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↑点击收听语音，解放你的双眼↑ 3月13日-3月20日 一 行业风向标 1.巴西卫生部长率团到访中广核技 共推中巴核医疗领域务实合作 3月16日，巴西卫生部长亚历山大·帕迪利亚率团到访中广核核技术发展股份有限公司，就深化中巴核医疗合作开展交流，并考察了中广核和质®质子治疗系统及核技术健康解决方案。双方围绕技术创新、临床应用及产业协同达成共识，明确合作方向。下一步将组建专项小组，推动核医疗解决方案在巴西落地，助力提升医疗装备水平与诊疗能力。 2.兰州新区：医用同位素量产示范装置建设取得新进展 近日，中国科学院近代物理研究所建设的IP-SAFE项目加速器装置主体在兰州新区完成合拢安装。该项目为国际首台基于超导直线加速器的阿尔法医用同位素量产示范装置，可破解我国高端同位素依赖进口问题。项目突破关键技术，建成后将提升核医学诊疗水平，助力生物医药产业发展。 3.中国同辐与迈瑞医疗续签战略合作协议 近日，中国同辐与迈瑞医疗在深圳续签战略合作协议。双方表示，近年来已在国际业务拓展、项目协同及市场开发等方面开展务实合作，此次续签将进一步深化产业协同与国际医疗产业合作。未来将围绕IVD、数智化赋能、国际本地化生产及核医学科室建设等领域加强合作，实现资源共享、优势互补，推动合作迈入新阶段。 4.河南建设质子治疗中心，中国医学科学院肿瘤医院河南医院 中国医学科学院肿瘤医院河南医院将建设质子治疗中心，选址郑州中原医学科学城。该院为国家区域医疗中心，由省肿瘤医院与中国医学科学院肿瘤医院合作建设，定位肿瘤专科研究型医院，规划床位1500张。建成后，将打造质子治疗、临床研究与转化及肿瘤大数据中心。 二 会议播报站 1.第七届全国核医学发展战略论坛在深圳成功举办 2026年3月13日至15日，第七届全国核医学发展战略论坛在深圳举办。本次会议围绕“核素诊疗一体化”开展深入交流，专家指出行业迎来政策支持、企业入局与AI赋能机遇，同时仍面临核心原料、监管、医保政策及人才等挑战。与会专家认为，应加强原创研发与临床协同，推动诊疗一体化发展，助力核医学高质量发展。 2.重庆市医学会核医学分会2026年核素诊疗新进展学术会议在万州成功举办 2026年3月14日，由重庆市医学会主办的“重庆市医学会核医学分会2026年核素诊疗新进展学术会议——医用回旋加速器及正电子药物新技术研讨会暨一季度读片会”在万州成功举办。本次会议汇聚重庆市内外核医学及相关临床学科专家120余人。与会专家围绕AD、前列腺癌诊疗、心脏核医学临床应用、甲状腺癌外科治疗进展等议题作专题报告，并开展五场学术讨论及青年医师读片会，全面展示核素诊疗新技术及临床应用，推动区域核医学学科发展。 3.2026年浙江省核医学与放射防护分会基层巡讲（台州站）圆满举行 近期，“2026年浙江省医学会核医学与放射医学防护分会基层巡讲（台州站）”在台州博爱医院成功举行。大会汇聚省级专家及台州百余位医师，围绕PET/CT在感染、神经、风湿及肿瘤等领域的临床应用及放射防护开展学术分享与研讨。会议同期开展甲状腺义诊，省级专家为市民提供面对面诊疗服务。本次巡讲推动了优质医疗资源下沉，提升基层核医学诊疗水平，取得圆满成功。 4.上海临床研究中心与上海药品审评核查中心开展党建交流，共话合作发展 3月13日，上海临床研究中心党支部与上海药品审评核查中心化学药品部党支部联合开展“党建凝聚合力，核医守护安康”主题党日活动。双方围绕党建工作、临床机构建设与备案、药品审评核查、监管科学研究、人才培养及创新性放射性药物研发等议题深入交流，共话合作发展。活动还包括核医学科平台建设介绍及中心建设工地参观，进一步推动党建引领业务发展与合作落地。 三 医院新动态 1.西南医科大学附属医院：全球最大的核医学中心冲刺七月完工 自正月初八复工以来，西南医科大学附属医院肿瘤中心建设项目已完成总工程量70%，预计今年7月完工。项目占地25亩，总建筑面积约2.86万平方米，规划床位160余张，是省级区域医疗中心重点工程。核医学科占地面积＞15000平方米，配备PET/CT、PET/MR、回旋加速器等设备，能自主生产多种放射性核素，开展177Lu、225Ac等前沿治疗，实现肿瘤精准诊疗、科研转化及临床培训一体化，建成后将成为全球最大的核医学中心。 2.新疆军区总医院首例药物负荷核素心肌灌注显像成功开展 近日，新疆军区总医院在西京医院驻点帮扶下，成功开展首例药物负荷核素心肌灌注显像。该技术适用人群广、流程可控、安全性高，标志医院心血管核医学诊疗迈入精准化、现代化新阶段。西京医院核医学科李国权教授全程指导，进行操作规范、显像参数优化及定量分析培训。首例检查顺利实施，为高危心血管患者提供更安全、精准的诊疗手段，推动技术落地与学科共建。 3.张店区中医院核医学科走进社区推动临床应用 2026年3月17日，张店区中医院核医学科到体育场街道社区卫生服务中心开展学科交流会。会议介绍核医学基本概念、科室工作及核素显像与治疗在肿瘤、骨、肾脏及甲状腺等领域的临床应用。双方围绕早期诊断及影像互补优势展开讨论，核医学科对社区医护疑问进行解答。会议最后强调，应加强核医学推广应用，发挥其在疾病诊治中的重要作用。 4.复旦大学附属肿瘤医院宋少莉教授团队:Nectin-4靶向多肽诊疗一体化核素探针 近日，复旦大学附属肿瘤医院宋少莉教授团队在《Journal of Nanobiotechnology》发表研究成果，开发⁶⁸Ga/¹⁷⁷Lu双标记Nectin-4靶向共价双环肽（⁶⁸Ga/¹⁷⁷Lu-FZ-NRs），实现尿路上皮癌诊疗一体化。研究覆盖体外、体内及首次人体试验，显示高靶点亲和力、优异肿瘤滞留、安全性良好，并精准识别原发灶及转移病灶。该成果为无创靶点评估、精准诊疗及Nectin-4靶向治疗提供全新分子工具和临床转化基础。 四 全球视野窗 1.FAP靶向治疗新核药临床转化研究 近日，德国大学医院核医学科团队在《Journal of Nuclear Medicine》发表研究，首次临床探索FAP靶向放射性药物[¹⁷⁷Lu]Lu-RTX-2358。研究显示，该药在晚期FAP阳性实体瘤患者中实现肿瘤特异性摄取、延长滞留时间（有效半衰期超150 h），关键器官吸收剂量可控，总体安全良好。两周期治疗后，66.7%患者达疾病控制，显示其在多线治疗失败患者中具潜在抗肿瘤价值。 2.比利时BR2研究堆2025年医用放射性同位素产量创纪录，满足约1300万患者诊疗需求 近日，比利时莫尔的核研究中心公布，其BR2研究堆在2025年实现医用放射性同位素产量创纪录，运行天数提升至210天。产出的诊断与治疗同位素可满足约1300万患者需求，较平均水平增加约500万人。BR2堆主要生产钼-99、镥-177等10至15种同位素，广泛用于癌症、心脏病等诊疗，凸显其在保障欧洲及全球核医学精准诊疗中的关键作用。 3.密歇根州立大学新建RadCore研究中心，助力人类与动物医学研究迈上新台阶 近日，密歇根州立大学新建放射化学与放射性药物解决方案中心及放射性药房正式启用，支持放射性同位素原料加工转化为高质量的显像剂与治疗药物，服务肿瘤、心血管及神经疾病临床试验。目前多项试验有序推进，涵盖糖尿病、膀胱癌及基因治疗显像。该中心具备药品生产质量管理规范标准生产能力，助力诊疗一体化药物研发与转化，推动人类与动物医学协同发展，标志放射性药物领域迈入快速发展新阶段。 4.FDA批准Pylarify TruVu上市，拓展前列腺癌影像学检查应用范围 近日，美国FDA批准Pylarify TruVu上市。这是一种高放射性浓度的piflufolastat F-18注射液制剂。该制剂在维持诊断效能的同时，能够提升生产批次规模与配送效率，改善供应受限地区PSMA PET检查可及性。Pylarify TruVu适用于疑似转移或治疗后PSA升高的前列腺癌患者，通过PET显像精准定位癌细胞，为个性化治疗方案提供参考，助力提升前列腺癌诊疗水平。 感谢阅读本周的核医新闻， 我们下周再见！

HIGHLIGHTS Oral presentation on key results from the Co-PSMA (NCT06907641)[1] Investigator-Initiated Trial (IIT) was delivered by Prof Louise Emmett (St Vincent's Hospital Sydney) at the European Association of Urology (EAU) Congress 2026 on the 16th of March 2026 in London, UK[2]. Co-PSMA trial data has also been accepted for publication in the prestigious European Urology, the official journal of EAU with an impressive impact factor of 25.2. Clarity's 64Cu-SAR-bisPSMA (24-hour imaging) demonstrated considerable improvement in diagnostic performance in a head-to-head comparison with standard-of-care (SOC) 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) in 50 patients with biochemical recurrence (BCR) of prostate cancer with low prostate-specific antigen (PSA; 0.2 – 0.75 ng/mL) who were candidates for curative salvage therapy following radical prostatectomy. The study's primary endpoint was to assess the difference in mean per-patient lesion between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11. Key secondary endpoints included evaluation of diagnostic accuracy against composite reference standard and patient management impact. Mean per-patient lesion was higher for 64Cu-SAR-bisPSMA (24-hour imaging) vs. 68Ga-PSMA-11 (1.26 vs. 0.48, respectively), difference: 0.78 (95% confidence interval [CI]: 0.52 – 1.04) ratio 2.63 (95% CI: 1.64 – 4.20) (p <0.0001). Next-day imaging with 64Cu-SAR-bisPSMA, compared with 68Ga-PSMA-11, identified a greater number of total lesions (63 vs. 24, respectively). The biggest difference in lesion detection between the tracers was in the prostate fossa and in lymph nodes. 64Cu-SAR-bisPSMA also resulted in a higher number of trial participants with a positive scan compared to 68Ga-PSMA-11 (78% vs. 36%, respectively). 64Cu-SAR-bisPSMA (24-hour imaging) demonstrated a higher true positive rate (71% vs. 29%) and lower false negative rate (21% vs. 65%) than 68Ga-PSMA-11. 64Cu-SAR-bisPSMA next-day imaging resulted in management change in 44% (22/50) of trial participants, with the majority changing from surveillance to targeted radiotherapy. Co-PSMA trial data, combined with Phase II COBRA and anticipated results from a pivotal Phase III AMPLIFY study, are intended to be submitted to the United States (US) Food and Drug Administration (FDA) for a market authorisation of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer. SYDNEY, March 17, 2026 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that the results from the Co-PSMA (NCT06907641)[1] IIT were presented by Prof Louise Emmett (St Vincent's Hospital Sydney) in an oral session at EAU Congress 2026, Europe's largest urological conference, on the 16th March in London, UK[2]. The study data has also been accepted for publication in European Urology, the official journal of EAU with an impressive impact factor of 25.2. Continue Reading Figure 1. PET/CT of 64Cu-SAR-bisPSMA (top: axial left, coronal centre and right) and 68Ga-PSMA-11 (bottom: axial left, coronal centre and right). The 24-hour 64Cu-SAR-bisPSMA PET/CT identified multiple sites of recurrence (pelvic lymph nodes and fossa), while only a single pelvic lymph node was reported on 68Ga-PSMA-11 PET/CT (red arrows). 64Cu-SAR-bisPSMA demonstrated higher lesion uptake and tumour-to-background contrast, while 68Ga-PSMA-11 showed higher bladder uptake (yellow arrows). Adapted and reproduced with permission from Prof Louise Emmett. Co-PSMA (Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy) was a Phase II IIT evaluating the performance of Clarity's diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to SOC 68Ga-PSMA-11 in 50 patients with low PSA (0.2 – 0.75 ng/mL) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy. 68Ga-PSMA-11 PET/CT was followed by 64Cu-SAR-bisPSMA PET/CT (at 1 hour and 24 hours post-injection, same-day and next-day imaging, respectively) on the same digital PET camera.[1],[3] The primary endpoint of the Co-PSMA study was to assess the difference in mean per patient lesion number. Using a paired means test, a sample size of 50 provided power of 90% to detect a minimum alternative mean difference greater than zero of 0.432. Secondary endpoints included management impact questionnaires between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 and accuracy of the PET findings determined using a comprehensive reference standard, including biopsy, response to targeted treatment without androgen deprivation therapy (ADT), PSA rise without treatment or corroborative imaging. Overall, 64Cu-SAR-bisPSMA PET/CT (24-hour imaging) was found to identify a higher number of disease recurrences than 68Ga-PSMA-11 PET/CT with substantial management impact and a high true positive rate in men with BCR post-radical prostatectomy. Participants enrolled had a median PSA of 0.43 (IQR: 0.31 – 0.63) and 74% had an International Society of Urological Pathologists (ISUP) grade of 3 or higher. The mean per-patient lesion for 64Cu-SAR-bisPSMA (24 -hour imaging) was 1.26, compared to 0.48 for 68Ga-PSMA-11, with a difference of 0.78 (95%CI: 0.52 – 1.04), ratio 2.63 (95%CI: 1.64 – 4.20) (p <0.0001). In total, 68Ga-PSMA-11 identified 24 lesions across all participants, while 24-hour 64Cu-SAR-bisPSMA imaging detected 63 lesions (representative image in Figure 1). The increase in the number of lesions identified by 64Cu-SAR-bisPSMA was noted in the prostatic bed region (local recurrence), pelvic/extra-pelvic lymph nodes and bone ( Table 1). Table 1. Comparison between 68Ga-PSMA-11 and 64Cu-SAR-bisPSMA scans: number of participants with a positive scan and location of recurrence. 24-hour 64Cu-SAR-bisPSMA scans resulted in a higher number of lesions detected and prostate-specific membrane antigen (PSMA) PET-positive participants as compared to 68Ga-PSMA-11 scans. The increase in the number of lesions identified by 64Cu-SAR-bisPSMA was noted in the prostatic bed region (local recurrence), pelvic/extra-pelvic lymph nodes and bone. On a per patient level, 36% (18/50) of participants were positive on 68Ga-PSMA-11 PET/CT, compared to 78% (39/50) on 64Cu-SAR-bisPSMA PET/CT (next-day imaging). Planned patient management changed following the assessment of the 64Cu-SAR-bisPSMA scans in 22/50 (44%) trial participants. Among the participants with an evaluable standard of truth (SOT), the true positive rate was 71% for 24-hour 64Cu-SAR-bisPSMA (24/34) compared to 29% (10/34) for 68Ga-PSMA-11. The false negative rate was 21% for 24-hour 64Cu-SAR-bisPSMA (7/34) vs. 65% for 68Ga-PSMA-11 (22/34). These results from the Co-PSMA IIT further build on the growing body of evidence demonstrating that 64Cu-SAR-bisPSMA improves the detection of prostate cancer compared to the current SOC PSMA PET agents which have lower sensitivity in patients with low PSA levels[4],[5]. In the Phase II COBRA trial, 64Cu-SAR-bisPSMA was evaluated in patients with BCR who had a negative or equivocal scan at study entry. Among participants with a follow-up SOC PSMA PET, 90% were positive on 24-hour 64Cu-SAR-bisPSMA PET compared with only 60% on SOC PSMA PET. Overall, next-day imaging with 64Cu-SAR-bisPSMA identified more than 2.6 times lesions than SOC PSMA PET[6]. The COBRA data, combined with the Co-PSMA IIT results, will complement the anticipated findings from the Phase III registrational trial, AMPLIFY, which recently reached its target number of participants[7]. Together, they are intended to be submitted to the US FDA for a market authorisation of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer. Prof Louise Emmett (St Vincent's Hospital Sydney), Principal Investigator in the Co-PSMA trial, commented, "Head-to-head trials are very important in helping clinicians determine the most appropriate products for their patients. The Co-PSMA study shows that a novel PSMA-targeted PET agent like 64Cu-SAR-bisPSMA can deliver improved imaging performance compared to other SOC PSMA agents. In Co-PSMA, 64Cu-SAR-bisPSMA at 24 hours identified more sites of recurrence and directly informed personalised treatment decisions, highlighting its potential to improve outcomes in prostate cancer patients with BCR." Clarity's Executive Chairperson, Dr Alan Taylor, commented, "Science underpins the entirety of our biotechnology sector, and as a science-driven organisation, nothing makes us more proud than to see our products progress from the Australian benchtop to now generating excellent results in the clinic and having this substantiated and quantified to the highest standard through the scientific method. We applaud the independent work of Prof Louise Emmett and her team at St Vincent's Hospital in Sydney who chose to progress this trial in such detail, leading to the acceptance of the data in European Urology, a top-tier journal with a high impact factor of 25.2. "The high quality of these data now adds to the substantial body of evidence supporting our product, the optimised SAR-bisPSMA. The discovery and pre-clinical work has been previously circulated in numerous journals, including publications by our long-term collaborator, Prof Paul Donnelly, sharing his seminal work on the sarcophagine (SAR) chelator as well as on the SARTATE, SAR-Bombesin and the optimised SAR-bisPSMA agents in 2023 in Chemical Reviews[8], one of the highest impact factor journals in chemistry with a 5-year impact factor of 67.5. "The extraordinary quality of the academic research is coupled with the feverish pace of commercialisation where our registrational Phase III trials, AMPLIFY and CLARIFY, are nearing completion. We have recently shared that AMPLIFY reached its target number of participants with rising or detectable PSA after initial definitive treatment at clinical sites across the US and Australia in just 9 months since imaging the first patient[7], and we look forward to collecting and analysing the final study data. Combined with results from the Co-PSMA and COBRA trials, we believe it will constitute a compelling application for approval of 64Cu-SAR-bisPSMA by regulatory authorities for the BCR indication. Armed with three Fast Track Designations for the one SAR-bisPSMA agent, we are ready to work closely with the US FDA to get it to patients in need as soon as possible, and we look forward to more positive interactions with the Agency on this journey. As always, we will continue updating the market on the progress of our bisPSMA program, including significant milestones in the AMPLIFY, CLARIFY and SECuRE trials, as well as on the supply chain and regulatory developments as we enter the market with our first product." About SAR-bisPSMA SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy. Disclaimer 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. Their safety and efficacy have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[9]. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease[10]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers. References Clinicaltrials.gov Identifier: NCT06907641. EAU26. The Congress. Emmett L et al. Prospective comparison of 64Copper [64Cu]SAR-bis-PSMA vs. 68Ga PSMA-11 PET CT for prostate cancer detection in patients with biochemical recurrence after radical prostatectomy (Co-PSMA trial). 2026 Annual European Association of Urology Congress: . Fendler WP et al. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096. PMID: 30920593; PMCID: PMC6567829. Mena E, Lindenberg ML, Turkbey IB, Shih JH, Harmon SA, Lim I, Lin F, Adler S, Eclarinal P, McKinney YL, Citrin D, Dahut W, Wood BJ, Krishnasamy V, Chang R, Levy E, Merino M, Pinto P, Eary JF, Choyke PL. 18F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy. J Nucl Med. 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1. PMID: 31676732; PMCID: PMC9374042. Nordquist et al. COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy. EANM 2024. Clarity Pharmaceuticals. Registrational Phase III AMPLIFY trial: Target number of participants achieved. Katherine A. Morgan, Stacey E. Rudd, Asif Noor, and Paul S. Donnelly. Theranostic Nuclear Medicine with Gallium-68, Lutetium-177, Copper-64/67, Actinium-225, and Lead-212/203 Radionuclides Focus Review. Chemical Reviews. 2023 123 (20), 12004-12035. DOI: 10.1021/acs.chemrev.3c00456 Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. American Cancer Society: Key Statistics for Prostate Cancer. This announcement has been authorised for release by the Executive Chairperson. SOURCE Clarity Pharmaceuticals 21% more press release views with Request a Demo