证券代码：000963 证券简称：华东医药 公告编号：2025-099 华东医药股份有限公司 关于全资子公司收到药品注册受理通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 2025年10月30日，华东医药股份有限公司（以下简称"公司"）全 资子公司杭州中美华东制药有限公司（以下简称"中美华东"）收到国 家药品监督管理局（NMPA）签发的《受理通知书》（受理号： JXHS2500123），罗氟司特乳膏（ZORYVE ®）0.3%上市许可申请获 得受理。现将有关详情公告如下： 一、该药物基本信息内容 药物名称：罗氟司特乳膏 申请事项：境外生产药品注册上市许可 注册分类：化学药品5.1类 规格：0.3% （60g：0.18g） 申报适应症：适用于 6 岁及以上斑块状银屑病患者的局部外用治 疗，包括间擦部位。 申请人：Arcutis Biotherapeutics INC 三、对上市公司的影响及风险提示 银屑病是一种慢性、多因素、免疫介导的炎症性皮肤疾病，存在 巨大未被满足的临床需求。罗氟司特乳膏（ZORYVE ®）0.3%可以快 速清除银屑病斑块并减少 ...

Group 1: Health Planning and Chronic Disease Management - The National Health Commission aims to increase the average life expectancy of Chinese residents from 79 years in 2024 to around 80 years within five years, supported by chronic disease prevention efforts [1] - Chronic diseases such as cardiovascular diseases and cancer are on the rise, with over 80% of total deaths attributed to these conditions, posing significant health and economic challenges [1] - The government has integrated chronic disease prevention into national strategy, focusing on obesity management as a key area for policy intervention [3][4] Group 2: Market Dynamics and Opportunities - The obesity treatment market is becoming increasingly competitive, with major pharmaceutical companies like Novo Nordisk and Eli Lilly leading with their GLP-1 products, while domestic companies are also advancing their offerings [5][8] - The CGM market in China is projected to grow from approximately 1.7 billion yuan in 2020 to 17.9 billion yuan by 2030, indicating a strong demand for diabetes management solutions [5] - The global market for obesity and metabolic drugs is expected to exceed $100 billion by 2030, with GLP-1 drugs being a significant growth driver [5] Group 3: Distribution and Accessibility - The retail market for GLP-1 products is expanding, with companies like Novo Nordisk and Eli Lilly actively pursuing this channel due to high entry barriers in hospital settings [6] - Online channels, particularly platforms like JD Health, are becoming dominant in the weight loss drug market, accounting for over 70% of sales, significantly outpacing traditional channels [6][7] - The shift from passive to proactive health management is driving growth in home medical devices, with a notable increase in demand for self-monitoring tools [7] Group 4: Innovation and Competitive Landscape - The GLP-1 market is characterized by a "dual oligopoly" with Novo Nordisk and Eli Lilly holding significant market share, but local companies are intensifying competition through differentiated product offerings [8][9] - Domestic firms are focusing on unmet clinical needs and expanding indications to build long-term competitiveness, moving the industry from a "follower" to a "leader" position [9] - Innovations in drug delivery methods and combination therapies are being explored by local companies to enhance their market presence and address diverse patient needs [9]

Core Viewpoint - The report highlights the performance and growth prospects of Huadong Medicine, focusing on its financial results, R&D investments, and innovative product pipeline. Financial Performance - For the first nine months of 2025, Huadong Medicine achieved revenue of 32.664 billion yuan, a year-on-year increase of 3.77% [2] - The net profit attributable to shareholders was 2.748 billion yuan, up 7.24% year-on-year [2] - The company’s R&D investment in the pharmaceutical industry reached 2.186 billion yuan, a significant increase of 35.99% [2] R&D and Innovation - The company’s innovative product sales and agency service revenue reached 1.675 billion yuan, a substantial growth of 62% year-on-year [4] - Huadong Medicine is advancing over 90 innovative drug pipeline projects, with five products approved for market and six under review as of 2025 [4] - The global first innovative drug, Remabizine injection, received domestic approval in October 2025 [4] Segment Performance - The pharmaceutical industrial segment, including CSO business, generated revenue of 11.045 billion yuan, a year-on-year increase of 11.10% [3] - The medical beauty segment faced challenges, with revenue declining by 17.90% to 1.568 billion yuan [5] - The industrial microbiology segment continued to grow rapidly, with a year-on-year increase of 28.48% [11] Future Product Pipeline - Upcoming products expected to be approved include Semaglutide injection and Insulin Degludec injection, among others [7] - The company anticipates significant sales potential for its innovative products, including the newly approved Malatonic Mevanetidine tablets, which could reach a peak sales potential of 1 billion yuan [6][7] Market Outlook - Despite current challenges in the medical beauty sector, the company remains optimistic about future growth driven by new product approvals and market expansion [7] - The company is actively pursuing international market opportunities, particularly in the medical beauty segment [7]

Summary of Key Points Core Viewpoint - In the past five trading days, a total of 305 companies were investigated by institutions, with significant interest in companies like Zhongmin Resources, Ninebot, and Dofluorid. The majority of the investigations were conducted by securities companies, followed by fund companies and private equity firms [1]. Institutional Research Activity - 288 companies were investigated by securities firms, accounting for 94.43% of the total [1]. - Fund companies conducted research on 261 companies, while private equity firms investigated 209 companies [1]. - 194 companies received attention from more than 20 institutions, with Ninebot and Zhongmin Resources being the most researched, each attracting 185 institutions [1]. Fund Flow and Stock Performance - Among the stocks investigated by more than 20 institutions, 56 saw net inflows in the past five days, with Shenghong Technology receiving the highest net inflow of 1.423 billion yuan [1]. - Other notable net inflows included Dofluorid and China Tungsten High-tech, with inflows of 1.398 billion yuan and 950 million yuan, respectively [1]. - In terms of stock performance, 127 stocks increased in value, with the highest gains seen in Litong Technology (44.15%), China Tungsten High-tech (36.49%), and Chutian Technology (32.09%) [2]. Quarterly Earnings Reports - Among the stocks investigated, 191 have released their third-quarter reports, with the highest year-on-year net profit growth reported by Chuangjiang New Materials (2089.49%) and Te Yi Pharmaceutical (985.18%) [2].

Financial Performance - For the first nine months of 2025, the company achieved a revenue of CNY 32.664 billion, a year-on-year increase of 3.77% [2] - The net profit attributable to shareholders was CNY 2.748 billion, up 7.24% year-on-year [2] - The net profit excluding non-recurring gains and losses was CNY 2.694 billion, reflecting an 8.53% increase [2] - In Q3 2025, the company reported a revenue of CNY 10.989 billion, a 4.53% increase year-on-year, and a net profit of CNY 0.933 billion, up 7.71% [3] R&D Investment - R&D investment for the first nine months of 2025 reached CNY 2.186 billion, a 35.99% increase year-on-year [2] - Direct R&D expenditure was CNY 1.767 billion, marking a 53.76% increase, which accounted for 16.21% of the pharmaceutical industrial revenue [2][14] Product Development and Approvals - The company has 90 innovative drug pipeline projects in progress [4] - Five new products have received market approval in 2025, with six applications under review [4] - The innovative product sales and agency service revenue reached CNY 1.675 billion, a significant increase of 62% year-on-year [17] Market Challenges and Opportunities - The aesthetic medicine segment faced challenges, with a revenue of CNY 1.568 billion, down 17.90% year-on-year [5] - The industrial microbiology segment showed robust growth, with a revenue increase of 28.48% [15] - The company anticipates a recovery in the aesthetic medicine sector as new products are launched [5][9] Future Product Pipeline - Expected product approvals in the next year include Semaglutide injection, Insulin degludec injection, and others [7] - The company is also preparing for the launch of several aesthetic products, including YY001 and Ellansé® [7][9] Clinical Trials and Research - The GLP-1 receptor agonist HDM1002 has completed patient enrollment for its clinical trials [10] - The three-target agonist DR10624 has shown promising results in clinical studies and will be presented at the AHA Scientific Sessions 2025 [10][19] Sales Projections - The sales peak for the drug Ustinumab is projected to reach CNY 2 billion [18] - The MediBeacon® TGFR product is expected to exceed CNY 1 billion in sales potential [6]

Group 1: Market Performance - The Hong Kong Innovative Drug Selected ETF (520690) increased by 0.22%, with the latest price at 0.89 yuan as of October 29, 2025 [3] - The ETF recorded a turnover of 4.25% during the trading session, with a total transaction value of 21.78 million yuan [3] - Over the past year, the average daily transaction volume of the ETF was 120 million yuan [3] Group 2: Clinical Data and Industry Insights - Grail presented initial data from its multi-cancer early detection product Galleri at the 2025 ESMO annual meeting, showing a positive predictive value of 61.6% and a specificity of 99.6% [3] - Among the detected new cancers, 69.3% were in stages I-III, with a tissue origin accuracy of 91.7% [3] - Guosen Securities views this data as a significant milestone in the multi-cancer early detection field, suggesting Galleri could enhance existing screening systems [3] Group 3: Company Earnings and Trends - Over 280 pharmaceutical and biotech companies, including Heng Rui Pharmaceutical and WuXi AppTec, reported strong Q3 results, driven by advancements in R&D pipelines and new drug launches [3] - The overall industry is exhibiting a positive trend characterized by "innovation as a foundation and overseas expansion" [3] Group 4: CDMO Sector Performance - Lonza, a leading overseas CDMO, reported strong Q3 results, maintaining a revenue growth forecast of 20-21% for the year, with core EBITDA margins between 30-31% [4] - Medpace has seen consecutive growth in new orders for two quarters, indicating a recovering financing environment for U.S. small and mid-sized biotech firms [4] - WuXi AppTec exceeded Q3 performance expectations and raised its full-year guidance, further confirming the positive outlook for the CXO industry [4] Group 5: ETF Size and Inflows - The latest size of the Hong Kong Innovative Drug Selected ETF reached 512 million yuan, marking a new high since its inception [4] - The ETF's share count also hit a record high of 574 million shares [4] - In the past five days, the ETF experienced continuous net inflows, with a peak single-day net inflow of 31.48 million yuan, totaling 82.81 million yuan in net inflows [4]

Core Viewpoint - Huadong Medicine's stock price has shown a mixed performance in recent months, with a year-to-date increase of 20.43% but a decline over the last 60 days by 9.22% [1] Financial Performance - For the period from January to September 2025, Huadong Medicine achieved a revenue of 32.664 billion yuan, representing a year-on-year growth of 3.77% [2] - The net profit attributable to shareholders for the same period was 2.748 billion yuan, reflecting a year-on-year increase of 7.24% [2] Shareholder Information - As of September 30, 2025, the number of Huadong Medicine's shareholders was 68,800, a decrease of 1.50% from the previous period [2] - The average number of tradable shares per shareholder increased by 1.53% to 25,466 shares [2] Dividend Distribution - Since its A-share listing, Huadong Medicine has distributed a total of 8.873 billion yuan in dividends, with 3.771 billion yuan distributed over the last three years [3] Institutional Holdings - As of September 30, 2025, Hong Kong Central Clearing Limited was the third-largest circulating shareholder, holding 52.0036 million shares, an increase of 12.1653 million shares from the previous period [3] - China Securities Finance Corporation remained the fourth-largest shareholder with 22.1868 million shares, unchanged from the previous period [3] - Other notable changes include a decrease in holdings by the top ten circulating shareholders, such as the reduction of 4.3243 million shares by the China Europe Medical Health Mixed A fund [3]

Core Insights - The Chinese innovative pharmaceutical industry is experiencing a "triple resonance" recovery, driven by continuous optimization of the industrial chain and active policy and capital injection [1][12] - The third-quarter reports from leading innovative pharmaceutical companies reflect this trend and serve as an important window for observing industry dynamics and future development prospects [1] Company Performance - Heng Rui Medicine reported a revenue of 23.188 billion yuan for the first three quarters of 2025, a year-on-year increase of 14.85%, and a net profit of 5.751 billion yuan, up 24.50% [1] - The company maintained high R&D investment, with R&D expenses reaching 4.945 billion yuan in the first three quarters, totaling over 50 billion yuan cumulatively [1] - East China Pharmaceutical achieved a revenue of 32.664 billion yuan, a 3.77% increase, and a net profit of 2.748 billion yuan, up 7.24% [2] Innovation and R&D Progress - Heng Rui has received approval for 24 first-class innovative drugs and 5 second-class new drugs in China, with 13 new drug applications accepted by the National Medical Products Administration in the first three quarters [3][4] - East China Pharmaceutical has achieved breakthroughs in first-in-class innovative drugs and is advancing over 90 innovative drug pipeline projects [4] - The new round of "National Major Special Projects for Innovative Drug Development" aims to enhance the country's drug research capabilities and transition from imitation to innovation [6] Market Dynamics and Challenges - The domestic innovative drug market is at a critical stage of "quantity increase and quality change," with increasing pressure on payment systems and a shift in market demands from "availability" to "quality" [7][11] - The concentration of popular drug targets in China is high, with the top 20 targets accounting for 41%, compared to 28% in the U.S., indicating a need for more diverse innovation [5] Business Development and International Collaboration - In 2025, business development (BD) transactions in the innovative drug sector have become a focal point, with Heng Rui entering significant collaborations with GSK and other companies [8][9] - The total value of BD transactions in the first half of the year reached $63.55 billion, surpassing the total for 2024, indicating growing international recognition of domestic R&D capabilities [9] Capital Market Trends - The Hong Kong stock market has seen a resurgence in biotech financing, with 59 companies listed in the first eight months of 2025, raising a net amount of 134.466 billion HKD [13] - Despite the recovery, the primary market for healthcare financing has shown a decline, with a 14% decrease in the number of financing transactions compared to the previous year [14]

Core Viewpoint - The article emphasizes the importance of efficiently identifying the true value of companies amidst the overwhelming influx of quarterly reports from A-share companies, with a focus on the innovative capabilities of the Alice Reader tool in enhancing research efficiency and depth [2][25]. Group 1: Quarterly Reports - A total of 851 A-share companies disclosed their third-quarter reports yesterday, with an additional 906 reports expected today, highlighting the busy reporting season for financial institutions [2]. - The article suggests that traditional document summaries only provide surface-level understanding, while Alice Reader aims to offer deeper insights into company announcements [8][9]. Group 2: Alice Reader Features - Alice Reader integrates professional research frameworks to summarize documents, moving beyond basic summaries to provide insights into the underlying logic of the information [10]. - The tool generates personalized analyses for each company, utilizing proprietary analytical models to decode the business logic and unique value behind the information [15]. - Users can obtain customized summaries in seconds, allowing for quick comprehension of a company's core highlights and potential risks [16]. Group 3: Performance Metrics - The article mentions that the pharmaceutical industry has seen a revenue increase of 9.50%, with a gross margin of 75.43%, despite a slight decline in margin percentage [21]. - For a specific company, total revenue reached 21.675 billion yuan, reflecting a year-on-year growth of 3.39%, while net profit increased by 7% [19]. - Another company reported a significant revenue growth of 18.6% year-on-year, with net profit soaring by 84.8%, indicating a strong improvement in profitability [22]. Group 4: Market Context - The article highlights the need for tools like Alice Reader in the context of information overload in the investment research world, where time is critical and deep understanding serves as a competitive advantage [25][26]. - Alice Reader is positioned as a reading assistant that not only speeds up reading but also enhances the depth of thought in company research [25].

Summary of Huadong Medicine Conference Call Company Overview - **Company**: Huadong Medicine - **Industry**: Pharmaceutical Key Financial Performance - **Revenue Growth**: In the first three quarters of 2025, Huadong Medicine achieved a revenue of 32.664 billion yuan, a year-on-year increase of 3.77% [3] - **Net Profit**: The net profit attributable to shareholders was 2.748 billion yuan, up 7.24% year-on-year [3] - **Pharmaceutical Industrial Revenue**: Revenue from the pharmaceutical industrial segment reached 11.045 billion yuan, growing by 11.1% year-on-year [2][3] - **Third Quarter Performance**: In Q3 2025, revenue was 10.989 billion yuan, a 4.53% increase year-on-year, with a net profit of 933 million yuan, up 7.71% [3] Innovation and R&D - **Innovation Product Revenue**: Revenue from innovative products and sales agency services reached 1.675 billion yuan, a significant increase of 62% year-on-year [2][4] - **R&D Investment**: R&D investment in the pharmaceutical industrial sector was 2.186 billion yuan, a 35.99% increase year-on-year, with direct R&D spending at 1.767 billion yuan, up 53.76% [2][6] - **R&D Proportion**: R&D spending accounted for 16.21% of pharmaceutical industrial revenue [6] Key Product Developments - **Oncology**: Multiple ADC (Antibody-Drug Conjugate) projects are in clinical trials, with HDM2005 and HDM2027 receiving FDA fast track designation [2][7] - **Endocrinology**: Successful clinical review for the diabetes indication of Semaglutide injection; GLP-1 oral small molecule 1,002 completed Phase III enrollment [2][7] - **Autoimmune**: Ustekinumab injection received approval for pediatric psoriasis; Crohn's disease application accepted [2][8] Market Performance and Challenges - **Public Health Sector**: Achieved over 28% revenue growth, with plans for overseas expansion [9] - **Aesthetic Medicine**: Revenue declined nearly 18% due to global economic cycles and competition; however, adjustments are expected to lead to growth in 2026 [10][15] - **Sales and Management Efficiency**: Continuous optimization of cost structure, with decreasing sales and management expense ratios [4][20] Future Outlook - **New Product Launches**: Anticipated launches of innovative drugs including Insulin Degludec and others in the coming year [12] - **ADC Pipeline**: Plans to expand ADC product lines with multiple IND applications and clinical trials [18] - **Metabolic Pipeline**: Comprehensive layout with multiple projects in development, aiming for significant clinical data releases in 2026 [13][16] Strategic Partnerships - **Collaborations**: Exclusive commercialization agreements with various partners to enhance product offerings and market reach [11][25] Conclusion - **Overall Performance**: Despite modest growth rates, Huadong Medicine shows strong potential in innovation and market expansion, particularly in oncology and autoimmune sectors, with a robust pipeline and strategic adjustments to navigate market challenges [31]