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].

2026年开年，远大医药(00512)再度传来核药重大利好——公司用于诊断前列腺癌的创新放射性核素偶联药物(RDC)TLX591-CDx向国家药监局递交的新 药上市申请(NDA)已获受理，这不仅标志着远大医药在核药抗肿瘤诊疗领域的上市产品管线将获得进一步增厚，更意味着中国前列腺癌患者即将迎来一 款全球领先的精准诊断工具，为疾病的早期发现、精准分型与治疗方案优化提供全新可能。 积极顶线临床数据惊艳，精准诊断彰显硬核实力 前列腺癌是我国男性群体中常见的癌症类型之一，且其发病率和病死率正随着人口老龄化加剧等因素呈明显升高趋势。根据弗若斯特沙利文数据， 2030年中国前列腺癌新发病例数将达到近20万人，其药物市场规模也将以约21.8%的复合年均增长率增长至近506亿元人民币。 | 期间 | 复合年增长率 | | --- | --- | | 2015-2019 | 24.5% | | 2019-2024E | 24.1% | | 2024E-2030E | 21.8% | 居高不下的发病率下，是我国前列腺癌患者较低的早期检出率以及5年生存率。《前列腺癌筛查中国专家共识》及柳叶刀数据显示，我国仅有3成的前 列腺癌在早期发 ...

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 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 recent advancements in the nuclear medicine pipeline of the company signify a major breakthrough, particularly with the FDA approval of the innovative radioactive drug conjugate (RDC) GPN01530 and the positive results from the Phase III clinical trial of TLX591-CDx for prostate cancer diagnosis, indicating imminent commercialization prospects [1][2]. Group 1: Product Development and Clinical Results - TLX591-CDx is a globally innovative diagnostic radioactive drug targeting prostate-specific membrane antigen (PSMA), showing a high positive predictive value (PPV) of 94.8% for overall tumor detection and 100.0% for recurrence in the prostate bed and non-bone metastatic tumors [2][3]. - The successful Phase III clinical trial results for TLX591-CDx provide robust evidence for its high accuracy and clinical utility in diagnosing prostate cancer, supporting its upcoming new drug application in China [3][4]. Group 2: Market Potential and Strategic Positioning - TLX591-CDx has demonstrated strong sales performance globally, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a growth rate exceeding 25% [3]. - The success of TLX591-CDx in China marks a significant step in the company's strategy to build an integrated diagnostic and therapeutic product portfolio for prostate cancer, which is expected to enhance treatment standards and improve patient quality of life [4].

Core Viewpoint - The company has achieved positive topline results in the Phase III clinical trial of its innovative radiopharmaceutical TLX591-CDx for prostate cancer diagnosis, meeting the primary clinical endpoint [1] Group 1: Product Development - TLX591-CDx is a globally innovative diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), suitable for both initial diagnosis and recurrent prostate cancer [1] - The company has secured exclusive rights for multiple innovative RDC products, including TLX591-CDx, in Greater China through a strategic cooperation agreement with Telix [1] - TLX591-CDx has been approved for sale in several countries, including the US, Australia, Canada, Brazil, and the UK, with projected 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% [1] Group 2: Research and Development - The company has initiated an international multicenter Phase III clinical study for another innovative RDC product, TLX591, in China [2] - The company has established a comprehensive layout in the nuclear medicine sector, covering research, production, distribution, and sales, with R&D bases in Boston and Chengdu [2] - The product pipeline includes 16 innovative products in the research registration stage, utilizing five types of radioactive isotopes and covering seven cancer types, including liver cancer and brain cancer [2] Group 3: Industry Positioning - The company has six innovative RDC products approved for registration clinical research, with four currently in Phase III clinical trials, indicating a harvest period for innovative nuclear medicine products [2] - The nuclear medicine R&D and production base in Chengdu received a Class A Radiation Safety License in May 2025 and commenced operations in June 2023, meeting the demand for various therapeutic and diagnostic nuclear medicines [2]

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 innovative RDC drug TLX591-CDx for diagnosing prostate cancer has achieved positive top-line results in a Phase III clinical trial in China, meeting its primary clinical endpoint [1] - TLX591-CDx is a globally innovative diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), suitable for both initial diagnosis and recurrence of prostate cancer [1] - The successful Phase III trial marks a significant step for the company in building an integrated diagnostic and therapeutic product portfolio for prostate cancer [2] Group 1 - TLX591-CDx was approved for market in Australia in November 2021 and in the United States in December 2021, with approvals in several other countries including Canada, Brazil, and the UK [2] - Projected sales for TLX591-CDx are approximately $517 million in 2024, with a year-on-year growth of over 25% expected in the first three quarters of 2025, amounting to around $461 million [2] - The success of the Phase III trial in China is expected to create a powerful synergy between TLX591-CDx and another innovative product, TLX591, enhancing treatment options for prostate cancer patients [2] Group 2 - Prostate cancer is a common cancer type among men in China, with increasing incidence and mortality rates due to an aging population; it is projected that by 2030, the incidence may exceed 165,000 cases [2] - The market size for prostate cancer drugs in China is expected to reach approximately 37.6 billion yuan by 2030 [2] - The company has established a comprehensive layout in the nuclear medicine oncology diagnosis and treatment sector, with 16 innovative products in the research and registration phase, covering multiple cancer types [3] Group 3 - The company aims to leverage its first-mover advantage and full industry chain capabilities to expand its share in the global nuclear medicine market, aligning with its "Go Global" development strategy [3]

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]