Core Viewpoint - The company, YuanDa Pharmaceutical, is experiencing significant advancements in its nuclear medicine pipeline, particularly with the innovative radiopharmaceutical TLX591-CDx for prostate cancer diagnosis, which has shown promising results in clinical trials and is approaching the new drug application stage [1][4]. Group 1: Clinical Trial Results - TLX591-CDx has demonstrated a high diagnostic rate with a positive predictive value (PPV) of 94.8% overall, and a PPV of 100.0% for recurrent tumors in the prostate bed and non-bone metastatic tumors [4][5]. - The product's PET imaging has shown significant clinical implications for early diagnosis in suspected biochemical recurrence of prostate cancer, potentially providing critical treatment time windows for patients [4]. Group 2: Market Potential - TLX591-CDx has already been approved in multiple countries, including the US, Australia, and Canada, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a growth of over 25% [6][7]. - The success of TLX591-CDx in clinical trials in China marks a crucial step in building a comprehensive prostate cancer nuclear medicine product portfolio for the company [7]. Group 3: Product Pipeline and Industry Position - The company has a robust pipeline with 16 innovative products in the research and registration phase, covering various radioactive isotopes and multiple cancer types, indicating a strong commitment to integrated cancer diagnosis and treatment [11]. - YuanDa Pharmaceutical has established a full industry chain layout in nuclear medicine, encompassing research, production, and sales, which enhances its global competitiveness and operational efficiency [11][15]. Group 4: Future Outlook - The company aims to leverage its first-mover advantage and comprehensive industry capabilities to expand its market share in the global nuclear medicine sector, contributing to the advancement of China's nuclear medicine industry on the international stage [16].

Core Insights - The company, YuanDa Pharmaceutical, has achieved significant breakthroughs in its nuclear medicine pipeline, particularly with the approval of its innovative radiopharmaceutical TLX591-CDx for prostate cancer diagnosis, which has shown promising results in clinical trials [1][2][4]. Group 1: Clinical Trial Results - TLX591-CDx demonstrated a high positive predictive value (PPV) of 94.8% for overall tumor detection, with a PPV of 100% for recurrent prostate cancer and non-bone metastatic tumors [4]. - The product's PET imaging has shown significant clinical implications for early diagnosis in suspected biochemical recurrence of prostate cancer, potentially providing critical treatment time windows for patients [4][5]. - Over two-thirds of patients had their treatment plans adjusted based on TLX591-CDx PET imaging results, indicating its substantial impact on clinical decision-making [5]. Group 2: Market Potential - TLX591-CDx has already been approved in multiple countries, including the US, Australia, and Canada, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a growth of over 25% [6][7]. - The success of TLX591-CDx in China’s Phase III clinical trials marks a critical step in building a comprehensive prostate cancer nuclear medicine product portfolio [7]. Group 3: Industry Positioning - YuanDa Pharmaceutical has established a full-spectrum nuclear medicine industry chain, encompassing research, production, distribution, and sales, with a global presence in over 50 countries [11]. - The company has a robust pipeline of 16 innovative products in development, covering various radioactive isotopes and multiple cancer types, positioning itself as a leader in integrated cancer treatment solutions [11][14]. - The company’s advanced nuclear medicine research and production facilities in Chengdu are recognized as one of the most automated and comprehensive platforms globally, enhancing its capability to meet diverse treatment needs [15]. Group 4: Future Outlook - With the ongoing expansion of the global nuclear medicine market, YuanDa Pharmaceutical aims to leverage its first-mover advantage and comprehensive industry capabilities to enhance its market share and provide superior treatment options for cancer patients worldwide [17].

Core Insights - The approval of GPN01530 for clinical trials in the U.S. marks a significant milestone for the company in the field of innovative pharmaceuticals, particularly in targeting fibroblast activation protein (FAP) for solid tumors [1] - GPN01530 is positioned as a potential game-changer in the diagnosis and treatment of solid tumors, with the ability to reshape the treatment landscape and provide new hope for patients globally [1][7] Group 1: Product and Technology - GPN01530 is not just another innovative nuclear drug; its unique application prospects and technological breakthroughs make it a core competitive asset for the company in the nuclear medicine sector [2] - The drug has shown superior performance in preclinical studies, demonstrating rapid tumor targeting, higher tumor uptake, and better pharmacokinetic properties compared to other FAP ligands [2][3] - GPN01530 has the potential to replace the current standard, 18F-FDG, in the market, setting a new benchmark for FAP-targeted drugs [2] Group 2: Market Potential - FAP is recognized as a promising target in nuclear medicine, with a high expression rate in 90% of epithelial tumors, making it suitable for various cancer types [3][4] - The global cancer incidence is projected to rise from 19.3 million in 2020 to 24.6 million by 2030, leading to an expanding drug market, with estimates suggesting a market size exceeding $200 billion in the U.S. by 2030 [4] - The compound is expected to benefit over ten million patients globally, significantly enhancing the standard of care for solid tumors [7] Group 3: Company Strategy and Globalization - The company has established a comprehensive global layout in the nuclear medicine industry, covering research, production, distribution, and sales [8] - With a robust pipeline of 16 innovative products in the registration phase, the company is one of the leaders in the nuclear medicine sector, particularly in the anti-tumor domain [8][11] - The recent establishment of a state-of-the-art production facility in Chengdu enhances the company's capability to meet global demand and supports its strategic goal of a fully integrated nuclear medicine supply chain [11][13] Group 4: Future Outlook - The company aims to leverage the "dual filing" international registration strategy to advance GPN01530's global development and registration efforts [14] - This approach not only enhances the company's clinical registration capabilities abroad but also allows for the integration of clinical trial experiences from mature markets back into domestic practices [14] - The successful development of GPN01530 could set a precedent for other Chinese innovative drugs to enter global markets, contributing to the global fight against cancer [14]

智通财经APP获悉，近日，中国医药创新领域迎来一项具有标杆意义的进展——远大医药(00512)自主研发的全球创新放射 性核素偶联药物(RDC)GPN01530正式获得FDA批准在美国开展用于诊断实体瘤的I/II期临床研究。 此举不仅意味着远大医药在成纤维细胞活化蛋白(FAP)这一明星靶点上的布局取得国际认可，更体现了公司在国际化临床开 发与注册申报上的综合实力，这也将成为公司后续推进其他创新药全球化布局的重要里程碑。未来若GPN01530开发顺利， 该产品有望成为破解实体瘤诊疗困境的重要突破口，凭借显著的产品优势重塑实体瘤诊疗格局，抢占全球领先的市场地 位，并为全球患者带来新的希望。 布局十亿美元级靶点，BIC惠及全球超千万患者 远大医药GPN01530并非寻常意义上的又一款创新核药，其特殊性源于产品靶点背后的泛实体瘤应用前景、所突破的技术瓶 颈以及所承载的"诊疗一体化"愿景，这也使得该产品成为企业在核药领域差异化竞争的核心抓手，更有望成为中国创新核 药出海的标杆范例。 公告显示，GPN01530优化了FAP配体的结构，提高了其在肿瘤组织中的摄取，同时降低其在正常组织中的摄取。临床前研 究结果显示，与其它FA ...

Core Viewpoint - Yuan Da Pharmaceutical (00512) is experiencing continuous revenue growth driven by the gradual launch of innovative products and efficient management, with a target price of HKD 11.88, indicating a potential upside of 45.23% from the current price, maintaining a buy rating [1] Group 1: Revenue Growth - The company achieved total revenue of HKD 6.11 billion in the first half of 2025, representing a year-on-year increase of 2.0% in RMB terms; normalized profit was HKD 1.02 billion, down 5.0% year-on-year in RMB terms [2] - The pharmaceutical technology segment contributed the most to revenue, generating HKD 3.845 billion, with a year-on-year increase of 2.9% in RMB terms [2] - Revenue from nuclear medicine for tumor diagnosis and treatment reached HKD 420 million, showing a significant year-on-year growth of 105.5%, primarily driven by the approval of SIR-Spheres Yttrium-90 microspheres for unresectable HCC [2] Group 2: Innovative Drug Pipeline - The company has five major technology platforms and eight R&D centers, with R&D and project investment of HKD 1.02 billion in the first half of 2025 [3] - The focus is on innovative nuclear medicine, with a leading global pipeline that includes radiolabeled drug conjugates (RDC) and interventional oncology products, with 27 innovative drug candidates currently in development [3] - The innovative drug STC3141 for treating sepsis has reached clinical endpoints in Phase II trials in China, showing significant improvement in SOFA scores compared to the placebo group [3] Group 3: Profit Forecast - Future revenue growth is expected, with projected revenues of HKD 12.35 billion, HKD 13.39 billion, and HKD 14.79 billion for 2024 to 2026, respectively; EPS is forecasted to be HKD 0.59, HKD 0.66, and HKD 0.77 for the same period [4]

Core Viewpoint - The completion of patient enrollment for the clinical study of GPN00289, a temperature-sensitive embolic agent for primary liver cancer, marks a significant advancement in the company's research and development in the field of nuclear medicine for tumor treatment [1][4]. Group 1: Product Overview - GPN00289 is an innovative temperature-sensitive embolic material recognized by the National Medical Products Administration of China, designed for treating hypervascular benign and malignant tumors [2]. - The product exhibits temperature-responsive properties, allowing it to transition from liquid to solid state, effectively embolizing various blood vessels [2]. - GPN00289 combines the advantages of liquid and solid embolization, addressing the limitations of current transcatheter arterial chemoembolization (TACE) methods [3]. Group 2: Market Context - According to GLOBOCAN 2022, there are approximately 870,000 new liver cancer cases globally, with around 760,000 deaths, highlighting the critical need for effective treatment options [3]. - In China, liver cancer accounts for about 37% of global new cases and 32% of deaths, indicating a significant market opportunity for innovative treatments [3]. Group 3: Strategic Development - The company holds global rights to GPN00289 and aims to advance its global registration and development, particularly in collaboration with the innovative internal radiotherapy drug, Yttrium-90 microspheres [4]. - The company has established a comprehensive nuclear medicine industry chain, including research, production, distribution, and sales, with over 900 employees globally [4][8]. Group 4: Collaborative Efforts - The company collaborates with Sirtex Medical Pty Ltd and Telix Pharmaceutical Limited to develop an international standard tumor intervention research and development platform [5]. - The company has a pipeline of 15 innovative products in the registration phase, covering various radioactive isotopes and multiple cancer types [5]. Group 5: Infrastructure and Innovation - The company’s new radioactive drug research and production base in Chengdu, China, is the first of its kind globally, covering the entire nuclear medicine industry chain [8]. - The base aims to enhance the company's research and production capabilities, ensuring high-quality development in the nuclear medicine sector [8][9].

Core Viewpoint - The completion of patient enrollment for the clinical study of GPN00289, a temperature-sensitive embolic agent for primary liver cancer, marks a significant advancement in the company's research and development in the field of nuclear medicine for tumor treatment [1][4]. Group 1: Product Overview - GPN00289 is an innovative temperature-sensitive embolic material recognized by the National Medical Products Administration of China, designed for treating hypervascular benign and malignant tumors [2]. - The product features temperature responsiveness and high plasticity, allowing it to transition from liquid to solid state, effectively embolizing various blood vessels [2]. - GPN00289 combines the advantages of liquid and solid embolization, addressing the limitations of current transcatheter arterial chemoembolization (TACE) methods [3]. Group 2: Market Context - According to GLOBOCAN 2022, there are approximately 870,000 new liver cancer cases globally, with around 760,000 deaths, highlighting the critical need for effective treatment options [3]. - In China, liver cancer accounts for about 370,000 new cases and 320,000 deaths annually, representing 42.5% and 42.1% of global figures, respectively [3]. - The prognosis for liver cancer patients is poor, with a high recurrence rate post-surgery and a low five-year survival rate, emphasizing the demand for effective treatment methods [3]. Group 3: Strategic Development - The company holds global rights to GPN00289 and aims to advance its global registration and development, particularly in collaboration with the innovative internal radiotherapy drug, Yttrium-90 microspheres [4]. - The company has established a comprehensive nuclear medicine industry chain, including research, production, distribution, and sales, with over 900 employees globally [4][8]. - The company is actively developing a pipeline of innovative products, with 15 products in the registration stage, covering multiple cancer types and utilizing various radioactive isotopes [5]. Group 4: Infrastructure and Innovation - The company has completed a state-of-the-art radioactive drug research and production base in Chengdu, China, which is the first of its kind to cover the entire nuclear medicine industry chain [8]. - This facility enhances the company's ability to produce a wide range of products autonomously, addressing previous reliance on imports and ensuring high standards of safety and quality [8]. - The company emphasizes innovation and advanced technology development, focusing on unmet clinical needs and aiming to provide diverse treatment options for patients globally [9].

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。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號: 00512) 自願性公告 全球創新溫度敏感性栓塞劑在中國的註冊性臨床研究 完成全部患者入組 -1- 不良反應，安全性高，且可即時顯影，滿足手術精准操作需求。 根據 GLOBOCAN 2022 年的數據，肝癌全球新發病例約 87 萬，位居腫瘤第六位；死亡 病例約 76 萬，居第三位。中國國家癌症中心 2024 年全國癌症報告顯示，2022 年中國 新發肝癌約 37 萬例（占全球 42.5%），居腫瘤第四位；死亡病例約 32 萬例（占全球 42.1%)，居第二位；佔比均居全球首位。手術切除是治療早期肝癌的首選方法，但由 於肝癌發病隱匿，早期症狀不明顯或不典型，早診困難，不足 30%的肝癌患者在初診 時適合根治性治療，治療棘手，因此預後較差，發病率與死亡率之比高達 1： ...

Core Viewpoint - The Hong Kong International Biotechnology Forum and Exhibition (BIOHK) 2025 serves as a significant platform for industry leaders to discuss the future of biotechnology, with a focus on the global strategy of the pharmaceutical company YuanDa Pharmaceutical [1][3]. Group 1: Company Strategy and Globalization - YuanDa Pharmaceutical is recognized as a leading global player in nuclear medicine, sharing its global strategy at the BIOHK 2025 forum [3][6]. - The company is implementing a "Go Global" strategy, focusing on global research, production, and sales to enhance the value of innovative products [3][10]. - YuanDa has achieved significant milestones in its nuclear medicine development, with its product Yttrium-90 microsphere injection being used in over 150,000 patients across more than 50 countries [6][10]. Group 2: Product Development and Market Expansion - The company has received CE mark certification for new indications of its innovative product, expanding its treatment scope to include multiple types of liver cancer, which is expected to double its market potential [6][10]. - YuanDa is advancing its pipeline with 15 innovative products in development, covering various cancers and utilizing five types of radioactive isotopes [7][9]. - The company is actively pursuing a "dual filing" strategy in the U.S. and China, with several products entering international Phase III clinical trials [9][10]. Group 3: Research and Production Capabilities - YuanDa has established a comprehensive global network for nuclear medicine, with research and production bases in Boston and Chengdu, and a sales network covering over 50 countries [11][13]. - The company has built a state-of-the-art production facility in Chengdu, recognized as one of the most automated and comprehensive nuclear medicine factories globally [11][13]. - YuanDa's global innovation strategy includes five research platforms and eight research centers, with a robust pipeline of 133 projects in various stages of development [13].

Core Viewpoint - The Hong Kong International Biotechnology Forum and Exhibition (BIOHK) 2025 serves as a significant platform for industry leaders to discuss the future of biotechnology, with a focus on the global strategy of Yuan Da Pharmaceutical in nuclear medicine [1][3]. Group 1: Company Strategy - Yuan Da Pharmaceutical is recognized as a leading global nuclear medicine company, sharing its unique global development strategy at the forum [3][5]. - The company is implementing a "Go Global" strategy, focusing on global R&D, production, and sales to enhance the long-term value of innovative products [3][5][9]. Group 2: Market Expansion - The recognition of Chinese innovative drugs is increasing globally, with a notable rise in the number of oral presentations by Chinese pharmaceutical companies at the ASCO conference, from 25 in 2023 to 84 in 2025 [3]. - In the first half of 2025, the transaction value of innovative drug licensing exceeded the total for 2024, indicating strong innovation capabilities [3]. Group 3: Product Development - Yuan Da Pharmaceutical has achieved significant breakthroughs in nuclear medicine, with its innovative product, Yttrium-90 microsphere injection, being used in over 50 countries and for more than 150,000 patients [5]. - The product is the first and only FDA-approved treatment for unresectable hepatocellular carcinoma (HCC) and colorectal cancer liver metastases, recently receiving CE mark certification for additional indications [5]. Group 4: R&D Pipeline - The company has 15 innovative products in the R&D registration phase, utilizing five types of radioactive isotopes to target eight different cancers [6][8]. - Yuan Da is advancing its "dual filing" strategy in the U.S. and China, with several products entering international multi-center Phase III clinical trials [8]. Group 5: Global Infrastructure - Yuan Da Pharmaceutical has established a comprehensive global sales network covering over 50 countries, supported by R&D bases in Boston and Chengdu, and production facilities in multiple international locations [10][12]. - The company’s Chengdu facility is noted for being one of the most automated and comprehensive nuclear medicine production plants globally, ensuring high-quality product supply [10]. Group 6: Long-term Vision - The company aims to deepen its global market penetration and brand development through its ongoing "Go Global" strategy, addressing unmet medical needs worldwide [12].