1H25，公司核药抗肿瘤板块收入4.22亿港币，剔除汇率影响同比+105.5%，主要由于国内易甘泰快速放 量。此外，报告期内易甘泰获FDA批准用于原发性肝细胞癌，成为全球首个获批原发性肝细胞癌和结直 肠癌肝转移的内放射治疗产品。RDC方面公司临床推进顺利，TLX-591CDx完成三期临床入组， TLX591、ITM-11等产品加入国际多中心III期临床试验，自研创新核药GPN02006亮相国际会议。 公司公布1H25业绩：收入61.07亿港币，同比+1.0%，剔除汇率影响同比+2.0%;归母净利润11.69亿港 币，超该行预期，主要由于收入超预期。 在创新和壁垒产品放量的支持下，公司上半年经营业绩稳健，体现良好的抗风险能力 智通财经APP获悉，中金发布研报称，由于1H25远大医药(00512)业绩体现了较好的抗风险能力，上调 2025年/2026年归母净利润预测3.3%/3.4%至19.1亿/21.0亿港币。当前股价对应2025年/2026年18.0倍/16.4 倍P/E。考虑到公司创新管线不断兑现，该行维持跑赢行业评级，上调目标价21.9%至11.7港币，对应 2025年/2026年21.7倍/19.8倍P ...

在创新和壁垒产品放量的支持下，公司上半年经营业绩稳健，体现良好的抗风险能力 根据公司公告，1H25公司持续推动创新结构转型，创新和壁垒产品收入占比约51%(vs去年同期 36.1%)。易甘泰、Lava、恩卓润/恩明润、能气朗、合心爽/合贝爽等产品快速增长。剔除第十批集采影 响，公司人民币口径收入同比增长约13.0%，支持收入实现可持续增长。 核药板块延续翻倍增长态势，创新核素偶联药物(RDC)管线进展丰富 中金发布研报称，由于1H25远大医药(00512)业绩体现了较好的抗风险能力，上调2025年/2026年归母净 利润预测3.3%/3.4%至19.1亿/21.0亿港币。当前股价对应2025年/2026年18.0倍/16.4倍P/E。考虑到公司创 新管线不断兑现，该行维持跑赢行业评级，上调目标价21.9%至11.7港币，对应2025年/2026年21.7 倍/19.8倍P/E，较当前股价有20.6%的上行空间。 中金主要观点如下： 1H25业绩超该行预期 公司公布1H25业绩：收入61.07亿港币，同比+1.0%，剔除汇率影响同比+2.0%;归母净利润11.69亿港 币，超该行预期，主要由于收入超预期。 关注 ...

Core Insights - The company reported a revenue of approximately HKD 6.11 billion for the first half of 2025, representing a year-on-year growth of about 1.0% [1] - Net profit for the period was approximately HKD 1.17 billion, with a slight decline of 5.9% in normalized profit [1] - The revenue share of innovative and high-barrier products increased to 51.0%, up from 36.1% in the same period last year, indicating a shift towards higher value-added products [1] - The decline in profit was attributed to price pressures from centralized procurement and increased marketing expenses for new product launches, which are seen as strategic investments for future growth [1] Financial Performance - The company achieved a revenue of approximately HKD 4.22 billion in its nuclear medicine segment, with a remarkable year-on-year growth of 105.5% [10][11] - The core product, Yttrium microsphere injection, drove this growth, with commercialization progressing in over 70 hospitals across 22 provinces in China [11] - The company invested approximately HKD 1.022 billion in research and development during the first half of 2025 [9] Product Development - The global innovative drug STC3141 for treating sepsis successfully reached its primary clinical endpoint in a Phase II trial in China [5] - The company holds global intellectual property rights for STC3141, which has the potential to become a First-in-Class (FIC) drug [6][8] - The innovative pipeline includes products like OC-01 and GPN01768, which have shown strong performance in overseas markets, with GPN01768 generating over USD 100 million in revenue, a nearly 152% increase year-on-year [7] Global Strategy - The company has established a global operational network, with a new radioactive drug research and production base in Chengdu, which is the first of its kind to cover the entire nuclear medicine value chain [15] - The base is equipped with 14 high-standard GMP production lines, ensuring a stable supply chain and supporting global market needs [15] - The company aims to build its global pharmaceutical brand through its "Go Global" strategy, leveraging its innovative products and international clinical trial capabilities [15] Conclusion - The mid-year financial report highlights a significant shift in the company's business structure, with innovative products now constituting over half of its revenue [16] - The pipeline of FIC drugs and the integrated diagnostic and therapeutic platform in nuclear medicine are expected to contribute significantly to revenue growth [16] - The operational infrastructure in Chengdu supports the execution of the company's global strategy, positioning it for future expansion [16]

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]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對 其準確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 加入國際多中心 III 期臨床試驗的申請已獲中國藥監局默示許可 本公告乃遠大醫藥集團有限公司(「本公司」，連同其附屬公司統稱「本集團」)之董事 會(「董事會」)自願刊發。 董事會欣然公告，本集團用於治療前列腺癌的全球創新在研放射性核素偶聯藥物 「( RDC」) TLX591 (177Lu-rosopatamab tetraxetan)加入國際多中心 III 期臨床試驗的申請， 近日已獲得中華人民共和國國家藥品監督管理局(「中國藥監局」)默示許可，這是本集 團在核藥抗腫瘤診療領域的重要研發進展。本集團高度重視核藥產業全球化發展戰略， 積極推進創新核藥產品的全球化開發及註冊進程，並將持續深化本集團核藥產品管線的 全球化拓展。 該研究是一項前瞻性、隨機、對照、開放標籤、國際多中心的 III 期臨床試驗，擬在中 國、美國、澳大利亞、新西蘭及歐洲等全球多個國家和地區入組 500 余名患者，旨在評 估 TLX591 ...

Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對 其準確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 本集團全球創新放射性產品 SIR-Spheres®釔[ 90Y]微球注射液 提前正式獲得 FDA 批准新增適應症 本公告乃遠大醫藥集團有限公司(「本公司」，連同其附屬公司統稱「本集團」)之董事 會(「董事會」)自願刊發。 ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 自願性公告 SIR-Spheres®釔[ 90Y]微球注射液，是一款針對肝臟惡性腫瘤的選擇性內放射治療產品， 採用全球領先的介入技術將釔[ 90Y]樹脂微球注入肝臟腫瘤血管，釋放高能量 β 放射線 殺滅腫瘤細胞，兼具了放射性藥物和精准介入治療的雙重優勢。本次新適應症的獲批是 基於一項前瞻性、多中心、開放標籤的臨床試驗（「DOORwaY90」）的中期結果。該 試驗中期數據顯示，DOORwaY90 成功達到預先設定的共同主要終點：經獨立中 ...

Core Viewpoint - The recent advancements in innovative nuclear medicine products by the company, particularly the Yttrium-90 microsphere injection, have garnered significant international recognition, showcasing the clinical potential of its nuclear medicine pipeline [1][4][9]. Group 1: Product Developments - The innovative nuclear medicine product, Yttrium-90 microsphere injection, has been highlighted at major international conferences, indicating its clinical value and potential in treating liver cancer [4][5]. - The company has successfully launched a global innovative ophthalmic drug for treating demodex blepharitis, which is expected to enhance its market presence in the Greater Bay Area and mainland China [3][9]. - The Yttrium-90 microsphere injection has achieved a disease control rate of 90.9% and an objective response rate of 87.8% in clinical studies, establishing it as a leading treatment for hepatocellular carcinoma (HCC) [7][8]. Group 2: Financial Performance - The company's stock price has surged over 50% since early May, reaching a historical high of 9.19 HKD, with a year-to-date increase of over 130% [3]. - The Yttrium-90 microsphere injection has treated nearly 2,000 patients and is projected to generate approximately 500 million HKD in sales revenue for 2024, reflecting a year-on-year growth rate exceeding 140% [7][8]. Group 3: Research and Clinical Impact - The Yttrium-90 microsphere injection has become a focal point in global HCC treatment, with multiple studies presented at the ASCO and APPLE conferences [5][6]. - The company has trained over 1,100 doctors across 70 hospitals to enhance the clinical application of its products, indicating a commitment to improving treatment accessibility [8][9]. Group 4: Infrastructure and Future Plans - The company is establishing a "zero-radiation" intelligent nuclear medicine factory in Chengdu, which will serve as a comprehensive platform for research, production, and sales, enhancing its operational capabilities [13][16]. - The factory is set to be the first of its kind globally, with a planned investment exceeding 3 billion RMB, focusing on isotope production and automated manufacturing processes [16][18].

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].

Core Viewpoint - The company, YuanDa Pharmaceutical, has achieved significant milestones in the development of its global nuclear medicine R&D and production base in Chengdu, which is set to become the world's first "zero-radiation" intelligent nuclear medicine factory, marking a strategic leap in the nuclear medicine industry [1][4][11]. Group 1: Company Developments - YuanDa Pharmaceutical's Chengdu base has received a Class A Radiation Safety License from the Ministry of Ecology and Environment, with operations expected to commence in June 2025 [1][11]. - The construction of the base has set a record in the industry, completing the main structure in just five months, and is recognized for its high level of automation and comprehensive range of isotopes [1][4]. - The company has seen its stock price rise significantly, reaching a historical high of HKD 8.95, a nearly 126% increase from its low point this year, with a market capitalization exceeding HKD 30 billion [3]. Group 2: Technological Innovations - The Chengdu base features a state-of-the-art cyclotron from Belgium's IBA, enabling the independent production of critical isotopes, addressing the domestic shortage of imported isotopes [5]. - The facility employs fully automated production processes, enhancing production stability and efficiency, and significantly reducing the production cycle by approximately 80% [7]. - A comprehensive radiation monitoring system has been integrated, ensuring compliance with international safety standards and establishing a new benchmark for safety in the nuclear medicine industry [9][12]. Group 3: Market Position and Growth - The global nuclear medicine market is projected to grow at a compound annual growth rate (CAGR) of 18% from 2022 to 2028, reaching approximately USD 18.7 billion, while China's market is expected to grow at a CAGR of 27% from 2023 to 2030, reaching around RMB 26 billion [12]. - YuanDa Pharmaceutical has established a complete industrial chain in the nuclear medicine sector, with a product pipeline that includes 15 innovative products targeting various cancers [12][15]. - The company is positioned as a leader in the nuclear medicine field, with the most extensive product pipeline and integrated treatment solutions, enhancing its competitive edge in the market [16][17].

Group 1 - The company is advancing its innovative radiopharmaceuticals, including GPN02006 for diagnosing hepatocellular carcinoma (HCC), with results from clinical research expected to be presented at the 2025 SNMMI annual meeting [1] - GPN02006 is a targeted diagnostic radiopharmaceutical based on radiolabeled antibody technology, aiming to provide a new and more precise molecular imaging solution for HCC diagnosis [1] - The company has also made progress with TLX591 and TLX591-CDx, with TLX591 being a therapeutic radiopharmaceutical that has received acceptance for international multi-center Phase III clinical application [2] Group 2 - The company's nuclear medicine segment has entered a growth phase, achieving revenue of HKD 589 million in 2024, a significant increase of 177% year-on-year [3] - The core product, Yttrium-90 microsphere injection, has become a key driver of revenue growth, contributing HKD 500 million, with a year-on-year increase of over 140% [3] - The company has established a comprehensive industrial layout covering research, production, sales, and regulatory qualifications, with a global R&D and production base for radiopharmaceuticals in Chengdu [3]