Sodium Pertechnetate (99mTc)

Enables Lantheus to focus on innovative radiopharmaceuticals, while maximizing the value of its SPECT business SHINE will acquire products TechneLite®, NEUROLITE®, Xenon Xe-133 Gas, and Cardiolite® BEDFORD, Mass., May 06, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company dedicated to helping clinicians Find, Fight, and Follow disease to deliver better patient outcomes, today announced a definitive agreement to sell its single photon emission computed tomography (SPECT) business to Illuminated Holdings, Inc., the parent company of SHINE Technologies, LLC (collectively, “SHINE”). Under the terms of the agreement, SHINE will acquire Lantheus’ SPECT business, including its diagnostic agents (TechneLite® (Technetium Tc 99m generator), NEUROLITE® (Kit for the Preparation of Technetium Tc 99m Bicisate for Injection), Xenon Xe-133 Gas (Xenon Xe-133 Gas), and Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection)), the portion of the North Billerica, Massachusetts campus that manufactures Lantheus’ SPECT products, and the SPECT-related Canadian operations. The transaction allows Lantheus to focus on growing its commercial portfolio of innovative PET radiodiagnostics and microbubbles, while advancing its pipeline of radiopharmaceuticals. SHINE is a global leader in nuclear medicine production and, with its proven expertise in developing next-generation fusion and fusion-based technology and sustainable medical isotope supply chains, is the ideal partner to ensure the continuity and expansion of the SPECT business. “This transaction enables Lantheus to concentrate our efforts on enhancing our radiopharmaceutical leadership focused on innovative diagnostics and therapeutics," said Brian Markison, CEO of Lantheus. “While the SPECT business has been a foundational part of Lantheus’ nearly 70-year history, we believe it is the right time for this business and its outstanding employees to continue driving success with SHINE, a company well-positioned to ensure its long-term growth and positive patient impact.” Markison continued, “Today’s announcement builds on our strong momentum and agreements to acquire Life Molecular Imaging and Evergreen Theragnostics. These strategic actions will enable us to focus on growing our portfolio, advancing and expanding our pipeline, and enhancing our capabilities across the radiopharmaceutical value chain.” "This acquisition builds on our longstanding partnership with Lantheus and we are confident the SPECT business and the talented team will significantly strengthen our platform," said Greg Piefer, CEO of SHINE. "We look forward to joining the operational strength of this business with our advanced isotope production capabilities to ensure continuity and growth of the SPECT business, a seamless transition for employees and a long-term reliable supply of essential radioisotopes.” Under terms of the agreement, Lantheus will receive an upfront cash payment, a note convertible into SHINE preferred stock, and additional consideration, including potential earnout milestones. The transaction has been approved by the Boards of Directors of both companies and is expected to close by the end of the year, subject to customary closing conditions. Advisors Solomon Partners Securities, LLC acted as financial advisor to Lantheus in this transaction, while Foley Hoag LLP and Ropes & Gray LLP acted as legal advisors, and Ernst & Young LLP acted as financial and tax advisor. TechneLite® (Technetium Tc 99m generator) INDICATIONS AND USAGE: The TechneLite® generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. Nasolacrimal Drainage System Imaging Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None known. IMPORTANT SAFETY INFORMATION: Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m Injection. WARNINGS Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer. PRECAUTIONS Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TechneLite®, Technetium Tc 99m Generator, elution. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides. Please see full Prescribing Information. Xenon (Xenon Xe-133 Gas) INDICATIONS AND USAGE Inhalation of Xenon Xe-133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None known. Adverse reactions related to the use of this agent have not been reported to date. WARNINGS Xenon Xe-133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leak-proof to avoid loss of radioactivity into environs not specifically protected by exhaust systems. Xenon Xe-133 adheres to some plastics and rubber and should not be allowed in tubing or respirator containers. The unrecognized loss of radioactivity from the dose for administration may render the study non-diagnostic. The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex. PRECAUTIONS General Xenon Xe-133, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to patients and to clinical personnel. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Please see full Prescribing Information. NEUROLITE® (Kit for the Preparation of Technetium Tc 99m Bicisate for Injection) INDICATIONS NEUROLITE® single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. NEUROLITE® is not indicated for assessment of functional viability of brain tissue or for distinguishing between stroke and other brain lesions. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None known. In clinical trials, NEUROLITE® has been administered to 1063 subjects (255 normals, 808 patients). In the 808 patients with neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to NEUROLITE®. The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis. WARNINGS None known. PRECAUTIONS General USE WITH CAUTION IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT. TECHNETIUM Tc99m BICISATE IS ELIMINATED PRIMARILY BY RENAL EXCRETION. WHETHER TECHNETIUM Tc99m BICISATE IS DIALYZABLE IS NOT KNOWN. DOSE ADJUSTMENTS IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT HAVE NOT BEEN STUDIED. Patients should be encouraged to drink fluids and to void frequently during the 2-6 hours immediately after injection to minimize radiation dose to the bladder and other target organs. As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other people. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides. Please see full Prescribing Information. Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) INDICATIONS AND USAGE Myocardial Imaging: Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Cardiolite® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g. exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: MIRALUMA®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. MIRALUMA® is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None known. Cardiolite® has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during Cardiolite® imaging. The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell. Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events. WARNINGS AND PRECAUTIONS In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure. Caution should be exercised and emergency equipment should be available when administering Cardiolite®. Before administering Cardiolite® patients should be asked about the possibility of allergic reactions to either Cardiolite® or Miraluma®. Miraluma® is an identical compound used in breast imaging. The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure. Please see full Prescribing Information. About Lantheus Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com. About SHINE Technologies, LLC Headquartered in Janesville, Wisconsin, SHINE is an industry leader in next-generation fusion, developing innovative fusion-based technology that combines safety, cost-efficiency and environmental responsibility. SHINE has successfully commercialized fusion across multiple applications, including neutron testing markets such as neutron radiography, radiation-effects testing and fusion material research. It has commercialized and is scaling its proprietary medical isotope production, supplying high-quality radioisotopes essential for procedures involving diagnosis of heart disease and cancer and therapeutic cancer treatments. Beyond these applications, SHINE is pioneering nuclear waste recycling to make nuclear energy more sustainable. Its long-term purpose is to change the way humans make energy by commercializing fusion energy. Unlike other fusion companies, SHINE takes a commercially driven path mirroring successful deep-tech industries. Through this visionary approach, SHINE is advancing technology, healthcare, and sustainable energy, making a lasting impact across multiple sectors. Safe Harbor for Forward-Looking and Cautionary Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “enables,” “expected,” “potential,” potentially,” “will,” and other similar terms and include, among other things, statements about (i) the potential benefits and results of the transaction; and (ii) the anticipated timing of the closing of the transaction. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) Lantheus’ and SHINE’s ability to complete the transaction on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory approvals and satisfaction of other closing conditions to consummate the transaction; (ii) the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive transaction agreement relating to the proposed transaction; (iii) risks related to diverting the attention of Lantheus’ management from ongoing business operations; (iv) failure to realize the expected benefits of the transaction; (v) significant transaction costs and/or unknown or inestimable liabilities; (vi) disruption from the proposed transaction, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; (vii) effects relating to the announcement of the transaction or any further announcements or the consummation of the transaction on the market price of Lantheus’ common stock; (viii) the possibility that, if Lantheus does not achieve the perceived benefits of the transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of Lantheus’ common stock could decline; (ix) potential litigation associated with the possible transaction; and (x) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q). Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus.com Melissa Downs Executive Director, External Communications 646-975-2533 media@lantheus.com Source: Lantheus Holdings, Inc.

集采常态化、医保谈判严格控费等政策的影响下，受政策影响小且兼具高壁垒、高增长的赛道不多，核药便是其中之一。 核药，即放射性药物，也被称为核素药物，是由放射性同位素搭配专门定位特定器官及组织的分子试剂组成的医药制剂，可用于影像诊断及临床治疗。根据用途可分为诊断用核素药物和治疗用核素药物。 由于所需的技术要求高，因此目前参与核药竞争的企业非常少。 图| 核药企业销售额TOP10 数据源| 摩熵医药 表格中的十家企业，合计占据了90%以上的核药市场，可谓相当集中。 原子高科股份有限公司——隶属于中核集团。 现有批准字号50个，全部是放射性药物，背靠中核集团，原子高科有强大的研发实力，今年9月获批国内首个用于骨显像的PET显像剂氟[18F]化钠注射液。 深圳市中核海得威生物科技有限公司——一家专注于做幽门杆菌检测同位素的企业。 现存批准字号5个，均是C13、C14同位素相关，典型的专研某一领域精准定位型企业。 北京华亘安邦科技有限公司——它家就一个药，尿素[13C]呼气试验诊断试剂盒。 一个品撑起近5亿的年销售额，核药市场真正潜力无穷！ 近年来，核药研发和投资领域都属于大热，与整体寒冬氛围对比下，核药的火热就更为突出。利好核药的政策频出，国家大力扶持之下，越来越多企业关注到这个小众赛道。 对此，本文盘点了2023年放射性药物销售额TOP10。核药的销售额与普通药易受各种政策影响而波动不同，几乎所有核药从获批上市起，每年的销售额都在逐年递增，且未有减缓之势，可见核药赛道之潜力有多大。 图| 核药药品销售额TOP10 数据源| 摩熵医药 逐个来看： 1、氟[18F]脱氧葡糖注射液 【适应症】本品用于正电子发射断层显像(PET)，利用病灶的异常糖代谢的特点进行定位诊断与评估。1.用于肿瘤PET显像，评估疑似或确诊病例肿瘤的恶性程度。2.用于冠状动脉疾病和左心室功能不全PET显像。与其他心肌灌注显像联用，用于评估左室功能不全病例左心室的心肌活性与心肌收缩功能的可恢复性。3.用于确定与不正常葡萄糖代谢相关的癫痫病人的癫痫病灶。 图源：摩熵医药 此品种北京善为正子医药技术有限公司在2022年首家过评，目前产品仅5个批准字号。 此产品2023年医院终端销售额5.77亿，销量连年上涨，2022至2023年增幅达34.31%，其中2023年原子高科股份有限公司市场占比42%。 2、尿素[13C]呼气试验诊断试剂 【适应症】诊断幽门螺杆菌(Hp)感染。 图源：摩熵医药 此产品目前仅2个批准字号，国内一个，进口一个，暂无过评。 此品销售额也在逐年上升，2023年达到近5亿，增幅28.28%，同样是诊断幽门螺杆菌(Hp)感染，与放射性C14同位素相比，稳定的C13同位素，完全无放射性，适用于所有年龄段，包括孕妇和儿童。 国内唯一一家上市企业北京华亘安邦科技有限公司，占市场99%，基本可以说是独家了。 3、尿素[14C]呼气试验药盒 【适应症】诊断幽门螺杆菌(Hp)感染。 图源：摩熵医药 尿素[14C]呼气试验药盒销售额在2022年增幅达118.73%，直线上升，到2023年达到4.68亿，在幽门螺杆菌检测上，C14检测更被医生所熟知，目前国内仅2个批准字号属于同一家公司深圳市中核海得威生物科技有限公司，完全无竞争。 4、碘[131I]化钠口服溶液 【适应症】主要用于诊断和治疗甲状腺疾病及制备碘[131I]标记化合物。 图源：摩熵医药 碘[131I]化钠口服溶液现行有效9个批准字号，但持有人只有三个，原子高科股份有限公司、深圳市中核海得威生物科技有限公司和中国工程物理研究院核物理与化学研究所。 产品在2023年全医院终端销售额3.95亿，增幅23.08%，产品销售趋势连年上涨，其中2023年原子高科股份有限公司市场占比67.8%。 5、碘[125I]密封籽源 【适应症】对于浅表、胸腹腔内的肿瘤(如头颈部肿瘤、肺癌、胰腺癌、早期前列腺癌)，如果其为不能切除、局部、生长缓慢、对放射线低度或中度敏感时，可试用本品进行治疗。本品也可适用于经放射线外照射治疗残留的肿瘤以及复发的肿瘤。 图源：摩熵医药 碘[125I]密封籽源目前有9个批准字号，没有过评的，2023年天津赛德生物制药有限公司销量最佳占市场41%。 不同于以上那些诊断类放射药物逐年上升的销售趋势，治疗类放射性药物碘[125I]密封籽源却在下降，曾经2018年至2022年碘[125I]密封籽源一直都是放射性药物销量最高的，但放射性疗法治疗手段更新迭代，放射性元素使用也在更新迭代，到了2023年，下跌至第五位，但仍旧有3.74亿元。 6、锝[99mTc]亚甲基二膦酸盐注射液 【适应症】用于全身骨显像及癌症骨转移显像。 图源：摩熵医药 现行5个批准字号，2023年销售额2.89亿，其中原子高科股份有限公司市场占比61%。 7、高锝[99mTc]酸钠注射液 【适应症】主要用于甲状腺显像、脑显像、唾液腺显像、异位胃粘膜显像及制备含锝[99mTc]放射性药品。 图源：摩熵医药 现行11个批准字号，过评一家，中国工程物理研究院核物理与化学研究所于2024年7月过评，原子高科股份有限公司占比62.8%。 8、氯化锶[89Sr]注射液 【适应症】本品为转移癌性骨痛的治疗剂，主要用于前列腺癌、乳腺癌等晚期恶性肿瘤继发骨转移所致骨痛的缓解，是转移癌性骨痛止痛的一种疗法。 图源：摩熵医药 同为放射性治疗药物，氯化锶[89Sr]注射液销量正在逐年上涨，现行有效7个批准字号，一个过评企业，成都欣科医药有限公司2023年首家过评，2023年成都中核高通同位素股份有限公司占比75%以上。 9、尿素[14C]胶囊 【适应症】诊断幽门螺杆菌(Hp)感染。 图源：摩熵医药 该产品是跟尿素[14C]呼气试验药盒协同使用的，销售额增长非常迅速，得益于现代人对幽梦螺旋杆菌的认识增加，越来越多人知道了检测幽门杆菌的重要性。目前2个批文，分别是上海欣科医药有限公司和深圳市中核海得威生物科技有限公司，产品与尿素[14C]呼气试验药盒相辅相成，2023年深圳市中核海得威生物科技有限公司占比接近86%。 10、钇[90Y]微球注射液 【适应症】钇[ 90Y]微球注射液适用于经标准治疗失败的不可手术切除的结直肠癌肝转移患者。 钇[90Y]微球注射液增速极快，仅一个批准字号，Sirtex Medical Pty Ltd在22年获批上市，23年就涨到了八千多万。 从上面的销量排行可以看出，核药赛道竞争还是一片蓝海，多个品种都是独家，Sirtex Medical Pty Ltd仅凭一个产品就晋升top10。 据公开资料可知，2015-2023年，核药市场就有23家企业发生55起融资事件，核药赛道成了新一个必争之地。 数据来源：摩熵医药 投稿/内容沟通：华籍美人（Ww_150525） 近期精华文章