will be made to improve the market development of raw materials and intermediates, as well as to introduce new products to increase sales and reduce production costs [6] - The company maintains an open attitude towards mergers and acquisitions that align with its strategic goals and can create synergies [2]

Core Viewpoint - Recent financial report from Rundu Co., Ltd. shows significant declines in key financial metrics, indicating potential challenges in operational performance and profitability [1][3]. Financial Performance Summary - Total revenue for the first half of 2025 was 548 million yuan, a decrease of 8.22% compared to 597 million yuan in 2024 [1]. - Net profit attributable to shareholders was -36.19 million yuan, reflecting a drastic decline of 195.75% from a profit of 37.80 million yuan in the previous year [1]. - Gross margin decreased to 36.41%, down 25.16% year-on-year, while net margin turned negative at -6.6%, a drop of 204.32% [1]. - Total expenses (selling, administrative, and financial) reached 174 million yuan, accounting for 31.73% of revenue, an increase of 8.51% year-on-year [1]. - Earnings per share fell to -0.11 yuan, a decrease of 200% from 0.11 yuan in the previous year [1]. Cash Flow and Debt Analysis - Operating cash flow per share decreased by 88.54% to 0.03 yuan, indicating reduced cash generation from operations [1][3]. - The company’s cash and cash equivalents increased by 58.84% to 202 million yuan, while interest-bearing liabilities rose by 17.55% to 607 million yuan [1][3]. - The cash flow from investing activities improved by 85.24%, attributed to reduced long-term asset investments [3]. Business Model and Market Position - The company’s return on invested capital (ROIC) was reported at 3.2%, significantly lower than the historical median of 16.01%, indicating weak capital returns [3]. - The business model relies heavily on research and marketing, necessitating a thorough examination of the underlying drivers of performance [3]. - The company is focusing on expanding its product matrix in various therapeutic areas, including cardiovascular, digestive, and pain relief medications [5][6]. Product Development and Market Trends - The company is developing a new chemical drug, the hydrochloride of deoxynoradrenaline, which is positioned for use in cardiac stress testing [5]. - Sales of nicotine products have shown significant growth, although they have not yet had a major impact on overall performance [5]. - The company aims to enhance its generics and innovative drug development, particularly in high-tech barrier generics and original new drugs [6].

Group 1 - The innovative drug sector is a key focus in the pharmaceutical industry, with multiple companies successfully obtaining product approvals this year and ongoing business development (BD) projects in China [1] - China's share of global innovative drug BD transactions has been increasing, from 10.8% in 2015 to an estimated 30.6% in 2024, with a significant rise to 52.5% as of August 8 this year [3] - The market size for innovative drugs in China reached 679 billion yuan in 2022, projected to exceed 1 trillion yuan by 2026 and reach 1.12 trillion yuan by 2027 [3] Group 2 - The proportion of innovative drugs in China's pharmaceutical market was 41% in 2022, expected to rise to 50% by 2026 and 51% by 2027 [3] - The pace of domestic innovative drug companies expanding overseas is accelerating, with 81 pharmaceutical and biotech companies involved in innovative drug business, generating over 100 billion yuan in overseas revenue from 2022 to 2024 [3] - Companies like Betta Pharmaceuticals and Rundu Co. have reported significant overseas revenue, with some companies exceeding 70% of their revenue from international markets in the first half of 2025 [3] Group 3 - Investor interest in innovative drugs has surged, with over 2,000 interactions related to "innovative drugs" recorded this year, highlighting companies such as Betta Pharmaceuticals, Rundu Co., and Zhendong Pharmaceutical [3][4] - Betta Pharmaceuticals plans to commercialize its innovative drug, Tarecitinib, which is expected to be approved by June 30, 2025 [4] - Rundu Co. has completed phase IIIb clinical trials for its innovative drug, a heart load test medication, and plans to submit a marketing application by March 2024 [4]

Core Viewpoint - China's innovative pharmaceuticals have transitioned from being followers to key players in global medical innovation, achieving significant breakthroughs in core treatment areas such as metabolic diseases and oncology, with a surge in new drug approvals and international progress [1][3]. Group 1: Market Trends - The attention of A-share investors towards innovative pharmaceuticals has significantly increased this year, with numerous companies actively disclosing their R&D and clinical progress [2]. - The total value of license-out transactions for innovative drugs in China is projected to exceed $60 billion by mid-2025, surpassing the total for 2024, with 16 transactions exceeding $1 billion each [3]. - The market size of China's innovative drugs reached 679 billion yuan in 2022, expected to exceed 1 trillion yuan by 2026 and reach 1.12 trillion yuan by 2027 [6]. Group 2: International Expansion - Chinese innovative drug companies are accelerating their international business, with 81 companies generating over 100 billion yuan in overseas revenue from 2022 to 2024, accounting for more than 14% of their total revenue [7]. - The proportion of China's innovative drug transactions in the global market has increased from 10.8% in 2015 to approximately 52.5% by August 2023 [6]. Group 3: Policy and Financial Support - The Chinese government has implemented policies to support the high-quality development of innovative drugs, significantly reducing the time from drug approval to inclusion in the medical insurance directory from about 5 years to approximately 1 year [8]. - From 2015 to 2024, the financing in China's innovative drug sector exceeded 1.23 trillion yuan, providing strong momentum for industry growth [9]. Group 4: R&D Investment - The number of companies in the pharmaceutical and biotechnology sector has increased from over 220 in 2015 to nearly 500 currently, with R&D investment in the sector exceeding 140 billion yuan in 2024, a fivefold increase since 2015 [9]. - Among the 81 innovative drug companies, R&D investment rose from approximately 8.8 billion yuan in 2015 to over 57.8 billion yuan in 2024, with R&D intensity increasing from 3.29% to 8.04% [9]. Group 5: Company Developments - Companies such as Betta Pharmaceuticals and Rundu Co. have reported significant advancements in their innovative drug pipelines, with Betta's drug expected to be approved by June 2025 and Rundu's drug completing phase III clinical trials [12]. - The stock performance of companies involved in innovative drugs has surged, with some companies experiencing average increases of over 50% since May 1, 2023 [13]. Group 6: Institutional Interest - 13 companies have received significant institutional interest this year, with some experiencing over 30% increase in financing, indicating strong market confidence in innovative drug investments [14]. - Companies like BeiGene and TaiGen Biotechnology are projected to see substantial profit growth in 2025 and 2026, with BeiGene potentially turning profitable this year [15].

Group 1: Sales and Market Performance - The sales of nicotine at the company's Jingmen facility have significantly increased compared to the same period last year, although this has not yet had a major impact on the overall business performance [1] - The sales of the antihypertensive drug, Rabeprazole enteric-coated capsules, have declined, which has significantly affected the company's performance [4] - The market competition for Sartans remains intense, with sales prices fluctuating in a low range due to various factors including supply and demand [5] Group 2: Product Development and Innovation - The company's Class 1 innovative drug, Dihydrocodeine injection, is classified as a chemical drug and is used for myocardial perfusion imaging (MPI) to diagnose and assess myocardial ischemia [2] - The core formulation product matrix covers various therapeutic areas including cardiovascular, digestive, analgesic, anti-infective, endocrine, respiratory, and anesthesia, with a focus on innovative dosage forms [3] - The company is committed to advancing green and synthetic biotechnology applications, accelerating the development and launch of generic and innovative drugs, particularly in cardiovascular and digestive systems [4] Group 3: Safety and Usage Guidelines - Dihydrocodeine injection has a good safety profile with mild adverse reactions that quickly resolve after discontinuation, making it suitable for use in myocardial perfusion imaging [2] - The specific usage of Dihydrocodeine injection should be determined by doctors based on individual patient conditions, adhering strictly to medical advice [2]

Group 1 - The core viewpoint of the news is that Mingyu Asset Management has conducted research on a listed company, Rundu Co., focusing on the development and commercialization of a new drug, and the company's operational performance [1] - Rundu Co. is advancing the registration application for its innovative drug, a hydrochloride injection of dehydroevodiamine, which has shown good safety in Phase III clinical trials [1] - The company plans to promote the drug through its own marketing team and collaborative promotion, while exploring more innovative results in the field of synthetic biology [1] Group 2 - Rundu Co.'s production value has significantly increased, with improved synergy between its two major bases in Zhuhai and Jingmen, and a substantial rise in nicotine sales compared to the same period last year [1] - However, the increase in nicotine sales has not yet had a significant impact on the company's overall performance [1]