Zirconium (89Zr) girentuximabum senvedoxamum

这家澳大利亚生物科技公司凭借差异化制造平台与全流程商业化能力，助力再生元正式叩开放射性药物市场大门 在当下的制药业并购与合作浪潮中，放射性药物公司正日益成为炙手可热的抢手标的。 自诺华在2018年收购Endocyte、并借此推出重磅抗癌药物Pluvicto（镥[177Lu]特昔维匹肽）以来，放射性药物这一细分领域的商业价值愈发凸显。 此后，诺华的竞争对手们纷纷加快步伐，争相与放射性药物企业展开合作：百时美施贵宝收购了RayzeBio，阿斯利康拿下了Fusion Pharmaceuticals，礼来将Point Biopharma收入囊中，而罗氏与赛诺菲则分别与Orano Med展开产品开发合作。 再生元同样一直在寻找进军放射性药物领域的路径。据Telix Pharmaceuticals创始人兼首席执行官Christian Behrenbruch介绍，再生元此前展开的合作伙伴甄选过程堪比一场“选美比赛”，众多候选企业竞相角逐，而Telix最终从中脱颖而出。 他表示，在与再生元的谈判过程中，Telix的制造平台成为公司最终胜出的关键优势所在。 Behrenbruch说：“他们看重的是，我们并非那种仅停留在纸面上、依靠风险投资支撑、还在摸索技术原理的管线型公司。我们在生物制剂类放射性药物的多中心临床试验放大生产与运营方面拥有切实的实战经验，同时在全球范围内也积累了丰富的监管申报经验。这是一种非常互补的合作关系。” 再生元与Telix已于今年4月达成协议，双方将按50/50的比例共同承担成本并分享利润，这笔交易最终有望为这家总部位于澳大利亚的放射性药物公司带来最高达21亿美元的收益。 根据协议条款，再生元将获得使用Telix制造平台的权利，用于推进四个肿瘤治疗领域的早期项目，其中包括多个来自再生元抗体产品组合、针对实体瘤靶点的项目。双方还将共同开发放射性诊断产品。延伸阅读：再生元首次进入放射性药物领域，与Telix达成43亿美元合作 值得一提的是，Telix本身也是一家已进入商业化阶段的企业，自主拥有一条丰富且处于后期开发阶段的产品管线。 Behrenbruch表示：“我们无疑拥有业内规模最大的放射性药物管线之一……目前公司有三项3期临床试验正在同步推进，分别针对肾癌、前列腺癌和脑癌。” Telix下一个有望获批的产品是Pixclara（TLX101-Px），这是一款用于胶质瘤成像的诊断药物，FDA预计将于9月11日作出审批决定。不过，这将是Pixclara第二次冲击获批——此前该产品曾在去年遭到FDA拒绝，监管机构要求公司补充“额外的确证性临床证据”。 Behrenbruch认为，Telix在放射性药物领域的竞争优势主要来自三个方面： 首先，公司将治疗性药物开发与诊断业务紧密结合； 其次，公司始终专注于在特定疾病领域深耕管线布局，因为“并非所有实体瘤领域都天然适合放射性药物”； 此外，公司还实现了同位素供应链与生产制造的垂直整合，Behrenbruch表示，这种模式“对于一家小型生物制药公司而言相当罕见”。 在采访中，Behrenbruch进一步阐述了与再生元的这笔合作将如何助力双方在创新层面实现突破，以及Telix得以在市场上取得成功背后的关键因素。放射性药物领域的演变，以及与再生元合作将带来哪些新的创新探索空间 Behrenbruch回顾道，人类对IgG（免疫球蛋白G）作用机制的最早认知，很大程度上正是源自放射性药物研究——通过对注射入体内的抗体进行追踪，研究人员得以观察其在体内的具体分布路径。 这也催生了上世纪80年代末至90年代初的一波免疫疗法研究热潮，当时研究人员将利妥昔单抗、曲妥珠单抗等抗体药物进行放射性标记，并在患者体内展开研究。 然而，那一时期的靶向载体在放射性适配方面，包括清除器官选择、血清半衰期以及靶向药物在目标组织相对于健康组织中的滞留时间等方面，并未得到真正意义上的优化。 他表示，与再生元的合作让公司得以突破以往简单地将放射性同位素附着于抗体、然后寄望于获得理想效果的做法。 如今，公司能够真正调动现代抗体药物研发所涉及的完整蛋白质工程技术体系，包括双特异性抗体及具备不同药理特性的工程化改造分子形式。Telix近期市场更新中强调的供应链韧性，以及这对再生元合作的重要意义 Behrenbruch表示，公司希望在这次合作中扮演联合开发与联合商业化伙伴的角色，这对于一家规模较小的生物制药公司而言实属少见。 Telix拥有自己的商业化团队，因为销售放射性药物与销售常规药片或注射剂型完全不同，其中涉及一整套临床工作流程，需要对客户开展辐射安全、废物处理，扫描仪校准，以及剂量分装、抽取与患者给药等方面的培训与指导。 他补充说，公司同时具备商业化团队以及制造与供应链能力，且这些能力具备足够的冗余度和韧性，能够在药物真正实现商业化成功后支撑起大规模放量生产。以去年为例，公司在全球范围内交付了三百万剂患者用药。 Behrenbruch表示，再生元当初寻找的正是一个拥有足够基础设施、能够实现全球范围放量生产与交付能力的合作伙伴，而要做到这一点，同位素供应链与生产制造环节就必须具备充足的产能与冗余保障。Telix精准医疗业务部门过去一年实现强劲增长的战略布局 Behrenbruch解释说，这主要得益于公司在特定产品领域持续构建纵深布局。 目前公司在前列腺癌影像诊断领域拥有两款产品，二者无论是在医保报销层面，还是在供应链与物流层面，都形成了良好的互补关系。其中，Illuccix产品表现十分出色，其保质期较短，这一特性恰好使其能够在各大都市地区实现按需剂量交付。 另一款产品Gozellix则是公司相对较新推出的产品，已于去年圣诞节前夕获得医保报销资格。该产品保质期更长，这使其能够运输到更远的地区，从而更好地覆盖更广泛的社区医疗场景。 Behrenbruch表示，公司在这两款第二代产品的研发过程中投入了大量创新，形成了一套“组合拳”式的战略布局，正是这一策略帮助公司持续抢占市场份额。 此外，公司即将推进Zircaix产品的生物制品许可申请（BLA）提交工作，该产品用于治疗肾癌，同时在膀胱癌领域也具备一定的潜在应用价值。 Behrenbruch总结说，公司的核心策略始终围绕着不断加深产品管线的纵深布局，并持续巩固与泌尿科及泌尿肿瘤科医生群体之间的紧密关系，而这正是该业务板块能够取得成功的关键所在。 他表示：“我们作为一家公司所秉持的，是一种高度重视沟通与专业投入的经营方式，始终以科学为导向、以临床医生为核心，一切工作的出发点都聚焦于我们能够为患者带来怎样的价值。” 来源： PharmaVoice #放射性药物 #并购交易 #肿瘤精准医疗 #再生元 #Telix

Melbourne (Australia) and Indianapolis, IN (United States) | July 21, 2026 Telix provides a market update on its commercial and operational performance for the quarter ended June 30, 2026 (Q2 2026). Q2 2026 Highlights[1] Group revenue of US$247 million, up 7% quarter-over-quarter (QoQ) and up 21% year-over-year (YoY). Precision Medicine continues to deliver strong growth, revenue of US$202 million, up 9% QoQ and up 30% YoY. Telix expects FY 2026 revenue and other income to be in excess of US$1 billion, with revenue tracking in line with the upper end of FY 2026 guidance of US$950 million to US$970 million plus US$40 million non-refundable other income received from Regeneron. United States (U.S.) Food and Drug Administration (FDA) alignment on ProstACT Global Phase 3 study of TLX591-Tx in mCRPC[2] to advance to Part 2 in the U.S.[3] BiPASSTM, patient enrollment nearing completion for study of Illuccix® and Gozellix® for initial prostate cancer diagnosis in the pre-biopsy setting[4]. Regeneron (NASDAQ: REGN) strategic collaboration to jointly develop and commercialize next generation radiopharmaceutical therapies, initially focused on lung cancer. FY 2026 research and development (R&D) expenditure guidance updated to US$230 million to US$270 million, enabled by the Company’s strong commercial performance and the non-refundable payment of US$40 million received from Regeneron. Q2 2026 Revenue Executive Commentary Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, “We delivered another quarter of growth with U.S. dose volumes increasing 7% during the quarter, driven by growing demand for Gozellix and continued strength across our PSMA[7] imaging portfolio. This performance underscores the strength of our differentiated two-product PSMA imaging strategy and reinforces Telix’s market leadership, built on clinical differentiation, supply chain resilience and commercial execution. During the quarter, we achieved key regulatory, commercial and clinical milestones across both our Precision Medicine and Therapeutics businesses. We are tracking in line with the upper end of our FY 2026 revenue guidance and are investing further in R&D to accelerate a number of high-value programs that have the potential to create significant future growth and shareholder value.” Therapeutics Business Unit Telix continues to progress its industry-leading Therapeutics pipeline, which spans multiple product candidates and disease areas. Q2 2026 highlights include: TLX591-Tx (lutetium (177Lu) rosopatamab tetraxetan): Achieved key regulatory milestone for ProstACT Global Phase 3 trial, with the FDA confirming that the safety data from Part 1 of the study of Telix’s lead prostate cancer therapy candidate is sufficient to enable progression of Part 2 in the U.S. The FDA and Telix also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. Initiation of Part 2 in the U.S. remains subject to the FDA’s review of an Investigational New Drug (IND) amendment[8]. Part 2 continues to enroll strongly in regions where recruitment is open including Australia, New Zealand, Canada, Türkiye, the United Kingdom, Singapore and South Korea and has also received regulatory approval to commence in China. TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA): OPTIMAL-PSMA study evaluatingTLX597-Tx for mCRPC has recently completed patient enrollment of 120 patients[9]. Building on initial findings of the OPTIMAL-PSMA study, the first patients have been dosed in the OPTIMAL-e Phase 2 study, evaluatingTLX597-Tx for metastatic hormone sensitive prostate cancer[10]. TLX597-Tx is a next generation small molecule PSMA-targeting prostate cancer radioligand therapy (RLT) candidate designed to improve efficacy and quality of life in earlier-stage metastatic prostate cancer. TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan): Dosed first patient in LUTEON[11], a pivotal trial of TLX250-Tx as a monotherapy in advanced ccRCC[12]. LUTEON will evaluate the efficacy of TLX250-Tx compared with investigator’s choice of monotherapy consistent with standard of care. LUTEON forms part of Telix’s global development program[13] for TLX250-Tx, Part 1 is expected to enroll up to 40 patients. TLX101-Tx (131I-iodofalan): Enrolled first patient cohort in Part 1 (assessing safety and dose optimization) of IPAX BrIGHT, an international, multi-center pivotal trial of TLX101-Tx in patients with recurrent glioblastoma[14]. The trial is open for enrollment in Australia, Austria, the Netherlands and Belgium, with approval being sought in additional jurisdictions. Completed patient enrollment in IPAX-2[15], a Phase 1 study evaluating TLX101-Tx in patients with newly diagnosed glioblastoma, with no dose-limiting toxicities observed to date[16]. Precision Medicine Business Unit PSMA imaging portfolio: Telix’s Precision Medicine business continues to expand its commercial reach and support broader patient access to PSMA-PET/CT imaging[17]. Q2 2026 highlights include: Rapid enrollment of 338 patients in BiPASS™ Phase 3 study of Illuccix and Gozellix for the initial diagnosis of prostate cancer, integrating non-invasive 68Ga-PSMA-11 PET imaging prior to biopsy. Building on the clinical foundation established by the PRIMARY[18] and PRIMARY 2[19] studies, BiPASS™ is intended to support regulatory submissions in major markets, including the U.S., Europe and Australia. Completed patient enrollment in Japan in Phase 3 registrational study of TLX591-Px (Illuccix)[20]. Telix is preparing a New Drug Application (NDA) for submission in Japan, with clinical data from the Phase 3 local study intended to support the application. In parallel, Telix’s application for Conditional Approval is under review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). If granted, Conditional Approval will enable an expedited NDA review process while the final study clinical dataset is prepared. TLX101-Px, (Floretyrosine F 18 or 18F-FET) for brain cancer imaging: Submitted an IND application to the FDA for Pixclara®, a Phase 3 registrational study for indication expansion for the diagnosis of brain metastases. The FDA has accepted Telix’s resubmitted NDA for Pixclara®[21] and has granted a PDUFA[22] goal date of September 11, 2026[23]. Telix’s Marketing Authorization Application (MAA) for Pixlumi®21 in Europe has been validated and accepted for review[24]. Zircaix®21 (TLX250-Px, 89Zr-DFO-girentuximab) for kidney cancer imaging: Telix continues to make good progress on its Biologics License Application (BLA) resubmission for Zircaix®21in the U.S. Final Chemistry, Manufacturing and Controls (CMC) documentation is nearing completion. Consistent with TLX250-Px’s Breakthrough Therapy designation, Telix has maintained regular consultation with the FDA and expects to resubmit the application shortly. Telix Manufacturing Solutions (TMS): Expanded global operations TMS continues to expand its global operations which are fundamental to Telix’s future growth, supporting supply chain resilience. Q2 2026 highlights include: Opened TMS North Melbourne, in partnership with the Melbourne Theranostic Innovation Centre (MTIC)[25]. The purpose-built facility combines radiochemistry laboratories, clinical product manufacturing, patient dosing and imaging that aims to provide advanced clinical infrastructure and R&D capabilities to accelerate the development of targeted radiopharmaceuticals. TMS Brussels South successfully completed its first Good Manufacturing Practice (GMP) production run of a lutetium-based therapeutic candidate, representing a significant operational milestone and further validating the facility’s capabilities to support the manufacture of Telix’s next-generation therapeutics. Installed ARTMS’ QUANTM® Irradiation System (QIS®) at TMS Yokohama, expanding isotope production capabilities and enabling local Zirconium-89 (89Zr) manufacturing to support Telix’s portfolio. The installation represents further progress in scaling the ARTMS network and advancing toward the Company’s target of 50 QIS® installations globally by the end of 2026. Corporate Updates Telix entered into a strategic collaboration with Regeneron to jointly develop and commercialize next-generation radiopharmaceutical therapies[26]. The strategic partnership combines Telix’s radiopharmaceutical development, manufacturing and supply chain capabilities with Regeneron’s leading antibody discovery and development platforms, creating a framework to advance multiple novel oncology programs and further strengthen Telix’s position in Precision Medicine. On execution of the agreement, Telix has received an initial non-refundable payment from Regeneron of US$40 million. Telix also completed a refinancing of its existing convertible bond structure, issuing US$600 million of new convertible bonds due 2031 and repurchasing all outstanding 2029 convertible bonds[27]. The transaction extends debt maturities, enhances financial flexibility and further strengthens the Company’s capital structure, supporting the execution of Telix’s long-term growth strategy, including developing its late-stage therapeutics pipeline. Three new Non-Executive Directors were appointed during the quarter as part of Telix’s Board expansion and succession planning. Effective May 11, 2026, David Gill, Maria Rivas, MD, and William Jellison[28] joined the Board, further strengthening the Board’s clinical, commercial, financial and governance expertise, enhancing the Company’s capabilities as a dual-listed, commercial stage biopharmaceutical company. FY 2026 guidance Telix expects FY 2026 revenue and other income to be in excess of US$1 billion, with revenue tracking in line with the upper end of FY 2026 guidance of US$950 million to US$970 million plus US$40 million non-refundable other income from Regeneron. Revenue guidance reflects product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS. Telix has updated FY 2026 R&D expenditure guidance to US$230 million to US$270 million, subject to achieving ongoing global clinical data outcomes and development milestones. The additional investment will support the advancement of high-value clinical programs beyond the Company’s original R&D forecast, including acceleration of the TLX597-Tx program and label expansion for Pixclara®, and progression of the Regeneron strategic collaboration. Illuccix® (kit for the preparation of gallium-68 gozetotide injection) is commercially available in 22 countries including the U.S. Gozellix® (kit for the preparation of gallium-68 gozetotide injection) is approved in the U.S. No other Telix product mentioned in this announcement has received a marketing authorization in any jurisdiction. [1] The financial information for the quarter ended June 30, 2026 is unaudited. [2] Metastatic castration-resistant prostate cancer. [3] Telix ASX disclosure July 2, 2026. ClinicalTrials.gov ID: NCT06520345. [4] ClinicalTrials.gov ID: NCT07052214. [5] Primarily sales of Illuccix and Gozellix in our Precision Medicine business. [6] Telix Manufacturing Solutions (TMS) third-party revenue predominantly driven by RLS Radiopharmacies (RLS), excludes Illuccix and Gozellix sales and TMS inter-segment revenue. [7] Prostate-specific membrane antigen. [8] Telix ASX disclosure July 2, 2026. [9] Telix LinkedIn June 25, 2026. Australian New Zealand Clinical Trials Registry ID: ACTRN12625000971437. [10] Telix media release July 16, 2026. Australian New Zealand Clinical Trials Registry ID: ACTRN12626000034336. [11] Telix media release July 21, 2026. ClinicalTrials.gov ID: NCT07197580. [12] Clear cell renal cell carcinoma. [13] Telix’s global development program for TLX250-Tx includes the separate LUTEON ATLAS study in the U.S. and Europe. [14] ClinicalTrials.gov ID: NCT07100730. [15] ClinicalTrials.gov ID: NCT05450744. [16] Telix media release May 19, 2026. [17] Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography. [18] Emmett et al. Eur Urol. 2021. [19] Buteau et al. Lancet Oncol. 2026. ClinicalTrials.gov ID: NCT05154162. [20] Telix media release July 17, 2026. Japan Registry of Clinical Trials identifier: JRCT2031250473. [21] Brand name subject to final regulatory approval. [22] Prescription Drug User Fee Act. [23] Telix ASX disclosure April 10, 2026. [24] Telix media release May 1, 2026. [25] Telix media release July 16, 2026. [26] Telix ASX disclosure April 13, 2026. [27] Telix ASX disclosure April 23, 2026. [28] Telix ASX disclosure April 2, 2026. Telix ASX disclosure April 9, 2026.