Itm Isotope Technologies Munich SE

Neufahrn / Garching / Munich, Germany, October 24, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, the Technical University of Munich (TUM) and the TUM University Hospital (Klinikum rechts der Isar der Technischen Universität or MRI), today announced a new framework agreement for the research and development of innovative radiopharmaceuticals and radionuclides for the treatment of cancer. This collaboration builds on a long-standing partnership and previously established cooperation agreement between ITM and TUM. The new agreement aims to further accelerate nuclear medicine initiatives by integrating ITM’s expertise in medical radioisotope production and radiopharmaceutical development with TUM’s cutting-edge research capabilities in nuclear physics (FRM II research reactor) and medical applications, alongside MRI’s renowned clinical expertise in diagnostics and patient care. The framework agreement also outlines how ITM and TUM will share and transfer the rights to any results or inventions that come from their future collaboration. Additional details of the framework agreement have not been disclosed. “TUM is a global leader in uniting top-tier academic research, scientific innovation and entrepreneurship. This agreement stems from two decades of collaboration with the TUM and will grant us valuable access to its world-class institutes and clinics, which are driving cutting-edge research in nuclear medicine,” said Dr. Andrew Cavey, CEO of ITM. “As we expand our pipeline of targeted radiopharmaceuticals, we look forward to working on future projects with the TUM to advance novel treatment options for patients living with cancer.” To formalize and sign the agreement, Udo J. Vetter, ITM Supervisory Board Chairman, Oliver Buck, ITM co-founder and Supervisory Board member, Dr. Mark Harfensteller, COO of ITM, and Dr. Sebastian Marx, CBO of ITM, Prof. Thomas F. Hofmann, President of the TUM, and Prof. Dr. med. Stephanie Combs, Dean of TUM School of Medicine and Health and Member of the Board of University Hospital met on September 26 and toured ITM’s NOVA Lutetium-177 production site in Neufahrn. “Our goal is to accelerate the development of effective cancer therapies. Therefore, we value the opportunity to combine TUM's research excellence in the natural sciences and medicine and the production of radioisotopes such as Lutetium-177 at the FRM II research reactor with ITM’s leadership in medical radioisotope manufacturing and radiopharmaceutical drug development and cutting-edge medicine at our TUM University Hospital. As partners, we aim to conduct innovative research for targeted cancer treatment and thus significantly improve treatment outcomes and quality of life for cancer patients,” said Prof. Thomas F. Hofmann, President of the TUM. Prof. Dr. med. Stephanie Combs, Dean of the TUM School of Medicine and Health and Board Member of the TUM University Hospital said: “Nuclear medicine is particularly important in the interdisciplinary fight against cancer. It plays a critical role in diagnosis, and provides innovative treatment options that open up new opportunities for patients and we are committed to contributing to new discoveries in this field. The unique collaboration between TUM and ITM offers the potential to combine ITM's leading position in the field of radioisotope production and drug development with the research expertise of our university hospital. I am very much looking forward to being able to provide our patients with the latest scientific discoveries." Since its founding in 2004, ITM and the TUM have forged a strong partnership that has contributed to the development of ITM’s highly pure, non-carrier-added Lutetium-177 (n.c.a.177Lu) and helped pave the way for ITM to establish its NOVA facility. ITM and its IAZ manufacturing facility are headquartered on the TUM’s Garching campus. This enduring collaboration also brings additional valuable projects, ranging from medical radionuclide production to clinical studies, to fruition. About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.com Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachments Contract signing at ITM's NOVA Lutetium-177 production site in Neufahrn Tour of ITM's NOVA Lutetium-177 production site in Neufahrn 24102024_ITM, TUM, and TUM University Hospital Sign New Framework Agreement

Extension of 2012 agreement grants NTP the rights to manufacture and distribute non-carrier-added Lutetium-177 (n.c.a. 177Lu)Companies enter into an additional manufacturing and supply agreement for NTP to produce and supply n.c.a. 177Lu to ITMExtending the collaboration strengthens production capacity and enhances the global supply of valuable medical radioisotopes Garching / Munich, Germany, and Pretoria, South Africa, October 18, 2024 – ITM Isotope Technologies Munich SE (ITM) and NTP Radioisotopes SOC Ltd. (NTP), both leading radiopharmaceutical companies, today announced that they have renewed their long-standing technology transfer- and license agreement for the production of non-carrier-added Lutetium-177 (n.c.a. 177Lu). Furthermore, the companies have entered a new manufacturing and supply agreement to further increase ITM’s n.c.a. 177Lu manufacturing capabilities, to meet the growing demand through a robust, reliable and sustainable global supply.Under the renewed licensing agreement, ITM grants NTP the use of intellectual property (IP) rights related to the manufacturing of n.c.a. 177Lu. ITM is a global leading producer and supplier of n.c.a. 177Lu, a medical radioisotope frequently used in Radiopharmaceutical Therapy (RPT) for the treatment of cancer. ITM’s expertise will support NTP in the manufacturing and distribution of these valuable medical radioisotopes within the Republic of South Africa and other agreed territories. In addition, the companies entered a new manufacturing and supply agreement under which NTP will produce and supply n.c.a. 177Lu to ITM by utilizing ITM’s IP, processes and quality specifications and to irradiate Ytterbium-176 (176Yb) leveraging NTP’s expertise and commercial access to the SAFARI-1 nuclear reactor operated by Necsa.“NTP is a trusted partner and the extension of our existing agreements with them underscores the value of our long-standing cooperation. That cooperation is built on a mutual commitment to ensuring a global supply for the radiopharmaceutical industry,” commented Dr. Andrew Cavey, CEO of ITM. “These agreements strengthen our position as the world’s largest manufacturer of n.c.a. Lutetium-177 and further secure our ability to supply the growing demand for medical radioisotopes around the world.”The international demand for medical radioisotopes, including n.c.a. 177Lu is projected to grow, creating a need for reliable manufacturing sites and supply chains. High-quality medical radioisotopes are key components for targeted radiopharmaceuticals used to treat an array of high-need cancer indications. Through this partnership, ITM and NTP are expanding their capabilities and capacities to produce as well as distribute these valuable radioisotopes to reach more patients globally.“ITM has been a long-term strategic partner for NTP in building our n.c.a. Lutetium-177 production and manufacturing facilities, which have enabled us to supply the South African radiopharmaceutical market and other territories as per our agreement with this critical and lifesaving medical radioisotope, with improved patient outcomes,” said Thabo Tselane, GMD of NTP. “We look forward to this fruitful, strategic collaboration and partnership as a producer and supplier of n.c.a. Lutetium-177 with ITM.”About Radiopharmaceutical Therapy (RPT)Radiopharmaceutical Therapy (RPT) is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope such as Lutetium-177 or Actinium-225 to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue.About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.comAbout NTP Radioisotopes SOC LtdNTP Radioisotope, a subsidiary of Necsa, is a global leader in the production and distribution of nuclear technology and radiation products as well as services and has over time evolved into a prominent player in the global medical and industrial radioisotope sector. Their integrated offering includes irradiation services, API’s, radiopharmaceuticals, single-dose medical radioisotopes, radioactive sealed sources, source containers and reliable logistics. Guided by core values, NTP fosters diversity, sustainability and ethical engagement whilst building partnerships with customers, colleagues, and communities’ word wide. NTP supplies high-quality radiation-based products and services to customers in more than 50 countries, further extending this reach through their subsidiaries, GammaTec NDT supplies SOC Ltd, NTP Logistics SOC Ltd and AEC-Amersham SOC Ltd. With a mission to excel in a competitive global arena, NTP priorities customer satisfaction through innovation and quality, investing strategically in its employees and infrastructure to uphold safety and NTP standards. ITM ContactCorporate CommunicationsKathleen Noonan / Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.comInvestor Relations Ben OrzelekPhone: +49 89 329 8986 1009 Email: investors@itm-radiopharma.comNTP Contact Marketing & Sales Annette Lubbe Phone: +27 833759239 Email: salesqueries@ntp.co.za Attachment 18102024_ITM and NTP Strengthen Global Radioisotope Production Capacities

本次ITM-11获受理的COMPETE桥接研究有望进一步扩大该产品的适用人群，有望实现该产品对于胃肠胰腺神经内分泌瘤各阶段病程的全方位覆盖； ITM-11使用的无载体的177Lu拥有更高的比活度和纯度，且放射污染小，产品已在美国和欧洲获得孤儿药资格认定，且其可与公司TOCscan®形成产品组合，实现对GEP-NETs的诊疗一体化； 目前，远大医药是进入中国III期临床研究中诊断和治疗类RDC创新药总计储备最多的企业，也是全球范围内在核药抗肿瘤领域拥有最丰富产品管线和诊疗一体化布局的创新药企之一。 近日，远大医药(0512.HK)用于治疗胃肠胰腺神经内分泌瘤的全球创新放射性核素偶联药物(RDC) ITM-11的一项III期临床研究（COMPETE桥接研究）的申请已获得国家药监局的正式受理。 关于COMPETE桥接研究 COMPETE桥接研究是一项前瞻性、随机、对照、开放性、多中心III期临床研究，拟在中国入组超过60例患者，旨在评估ITM-11多肽受体放射性核素治疗（PRRT）对比标准治疗，在不可手术、进展性、高分化1级或2级、生长抑素受体阳性（SSTR+）的胃肠或胰腺神经内分泌瘤（GEP-NETs）患者中的有效性和安全性。此前公司已于今年三月获得药监局批准开展ITM-11针对高分化侵袭性2级和3级GEP-NETs的III期临床研究（COMPOSE研究），目前该临床研究正在顺利推进中。此次COMPETE 桥接研究将有望进一步扩大ITM-11产品的适用人群，有望实现该产品对于胃肠胰腺神经内分泌瘤各阶段病程的全方位覆盖。 关于ITM-11 ITM-11是一款基于放射性核素偶联技术靶向杀伤治疗GEP-NETs的RDC药物，该产品是将无载体177Lu与生长抑素类似物偶联，通过与GEP-NETs表面高水平表达的生长抑素受体(SSTR)结合靶向杀伤肿瘤细胞。与目前常用的有载体177Lu核素产品相比，无载体的177Lu拥有更高的比活度和纯度，而且生产过程中产生的长半衰期杂质少，放射性废物更易于处理。该产品已经获得美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)等机构的孤儿药资格。 关于胃肠胰腺神经内分泌瘤 根据Frost & Sullivan的数据，2020年，中国胃肠胰腺神经内分泌瘤的新发确诊病例为71,300例，发病率逐年上升。《CSCO神经内分泌肿瘤诊疗指南2021》中提示，基于177Lu的肽受体放射性核素治疗在无进展生存时间(PFS)和客观缓解率(ORR)等指标方面优于目前临床一线使用的高剂量奥曲肽（生长抑素类似物），可带来明显的患者获益。 ITM-11可与公司另一款用于诊断GEP-NETs的RDC产品TOCscan®形成产品组合，实现对GEP-NETs的诊疗一体化，有望为中国GEP-NETs患者提供全新的诊疗方案。 持续推进创新产品研发 夯实全球核药领军地位 核药抗肿瘤诊疗板块是远大医药的重点布局的领域之一。围绕肿瘤诊疗一体化的治疗理念，公司核药抗肿瘤诊疗板块目前已储备12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；在产品种类方面，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全球领先的抗肿瘤方案。 目前，远大医药在核药抗肿瘤诊疗板已有4款 RDC创新药获批开展临床研究，其中3款已进入III期临床阶段，包括诊断前列腺癌的产品TLX591-CDx、诊断透明细胞肾细胞癌产品TLX250-CDx，以及治疗GEP-NETs的产品ITM-11。截至目前，公司是进入中国III期临床研究中诊断和治疗类RDC创新药总计储备最多的企业，也是全球范围内在核药抗肿瘤领域拥有最丰富产品管线和诊疗一体化布局的创新药企之一。 关于远大医药核药抗肿瘤诊疗平台 核药抗肿瘤诊疗平台是公司在抗肿瘤领域重点打造的高端技术平台，目前公司已实现了研发、生产、销售、监管资质等多个环节的全方位布局，建立了完整的产业链。远大医药联合Sirtex Medical Pty Limited并与Telix Pharmaceutical Limited (ASX: TLX)和ITM Isotope Technologies Munich SE合作，搭建了具有国际化一流水平的肿瘤介入研发平台和RDC药物研发平台，已拥有近650名员工，是远大医药全球化程度最高的板块之一。同时，公司与山东大学联合成立了远大医药-山东大学放射药物研究院，并以该研究院为核心建立了核药早期研发平台，进行RDC药物的自主研发。目前早期研发阶段的产品储备已达12款。 远大医药正在有序推进甲级资质核素生产平台的建设。未来，公司将持续加强核药抗肿瘤诊疗板块的研发和建设，丰富和完善产品管线及产业布局，形成以易甘泰®钇[90Y]微球注射液为核心的核药抗肿瘤诊疗产品集群，持续夯实远大医药在全球核药抗肿瘤诊疗领域领军企业地位。 远大医药集团有限公司董事会表示：“本集团一直高度重视创新产品和先进技术的研发，未来将持续加大对全球创新产品和先进技术的投入，丰富和完善产品管线及产业布局，坚持‘全球化运营布局，双循环经营发展’策略，充分发挥本集团的产业优势和研发实力，快速将科技创新产品落地上市，为全球患者提供更先进更多样的治疗方案。” 大家都在看 ▲希望照进现实：中晚期肝癌患者求生记 ▲ 砥砺三载 共赴山海 | 数说钇90这三年 ▲世界清洁日 | 远大医药：绿色先行 健康守护 ↑↓ 上下滑动了解更多 ➤关于远大医药 远大医药是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。公司以医药及生物工业为基础，以患者需求为核心，以科技创新为源动力，针对尚未满足的临床需求，加大对全球创新产品和先进技术的投入，丰富和完善产品管线，巩固和强化产业链布局，充分发挥产业优势和研发实力，为全球患者提供更先进更多样的治疗方案。 「稳增长、强创新、谋布局」，远大医药将继续秉承「综合优势、创新引领和全球拓展」的发展理念，采用「自主研发和全球拓展双轮驱动，全球化运营布局和双循环经营发展」策略，形成国内国外双循环联动发展并相互促进的新格局，致力于成为一家受医生和患者尊重并还原于社会的科技创新型国际化医药企业。    ➤前瞻性声明 本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本集团有关的，均属于前瞻性表述。本集团并无义务不断地更新这些预测性陈述。 这些前瞻性表述是基于本集团管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险不确性及其他因素的影响，有些是超出本集团的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 本集团、本集团董事及雇员代理概不承担(1)更正或更新本网站所载前瞻性表述的任何义务;及(2)若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。