Illuccix® Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin America
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received approval from Brazil's Health Regulatory Agency (ANVISA) for Illuccix®, its prostate cancer imaging agent. This marks the first PSMA-PET imaging agent approval in Latin America.
The approved diagnostic agent is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer, specifically for those with suspected metastasis candidates for initial therapy and those with suspected recurrence based on elevated PSA levels.
The marketing authorization is granted to Telix's partner R2PHARMA, Brazil's leading cold kit manufacturer and nuclear pharmacy network. Additionally, Telix announced a joint venture with R2PHARMA (Telix Innovations Brazil, Ltda.) to commercialize and distribute Telix's therapeutic and diagnostic radiopharmaceuticals in Brazil. The Brazilian radiopharmaceuticals market is projected to reach US$330 million over the next decade.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) ha ricevuto l'approvazione dall'Agenzia Nazionale di Vigilanza Sanitaria del Brasile (ANVISA) per Illuccix®, il suo agente di imaging per il cancro alla prostata. Questo segna la prima approvazione di un agente di imaging PSMA-PET in America Latina.
L'agente diagnostico approvato è indicato per l'imaging PET delle lesioni positive al PSMA negli uomini con cancro alla prostata, specificamente per coloro che sono sospettati di metastasi candidati per una terapia iniziale e per quelli con sospetta recidiva basata su livelli elevati di PSA.
La autorizzazione al commercio è concessa al partner di Telix, R2PHARMA, il principale produttore di kit freddi del Brasile e rete di farmacie nucleari. Inoltre, Telix ha annunciato una joint venture con R2PHARMA (Telix Innovations Brazil, Ltda.) per commercializzare e distribuire i radiomarcatori terapeutici e diagnostici di Telix in Brasile. Si prevede che il mercato dei radiopharmaceuticals in Brasile raggiunga i 330 milioni di dollari nei prossimi dieci anni.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) ha recibido la aprobación de la Agencia Nacional de Vigilancia Sanitaria de Brasil (ANVISA) para Illuccix®, su agente de imagen para el cáncer de próstata. Esto marca la primera aprobación de un agente de imagen PSMA-PET en América Latina.
El agente diagnóstico aprobado está indicado para la imagen PET de lesiones positivas al PSMA en hombres con cáncer de próstata, específicamente para aquellos con sospecha de metástasis que son candidatos para terapia inicial y aquellos con sospecha de recurrencia basada en niveles elevados de PSA.
La autorización de comercialización se concede al socio de Telix, R2PHARMA, el principal fabricante de kits fríos de Brasil y red de farmacias nucleares. Además, Telix anunció una empresa conjunta con R2PHARMA (Telix Innovations Brazil, Ltda.) para comercializar y distribuir los radiofármacos terapéuticos y diagnósticos de Telix en Brasil. Se proyecta que el mercado de radiofármacos en Brasil alcance los 330 millones de dólares en la próxima década.
텔릭스 제약 (ASX: TLX, Nasdaq: TLX)은 브라질 보건 규제 기관 (ANVISA)으로부터 일루시픽스®의 승인을 받았습니다. 이는 라틴 아메리카에서 첫 번째 PSMA-PET 이미징 에이전트 승인을 의미합니다.
승인된 진단 에이전트는 전립선 암 환자에서 PSMA 양성 병변의 PET 이미징에 사용되며, 초기 치료 후보인 전이 의심 환자와 PSA 수치가 상승한 재발 의심 환자를 위한 것입니다.
상업화 허가는 텔릭스의 파트너인 R2PHARMA에 부여되었으며, 이는 브라질의 주요 냉각 키트 제조업체이자 핵약국 네트워크입니다. 또한, 텔릭스는 R2PHARMA와 함께 (Telix Innovations Brazil, Ltda.) 텔릭스의 치료 및 진단 방사선 의약품을 브라질에서 상업화하고 배포하기 위한 합작 투자도 발표했습니다. 브라질의 방사선 의약품 시장은 향후 10년 동안 3억 3천만 달러에 이를 것으로 예상됩니다.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) a reçu l'approbation de l'Agence nationale de surveillance sanitaire du Brésil (ANVISA) pour Illuccix®, son agent d'imagerie pour le cancer de la prostate. Cela marque la première approbation d'un agent d'imagerie PSMA-PET en Amérique latine.
L'agent diagnostique approuvé est indiqué pour l'imagerie PET des lésions positives au PSMA chez les hommes atteints de cancer de la prostate, spécifiquement pour ceux présentant des métastases suspectées candidates à une thérapie initiale et ceux avec une récidive suspectée basée sur des niveaux de PSA élevés.
L'autorisation de mise sur le marché est accordée au partenaire de Telix, R2PHARMA, le principal fabricant de kits froids au Brésil et réseau de pharmacies nucléaires. De plus, Telix a annoncé une coentreprise avec R2PHARMA (Telix Innovations Brazil, Ltda.) pour commercialiser et distribuer les radiopharmaceutiques thérapeutiques et diagnostiques de Telix au Brésil. Le marché brésilien des radiopharmaceutiques devrait atteindre 330 millions de dollars au cours de la prochaine décennie.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) hat die Genehmigung der brasilianischen Gesundheitsbehörde (ANVISA) für Illuccix®, sein Bildgebungsagent für Prostatakrebs, erhalten. Dies markiert die erste Genehmigung eines PSMA-PET-Bildgebungsagents in Lateinamerika.
Das genehmigte diagnostische Mittel ist für die PET-Bildgebung von PSMA-positiven Läsionen bei Männern mit Prostatakrebs angezeigt, insbesondere für diejenigen mit Verdacht auf Metastasen, die für eine Ersttherapie in Frage kommen, und für diejenigen mit Verdacht auf Rückfall basierend auf erhöhten PSA-Werten.
Die Vermarktungsgenehmigung wird dem Partner von Telix, R2PHARMA, dem führenden Hersteller von Kaltkits in Brasilien und Netzwerk von Nuklearapotheken, erteilt. Darüber hinaus kündigte Telix ein Joint Venture mit R2PHARMA (Telix Innovations Brazil, Ltda.) an, um die therapeutischen und diagnostischen Radiopharmazeutika von Telix in Brasilien zu vermarkten und zu vertreiben. Der brasilianische Markt für Radiopharmazeutika wird in den nächsten zehn Jahren voraussichtlich 330 Millionen US-Dollar erreichen.
- First PSMA-PET imaging agent approved in Brazil, securing first-mover advantage
- Access to large Brazilian market through established partnership with leading distributor R2PHARMA
- Strategic joint venture established for future product commercialization
- Market potential of US$330 million in Brazilian radiopharmaceuticals
- None.
Insights
Telix Pharmaceuticals has achieved a significant regulatory milestone with the Brazilian Health Regulatory Agency (ANVISA) approval of Illuccix®, its lead prostate cancer imaging agent. This represents the first marketing authorization in Latin America and establishes Illuccix® as the first and only PSMA-PET prostate cancer imaging agent with full regulatory approval in Brazil.
The approval expands Telix's global commercial footprint, adding to existing approvals in Australia, Canada, New Zealand, United States, United Kingdom, and multiple European countries. The cold kit format with generator-produced gallium will enable broader access across both metropolitan and rural areas of Brazil.
Beyond the immediate approval, Telix has strategically formed a joint venture with R2PHARMA (Telix Innovations Brazil, Ltda.) to commercialize and distribute not only Illuccix® but also future product candidates from Telix's theranostic pipeline. This partnership leverages R2PHARMA's established position as Brazil's leading cold kit manufacturer and nuclear pharmacy network.
The Brazilian radiopharmaceuticals market represents a substantial growth opportunity, projected to reach US$330 million over the next decade. This growth is driven by increasing cancer prevalence, imaging technology advancements, and demographic shifts toward an aging population.
This dual development—regulatory approval plus joint venture formation—provides Telix with both immediate market access and a long-term commercialization infrastructure in Latin America's largest healthcare market.
The ANVISA approval for Illuccix® marks a critical entry point into Latin America for Telix, establishing first-mover advantage in Brazil's specialized prostate cancer imaging market. This approval is strategically significant as it positions Telix with exclusive market access for its PSMA-PET technology in a region with growing diagnostic needs.
The partnership structure with R2PHARMA offers Telix an optimized market entry strategy. By leveraging an established local partner with existing cold kit manufacturing capabilities and distribution networks, Telix can accelerate market penetration while navigating Brazil's complex regulatory environment. The exclusive license arrangement creates a clear commercialization pathway while minimizing direct investment requirements.
The joint venture formation extends beyond Illuccix® to include Telix's broader theranostic pipeline, suggesting a long-term strategic commitment to the Brazilian market. This provides infrastructure for future product introductions without requiring new partnership negotiations for each product launch.
Brazil represents an attractive market expansion opportunity due to its large population base (over 210 million), established healthcare infrastructure, and growing cancer diagnostic needs. The projected market growth to US$330 million for radiopharmaceuticals indicates substantial commercial potential, though Telix's specific market share will depend on adoption rates, reimbursement policies, and competitive dynamics.
The cold kit formulation mentioned specifically addresses distribution challenges in geographically diverse markets like Brazil, enabling both urban and rural healthcare facilities to provide advanced diagnostic capabilities.
MELBOURNE, Australia and PORTO ALEGRE, Brazil, March 18, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘ANVISA’) has approved Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company’s lead prostate cancer imaging agent. Illuccix® is the first and only PSMA-PET1 prostate cancer imaging agent to receive full regulatory approval in Brazil.
Illuccix®, after radiolabeling with 68Ga, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
- With suspected metastasis who are candidates for definitive initial therapy treatment, and
- With suspected recurrence based on an elevated specific antigen (PSA) level in the serum.
The marketing authorization is granted to Telix’s partner R2PHARMA, Brazil’s leading cold kit manufacturer, nuclear pharmacy and cyclotron network, and a subsidiary of GSH Corp Participações S.A. (Grupo GSH). Telix has provided Grupo GSH with an exclusive license to manufacture, distribute and market Illuccix® in Brazil2.
PSMA-PET is a diagnostic technology demonstrated to detect advanced prostate cancer. ANVISA becomes the latest regulatory body worldwide to approve Illuccix®3, which is already commercially available in Australia, Canada, New Zealand and the United States, and has recently been approved in the United Kingdom and in multiple countries within the European Economic Area (EEA).
Dr. Sérgio Altino de Almeida, nuclear medicine specialist, at Rede D’Or, the largest integrated healthcare network in Brazil said, “The ANVISA approval of Illuccix provides access to advanced prostate cancer imaging for men across Brazil, a large and rapidly growing market for gallium-68 based radiopharmaceuticals. The ‘cold kit’ format with generator-produced gallium will facilitate broad equity of access for men living with prostate cancer, regardless of whether they are based in regional, rural or metropolitan areas.”
JV to manufacture and distribute radiopharmaceuticals for clinical and commercial use in Brazil
Telix also announces a joint venture (JV) with R2PHARMA to commercialize and distribute Telix’s therapeutic and diagnostic radiopharmaceutical products in Brazil, building on the existing partnership established in 2019. The JV further strengthens this relationship with a commitment to jointly bring to market innovative and first-in-class therapeutic radiopharmaceuticals and imaging agents in Brazil.
The market for radiopharmaceuticals in Brazil is experiencing significant growth driven by the increasing prevalence of chronic diseases such as cancer, advancements in imaging technologies, and a growing senior population. Over the next decade, the Brazilian radiopharmaceuticals market is projected to reach US
Under the agreement, Telix and R2PHARMA will establish a JV company in Brazil (Telix Innovations Brazil, Ltda.). Telix Innovations Brazil will hold the exclusive licence to commercialize and distribute Illuccix® as well as future product candidates from Telix’s industry-leading theranostic pipeline. Telix Innovations Brazil will leverage the local knowledge and expertise of R2PHARMA to obtain the necessary licenses and governmental authorizations in Brazil5.
Raphaël Ortiz, CEO Telix International, added, “Telix is pleased to bring Illuccix to Brazil and Latin America, with this new imaging modality now recognized in leading clinical practice guidelines and already being adopted in other parts of the world. We would like to acknowledge our partner R2PHARMA for their commitment to gallium-based PSMA-PET and the hope this brings for men living with prostate cancer in Brazil. The JV takes our collaboration to the next stage with the aim to address unmet need for therapeutic and diagnostic radiopharmaceuticals across a range of disease areas.”
R2PHARMA Nuclear Medicine & Innovation Vice-President, Rafael Madke, continued, “We are delighted to have been granted this marketing authorization for Illuccix in Brazil. The combination of Telix’s innovative theranostic pipeline and R2PHARMA’s manufacturing and distribution capabilities will support widespread access for patients and physicians to Illuccix and future additional products that until now have not been available in Latin America.”
About Prostate Cancer in Brazil
Prostate cancer is the most commonly diagnosed male cancer in Brazil with an estimated 71,730 new cases in 20236. Prostate cancer was also the second most common cause of cancer death in men (after lung cancer), with approximately 20,000 men dying from their disease in 2022. More than 250,000 men in Brazil were estimated to be living with prostate cancer in 20227.
About Illuccix®
Illuccix® is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for PET imaging combined with computerized tomography (CT) scan in case of suspicion of prostate cancer relapse in adult males to detect and localize recurrent cancerous lesions. 68Ga gozetotide injection targets PSMA, a protein that is overexpressed on the surface of more than
Illuccix® has been approved by the U.S. Food and Drug Administration (FDA)8, by the Australian Therapeutic Goods Administration (TGA)9, by Health Canada10, by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)11, by the Brazilian Health Regulatory Agency (ANVISA)12 and in multiple countries within the EEA13 following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM14.
About R2PHARMA
Operating since 2002, R2PHARMA commercially delivers Cold Kits for 99mTc and 68Ga preparation for the Brazilian market. R2PHARMA is also the owner of the only private fully Good Manufacturing Practice (GMP) production facility in Brazil for nuclear medicine products. R2PHARMA products are sold throughout Brazil, serving more than 420 customers on a daily basis, and exports their products to more than 10 countries around the world. R2PHARMA is also a pioneer of the nuclear pharmacy model in Brazil with two operating centers in São Paulo and Rio de Janeiro. The company also operates the largest production network of cyclotrons in South America, with five sites distributed in the states of Paraná, São Paulo, Rio de Janeiro and Pernambuco. The last installed facility will include, in addition to the production of 18F radiopharmaceuticals, a solid target for the production of 89Zr, 68Ga and 64Cu, as well as a laboratory dedicated to the production of molecules labeled with 177Lu. For more information visit: http://r2pharma.com.
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. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).
Visit www.telixpharma.com 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: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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1 Imaging of prostate-specific membrane antigen (PSMA) via a positron emission tomography (PET) scan (known as PSMA-PET).
2 Telix ASX disclosure 3 July 2019. The license for Illuccix® in Brazil was granted by Telix to MJM Produtos Farmacêuticos e de Radioproteção S.A., a subsidiary of Grupo R2PHARMA.
3 Illuccix® has been previously available in Brazil under an exceptional authorisation granted in December 2021 (Telix ASX disclosure 1 December 2021).
4 Allied Market Research 2022.
5 Marketing authorizations in Brazil will be held by Telix Innovations Brazil, Ltda., returned to Telix on expiry or termination of the relevant license agreement.
6 Brazilian Cancer Institute.
7 Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.
8 Telix ASX disclosure 20 December 2021.
9 Telix ASX disclosure 2 November 2021.
10 Telix ASX disclosure 14 October 2022.
11 Telix ASX disclosure 13 February 2025.
12 Resolution-RE No. 954, of 13 March 2025, published at D.O.U. No. 51, page 75, 17 March 2025.
13 Denmark, Luxembourg, Malta, and Norway at time of release.
14 Telix ASX disclosure 17 January 2025.
FAQ
What is the significance of Illuccix's approval in Brazil for TLX shareholders?
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