Core Viewpoint - The company has made significant progress in the development of innovative radiopharmaceuticals for prostate cancer diagnosis and treatment, with the recent submission of a New Drug Application (NDA) for TLX591-CDx to the National Medical Products Administration of China, marking a key milestone in its oncology pipeline [1][2]. Group 1: Product Development and Clinical Trials - TLX591-CDx has shown a positive predictive value (PPV) of 94.8% in a clinical study involving over 100 prostate cancer patients, indicating its effectiveness in diagnosing the disease [2]. - The NDA submission includes data from a clinical study that demonstrated the impact of TLX591-CDx on treatment decisions, with 67.2% of patients experiencing changes in their treatment plans based on PET imaging results [2]. - The company has a total of six innovative RDC products approved for clinical research, with four currently in Phase III trials, including TLX591-CDx and TLX591 [8]. Group 2: Strategic Partnerships and Collaborations - The company signed a strategic cooperation agreement with Telix Pharmaceutical Limited in November 2020, securing exclusive rights to several innovative RDC products in Greater China [3]. - Collaborations with Sirtex Medical Pty Ltd and ITM Isotope Technologies Munich SE have established a world-class tumor intervention research and development platform [5]. Group 3: Market Expansion and Sales Performance - TLX591-CDx has been approved in multiple countries, including Australia, the United States, and Canada, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting over 25% year-on-year growth [4]. - The company has established a global sales network covering over 50 countries, enhancing its market presence in the oncology sector [4]. Group 4: Infrastructure and Production Capabilities - The company’s radiopharmaceutical research and production base in Chengdu, China, is the first of its kind to cover the entire nuclear medicine supply chain, from isotope preparation to commercialization [9]. - The facility is designed to meet international standards with advanced automation and safety measures, ensuring high-quality production and operational efficiency [9]. Group 5: Commitment to Innovation and Future Development - The company emphasizes innovation and advanced technology development, focusing on unmet clinical needs and expanding its product pipeline [10]. - Plans are in place to strengthen the research and development of its oncology products, aiming to solidify its position as a leader in the global radiopharmaceutical market [9][10].

Core Viewpoint - The company has made significant progress in the development of innovative radiopharmaceuticals for prostate cancer diagnosis and treatment, with the recent submission of a New Drug Application (NDA) for TLX591-CDx to the National Medical Products Administration of China, marking an important milestone in the field of nuclear medicine for oncology [1][2]. Group 1: Product Development and Clinical Trials - TLX591-CDx has shown a positive predictive value (PPV) of 94.8% in a clinical study involving over 100 patients, indicating its effectiveness in diagnosing prostate cancer [2]. - The NDA application includes data from a clinical study that demonstrated significant changes in treatment plans for 67.2% of patients after using TLX591-CDx for imaging, highlighting its impact on clinical decision-making [2]. - The company has a total of six innovative RDC products approved for clinical research, with four currently in Phase III trials, including TLX591-CDx and TLX591 [8]. Group 2: Strategic Partnerships and Market Expansion - The company signed a strategic cooperation agreement with Telix Pharmaceutical Limited in November 2020, securing exclusive rights for several innovative RDC products in Greater China [3]. - TLX591-CDx has been approved in multiple countries, including Australia, the United States, and Canada, with sales reaching approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting over 25% year-on-year growth [4]. Group 3: Research and Development Infrastructure - The company has established a comprehensive R&D and production base in Chengdu, China, which is the world's first closed-loop platform for the entire nuclear medicine industry chain, enhancing its R&D efficiency and production capabilities [9]. - The company is focused on integrating innovative treatment concepts and has a pipeline of 16 innovative products in various stages of development, covering multiple cancer types [5][6]. Group 4: Future Outlook and Strategic Goals - The company aims to strengthen its position as a leading player in the global nuclear medicine oncology sector by continuously enhancing its product pipeline and industry layout, with a focus on high-value products [10]. - The company is committed to addressing unmet clinical needs through technological innovation and aims to provide advanced treatment options for patients worldwide [10].

Group 1 - The company, Yuan Da Pharmaceutical, has submitted a New Drug Application (NDA) for its innovative radiolabeled drug TLX591-CDx for prostate cancer diagnosis to the National Medical Products Administration of China, marking a significant advancement in its research and development in the field of nuclear medicine for cancer treatment [1] - TLX591 has been approved to participate in an international multicenter Phase III clinical study in China, which is expected to provide more precise and effective diagnostic solutions for prostate cancer patients [1] Group 2 - The NDA submission includes data from a clinical study that reported positive preliminary results in December 2025, involving over 100 patients with biochemical recurrence of prostate cancer [2] - The Phase III clinical study demonstrated a positive predictive value (PPV) of 94.8% for TLX591-CDx in detecting tumors, confirming that the clinical experience in Chinese patients aligns with results from non-Chinese studies, even in patients with very low prostate-specific antigen (PSA) levels [2]

自願性公告 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) 此外，超過三分之二（67.2%）的患者在 TLX591-CDx 的 PET 成像檢測後，其治療方案 較基線時的初始方案發生了調整。這表明 TLX591-CDx 的 PET 成像檢測對臨床決策具 有重要影響，可優化疑似生化復發的前列腺癌患者的臨床治療策略。 此前，本集團於二零二零年十一月與 Telix Pharmaceutical Limited (ASX: TLX; NASDAQ: TLX，與其全球子公司統稱「Telix」)簽署了產品戰略合作協議，並獲得其開發的包括 TLX591、TLX591-CDx、TLX250-CDx 在內的多款創新 RDC 產品在大中華區（中國大 陸、中國香港特別行政區、中國澳門特別行政區、中國台灣地區）的獨家權益。 ...

Core Insights - The company has achieved significant breakthroughs in the field of nuclear medicine, particularly with the successful completion of the Phase I clinical trial of TLX250-CDx for diagnosing clear cell renal cell carcinoma (ccRCC) in China, which has been published in a leading international journal [1][6] - TLX250-CDx is expected to provide a non-invasive and accurate diagnostic option for millions of suspected ccRCC patients in China, enhancing the diagnostic landscape [1][6] Group 1: Clinical Research and Results - The ZIRDOSE-CP clinical study is a single-arm, open-label, prospective Phase I trial assessing the safety, tolerability, and pharmacokinetics of TLX250-CDx in 10 Chinese patients with uncertain renal masses or suspected recurrence of ccRCC [2] - The study demonstrated good safety and tolerability of TLX250-CDx in Chinese patients, with organ and tumor dosimetry similar to previous reports in other populations, supporting its clinical value [6][10] Group 2: Market Potential and Growth - The ccRCC market is expanding, with the number of patients in China increasing from 66,000 in 2015 to 81,000 in 2023, reflecting a compound annual growth rate (CAGR) of 2.0%, and projected to reach 93,000 by 2030 [2] - The global renal cancer diagnostic market is expected to grow from USD 5.37 billion in 2024 to USD 8.36 billion by 2035, with a CAGR of 4.11%, indicating a strong demand for more precise diagnostic methods [5] Group 3: Company Capabilities and Innovations - The company has established a comprehensive nuclear medicine industry chain, covering research, production, distribution, and sales, with over 900 employees globally [7][14] - The company has a robust pipeline with 16 innovative products in the registration phase, including five key radioactive isotopes, and aims to provide integrated treatment options for various cancers [7][10] - The company’s production facility in Chengdu is the world's first closed-loop platform for nuclear medicine, ensuring 100% self-production and addressing import dependency issues [12][14]

Core Insights - The company, YuanDa Pharmaceutical, has achieved significant breakthroughs in the field of nuclear medicine for cancer diagnosis, particularly with the successful completion of the Phase I clinical trial of TLX250-CDx for diagnosing clear cell renal cell carcinoma (ccRCC) in China [1][6]. Group 1: Clinical Research and Results - TLX250-CDx has demonstrated good safety and tolerability in Chinese patients, with organ and tumor dosimetry similar to previous reports in other populations, supporting its safety and efficacy for future registration and market launch in China [1][6]. - The ZIRDOSE-CP clinical study, a single-arm, open-label, prospective Phase I trial, evaluated the safety, tolerability, and pharmacokinetics of TLX250-CDx in 10 Chinese patients with uncertain renal masses or suspected recurrence of ccRCC [2][5]. - The sensitivity and specificity of TLX250-CDx for detecting ccRCC were reported at 85.5% and 87%, respectively, indicating its potential as a new clinical diagnostic standard [5][6]. Group 2: Market Potential and Growth - The ccRCC patient population is growing, with the incidence in China increasing from 66,000 in 2015 to 81,000 in 2023, reflecting a compound annual growth rate (CAGR) of 2.0%, and projected to reach 93,000 by 2030 [2]. - The global renal cancer diagnostic market is expected to grow from USD 5.37 billion in 2024 to USD 8.36 billion by 2035, with a CAGR of 4.11%, highlighting the demand for more precise and efficient diagnostic methods [5]. Group 3: Company Capabilities and Innovations - YuanDa Pharmaceutical has established a comprehensive nuclear medicine industry chain, covering research, production, distribution, and sales, with over 900 employees globally [7][14]. - The company has a strong pipeline of 16 innovative products in the registration phase, including five key radioactive isotopes, and aims to provide integrated treatment options for various cancers [7][10]. - The company’s production facility in Chengdu is the world's first closed-loop platform for nuclear medicine, ensuring 100% self-sufficiency in production and addressing import dependency issues [12][14].

Core Viewpoint - The company, YuanDa Pharmaceutical, has made significant advancements in innovative products, showcasing its "self-research + introduction" strategy in the fields of nuclear medicine, traditional Chinese medicine for depression, and emergency treatments, indicating a strong potential for sustainable growth in the innovative drug sector [1][16]. Group 1: Innovative Product Developments - The company achieved success in its Phase II clinical trial for an innovative traditional Chinese medicine for depression [1]. - The FDA approved the company's self-researched FAP-targeted nuclear medicine for clinical research, while an introduced prostate cancer diagnostic nuclear medicine reached the end of its Phase III clinical trial in China, indicating imminent commercialization [1][2]. - The company launched the world's first epinephrine nasal spray for emergency treatment of type I allergic reactions in China, enhancing its cardiovascular emergency product line [1][14]. Group 2: Nuclear Medicine Advancements - The GPN01530 nuclear medicine, targeting FAP, has shown superior performance compared to current cancer diagnostic products, with a sensitivity of 80%-90% for certain cancers, potentially replacing the mainstream product 18F-FDG [2][3]. - TLX591-CDx, a prostate cancer diagnostic nuclear medicine, achieved a positive top-line result in its Phase III clinical trial, demonstrating a 100% positive predictive value for recurrent prostate cancer [4][5]. - The company has a robust pipeline with 16 innovative products in the registration phase, covering various radioactive isotopes and cancer types, indicating a comprehensive approach to nuclear medicine [7]. Group 3: Strategic Initiatives - The company employs a dual strategy of "self-research + global introduction," enhancing its innovation capabilities and product offerings in the nuclear medicine sector [6][10]. - The establishment of a comprehensive global industrial network, including R&D and production bases in Boston and Chengdu, supports the company's competitive edge in the nuclear medicine market [10][13]. - The company's proactive "China-US dual reporting" strategy accelerates drug approvals in major markets, enhancing the international market value of its products [10]. Group 4: Financial Performance and Market Outlook - The company reported a significant increase in revenue from innovative and barrier products, accounting for approximately 51% of total revenue, reflecting a year-on-year increase of 14.9 percentage points [16]. - The global nuclear medicine market is projected to grow from approximately $10.65 billion in 2023 to $31.44 billion by 2033, with a compound annual growth rate of about 11.45%, positioning the company to benefit from this market expansion [13]. - The company's market capitalization has doubled since the beginning of the year, indicating strong market recognition of its innovative strategy and growth potential [16].

Investment Rating - The industry investment rating is "Outperform the Market," indicating an expected performance that exceeds the market by more than 5% over the next six months [29]. Core Insights - The report highlights that the national government will continue to support the renewal of medical equipment in 2026, which is expected to drive demand in the medical device sector. The focus is on high-end equipment and companies with significant performance improvements and international expansion, such as Mindray Medical, United Imaging, Aohua Endoscopy, and Kaili Medical [3]. - The report emphasizes the optimization of application conditions and review processes for equipment renewal projects, aiming to lower investment thresholds and enhance support for small and medium-sized enterprises [3]. - The ongoing policy for equipment renewal is anticipated to sustain a favorable bidding environment for medical devices, with a gradual improvement in performance as inventory clears [3]. Summary by Sections Industry Overview - The report discusses the government's announcement on December 30, 2025, regarding large-scale equipment renewal and the inclusion of various sectors, including healthcare, in the support framework for 2026 [3]. - It outlines the measures to improve the application process for equipment renewal, including stricter requirements for equipment depreciation and minimum usage periods [3]. Investment Opportunities - The report suggests focusing on companies that are expected to show significant performance improvements and have a leading international presence in the medical device sector [3]. - Specific companies recommended for investment include Mindray Medical, United Imaging, Aohua Endoscopy, and Kaili Medical, which are well-positioned to benefit from the anticipated demand for high-end medical equipment [3]. Market Performance - The medical sector has experienced a decline, with a reported drop of 2.06% in the last week, ranking 25th among 28 industries [8][18]. - The report notes that the medical device market is under pressure in the short term due to policy impacts, but improvements are expected as companies innovate and expand internationally [5].

致：香港交易及結算所有限公司 公司名稱: 遠大醫藥集團有限公司 呈交日期: 2026年1月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00512 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 100,000,000,000 | HKD | | 0.01 HKD | | 1,000,000,000 | | 增加 / 減少 (-) | | | | | | HKD | | | | 本月底結存 | | | 100,000,000,000 | HKD | | 0.01 HKD | | 1,000,000,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 本月底法定/註冊股本總額： HKD ...

Group 1 - The core point of the article is that Yuan Da Pharmaceutical is strategically expanding its biotechnology sector by acquiring Hebei Yuan Da Jiu Fu Biotechnology Co., thereby enhancing its amino acid industry chain layout [1] - The acquisition will improve the stability of upstream amino acid raw material supply, enrich the midstream product pipeline, and accelerate market penetration of downstream health products, achieving synergistic development of the industry chain [1][6] - This move is expected to strengthen the company's competitive edge and global market influence, laying a solid foundation for its diversified development strategy in the biotechnology field [1][4] Group 2 - The amino acid industry is experiencing significant growth, with the global market size reaching approximately $26.19 billion in 2021 and projected to grow at a compound annual growth rate of about 7.5% to approximately $49.42 billion by 2030 [2] - China holds a dominant position in the global amino acid market, accounting for 32.23% of the market share in 2020, making it the largest producer and consumer of amino acids [2][4] - Yuan Da Pharmaceutical has over 20 years of experience in the amino acid sector, with a diverse product matrix and strong technical advantages, including nearly 50 types of amino acids and the highest number of registered amino acid raw material numbers in China [4][5] Group 3 - The company has established a comprehensive sales network, serving high-quality clients, including Fortune 500 companies, with approximately 40% of its business coming from overseas markets [5] - In the first half of 2025, the amino acid segment (including taurine) generated revenue of HKD 1.347 billion, solidifying the company's leading position in the amino acid industry [5] - The acquisition will allow Yuan Da Pharmaceutical to quickly gain advanced production technologies, quality customer resources, and mature sales channels, enhancing efficiency in raw material procurement, production collaboration, and market expansion [7][8] Group 4 - The acquired company possesses unique technical advantages and a diverse product pipeline in the amino acid field, contributing to a complete industry chain from raw materials to end health products [6][8] - The integration of the acquired company's mature technologies in fermentation and enzyme engineering with Yuan Da's synthetic biology technology platform will further strengthen technical barriers [8] - The company aims to focus on high-value areas such as high-end parenteral nutrition formulations, innovative peptide drugs, and health-related products, continuously enhancing its core competitiveness in high-quality amino acids [8]