Core Viewpoint - The acceptance of the new drug application (NDA) for TLX591-CDx by the National Medical Products Administration marks a significant advancement for the company in the field of nuclear medicine for cancer diagnosis [1][2]. Group 1: Product Development and Market Potential - TLX591-CDx is a diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), suitable for diagnosing both newly diagnosed and recurrent prostate cancer [1]. - The NDA application includes data from a clinical study conducted in China, which is a Phase III open-label study involving over 100 patients with biochemical recurrence of prostate cancer [1]. - The incidence of prostate cancer in China is on the rise, with projections indicating nearly 200,000 new cases by 2030 according to Frost & Sullivan data [1]. Group 2: Commercial Performance and Expansion - TLX591-CDx has been approved for commercialization in 24 countries, including Australia, the USA, and several European nations, demonstrating strong commercial performance with sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a year-on-year growth of over 25% [2]. - The acceptance of the NDA is a crucial step in the company's strategy to build an integrated diagnostic and therapeutic product portfolio for prostate cancer, with the complementary therapeutic product TLX591 already approved for international Phase III clinical studies in China [2]. Group 3: Strategic Positioning and Future Outlook - The company has established a comprehensive layout in the nuclear medicine sector, covering research and development, production, distribution, and sales [2]. - The ongoing "Go Global" strategy and the anticipated launch of TLX591-CDx and other innovative products are expected to enhance the company's core competitiveness in the nuclear medicine field [2].

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].

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， ...

Core Insights - The company Yongda Pharmaceutical (00512) has reported positive topline results from a Phase III clinical trial of its innovative radiolabeled drug conjugate (RDC) TLX591-CDx (Illuccix, gallium Ga68PSMA-11) for diagnosing prostate cancer in China, successfully meeting its primary clinical endpoint [1] - The RDC product TLX591 for treating prostate cancer has also been approved to join an international multicenter Phase III clinical study, indicating a strong potential for both products to provide more precise and effective diagnostic and treatment options for prostate cancer patients in China [1] Summary by Sections Clinical Trial Results - The study is a single-arm, open-label Phase III clinical trial involving over 100 patients with biochemical recurrence of prostate cancer, utilizing TLX591-CDx along with PET/CT or PET/MRI imaging to assess diagnostic efficacy and safety in the Chinese population [2] - The topline results indicate that the overall positive predictive value (PPV) of TLX591-CDx for detecting tumors is 94.8% (confidence interval: 85.9%-98.2%) [2] - For tumors recurring in the prostate bed and metastasizing to soft tissues, lymph nodes, and organs (non-bone metastasis), the PPV is 100.0%; for tumors recurring outside the prostate bed in pelvic regions (including lymph nodes), the PPV is 94.7%; and for bone metastasis, the PPV is 87.0% [2] PSA Level Group Analysis - The trial categorized participants based on baseline prostate-specific antigen (PSA) levels, showing high PPV across all groups, with PPV exceeding 90% even in the subgroup with very low PSA levels [3] - This suggests that TLX591-CDx PET imaging has significant clinical implications for the early diagnosis of suspected biochemical recurrence in prostate cancer patients [2][3] Impact on Clinical Decision-Making - More than two-thirds (67.2%) of patients had their treatment plans adjusted following PET imaging with TLX591-CDx, indicating its important role in clinical decision-making and the potential to optimize treatment strategies for suspected biochemical recurrence of prostate cancer [3]

Core Viewpoint - The innovative radiolabeled drug conjugate TLX591-CDx for diagnosing prostate cancer has achieved positive top-line results in a Phase III clinical trial in China, successfully meeting its primary clinical endpoint, indicating potential for more precise and effective diagnostic solutions for prostate cancer patients in China [1]. Group 1: Clinical Trial Results - The Phase III clinical study was a single-arm, open-label trial involving over 100 patients with biochemical recurrence of prostate cancer, utilizing TLX591-CDx for diagnostic imaging through PET/CT or PET/MRI to assess diagnostic efficacy and safety in the Chinese population [2]. - TLX591-CDx demonstrated an overall positive predictive value (PPV) of 94.8% (confidence interval: 85.9%-98.2%) for detecting tumors, with a PPV of 100.0% for tumors recurring in the prostate bed and metastasizing to soft tissues, lymph nodes, and organs (non-bone metastases) [2]. Group 2: Subgroup Analysis - The PPV for tumors recurring in pelvic regions outside the prostate bed (including lymph nodes) was 94.7%, while for bone metastases, the PPV was 87.0% [2]. - TLX591-CDx showed high PPV across all subgroups based on baseline prostate-specific antigen (PSA) levels, with PPV exceeding 90% even in the subgroup with extremely low PSA levels [2][3]. Group 3: Clinical Decision Impact - More than two-thirds (67.2%) of patients had their treatment plans adjusted following PET imaging with TLX591-CDx, indicating its significant impact on clinical decision-making and optimization of treatment strategies for suspected biochemical recurrence of prostate cancer [3].

远大医药(00512)发布公告，集团自主研发的全球创新放射性核素偶联药物(RDC) GPN01530 近日获得美 国食品药品监督管理局(FDA)正式批准开展用于诊断实体瘤的 I/II 期临床研究，这标志着集团在核药抗 肿瘤诊疗领域的全球化布局上又迈出坚实一步。作为集团首款获得 FDA 批准开展临床研究的自研 RDC 产品，GPN01530 临床研究的成功获批为集团核药产品管线的国际化开发提供了重要范式，是集团核药 抗肿瘤诊疗板块全球化研发与注册进程中的重要里程碑，充分体现了集团在前沿核药技术平台建设、国 际化临床开发与注册申报等方面的综合实力。集团将依托"中美双报"的国际化注册路径，持续推进 GPN01530 的全球研发与注册工作，并以此为基础，进一步深化该板块的全球化发展战略，积极推动更 多自主研发的创新核药产品的国际临床研究与注册申报工作，不断提升集团在核药抗肿瘤诊疗领域的核 心竞争力与国际影响力。 ...

智通财经APP讯，远大医药(00512)发布公告，集团自主研发的全球创新放射性核素偶联药物(RDC) GPN01530 近日获得美国食品药品监督管理局(FDA)正式批准开展用于诊断实体瘤的 I/II 期临床研究， 这标志着集团在核药抗肿瘤诊疗领域的全球化布局上又迈出坚实一步。作为集团首款获得 FDA 批准开 展临床研究的自研 RDC 产品，GPN01530 临床研究的成功获批为集团核药产品管线的国际化开发提供 了重要范式，是集团核药抗肿瘤诊疗板块全球化研发与注册进程中的重要里程碑，充分体现了集团在前 沿核药技术平台建设、国际化临床开发与注册申报等方面的综合实力。集团将依托"中美双报"的国际化 注册路径，持续推进 GPN01530 的全球研发与注册工作，并以此为基础，进一步深化该板块的全球化发 展战略，积极推动更多自主研发的创新核药产品的国际临床研究与注册申报工作，不断提升集团在核药 抗肿瘤诊疗领域的核心竞争力与国际影响力。 ...

Core Viewpoint - The approval of GPN01530 by the FDA for clinical research marks a significant milestone in the company's global strategy for nuclear medicine in oncology, enhancing its competitive edge and international influence in the field [1]. Group 1: Product Development - GPN01530 is a small molecule RDC drug targeting Fibroblast Activation Protein (FAP), a key marker in cancer-associated fibroblasts, which plays a role in tumor growth and invasion [2]. - The drug has shown improved tumor targeting and pharmacokinetic properties compared to other FAP ligands, indicating its potential for better diagnostic efficacy in various malignancies [2][3]. Group 2: Clinical Research and Efficacy - Initial human studies indicate that GPN01530 has good safety profiles, with rapid background clearance and strong, sustained tumor uptake, outperforming traditional imaging agents like F-FDG in clinical image contrast and accuracy of positive lesion detection [3]. - The product's development is expected to provide a new diagnostic solution for a wide range of solid tumor patients, significantly enhancing the diagnostic capabilities of FAP-targeted RDC drugs [3].

Core Viewpoint - The company has successfully administered the first dose of its self-developed radiolabeled drug, 177Lu-PSMA-3D1015 (3D1015), to a patient, marking a significant milestone in its clinical research for treating PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) [1] Group 1: Clinical Research Focus - The study specifically targets patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) [1] - The research will systematically evaluate the core clinical value of 3D1015, focusing on the drug's safety and radiation dosimetry assessment [1] - The study aims to collect in-depth pharmacokinetic characteristics and dose exploration data of the drug in humans, providing direct clinical evidence for dose determination and risk control in subsequent registration clinical trials [1]

Core Viewpoint - The company has successfully administered its first self-developed radiopharmaceutical drug, 177Lu-PSMA-3D1015 (3D1015), to a patient, marking a significant milestone in its clinical research for treating PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) [1] Group 1: Clinical Research - The study focuses on evaluating the safety and preliminary efficacy of 3D1015 in patients with PSMA-positive mCRPC [1] - The research aims to systematically assess the core clinical value of 3D1015, emphasizing drug safety and dosimetry evaluation [1] - The study will collect in-depth pharmacokinetic characteristics and dose exploration data to provide direct clinical evidence for dose determination and risk control in subsequent registration clinical trials [1]