Telix Pharmaceuticals Ltd.

MELBOURNE, Australia, June 5, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that its prostate cancer PET[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Germany by BfArM[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enhances the options available to healthcare providers across Germany for PSMA-PET[3] imaging and will ensure more patients can access this essential diagnostic tool. Illuccix, after radiolabelling with gallium-68, is indicated in Germany for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated. PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods such as bone scans and CT[4] scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognize its superior accuracy in staging primary disease and assessing BCR[5]. Illuccix® PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy. Illuccix's broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial[6]. Despite the proven benefits of PSMA-PET imaging, men in Germany have faced long wait times due to tracer shortages and infrastructure constraints. Illuccix® has the potential to resolve these access challenges by enabling hospitals and clinics to prepare PSMA-PET scans on-site, freeing physicians to manage other important duties and focus on patient needs. In particular, in settings where there is a reliance on fluorine-18 (18F) tracers, the availability of Illuccix®, a GMP-quality prostate cancer imaging product, will help to avoid delivery delays and other logistical barriers, improving access. Professor Ken Herrmann, Chair of the Department of Nuclear Medicine at University Hospital Essen, commented, "PSMA-PET imaging has changed how we detect and monitor prostate cancer, offering greater accuracy and confidence in treatment planning. However, limited availability has meant that many patients face delays in accessing this essential diagnostic tool. The approval of Illuccix® in Germany is an important development, ensuring that more hospitals can integrate this imaging technology into routine clinical practice." With its broad indication, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows. "We are pleased that Illuccix® has been approved in Germany with a broad label that reflects its clinical value at multiple stages of prostate cancer care. Germany has played a key role in the advancement of PSMA-PET imaging, and this approval ensures that physicians now have access to Telix's gallium-based PSMA-PET imaging agent, which offers high diagnostic accuracy alongside the efficiency and flexibility of generator-produced gallium. This milestone reflects our commitment to expanding access to world-class prostate cancer imaging solutions across Europe" said Raphaël Ortiz, Chief Executive Officer, Telix International. Illuccix® will be distributed in Germany by Eckert & Ziegler SE, a leading provider of nuclear medicine and diagnostic imaging solutions. Dr. Harald Hasselmann, Chief Executive Officer of Eckert & Ziegler SE added: "Our collaboration with Telix on Illuccix® leverages our established distribution network and market expertise to ensure broad access to this important PSMA-PET imaging agent for German physicians and their patients. This partnership reinforces our commitment to delivering advanced diagnostic solutions for improved prostate cancer care." German healthcare professionals interested in ordering Illuccix® or learning more about availability can email [email protected] or call + 49 30 941084 280. Prostate Cancer in Germany Prostate cancer is the most common cancer in men in Germany, with over 65,000 new cases diagnosed annually, and a significantly higher incidence in men than either lung cancer (37,000 new cases) or bowel cancer (33,000 new cases). Prostate cancer was also the second most common cause of cancer death in men, with over 18,000 men dying from their disease in Germany in 2022[7]. About Illuccix®  Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the United States Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the Brazilian Health Regulatory Agency (ANVISA)[11], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[12], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[13], by the German Federal Institute for Drugs and Medical Devices (BfArM), and in multiple other countries within the European Economic Area (EEA)[14] following a positive decentralized procedure (DCP) opinion by the German medical regulator[15]. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Visit for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

As per DelveInsight's estimates, among the 7MM, the US captured the highest market of intra-tumoral cancer therapies of nearly USD 74 million in 2024, which is expected to increase due to the launch of emerging therapies such as CAN-2409, RP1 (vusolimogene oderparepvec), SP-002 (ASN-002), Bizaxofusp (MDNA55), and others. LAS VEGAS, May 19, 2025 /PRNewswire/ -- DelveInsight's Intra-tumoral Cancer Therapies Market report includes a comprehensive understanding of current treatment practices, emerging intra-tumoral cancer therapies, market share of individual therapies, and current and forecasted intra-tumoral cancer therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Intra-tumoral Cancer Therapies Market Report Currently, only three Intra-tumoral Cancer Therapies are approved; namely, IMLYGIC (Talimogene laherparepvec/T-VEC; Amgen), approved in the US and Europe in 2015, DELYTACT (teserpaturev/G47Δ; Daiichi Sankyo) approved in Japan in 2021, and HENSIFY in Europe in 2019. As per DelveInsight's analysis, the total market size of intra-tumoral cancer therapies in the 7MM was USD 109 million in 2024 and is projected to grow during the forecast period (2025-2034). In 2024, the total cases of selected indication (based on current landscape and pipeline activity) were 8.9 million in the 7MM, which is anticipated to increase by 2034. Leading intra-tumoral cancer therapies companies, such as Janssen, Stamford Pharmaceuticals, Ascend Biopharmaceuticals, Replimune, Highlight Therapeutics, Cytovation ASA, Intensity Therapeutics, Ascendis Pharma, Treovir, Matica Biotechnology, QBiotics, NanOlogy, Lokon Pharma AB, EpicentRx, Medicenna Therapeutics, Philogen S.p.A., Candel Therapeutics, Lytix Biopharma, Verrica Pharmaceuticals, CEI-SCI, and others, and others, are developing novel intra-tumoral cancer therapies that are expected to enter the intra-tumoral cancer therapies market in the coming years. Some of the key intra-tumoral cancer therapies in the pipeline include INT230-6, Vusolimogene oderparepvec (RP1), Nidlegy (Daromun), G207, Ilixadencel (INTUVAX), Tigilanol tiglate, SP-002 (ASN-002), BO-112, Bizaxofusp (MDNA55), and others. In March 2025, NANOBIOTIX announced topline data from the completed dose-escalation portion of a Phase I study, conducted under the sponsorship of The University of Texas MD Anderson Cancer Center, evaluating JNJ-1900 (NBTXR3) activated by radiation therapy as a second-line or later (2L+) treatment for patients with locally advanced NSCLC eligible for re-irradiation. In March 2025, NANOBIOTIX announced an amendment to its global licensing agreement with Janssen Pharmaceutica NV. The amendment removes NANOBIOTIX's funding obligation for NANORAY- 312 and releases Johnson & Johnson from select future potential milestone payments while safeguarding NANOBIOTIX's path to sustainable cash flow through significant potential milestone payments. In March 2025, Candel Therapeutics and IDEA Pharma announced a strategic commercial partnership. Under this agreement, IDEA will provide strategic commercial input throughout the development and commercialization process for Candel's lead asset, CAN-2409. In January 2025, Lokon Pharma AB announced that the Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) for the company's product candidate LOAd703 for the treatment of pancreatic cancer. In January 2025, Intensity Therapeutics announced that the Data Monitoring Committee (DMC) recommended the continuation of its Phase III sarcoma trial (INT230-6, INVINCIBLE-3) without modification based on data reviewed from July 2024 to December 2024. Some factors, such as the precedence of failure of emerging therapies, insufficient knowledge about Intra-tumoral Cancer Therapies , and several other drawbacks, might hinder the Intra-tumoral Cancer Therapies market growth. Discover which therapies are expected to grab the intra-tumoral cancer therapies market share @ Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Market Dynamics The intra-tumoral cancer therapies market dynamics are expected to change in the coming years. Various classes of intra-tumoral immunotherapies, including radioenhancer nanoparticles, recombinant fusion proteins, oncolytic therapy, gene therapy, synthetic dsRNA complexes, and others, are currently in preclinical and clinical development. These therapies increase drug concentration and availability within the tumor microenvironment while limiting systemic exposure and reducing the likelihood of immune-related side effects in other parts of the body. Intra-tumoral therapeutic strategies offer a powerful approach to in situ vaccine development, utilizing immune-stimulating agents to trigger local and systemic anti-tumor immune responses. Additionally, the ability of intra-tumoral immunotherapy combinations to elicit both T-cell and B-cell antitumor responses presents a potential strategy to overcome immune escape mechanisms, such as the loss of HLA-I expression on tumor cells, which are often associated with immune checkpoint therapy monoclonal antibody monotherapies. Furthermore, potential therapies are being investigated, and it is safe to predict that the treatment space will significantly impact the intra-tumoral cancer therapies market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the intra-tumoral cancer therapies market in the 7MM. However, several factors may impede the growth of the intra-tumoral cancer therapies market. The lack of standardized guidelines for intra-tumoral immunotherapy delivery results in variations in lesion selection, injection frequency, and needle technique, which directly affect treatment outcomes and safety. Patients are required to visit clinics for each dosing session, and the administration necessitates both trained radiologists and logistics support alongside skilled physicians. While research into intra-tumoral therapies has grown in recent years, several therapies, such as tilsotolimod/Ipilimumab, sotigalimab (APX005M), and vidutolimod (CMP-001), have failed clinical trials, impacting the market. Additionally, tumors with high intra-tumoral heterogeneity may lead to poorer clinical outcomes for patients. Intra-tumoral Cancer Therapies Therapeutics Market Although significant progress has been made in cancer treatment through methods like surgery, chemotherapy, radiation, immunotherapy, and targeted therapies, many of these treatments still face limitations such as systemic toxicity, inadequate tumor penetration, and poor targeting. These issues contribute to high mortality rates, underscoring the need for more precise and localized treatment options. Recently, cancer treatment strategies have increasingly focused on alternative delivery methods, including intra-tumoral administration. This approach is being actively researched, with several therapeutic candidates—such as immune receptor agonists, viral therapies, fusion proteins, monoclonal antibodies, and gene therapies—currently undergoing preclinical and clinical trials. Intra-tumoral immunotherapy, which involves directly delivering agents into or near the tumor site, is emerging as a promising approach. This strategy aims to boost localized immune responses while reducing systemic side effects. The first oncolytic virus, IMLYGIC (T-Vec; Amgen), was approved by the US FDA for treating unresectable melanoma lesions after surgery, following a Phase III trial. The European Commission approved the treatment of advanced melanoma in 2015. In 2019, Nanobiotix's HENSIFY (NBTXR3), a hafnium oxide nanoparticle therapy combined with radiation, received European approval for soft tissue sarcoma, with plans for data releases through 2025-2026 across multiple cancers. For STS the drug is approved in Europe but not yet launched. In Japan, DELYTACT (G47∆; Daiichi Sankyo) was granted conditional approval for malignant glioma, marking the first oncolytic virus for brain cancer, and is still under evaluation for its clinical benefits. IMLYGIC from Amgen is the first and only FDA-approved viral therapy that is injected directly into melanoma tumors. Despite the initial hype for this exciting intra-tumoral mode of cancer gene therapy, IMLYGIC's debut did not translate into much commercial success in the melanoma market. Limitations of the intra-tumoral administration, no statistically significant benefit in overall survival (OS), and the intense competition from immune checkpoint inhibitors (ICIs) due to their efficacy and manageable side effects are some of the main factors for ithe nsignificant revenues of this novel therapy. Learn more about the FDA-approved intra-tumoral cancer therapies @ Intra-tumoral Cancer Therapies Treatment Key Emerging Intra-tumoral Cancer Therapies and Companies The emerging pipeline of intra-tumoral cancer therapies is robust, including drugs from key players such as Candel Therapeutics (CAN-2409), Lytix Biopharma/Verrica Pharmaceuticals (LTX-315 [VP-315]), CEI-SCI (MULTIKINE), Philogen (Daromun [NIDLEGY; a combo of L19IL2 + L19TNF]), Replimune (RP2 and RP1 [vusolimogene oderparepvec]), Highlight Therapeutics (BO-112), Cytovation ASA (CY-101), Intensity Therapeutics (INT230-6), Ascendis Pharma (TransCon IL-2 β⁄γ), Treovir/Matica Biotechnology (G207), QBiotics (Tigilanol tiglate), NanOlogy (NanoPac), EpicentRx (AdAPT-001), Medicenna Therapeutics (Bizaxofusp [MDNA55]), and others. RP1 (vusolimogene oderparepvec), Replimune's lead product candidate, is based on a proprietary strain of Herpes Simplex Virus (HSV) engineered with a fusogenic protein (GALV-GP R-) and GM-CSF to enhance tumor killing potency, immunogenicity, and activation of a systemic antitumor immune response. In November 2024, Replimune announced that the FDA granted Breakthrough Therapy Designation (BTD) to RP1 in combination with nivolumab for the treatment of advanced melanoma in adult patients who have previously received an anti-PD1 regimen. Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF, which are manufactured independently and which are mixed prior to intralesional administration. In July 2024, Philogen and Sun Pharmaceutical announced that the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy. CAN-2409 (Candel Therapeutics) is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV thymidine kinase (HSV-tk) gene to a patient's specific tumor and induce an individualized, systemic immune response against the tumor. In March 2025, according to the company's corporate highlights, the preparations for Biologics License Application (BLA) for CAN-2409 in prostate cancer are underway, with submission expected in Q4 2026. The anticipated launch of these emerging therapies are poised to transform the intra-tumoral cancer therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the intra-tumoral cancer therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about intra-tumoral cancer therapies clinical trials, visit @ Intra-tumoral Cancer Therapies Intra-tumoral Cancer Therapies Overview Cancer is a highly diverse disease, with its signs, symptoms, and treatments varying across different types, making it crucial to create targeted therapies for individual patients. Current treatment options for cancer include immunotherapy, radiotherapy, chemotherapy, targeted drug therapies, and more. While these approaches have improved OS and patient outcomes, they still have limitations and are not effective for everyone. Researchers are therefore working to develop new treatments that can overcome these challenges, with intra-tumoral cancer therapies emerging as a promising strategy. Intra-tumoral immunotherapy represents an innovative approach, where sophisticated antibodies are directly injected into tumors instead of being administered intravenously. This method focuses on delivering immunostimulatory agents straight into primary or metastatic tumor sites to initiate or enhance an antitumor immune response. Normally, the immune system detects and eliminates early tumors, but in immunosuppressive tumor environments, malignant cells can proliferate undetected. Regulatory T cells (Tregs), drawn to the tumor by chemokines, suppress Antigen-Presenting Cells (APCs) that would otherwise trigger an immune attack on tumor antigens. Moreover, tumor cells often release anti-inflammatory and regulatory cytokines like TGF-β and IL-10, which promote tumor growth and inhibit dendritic cell (DC) activation. To counteract this immunosuppressive environment, immunostimulants can be introduced. These agents work by attracting immune cells to the tumor or by activating the immune system to recognize and destroy cancer cells. Immunostimulants activate immune cells in the presence of tumor antigens, allowing them to travel to lymph nodes, where they stimulate tumor antigen-specific T cells through cross-presentation. These activated T cells can then return to the tumor or spread to distant tumors, leading to the targeted destruction of cancer cells. Intra-tumoral Cancer Therapies Epidemiology Segmentation In 2024, the total indication-wise treated cases of Intra-tumoral Cancer Therapies were 3.3 million in the 7MM, which is anticipated to increase by 2034. The intra-tumoral cancer therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of Selected Indications Indication-wise Target Patient Pool of Intra-tumoral Cancer Therapies Indication-wise Treated Cases of Intra-tumoral Cancer Therapies Scope of the Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Therapeutic Assessment: Intra-tumoral current marketed and emerging therapies Intra-tumoral Cancer Therapies Market Dynamics: Conjoint Analysis of Emerging Intra-tumoral Cancer Therapies Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Intra-tumoral Cancer Therapies Market Access and Reimbursement Discover more about intra-tumoral cancer therapies in development @ Intra-tumoral Cancer Therapies Clinical Trials Table of Contents Related Reports Oncolytic Virus Market Oncolytic Virus Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of oncolytic virus, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key oncolytic virus companies, including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichio Sankyo, among others. 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About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Radiopharmaceuticals, which combine radioactive isotopes with specific molecular carriers, are ushering in a new era of personalized medicine. These specialized drugs precisely target diseased tissues within the human body and release ionizing radiation for diagnostic or therapeutic purposes, significantly enhancing the accuracy and effectiveness of disease management. From traditional thyroid function tests to their current widespread application in cancer, cardiovascular diseases, and neurodegenerative disorders, the development of radiopharmaceuticals reflects how advancements in science and technology are driving innovation in medicine. With the advent of cutting-edge technologies such as radioligand therapies (RDCs), radiopharmaceuticals are not only improving the accuracy of tumor diagnostics but also offering new treatment options for previously intractable diseases. Notably, innovative drugs such as 177Lu-PSMA-617 and 18F-PSMA-1007 are leading the way in precision medicine for malignancies like prostate cancer and renal cell carcinoma. Mechanism of Action of RadiopharmaceuticalsRadiopharmaceuticals, also known as radioactive drugs or radionuclide formulations, are specialized agents that utilize radioactive isotopes bound to specific molecular carriers for medical diagnosis and treatment. These compounds can selectively target specific areas of the body—such as tumors or other diseased tissues—and emit ionizing radiation to fulfill their intended function. Over the past decades, the application of radiopharmaceuticals has expanded from traditional thyroid diagnostics to the treatment and imaging of cancer, cardiovascular conditions, and neurodegenerative diseases. With technological progress, especially in radioligand therapy, radiopharmaceuticals can act more precisely on target cells while minimizing damage to surrounding healthy tissues. The introduction of alpha-particle emitters has brought new hope to therapy, thanks to their higher cytotoxicity and shorter range, making them especially suitable for hard-to-treat tumors. Mechanism of Action of RDC Drugs1The mechanism by which radiopharmaceuticals function in cancer treatment relies on the ionizing radiation emitted by radioactive isotopes. This radiation damages the DNA of cancer cells, inhibiting their division and proliferation. Different isotopes emit various types of radiation, such as beta particles or alpha particles, each affecting cancer cells differently. Beta particles, which have moderate penetration ability, can affect cancer cells several cell diameters away, creating a "crossfire effect" that extends the therapeutic range. In contrast, alpha particles possess extremely high energy density and short range, enabling them to inflict severe damage within a limited area—often requiring only a few alpha particles to pass through a cancer cell nucleus to achieve cytotoxicity. One of the key advantages of radiopharmaceuticals lies in their high specificity and low systemic toxicity. By conjugating radioactive isotopes to targeting ligands—such as antibodies or specific peptides—the isotopes can accumulate selectively in tumor sites, substantially increasing the local radiation dose while minimizing exposure to healthy tissue. This strategy not only improves therapeutic efficacy but also reduces the incidence of side effects. In addition, some radiopharmaceuticals can also serve diagnostic purposes, allowing physicians to monitor disease progression in real time during treatment—thus achieving a theranostic (therapy + diagnostic) approach. Another benefit is their low likelihood of inducing drug resistance. Because their mechanism of action differs from that of conventional chemotherapeutics, cancer cells have a harder time developing resistance. Therefore, radiopharmaceuticals can be used as standalone therapies or in combination with other modalities, such as immunotherapy, to enhance overall treatment outcomes. Radioligand therapy (RLT), also known as radioimmunotherapy or radionuclide-conjugated drug therapy, involves binding a radioactive isotope to a molecule that targets specific cancer cells. This approach uses the emitted particles from radioactive substances to damage cancer cell DNA, thereby halting their growth and division. RLT plays a pivotal role in precision medicine, offering highly selective treatment of tumors while minimizing collateral damage to healthy tissues. The core of RLT lies in the use of radioligands—compounds composed of four key elements: a targeting moiety (e.g., antibody, peptide, or small molecule), a linker, a chelator, and a radioactive isotope. Once administered, these radioligands seek out and bind to overexpressed biomarkers on cancer cell surfaces. Upon binding, the isotope emits radiation that directly damages the cancer cell’s DNA, leading to cell death. Additionally, the so-called “bystander effect”—in which ionization of nearby water molecules produces free radicals—can also contribute to the destruction of adjacent cancer cells. Application of Radiopharmaceuticals in Cancer Treatment1）177Lu-PSMA-617 177Lu-PSMA-617 is an innovative targeted radioligand therapy specifically designed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This therapy achieves high selectivity and precision in targeting prostate cancer cells by combining Lutetium-177—a radioactive isotope that emits beta particles—with a small-molecule compound that specifically binds to prostate-specific membrane antigen (PSMA). Schematic overview of the structure of a PSMA receptor1177Lu-PSMA-617 circulates in the bloodstream, identifying and binding to prostate cancer cells that overexpress PSMA. PSMA is highly expressed on the surface of prostate cancer cells and their metastases, while its expression in normal tissues is minimal. This allows the drug to effectively target cancer cells while sparing most healthy tissues. Once bound to PSMA on the surface of cancer cells, 177Lu-PSMA-617 is internalized. Inside the cell, Lutetium-177 emits beta particles that cause DNA damage, impairing the cancer cell's ability to replicate or inducing cell death directly. Although these beta particles are potent enough to destroy cancer cells, their limited penetration range—typically just a few millimeters—means that surrounding healthy tissues are largely unaffected. This reduces systemic side effects and enhances the safety profile of the treatment. The VISION study demonstrated that 177Lu-PSMA-617 in combination with the best standard of care (SOC) provides significant benefits over SOC alone in terms of prolonging overall survival (OS) and radiographic progression-free survival (rPFS). Specifically, patients treated with 177Lu-PSMA-617 showed higher overall survival rates and longer progression-free periods, along with improved objective response rates and disease control rates. Despite its high specificity and efficacy, 177Lu-PSMA-617 is not without side effects. For instance, salivary gland dysfunction may occur due to off-target uptake, as salivary glands also express PSMA. Therefore, during clinical application, physicians must closely monitor patients and take appropriate measures to manage and mitigate potential adverse effects. 2) 177Lu-Rosopatamab Tetraxetan TLX591 (177Lu-Rosopatamab Tetraxetan) is another radiolabeled compound that targets prostate-specific membrane antigen (PSMA). It couples the radioactive isotope 177Lutetium with the monoclonal antibody rosopatamab tetraxetan. Rosopatamab tetraxetan specifically recognizes and binds to PSMA, which is overexpressed on the surface of prostate cancer cells. 177Lutetium serves as a beta particle emitter, delivering cytotoxic radiation that damages the DNA of cancer cells. Upon administration, rosopatamab tetraxetan seeks out and attaches to PSMA-positive prostate cancer cells, enabling 177Lutetium to emit beta radiation with sufficient energy to destroy nearby tumor cells while limiting damage to distant healthy tissue, thus preserving normal function. Multiple completed Phase I and II clinical trials have shown that TLX591 has a favorable safety and efficacy profile, and have validated the effectiveness of optimized fractionated dosing regimens. The ProstACT SELECT study demonstrated that, in patients with progressive mCRPC who had already undergone treatment, the median radiographic progression-free survival (rPFS) following TLX591 therapy was 8.8 months, indicating significant clinical benefit. Moreover, TLX591 is currently being evaluated in a Phase III international, multicenter, randomized controlled trial named ProstACT GLOBAL—the first such study targeting PSMA-positive mCRPC patients—to further assess its efficacy and safety compared to standard-of-care therapies. Grand Pharmaceutical has acquired the rights to develop and commercialize TLX591 in the Chinese market through a collaboration with Telix Pharmaceuticals. This strategic partnership not only facilitates the introduction of innovative therapies in China but also enhances the company’s global R&D and manufacturing capabilities, supporting the advancement of cutting-edge cancer diagnosis and treatment solutions. With TLX591's promising performance in the international market and its progressing rollout in China, it is expected to offer a new therapeutic option for prostate cancer patients in the coming years. Application of Radiopharmaceuticals in Early Tumor Diagnosis1) 18F-PSMA-1007 18F-PSMA-1007 is a positron emission tomography (PET) imaging agent specifically used for the diagnosis and staging of prostate cancer. This radiotracer targets prostate-specific membrane antigen (PSMA), which is highly expressed in prostate cancer cells, particularly in cases of recurrence or metastasis. By labeling a small-molecule PSMA inhibitor with the radioisotope fluorine-18 (18F), 18F-PSMA-1007 enables highly sensitive and specific detection of prostate cancer lesions. 18F-PSMA-1007 PET/CT (arrow) staining of the PSMA-positive primary tumor2For patients who experience a rise in serum PSA levels after radical prostatectomy, recurrence is often suspected. However, traditional imaging techniques frequently fail to precisely localize recurrent lesions. 18F-PSMA-1007 PET/CT has demonstrated significant advantages in detecting small lesions in such patients due to its high sensitivity and specificity, enabling earlier detection of recurrence and timely adjustment of therapeutic strategies. In patients with PSA levels in the “gray zone” (i.e., between 4 and 10 ng/mL), determining the presence of prostate cancer poses a diagnostic challenge. 18F-PSMA-1007 PET/CT, when combined with PSA-derived indicators such as PSA density (PSAD), can improve diagnostic accuracy in this group and reduce the number of unnecessary biopsies. This approach not only helps avoid overdiagnosis and overtreatment but also provides more precise therapeutic guidance for patients who do have prostate cancer. 18F-PSMA PET/CT for primary staging showed high PSMA uptake in the prostate gland2By leveraging radiomics models based on 18F-PSMA-1007 PET/CT, researchers can extract numerous features from PET images and analyze them using machine learning algorithms to effectively distinguish prostate cancer from benign prostatic hyperplasia (BPH). This enhances diagnostic accuracy and contributes to more evidence-based clinical decision-making. Studies also suggest that 18F-PSMA-1007 PET/CT can be used to predict the pathological grade of prostate cancer, which is critical for prognosis assessment. This imaging technique provides important insights into tumor biology, enabling the formulation of personalized treatment plans. Compared to conventional 18F-FDG PET/CT, 18F-PSMA-1007 PET/CT offers higher sensitivity and specificity in detecting bone metastases from prostate cancer. This improves the detection of distant metastases, which is particularly important in managing advanced prostate cancer. Moreover, for suspected metastatic cases, the combined use of 18F-FDG and 18F-PSMA-1007 PET/CT can further enhance staging accuracy and guide clinical treatment decisions. 2) TLX250-CDx (89Zr-TLX250) TLX250-CDx (89Zr-TLX250) is a radiopharmaceutical diagnostic conjugate (RDC) that targets carbonic anhydrase IX (CA9) and is specifically designed for the diagnosis of clear cell renal cell carcinoma (ccRCC). Zirconium-89 (89Zr) is a positron-emitting isotope with a physical half-life of approximately 78.4 hours, making it well-suited for use with monoclonal antibodies due to its alignment with the biological distribution timeline of antibodies in the body. This allows 89Zr-labeled antibodies to achieve optimal tumor accumulation, thereby improving imaging sensitivity and specificity. The anti-CA9 antibody used in TLX250-CDx binds selectively to the CA9 protein, which is overexpressed on the surface of cancer cells. CA9 expression is minimal in normal tissues but significantly elevated in various cancers, especially ccRCC, making it an ideal diagnostic target. Scheme of the bioconjugation and radiolabeling of 89Zr-TLX2504Once injected into the patient, TLX250-CDx circulates through the bloodstream and accumulates at tumor sites due to its high affinity for CA9. Using PET imaging, detailed in vivo images can then be generated, revealing the tumor’s location, size, and potential metastasis. This method not only improves diagnostic accuracy but also avoids the risks associated with invasive procedures such as biopsies. In the pivotal Phase III ZIRCON clinical trial, TLX250-CDx demonstrated outstanding performance. For patients suspected of having ccRCC but not yet diagnosed, the agent achieved a sensitivity of 86% and specificity of 87% in diagnosing ccRCC, with a positive predictive value (PPV) of 93%. These results suggest that TLX250-CDx could become a vital non-invasive diagnostic tool, enabling more precise clinical decision-making. In addition to ccRCC, ongoing research is exploring the utility of TLX250-CDx in other CA9-expressing cancers, such as bladder cancer and urothelial carcinoma. These cross-indication studies could expand the market potential of TLX250-CDx and provide effective diagnostic solutions for a broader range of cancers. ZIRCON is a global Phase III clinical trial designed to evaluate the efficacy and safety of TLX250-CDx in diagnosing ccRCC. The results have been encouraging: for patients with renal masses identified by CT or MRI but not definitively diagnosed as ccRCC, TLX250-CDx PET imaging showed 86% sensitivity and 87% specificity, with a PPV of 93%. These figures far exceed the U.S. FDA’s predefined thresholds (sensitivity and specificity ≥70%), indicating that TLX250-CDx has strong potential to become a new clinical diagnostic standard for ccRCC. Beyond its diagnostic role in ccRCC, TLX250-CDx has shown promise in other cancer types. Studies are underway to assess its use in triple-negative breast cancer (TNBC), non-muscle-invasive bladder cancer (NMIBC), and urothelial carcinoma. If approved, TLX250-CDx would become the first commercially available imaging agent for ccRCC, addressing a significant unmet need. Given the often asymptomatic nature of early-stage kidney cancer, many patients are diagnosed at an advanced stage. Therefore, the early diagnostic capabilities provided by TLX250-CDx could substantially improve treatment outcomes and quality of life. ConclusionRadiopharmaceuticals offer tremendous potential in the diagnosis and treatment of cancer and other diseases due to their high selectivity and low systemic toxicity. They enhance diagnostic accuracy and enable earlier detection, while also providing safer and more effective therapeutic options for patients. For instance, 177Lu-PSMA-617 and TLX591 target prostate-specific membrane antigen (PSMA), bringing new hope to patients with metastatic castration-resistant prostate cancer (mCRPC); while 18F-PSMA-1007 and TLX250-CDx have shown remarkable success in the early diagnosis of prostate cancer and clear cell renal cell carcinoma (ccRCC), respectively. Furthermore, the use of these agents supports the development of theranostics—combining diagnosis and treatment—allowing clinicians to monitor disease progression in real-time and tailor treatment strategies to individual patient needs. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery! Reference 1.Chiliveri SC, Robertson AJ, Shen Y, Torchia DA, Bax A. Advances in NMR Spectroscopy of Weakly Aligned Biomolecular Systems. Chem Rev. 2022 May 25;122(10):9307-9330. doi: 10.1021/acs.chemrev.1c00730. Epub 2021 Nov 12. PMID: 34766756.2.van der Gaag S, Bartelink IH, Vis AN, Burchell GL, Oprea-Lager DE, Hendrikse H. Pharmacological Optimization of PSMA-Based Radioligand Therapy. Biomedicines. 2022 Nov 23;10(12):3020. doi: 10.3390/biomedicines10123020. PMID: 36551776; PMCID: PMC9775864.3.Jochumsen MR, Bouchelouche K. PSMA PET/CT for Primary Staging of Prostate Cancer - An Updated Overview. Semin Nucl Med. 2024 Jan;54(1):39-45. doi: 10.1053/j.semnuclmed.2023.07.001. Epub 2023 Jul 22. PMID: 37487824.4.Yoon JK, Park BN, Ryu EK, An YS, Lee SJ. Current Perspectives on 89Zr-PET Imaging. Int J Mol Sci. 2020 Jun 17;21(12):4309. doi: 10.3390/ijms21124309. PMID: 32560337; PMCID: PMC7352467.