Fluciclovine 18F

在过去的几十年里，放射性药物经历了重大的转变。最初，这些药物主要用于成像，以便早期诊断癌症和其他疾病。随着治疗和诊断技术的结合，放射性药物的发展已经彻底改变了这个领域。 诊疗一体化的放射性药物既能检测疾病，又能治疗疾病，为医疗提供了更具个性化的方法。正如Lantheus首席执行官Brian Markison所指出的那样，“放射性药物可以发现、战斗和跟踪。这些药物具有靶向特定癌细胞的独特能力，可提供诊断成像，并递送靶向治疗辐射来摧毁癌细胞”。 放射性药物市场呈指数级增长。一份Statista市场研究报告显示，预计到2032年，放射性药物领域的价值将达到140亿美元，而目前还未达到70亿美元。“这种增长将受到诊断和治疗放射性药物的创新、接受治疗的患者数量的增加，以及这些技术在各种癌症和神经病学中应用扩大的驱动。”Markison补充道。 1 发现、对抗、跟随 放射性药物正在成为一种强大的精准医学，能够“发现”、“对抗”和“跟踪”癌细胞。放射性药物包括一种靶向剂，结合放射性同位素，与癌细胞上的特定生物靶点结合。这种组合可以精确地将辐射输送到肿瘤，同时最大限度地减少对周围健康组织的伤害。这种方法使药物能够寻找到癌细胞，用靶向辐射摧毁，并跟踪治疗的有效性。 在“发现”阶段，放射性药物与肿瘤特异性抗原或受体结合，如前列腺特异性膜抗原（PSMA），用于前列腺癌的治疗。附着的放射性同位素会发出γ射线，可以通过PET（正电子发射断层显像术）或SPECT（单光子发射计算机断层显像术）等成像技术探测到，这使得临床医生能够可视化肿瘤的位置和大小。 “战斗”阶段包括将β或α粒子输送到癌细胞的放射性治疗。 “大多数已确立的疗法使用发射β粒子。这些粒子（比如镥-177）在体内传播的距离相对较远，会导致单链DNA断裂，从而破坏癌细胞的生长。”Back Bay Life Science Advisors管理合伙人Peter Bak解释道。 而发射α粒子（比如使用锕-225或铅-212粒子）可以造成短程辐射，这些粒子会导致双链DNA断裂。这意味着，α射线会不可逆转地破坏癌细胞，而不会损害肿瘤附近的健康组织。 在“跟随”阶段，放射性药物成像可以监测治疗效果，确保剩余癌细胞被识别和处理。Clarivate医疗保健研究和数据分析师Suchitra Ghoshal说：“许多放射性药物可以使用核医学技术进行成像，从而实现对治疗的精确靶向和监测。” 这种完整的治疗和监测周期，使放射性药物成为精准肿瘤学的有效和通用方法。最近，在投资和创新方面，该领域都在加速发展。 Ghoshal分享了她认为需要改进的关键领域： • 下一代放射性示踪剂 放射性示踪剂是一种先进的放射性化合物，用于PET和SPECT等成像技术，以可视化体内的生物过程。这些示踪剂通常针对与疾病（尤其是癌症）相关的特定生物标志物或代谢通路。市售放射性示踪剂的例子包括氟代脱氧葡萄糖（FDG）等。 • 诊疗学 将诊断和治疗能力结合在一起的诊疗放射性药物的发展增强了核医学个性化治疗方法。Ghoshal强调，诊疗市场正在经历显著增长，特别是在各种癌症的治疗方面，包括前列腺癌、神经内分泌肿瘤和淋巴瘤。研究人员也正在研究将纳米技术整合到诊疗放射性药物中，使用各种纳米载体，如脂质体和树枝状聚合物，以改善放射性核素的递送和靶向。 • 靶向放射性药物（TRPs） TRPs用于将放射性同位素特异性地递送到表达特定生物标志物的癌细胞或组织。这些药物由靶向分子、连接剂、螯合剂和放射性核素组成，可以精确靶向肿瘤细胞，类似于抗体-药物偶联物，旨在取代传统化疗。主要目标是最大限度地提高治疗效果，同时最大限度地减少对周围健康组织的损伤。TRPs正逐渐用于神经退行性疾病的诊断。 • 放射性药物领域的AI Ghostal强调了AI对该领域做出特别贡献的一种方法——计算机分子设计。“AI通过计算机模拟方法增强了放射性药物的设计和验证。这些方法利用计算模型来预测化合物的行为，包括它们的结合性质和药代动力学（吸收、分布、代谢、排泄和毒性）。这种预测能力使开发过程更快、成本更低，减少了对传统体外和体内测试的依赖。AI的融合有望大幅扩大核医学的能力。” 2 待克服的挑战 Ghoshal指出，供应链管理是核医学面临的重大挑战。事实上，对于高效生产和分销放射性药物来说，特别是半衰期短的药物，维持可靠的供应链至关重要。 这一领域还需要专门的基础设施和目前缺乏的专业工作人员。Ghoshal表示：“训练有素的核医学医生数量有限，而且我们需要多学科专业知识来有效管理放射性药物，这阻碍了放射性药物的广泛应用。” 开发和生产的高成本从长远来看，可能会限制放射性药物的可及性。除了技术挑战之外，监管也是需要解决的问题。 “由于放射性药物的独特性，包括其放射性和辐射安全要求，我们有必要建立专门的监管框架。放射性药物需要广泛的非临床和临床研究以确保其安全性和有效性。”Ghoshal补充道。 这些研究除了非临床药理学、辐射暴露和影响以及影像学研究外，还包括确保人员安全参与生产和质量控制，以及在诊断过程中最大限度地减少对患者的辐射暴露，并最大限度地发挥治疗效果，同时最大限度地减少对健康组织的伤害。 因此，高速发展的放射性药物行业面临的挑战也确实阻碍了该领域的投资、合作和并购。 3 “重磅”放射性药物交易 目前放射性制药市场非常火爆，几笔交易对该领域产生了重大影响，其中包括Bracco Imaging和Blue Earth Diagnostics的收购案。 该笔收购扩大了Bracco Imaging在精准医疗和个性化诊断方面的投资组合。Blue Earth Diagnostics带来了新型PET显像剂，如Axumin（fluciclovine F 18），可用于疑似复发性前列腺癌患者的PET显像。 此外，Lantheus从Life Molecular Imaging获得了177Lu-DOTA-RM2和68Ga-DOTA-RM2的权益，使Lantheus的产品组合除了可用于治疗前列腺癌外，还增加了乳腺癌的适应症。这不仅加强了Lantheus在市场上的地位，也为患者提供了更广泛的治疗选择。 去年10月，GE医疗与SOFIE生物科学公司达成的协议，有望对放射性药物领域产生重要影响。根据合作协议，GE医疗将商业化和生产SOFIE生物科学公司的两种用于癌症成像应用的试验性成纤维细胞激活蛋白抑制剂（FAPI）PET显像剂。 FAP是一种在癌症相关成纤维细胞（CAF）中高度表达的酶，CAF是肿瘤微环境的关键组成部分，支持癌细胞的生长和扩散。由于CAF存在于大多数肿瘤类型中，包括乳腺、胰腺、结肠、肺、肝和胃，因此FAP靶向诊断在肿瘤以及其他疾病（包括炎症、纤维化和关节炎）中具有巨大的潜力。 这些PET放射性示踪剂目前正在美国进行II期临床试验。 4 哪些放射性药物值得留意？ 过去的几年里，FDA已在该领域批准了多项产品。比如，Lantheus针对癌症的靶向PET显像剂PYLARIFY于2021年获批，用于基于血清前列腺特异性抗原（PSA）水平升高的疑似前列腺癌症转移患者和疑似复发患者。 2023年，Blue Earth Diagnostics用于识别PSMA阳性病变和用于检测前列腺癌复发的高灵敏度的POSLUMA获得批准。同年，Telix Pharmaceuticals的Illucix也被批准用于选择转移性去势抵抗性前列腺癌患者，适合接受靶向PSMA放射性配体疗法Pluvicto治疗者。 Ghoshal表示，放射性药物领域的大多数临床试验都集中在PSMA和FAPI靶点上。 以下是一些值得关注的试验： 此外，Lantheus在肿瘤学方面还拥有几个值得关注的候选产品：PNT2002在SPLASH试验中已显示出积极的顶线结果，预计今年还会披露更多数据；治疗阿尔茨海默病的晚期β淀粉样蛋白PET显像剂NAV-4694目前处于III期开发阶段。 被阿斯利康收购的Fusion Pharmaceuticals也是该领域的参与者，其用于转移性去势抵抗性前列腺癌患者的FPI-2265疗法正处于II/III期临床阶段。FPI-2059是另一项处于I期临床的候选产品。这是一种NTSR1靶向α疗法，使用actinium-225，旨在治疗多种类型的实体瘤，包括胃肠道和胰腺癌。 5 放射性制药投资前景 大型制药公司正在积极收购放射性药物初创公司，增强他们在这一领域的能力。 2024年5月，诺华宣布收购Mariana Oncology。此次收购涵盖了一个强大的RLT项目组合，涉及一系列实体瘤适应症（如乳腺癌、前列腺癌和肺癌），包括针对小细胞肺癌的基于锕的先导RLT项目MC-339。 不少公司也选择建立战略伙伴关系，开发新型放射性药物。一个主要的例子是Eckert & Ziegler和Alpha-9 Theranostics之间的合作，以确保actinium-225的供应，这是下一代靶向放射性核素疗法的关键组成部分。 Lantheus首席执行官认为，未来几年将会出现一波新一代放射性药物，改善靶向制剂、螯合剂、安全持有放射性同位素的分子，确保同位素安全地运输到体内的目标部位，以及调整治疗指数的同位素。 毫无疑问，核医学将在未来不断发展，并为市场带来更多新的治疗方案，从癌症开始，拓展至神经退行性疾病等更多其他疾病。 国内众多中国医药公司也已进军核医学领域，越来越多的资本投向这一赛道。面对相对蓝海的核药产业，如何把握机遇，用好上下游资源，避免内卷，成就高质量的创新，实现临床疗效与商业价值的双赢？ 10月24-26日，同写意将携手烟台生物医药健康产业发展集团，邀请核药领域领军人物去往烟台，在蓝色药谷生命岛深度探讨中国核药产业创新的未来。 活动的第一天，中国科学院上海药物研究所分子影像中心主任、美国医学与生物工程院会士程震，东诚药业副总经理、蓝纳成生物总经理吴晓明，中信证券医药分析师袁聪敏，埃格林医药联合创始人兼CMO李长青等嘉宾，将针对核药行业现在和未来趋势进行现场分享，共寻企业合作发展大计。 会议日程 2024年10月24日 09:00-12:00　注册签到 12:00-13:00　写意午宴 14:00-15:00　参观学习 15:00-15:05　开场发言 15:05-15:20　领导致辞 15:20-15:35　园区推介 15:35-16:00　科学家说 中国放射性药物研究现状 程　震：中国科学院上海药物研究所分子影像中心主任，美国医学与生物工程院会士 16:00-16:20　企业家说 放射性药物产业发展实践及创新机遇  吴晓明：东诚药业副总经理，蓝纳成生物总经理 16:20-16:40　投资者说 百亿蓝海与投资方向，BD全球进展，未来趋势分析 袁聪敏：中信证券医药分析师 16:40-17:00　“核”以出海？ 核药的全球化开发 李长青：埃格林医药联合创始人兼CMO 17:00-17:10　茶歇☕ 17:10-18:00　圆桌对话 中国核药向何处去 ▶　核药原始创新-放射性药物靶点多样化趋势；火爆的市场与BD交易 须　涛（主持）：智核生物CEO，同写意核药俱乐部秘书长 ▶　核药全产业链开发与合作-同位素、供应链、CMC、安全评价、临床需求 喻   峰（主持）：亦立医药创始人、CEO 18:30-20:00　写意晚宴 2024年10月25日 参观考察交流 （本次活动定向邀约） 参考文章： The radiopharmaceutical revolution：From diagnosis to treatment, oncology and beyond；labiotech 同写意媒体矩阵，欢迎关注↓↓↓

MONROE TOWNSHIP, N.J. & OXFORD, England--( BUSINESS WIRE )--Bracco and Blue Earth Diagnostics Ltd, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, welcomes proposed changes announced on July 10, 2024, by the Centers for Medicare & Medicaid Services (CMS) for the Hospital Outpatient Prospective Payment System (OPPS) Rule. The rule is designed to improve payments for diagnostic radiopharmaceuticals for U.S. Medicare patients, and has the potential to increase access to innovative radiopharmaceuticals that have lost, or will lose, their Transitional Pass-Through payment status. Blue Earth Diagnostics has been a pioneer in championing the discussions with CMS to secure this rule change. “ We are excited about this proposed CMS rule, which will increase patient access to advanced diagnostic imaging products to inform patient management, and, at the same time, enhance industry innovation and sustainability,” said Marco Campione, Chief Executive Officer of Blue Earth Diagnostics. “ Adoption of innovative radiopharmaceutical products, and importantly, patient access to these products, has been hampered for years by limitations of the CMS payment methodology,” added Terri Wilson, President, Blue Earth Diagnostics, Inc. “ In the case of Blue Earth Diagnostics, this new proposed rule will support our entire portfolio of diagnostic imaging agents. POSLUMA ® (flotufolastat F 18) will maintain its Pass-Through payment status for diagnostic imaging radiopharmaceutical reimbursement until September 30, 2026. Upon passage of the proposed rule, Axumin ® (fluciclovine F 18), which previously lost Pass-Through status in January 2020, will gain separate payment.” The proposed OPPS rule requires further refinement over a 60-day comment period. Blue Earth Diagnostics is looking forward to continued cooperation with CMS to determine necessary details to identify the new separate payment rates (which are proposed to differ from those under Transitional Pass-Through), build a model for future adjustments and ensure successful implementation of the rule. The final rule will be issued in early November 2024 and take effect January 1, 2025. Indication and Important Safety Information About Axumin INDICATION Axumin ® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended. Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available. Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers. Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia. To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf . Indication and Important Safety Information About POSLUMA INDICATION POSLUMA ® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf . About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com . This press release is for U.S. audiences only