科技创新铸就核心实力，抗肿瘤产品组合企稳领先地位 在本次浦江泌尿肿瘤学术大会上，远大医药联合多方学术力量，正式发布"四基因联检尿路上皮癌早筛早诊项目"，该项目面向尿路上皮癌诊断、随访、疗效 评估等关键场景，推动无创、便捷、可重复的分子检测进入日常临床路径，其四基因联检拥有基因突变+甲基化双重检测机制、补足传统方法盲区的卓越检 出性能、无创便捷，以及高级别证据导向等技术要点——相关注册临床研究已发布在国际权威期刊《Molecular Cancer》，并成功纳入《中国临床肿瘤学会 (CSCO)尿路上皮癌诊疗指南2024》及《膀胱癌早诊早治专家共识(2024年版)》，获得国内外专业权威认可。 公司表示，未来将持续深耕分子诊断、精准诊疗与核药研发三大核心领域，并依托全球核药等创新资源与自主研发体系，致力于打造泌尿肿瘤诊疗一体化解 决方案。 智通财经APP获悉，近日，浦江泌尿肿瘤学术大会暨上海市抗癌协会泌尿肿瘤专委会年会在上海举行，国内外泌尿肿瘤领域顶尖专家齐聚一堂，远大医药 (00512)在会上重磅发布"尿路上皮癌早筛早诊项目"，并带来专题报告《尿路上皮癌精准诊疗与泌尿肿瘤核药研发进展》，集中展示公司在早筛早诊、精准 ...

丨证券研究报告丨 港股研究丨公司点评丨远大医药（0512.HK） [Table_Title] 创新和壁垒产品持续放量，研发管线齐推进 报告要点 [Table_Summary] 2025 年 8 月 19 日，远大医药发布 2025 年中期业绩报告，2025H1 收入为 61.1 亿港币，同比 增长 1.0%，归母净利润为 11.7 亿港币，同比下滑 25.0%，如若剔除 Telix 投资对利润端的影 响，归母净利润为 10.2 亿港币，同比下滑 5.9%。 分析师及联系人 [Table_Author] 彭英骐 万梦蝶 SAC：S0490524030005 SAC：S0490525050001 SFC：BUZ392 请阅读最后评级说明和重要声明 %% %% %% %% research.95579.com 1 远大医药（0512.HK） cjzqdt11111 [Table_Title2] 创新和壁垒产品持续放量，研发管线齐推进 2025 年 8 月 19 日，远大医药发布 2025 年中期业绩报告，2025H1 收入为 61.1 亿港币，同比 增长 1.0%，归母净利润为 11.7 亿港币，同比下滑 25.0 ...

Core Insights - The company reported a record revenue of approximately HKD 61.1 billion for the first half of 2025, with innovative and barrier products accounting for about 51% of total revenue, reflecting a year-on-year increase of nearly 15 percentage points [1] - The net profit for the period was approximately HKD 11.7 billion, indicating strong financial performance [1] - The company achieved 38 significant milestones during the first half of the year, including 16 innovative products, and successfully launched the world's first closed-loop nuclear medicine R&D and production base [1] Revenue and Growth - The revenue from the nuclear medicine segment reached approximately HKD 4.2 billion, maintaining a substantial year-on-year growth of 106% [5] - Excluding the impact of centralized procurement and exchange rates, the company's revenue grew by about 13% year-on-year [1] Product Development and Innovation - The company is advancing its innovative drug pipeline, with STC3141 for sepsis completing its domestic Phase II clinical study, representing a novel treatment approach [3] - The nasal spray product OC-01 for dry eye syndrome achieved over 97,000 prescriptions in its first year in the U.S., generating approximately USD 42 million in sales in 2023 [4] - The global innovative eye drug GPN01768 (TP-03) reported overseas sales exceeding USD 100 million in the first half of the year, a year-on-year increase of nearly 152% [4] Nuclear Medicine Advancements - The company has developed a robust product pipeline in nuclear medicine, with 15 innovative products in the research and registration phase [7] - The flagship nuclear medicine product, 易甘泰® (Yigantai), received FDA approval for treating unresectable hepatocellular carcinoma (HCC), becoming the first and only product approved for both HCC and colorectal cancer liver metastasis [6][7] Global Expansion and Infrastructure - The company’s nuclear medicine R&D and production base in Chengdu, which is the world's first closed-loop platform, commenced operations in June, enhancing its global innovation and R&D capabilities [8] - The facility is designed to be one of the most automated and comprehensive in the international market, addressing import dependency issues [8]

Group 1 - The core viewpoint of the articles highlights the financial performance and strategic initiatives of the company, with a revenue of HKD 6.107 billion for the first half of 2025, reflecting a year-on-year increase of 0.99% [1] - The company achieved a gross profit of HKD 3.6 billion, up 0.25% year-on-year, and a shareholder profit of HKD 1.169 billion, with basic earnings per share at HKD 0.3338 [1] - The company has maintained a compound annual growth rate (CAGR) of 12.1% in revenue over the past five years, despite facing significant pressure from price reductions due to centralized procurement [1] Group 2 - The company has a diverse and differentiated pipeline that establishes its competitive advantage in niche markets, particularly in the nuclear medicine oncology treatment sector, where it has one of the richest product lines globally [2] - The nuclear medicine segment saw a doubling of revenue, driven by the growth of products like Yttrium-90 microsphere injection and liquid embolic agent Lava [2] - In the cardiovascular emergency sector, products such as Coenzyme Q10 tablets continue to lead the market, with significant growth from the recently acquired Tianjin company [2] Group 3 - Innovation is identified as the core driver for the company's future, with substantial investment in R&D and the establishment of eight research platforms across major global markets [3] - The company’s innovation pipeline spans early research, clinical development, and registration processes, with projects extending from China to the US, Australia, and Europe [3] - The focus on cutting-edge technologies such as nuclear medicine, high-end medical devices, glycomics, and mRNA is emphasized as part of the company's strategic direction [3]

Core Insights - Company reported record revenue of approximately HKD 6.11 billion for the first half of 2025, with innovative and barrier products accounting for about 51% of total revenue, a year-on-year increase of nearly 15 percentage points [1] - Net profit for the period was approximately HKD 1.17 billion, with a year-on-year revenue growth of about 13% after excluding the impact of centralized procurement and exchange rates [1] - The company achieved significant milestones in its research and development efforts, with total investment in R&D and projects amounting to approximately HKD 1.02 billion, resulting in 38 major milestone advancements [1] Nuclear Medicine Segment - As a leader in nuclear medicine, the company achieved impressive performance in the nuclear medicine oncology diagnosis and treatment sector, generating a record revenue of HKD 420 million, reflecting a year-on-year growth of nearly 106% [1][2] - The product Yttrium-90 microsphere injection (易甘泰®) continues to demonstrate strong market potential, maintaining rapid growth [1][2] - The company received early FDA approval for 易甘泰® for the treatment of unresectable hepatocellular carcinoma (HCC), becoming the first and only selective internal radiation therapy product approved for both unresectable HCC and colorectal cancer liver metastases [2] Innovative Products and Clinical Research - The company’s innovative product STC3141 for treating sepsis has successfully reached the endpoint of its Phase II clinical trial in China, representing a potential breakthrough in sepsis treatment [3] - STC3141 is the first global product aimed at re-establishing immune homeostasis for sepsis treatment, with clinical approvals obtained in five countries across three continents [3] - In the respiratory and critical care sectors, the company is advancing several innovative products, including nasal sprays and coenzyme Q10 tablets, which are expected to enhance commercial performance [4] Overall Growth and Competitive Advantage - The company has established a mature technological innovation development system, continuously reinforcing its differentiated advantages across various sectors [4] - The successful commercialization of innovative products is expected to provide ongoing development momentum, enhancing the company's core competitive advantages and creating value for investors [4]

Investment Rating - The report assigns a "Buy" rating for the company with a target price of 13.07 HKD, based on a 20x PE for 2025 [5]. Core Insights - The company is positioned for accelerated growth through a dual strategy of "independent research and global expansion," which enhances its international transformation potential [1][12]. - In 2024, the company achieved a revenue of 10.784 billion RMB, a year-on-year increase of 10.59%, and a net profit of 2.286 billion RMB, up 31.28% year-on-year, driven by increased demand for core products in nuclear medicine and cardiovascular precision intervention [21]. Summary by Sections 1. Company Overview - Founded in 1939, the company operates across three main sectors: nuclear medicine for tumor diagnosis and treatment, cardiovascular precision intervention, and pharmaceutical technology [1][12]. - The company has over 10,000 employees globally and more than 30 subsidiaries, with a diverse product portfolio exceeding 200 items in the medical insurance directory [1][12]. 2. Pharmaceutical Technology - The company is focused on developing innovative drugs in respiratory and critical care, with STC3141 showing promise as a new treatment for sepsis [2][31]. - The global market for sepsis treatment is projected to grow from 12.54 billion USD in 2024 to 19.37 billion USD by 2032, indicating significant unmet clinical needs [40]. 3. Nuclear Medicine - The company has established a complete industrial chain in nuclear medicine, with its core product, Yttrium-90 microsphere injection, rapidly gaining market traction since its approval in 2022 [3][4]. - The company is advancing multiple nuclear medicine products through clinical trials, including TLX591 for prostate cancer and GPN02006 for liver cancer diagnosis, positioning itself in the global first-tier of development [4][12]. 4. Financial Forecast - Revenue projections for 2025-2027 are 12.405 billion RMB, 13.729 billion RMB, and 15.113 billion RMB, respectively, with net profits expected to be 2.121 billion RMB, 2.396 billion RMB, and 2.773 billion RMB [5].

Core Insights - The Yttrium-90 microsphere injection, 易甘泰®, has benefited over 3,000 liver cancer patients since its launch in mainland China in 2022, showcasing its significant impact in the treatment of liver tumors [1] - The product received FDA approval for a new indication for unresectable hepatocellular carcinoma (HCC) on July 7, 2025, making it the first and only selective internal radiation therapy product approved for both unresectable HCC and colorectal cancer liver metastases [1][5] - The 15 abstracts related to Yttrium-90 microspheres presented at the 15th Asia-Pacific Primary Liver Cancer Expert Alliance (APPLE) conference highlight its clinical applicability and effectiveness across different stages of HCC [4][2] Group 1: FDA Approval and Clinical Impact - The FDA's early approval was based on the promising mid-term results of the DOORwaY90 clinical trial, which reported an objective response rate of 98.5% and a local tumor control rate of 100% [4][5] - The approval aligns with real-world data from Chinese patients, indicating broad applicability of 易甘泰® in local clinical settings [4] - The product's success is expected to accelerate its commercialization in China and reshape the treatment landscape for liver cancer [1][5] Group 2: Market Context and Future Prospects - According to GLOBOCAN 2022, liver cancer is the sixth most common cancer globally, with approximately 870,000 new cases and 760,000 deaths annually [6] - In China, liver cancer accounted for about 370,000 new cases in 2022, representing 42.5% of global cases, and the mortality rate was approximately 320,000, also the highest globally [6][8] - The Chinese liver cancer drug market is projected to grow at a compound annual growth rate (CAGR) of 12.3%, reaching 45.21 billion yuan by 2030 [8][9] Group 3: Company Development and Innovation - The company has established a comprehensive nuclear medicine industry chain, covering research, production, sales, and regulatory qualifications, with 15 innovative products in the pipeline targeting various cancers [11][17] - The newly launched Chengdu Wenjiang nuclear medicine R&D and production base, with an investment exceeding 3 billion yuan, aims to enhance production capabilities and meet domestic and international demands [17][19] - The base features advanced automation and a full-process radiation monitoring system, positioning the company as a leader in the nuclear medicine sector [18][19]

Core Viewpoint - Global nuclear medicine leader, YuanDa Pharmaceutical, has achieved a significant milestone in overseas research and development, particularly in the treatment of unresectable hepatocellular carcinoma (HCC) with its innovative product SIR-Spheres® Yttrium-90 microsphere injection (EganTai®) [2] Group 1: Product Approval and Market Potential - The FDA has granted early approval for SIR-Spheres® Yttrium-90 microsphere injection for the treatment of unresectable HCC, with no restrictions on tumor diameter, marking it as the first and only product approved for both unresectable HCC and colorectal cancer liver metastases [2][3] - The product utilizes advanced interventional techniques to deliver high-energy beta radiation directly to liver tumors, combining the benefits of radiopharmaceuticals and precise interventional therapy [3] - The global liver cancer treatment market is projected to reach $9.81 billion by 2030, indicating a substantial opportunity for innovative treatments like EganTai® [5] Group 2: Clinical Recognition and Usage - Since its launch, SIR-Spheres® has been used by over 150,000 patients across more than 50 countries, receiving endorsements from multiple international clinical guidelines [4] - In China, EganTai® has treated nearly 2,000 patients, achieving sales revenue of approximately HKD 500 million in 2024, with a year-on-year growth rate exceeding 140% [4] Group 3: Comprehensive Industry Position - YuanDa Pharmaceutical has established a full industry chain in nuclear medicine, encompassing research, production, sales, and regulatory qualifications, positioning itself as a leading player in the field [6] - The company has a robust pipeline of 15 innovative products targeting various cancers, including prostate, kidney, and brain cancers, utilizing five types of radioactive isotopes [6][7] - YuanDa aims to strengthen its nuclear medicine segment and expand its product pipeline, focusing on creating a comprehensive cluster of anti-tumor diagnostic and therapeutic products centered around EganTai® [7]

Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [1][10]. Core Insights - The company is expected to experience significant growth in its nuclear medicine sector, with the STC3141 sepsis product projected to become a major global drug. The report emphasizes the potential of new products in various therapeutic areas, including respiratory, critical care, and ophthalmology [3][9]. - The company has a diversified product portfolio and a robust pipeline, with a focus on innovative therapies and strategic acquisitions to enhance its market position [9][18]. Summary by Sections 1. Company Overview - The company operates in three main segments: nuclear medicine, pharmaceutical technology, and biotechnology, with a strong emphasis on innovation and market expansion through acquisitions [9][18]. 2. Nuclear Medicine Sector - The nuclear medicine segment is rapidly growing, with a focus on the core product Yttrium-90 (Y[90]) and a pipeline of 12 innovative products targeting various cancers. The company has established partnerships with leading international firms to enhance its research and development capabilities [9][35][37]. 3. Pharmaceutical Technology - The pharmaceutical technology segment is expected to see growth from new products in the respiratory and critical care fields, as well as in ophthalmology. The company is well-positioned to capitalize on the market opportunities presented by these new therapies [3][9]. 4. Financial Projections - The company forecasts revenue growth from 116.45 billion HKD in 2024 to 146.63 billion HKD by 2027, with net profit expected to rise from 24.68 billion HKD to 27.64 billion HKD in the same period. The projected P/E ratios indicate that the company is undervalued compared to its peers [1][10][24]. 5. Market Potential - The global nuclear medicine market is projected to grow significantly, with estimates suggesting a rise from 10.7 billion USD in 2023 to 22.8 billion USD by 2030. The Chinese market for radiopharmaceuticals is also expected to expand rapidly, driven by increasing demand and regulatory support [36][38].

Core Viewpoint - The recent diagnosis of prostate cancer in former U.S. President Biden has highlighted the importance of early cancer screening, which aligns with the comprehensive strategies of Yuan Da Pharmaceutical in the prostate cancer sector [1][3]. Company Overview - Yuan Da Pharmaceutical has established a robust presence in the prostate cancer market with innovative medical devices and a comprehensive product portfolio that integrates diagnosis and treatment [1][2]. - The company has seen a significant stock price increase, reaching a nearly ten-year high of 9 HKD per share, with a cumulative rise of approximately 50% over the past two weeks [1]. Market Dynamics - The global prostate cancer treatment market is projected to grow from 13.5 billion USD in 2025 to 29.9 billion USD by 2034, with a CAGR of 9.2% [7]. - In China, the prostate cancer medication market was valued at approximately 30.3 billion CNY in 2023, reflecting a year-on-year growth of 15.07% [7]. Early Screening Importance - The early detection rate of prostate cancer in China is only 32%, significantly lower than the 92% in the U.S., leading to a higher incidence of late-stage diagnoses [9]. - Early-stage prostate cancer patients have a survival rate of up to 100%, while those with metastatic disease have only a 31% five-year survival rate [3]. Product Development and Clinical Trials - Yuan Da Pharmaceutical's innovative products include TLX591-CDx, which has completed patient enrollment for its Phase III clinical trial in China and is expected to submit for market approval within the year [2][10]. - The company has a pipeline of 15 innovative products in the nuclear medicine sector, covering multiple cancer types, and has achieved significant clinical milestones [16][17]. Strategic Positioning - The establishment of a global nuclear medicine R&D and production base in Chengdu, set to commence operations in June 2025, will enhance Yuan Da's capabilities in the nuclear medicine field [19]. - The company aims to create a comprehensive ecosystem for urogenital system diseases, integrating early screening and treatment solutions [15][20]. Future Outlook - Yuan Da Pharmaceutical is positioned to become a key player in the global pharmaceutical market, with a focus on innovation and expanding its market share in cancer diagnostics and treatment [20].