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 ...

智通财经APP获悉，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。 凭借杰出的产品优势，远大医药TLX591-CDx有望改善这一局面。根据公司12月公布的该产品国内III期临床研究积极顶线结果，TLX591-CDx检测肿瘤 的总体阳性预测值（PPV）高达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。更值 ...

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].

Core Insights - The global nuclear medicine industry is rapidly advancing towards an integrated diagnosis and treatment era, with YuanDa Pharmaceutical being one of the few companies successfully commercializing innovative nuclear drugs globally [1][2]. Group 1: Nuclear Medicine Achievements - YuanDa Pharmaceutical's GPN01530, a novel radiolabeled drug, has received FDA approval for I/II phase clinical trials for diagnosing solid tumors, marking a significant step in its global commercialization efforts [1][11]. - The TLX591-CDx, used for prostate cancer diagnosis, has shown positive results in its Phase III clinical trial in China, achieving its primary clinical endpoint with a positive predictive value (PPV) of 94.8% [3][4]. - The company has established a comprehensive industry chain in nuclear medicine, covering research, production, sales, and regulatory qualifications, positioning itself as a leading player in the global nuclear medicine market [2][24]. Group 2: Financial Performance and Market Potential - TLX591-CDx is projected to generate global sales of $517 million in 2024, with a year-on-year growth of over 25% in the first three quarters of 2025 [6]. - The global prostate cancer market is expected to grow from $23.76 billion in 2025 to $36.26 billion by 2030, with a compound annual growth rate (CAGR) of 8.82% [6][9]. - The Chinese prostate cancer treatment market is anticipated to reach $1.514 billion by 2030, with a CAGR of 8.5% from 2025 to 2030, indicating significant growth opportunities [9]. Group 3: Innovative Product Development - Neffy, the world's first epinephrine nasal spray for emergency treatment of type I allergic reactions, has been approved for commercialization in China, filling a gap in the domestic emergency market [17][18]. - GPN01360, an innovative traditional Chinese medicine for depression, has successfully reached its clinical endpoint in Phase II trials, showcasing significant efficacy and safety advantages [17][19]. - The company has developed a multi-targeted integrated diagnosis and treatment strategy, exemplified by the TLX250-CDx/TLX250 combination for renal cell carcinoma, which has shown promising clinical results [10]. Group 4: Strategic Global Expansion - YuanDa Pharmaceutical's "Go Global" strategy is supported by a robust R&D infrastructure, with eight research centers and five core technology platforms, leading to a total of 133 projects in development [23][24]. - The company has established a fully autonomous production capability for nuclear drugs at its Chengdu facility, addressing supply chain challenges and ensuring the scalability of its innovative products [26]. - The successful commercialization of its core product, Yttrium-90 microspheres, is expected to achieve nearly HKD 500 million in sales in 2024, reflecting a growth rate of over 140% [25].

Core Insights - The global nuclear medicine industry is rapidly advancing towards an integrated diagnosis and treatment era, with Yuan Da Pharmaceutical being one of the few companies successfully commercializing innovative nuclear drugs globally [1][2] Group 1: Nuclear Medicine Achievements - Yuan Da Pharmaceutical's GPN01530, a radioactive nuclide-conjugated drug, has received FDA approval for I/II phase clinical trials for diagnosing solid tumors, marking a significant step in its global commercialization efforts [1][11] - The TLX591-CDx, used for prostate cancer diagnosis, has shown positive results in its Phase III clinical trial in China, achieving its primary clinical endpoint with a positive predictive value (PPV) of 94.8% [3][4] - The company has established a comprehensive industrial chain in nuclear medicine, covering research, production, sales, and regulatory qualifications, positioning itself as a leading player in the global nuclear medicine market [2][23] Group 2: Product Innovations and Market Potential - The TLX591-CDx has demonstrated a high clinical decision-making value, with over 67.2% of patients adjusting their treatment plans post-diagnosis [4][6] - The global prostate cancer market is projected to grow from $23.76 billion in 2025 to $36.26 billion by 2030, with a compound annual growth rate (CAGR) of 8.82% [6][9] - Yuan Da Pharmaceutical's GPN01530 targets fibroblast activation protein (FAP), which is highly expressed in over 90% of epithelial-derived solid tumors, indicating significant market potential [11][14] Group 3: Strategic Developments in Other Therapeutic Areas - The company has launched Neffy®, the first epinephrine nasal spray for emergency treatment of type I allergic reactions, filling a gap in the domestic emergency market [2][17] - GPN01360, an innovative traditional Chinese medicine for depression, has shown significant efficacy and safety in its Phase II clinical trial, addressing the need for safer antidepressant options [2][19] - The Chinese depression medication market is expected to grow at a CAGR of 8.1%, reaching a scale of over 10 billion yuan by 2029, highlighting the potential for GPN01360 [19] Group 4: Comprehensive Innovation Strategy - Yuan Da Pharmaceutical has established eight R&D centers and five core technology platforms, with a total of 133 projects in development, including 42 innovative projects with high clinical potential [22] - The company has invested over 1 billion HKD in R&D in the first half of 2025, ensuring the steady progression of its innovation pipeline [22] - The integrated approach of "self-research + global expansion" has positioned the nuclear medicine sector as a key growth engine for the company, driving high-quality development [22][25]

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, 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]