根据公告，TLX591-CDx是一款全球创新、基于放射性核素-小分子偶联技术的靶向前列腺特异性膜抗原 （PSMA）的诊断型放射性药物，适用于初诊和复发性前列腺癌的诊断。公开数据显示，TLX591-CDx 中的靶向剂PSMA-11能以高亲和力的方式特异性结合在前列腺癌中高表达的PSMA上，具有可内化入细 胞、生物学活性稳定、体内循环半衰期短以及对肿瘤实质的渗透性好且可被非靶向组织快速清除的五大 特点。 根据本次临床顶线结果，TLX591-CDx表现出了较高水平的诊断率，该产品检测肿瘤的总体阳性预测值 （PPV）达94.8%，其对于前列腺床区复发和非骨转移肿瘤的 PPV达100.0%；同时，对于骨转移以及不 同的前列腺特异性抗原（PSA）基线水平的患者，TLX591-CDx也均显示出了较高的PPV。优异的临床 结果提示了TLX591-CDx的PET成像检测对于疑似生化复发的前列腺癌患者的早期诊断有着非常积极的 临床意义，有望更早地提示疾病进展，为患者争取宝贵的治疗时间窗口。 远大医药核药管线正全面爆发！继公司自主研发的全球创新FAP靶点放射性核素偶联药物(RDC) GPN01530美国I/II期临床获FDA批准后 ...

在前列腺癌治疗方面，公司另一创新RDC产品TLX591已在中国获批加入国际多中心III期临床研究。目 前，远大医药已经在核药抗肿瘤诊疗板块实现了研发、生产、配送、销售等多个环节的全方位布局，公 司以波士顿、成都为核心的研发基地，波士顿、法兰克福、新加坡、成都所在的生产基地以及覆盖全球 50多个国家和地区的销售网络为基础，实现了全球化的核药产业链布局。 产品管线方面，远大医药围绕肿瘤诊疗一体化的治疗理念，目前在研发注册阶段已储备16款创新产品， 涵盖68Ga、177Lu、131I、90Y、89Zr在内的5种放射性核素，覆盖了肝癌、前列腺癌、脑癌等在内的7 个癌种；早期研发阶段以RDC药物为主，产品储备10余款，产品种类涵盖诊断和治疗两类核素药物， 为患者提供多适应症治疗选择、多手段且诊疗一体化的抗肿瘤方案。 目前，远大医药已有六款创新RDC获批开展注册性临床研究，其中四款已进入III期临床阶段，公司已 进入创新核药产品的收获期。 产业布局方面，远大医药位于四川成都的核药研发及生产基地于2025年5月获得甲级《辐射安全许可 证》，并于今年6月投入运营，可充分满足公司治疗性与诊断性核药的多品种、规模化制备需求。 根 ...

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].

TLX591-CDx在中国Ⅲ期临床试验的成功，也意味着远大医药在构建"诊疗一体化"的前列腺癌核药产品组合上迈出了关键 一步。在前列腺癌治疗方面，公司另一创新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，有望为中国前列腺癌患者带来更为精准、高效的诊疗方案，并将在商业上形成强大的协同效应，释放巨大的市场价值，巩 固远大医药在核药领域的综合优势。 据悉，前列腺癌是我国男性群体中常见的癌症类型，且随着人口老龄化加剧等原因，我国前列腺癌患者的发病率和病死率 呈明显上升趋势。据弗若斯特沙利文数据，到2030年我国前列腺癌发病率或将超过16.5万例，同期我国前列腺癌药物市场规模 有望达到约376亿元。 本报讯 （记者张敏）12月21日，港股上市公司远大医药集团有限公司（以下简称"远大医药"）发布的公告显示，公司用于 诊断前列腺癌的创新RDC药物TLX591-CDx（Illuccix®，gallium Ga68 PSMA-11）在中国进行的Ⅲ期临床试验已取得积极的顶 线结果，并成功达到了主要临床终点。 根据公告，TLX591-CDx是一款全球创新、基于放射性核素-小分子偶联技术的靶向前列 ...

远大医药(00512)公布，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 Ga68PSMA-11)在中国进行的III期临床试验，近日取得了积极的顶线结果，并成功达到 了主要临床终点。此外，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。 此外，超过三分之二(67.2%)的患者在TLX591-CDx的PET成像检测后，其治疗方案较基线时的初始方案发 生了调整。这表明TLX591-CDx的PET成像检测对临床决策具有重要影响，可优化疑似生化复发的前列腺癌 患者的临床治疗策略。 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。根据临床顶线结果显示，TLX591- CDx检测肿瘤的总体阳性预测值 ...

| 基線 PSA 水平 | PPV (95% CI) | | | --- | --- | --- | | ≥ 5.0 ng/mL | 100.0% (78.5%, 100.0%) | | | < 5.0 to 2.0 ng/mL | 100.0% (67.6%, 100.0%) | | | < 2.0 to 1.0 ng/mL | 90.9% (62.3%, 98.4%) | | | < 1.0 to 0.5 ng/mL | 90.0% (59.6%, 98.2%) | | | < 0.5 to 0.2 ng/mL | 93.3% (70.2%, 98.8%) | @智通财经APP | 此外，超过三分之二(67.2%)的患者在 TLX591-CDx 的 PET 成像检测后，其治疗方案较基线时的初始方案 发生了调整。这表明 TLX591-CDx 的 PET 成像检测对临床决策具有重要影响，可优化疑似生化复发的前列 腺癌患者的临床治疗策略。 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 ...

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) 自願性公告 本集團創新放射性核素偶聯藥物 TLX591-CDx 中國 III 期臨床研究成功達到主要臨床終點 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。 董事會欣然公告，本集團用於診斷前列腺癌的創新在研放射性核素偶聯藥物(「RDC」) TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11)在中國進行的 III 期臨床試驗，近日取 得了積極的頂線結果，並成功達到了主要臨床終點。此外，本集團用於治療前列腺癌的 RDC 產品 TLX591 已在中國獲批加入國際多中心 III 期臨床研究，未來，兩款產品組合 蓄勢待發，有望為中國前列腺癌患者帶來更為精准、高效的診療方案。 該研究是一項單臂、開放標籤的 III 期臨床研究，在超過 100 例前列腺癌生化復發患者 中使用 ...

We recently published 7 Best ASX Stocks to Buy Right Now.  Telix Pharmaceuticals Limited (NASDAQ:TLX) is one of the best ASX stocks. Telix Pharmaceuticals Limited (NASDAQ:TLX) is a biotechnology company developing treatments for ailments such as prostate and kidney cancer. The firm’s prostate cancer therapy candidate TLX591 is currently in a phase three study. On this front, Telix Pharmaceuticals Limited (NASDAQ:TLX) shared important news on December 8th when it announced that it had dosed the first patie ...

Core Viewpoint - Yuan Da Pharmaceutical (00512) is experiencing continuous revenue growth driven by the gradual launch of innovative products and efficient management, with a target price of HKD 11.88, indicating a potential upside of 45.23% from the current price, maintaining a buy rating [1] Group 1: Revenue Growth - The company achieved total revenue of HKD 6.11 billion in the first half of 2025, representing a year-on-year increase of 2.0% in RMB terms; normalized profit was HKD 1.02 billion, down 5.0% year-on-year in RMB terms [2] - The pharmaceutical technology segment contributed the most to revenue, generating HKD 3.845 billion, with a year-on-year increase of 2.9% in RMB terms [2] - Revenue from nuclear medicine for tumor diagnosis and treatment reached HKD 420 million, showing a significant year-on-year growth of 105.5%, primarily driven by the approval of SIR-Spheres Yttrium-90 microspheres for unresectable HCC [2] Group 2: Innovative Drug Pipeline - The company has five major technology platforms and eight R&D centers, with R&D and project investment of HKD 1.02 billion in the first half of 2025 [3] - The focus is on innovative nuclear medicine, with a leading global pipeline that includes radiolabeled drug conjugates (RDC) and interventional oncology products, with 27 innovative drug candidates currently in development [3] - The innovative drug STC3141 for treating sepsis has reached clinical endpoints in Phase II trials in China, showing significant improvement in SOFA scores compared to the placebo group [3] Group 3: Profit Forecast - Future revenue growth is expected, with projected revenues of HKD 12.35 billion, HKD 13.39 billion, and HKD 14.79 billion for 2024 to 2026, respectively; EPS is forecasted to be HKD 0.59, HKD 0.66, and HKD 0.77 for the same period [4]

Core Viewpoint - The article discusses a securities class action lawsuit against Telix Pharmaceuticals Ltd. due to alleged misrepresentations regarding the development of its therapeutic candidates and supply chain issues, with a significant stock decline following regulatory setbacks [2][3]. Regulatory Failures - The lawsuit highlights two major regulatory events that allegedly corrected market perceptions of Telix's business: - On July 22, 2025, Telix disclosed an SEC subpoena related to its prostate cancer therapeutic candidates, which raised concerns about misleading disclosures on drug development progress [4]. - On August 28, 2025, the FDA rejected the Zircaix application, citing deficiencies in Chemistry, Manufacturing, and Controls (CMC) and documented Form 483 deficiencies at third-party manufacturers [4]. Stock Impact - Following these regulatory revelations, Telix's American Depositary Shares (ADSs) experienced a sharp decline, with a total stock drop of 21% after the final regulatory news [2][4]. Legal Issues - The complaint raises key legal issues, including whether Telix made misleading disclosures regarding drug development progress and whether the company concealed foundational weaknesses in its third-party supply chain and manufacturing processes [4]. Investor Actions - Hagens Berman, the law firm leading the litigation, is actively advising investors who purchased TLX ADSs during the class period and suffered losses due to undisclosed supply chain and therapeutic progress flaws [5]. Important Dates - The deadline for investors to move the court for appointment as lead plaintiff in the lawsuit is January 9, 2026 [1][6].