Core Insights - The submission of the New Drug Application (NDA) for TLX591-CDx by YuanDa Pharmaceutical marks a significant advancement in the field of nuclear medicine for prostate cancer diagnosis, indicating the potential for a leading global diagnostic tool for early detection and treatment optimization [1][12] Industry Overview - Prostate cancer is one of the most common cancers among men in China, with increasing incidence and mortality rates due to factors such as population aging. The number of new cases is projected to reach nearly 200,000 by 2030, with the drug market expected to grow at a compound annual growth rate (CAGR) of approximately 21.8%, reaching nearly 50.6 billion RMB [2][4] - The early detection rate of prostate cancer in China is low, with only 30% diagnosed at an early stage, leading to significantly lower five-year survival rates compared to the US and Japan [6] Product Advantages - TLX591-CDx has demonstrated a high positive predictive value (PPV) of 94.8% in clinical trials, confirming its diagnostic efficacy comparable to studies conducted on non-Chinese patients. The product maintains high diagnostic accuracy across various lesion types, even in patients with low PSA levels [9][10] - Over 67.2% of patients had their treatment plans adjusted based on TLX591-CDx PET imaging results, highlighting its significant impact on clinical decision-making [9] Technological Edge - The product's unique design features a targeted agent, PSMA-11, which binds specifically to PSMA expressed in prostate cancer, offering advantages such as high affinity, biological stability, and effective tumor penetration [10][11] - TLX591-CDx's characteristics of "precise targeting, efficient imaging, and safety" meet clinical needs for prostate cancer diagnosis and monitoring, providing strong evidence for its market application [11] Market Potential - TLX591-CDx has been approved for commercialization in 24 countries, including the US, Australia, and Canada, achieving impressive sales figures of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting over 25% year-on-year growth [11] - The acceptance of the NDA for TLX591-CDx is a crucial step in YuanDa Pharmaceutical's strategy to build an integrated diagnostic and therapeutic nuclear medicine product portfolio for prostate cancer [12] Strategic Development - YuanDa Pharmaceutical has established a comprehensive global layout in the nuclear medicine sector, with R&D and production bases in Boston and Chengdu, and a sales network covering over 50 countries [13] - The company has a pipeline of 16 innovative products targeting various cancers, including prostate cancer, and aims to provide integrated treatment options through its diagnostic and therapeutic products [13][17] Future Outlook - The successful NDA submission and ongoing development of TLX591-CDx and other innovative products are expected to enhance YuanDa Pharmaceutical's competitive edge in the global nuclear medicine market, contributing to improved treatment options for cancer patients worldwide [17]

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].

智通财经APP讯，远大医药(00512)发布公告，本集团用于诊断前列腺癌的创新在研放射性核素偶联药物 (RDC) TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11)近日正式向中华人民共和国国家药品监督管理局 (药监局)递交了新药上市申请(NDA)并获得了受理，这是本集团在核药抗肿瘤诊疗领域的重要研发进 展。此外，本集团用于治疗前列腺癌的 RDC 产品 TLX591 已在中国获批加入国际多中心III期临床研 究，未来，两款产品组合蓄势待发，有望为中国前列腺癌患者带来更为精准、高效的诊疗方案。 本次NDA申请包含了TLX591-CDx中国临床研究的数据，该研究于2025年12月公布了积极的初步结果， 该研究是一项单臂、开放标签的III期临床研究，在超过100例前列腺癌生化复发患者中使用 TLX591- CDx 并进行正电子发射断层成像/电脑断层扫描(PET/CT)或正电子发射断层成像/磁共振成像(PET/MRI) 检测，以评估产品的诊断有效性，同时评估产品在中国人群中的安全性和耐受性。根据临床顶线结果， TLX591 CDx 检测肿瘤的总体阳性预测值(PPV)达94.8%( ...

本次NDA申请包含了TLX591-CDx中国临床研究的数据，该研究于2025年12月公布了积极的初步结果， 该研究是一项单臂、开放标签的III期临床研究，在超过100例前列腺癌生化复发患者中使用TLX591- CDx并进行正电子发射断层成像/电脑断层扫描(PET/CT)或正电子发射断层成像/磁共振成像(PET/MRI) 检测，以评估产品的诊断有效性，同时评估产品在中国人群中的安全性和耐受性。根据临床顶线结果， TLX591-CDx检测肿瘤的总体阳性预测值(「PPV」)达94.8%(置信区间，CI：85.9%-98.2%)，证实了中国 患者使用TLX591-CDx诊断的临床经验与非中国患者的研究结果相当，即使在前列腺特异性抗原(PSA) 值极低的患者中，以及在不同的转移部位，其PPV也始终保持在较高水平。 格隆汇1月19日丨远大医药(00512.HK)公告，集团用于诊断前列腺癌的创新在研放射性核素偶联药物 (「RDC」)TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11)近日正式向中华人民共和国国家药品监督管 理局(「药监局」)递交了新药上市申请(「NDA」)并获得了受理， ...

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 ...