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 (.

澳大利亚墨尔本和巴西阿雷格里港，2025年3月18日（环球新闻社）-- Telix Pharmaceuticals Limited（ASX：TLX，纳斯达克：TLX，Telix，公司）今日宣布，巴西卫生监管局（Agencia Nacional de Vigilancia Sanitaria或“ANVISA”）已批准Illuccix?（用于制备镓-68的试剂盒）。

Ga) gozetotide injection) the Company’s lead prostate cancer imaging agent. Illuccix? is the first and only PSMA-PET

Ga) gozetotide注射剂，是该公司的主要前列腺癌成像剂。Illuccix? 是首个也是唯一的PSMA-PET。

prostate cancer imaging agent to receive full regulatory approval in Brazil.

前列腺癌成像剂在巴西获得完全监管批准。

Illuccix?, after radiolabeling with

Illuccix?，在放射性标记后

Ga, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

镓，是一种放射性诊断剂，适用于前列腺癌患者中前列腺特异性膜抗原（PSMA）阳性病灶的正电子发射断层扫描（PET）。

With suspected metastasis who are candidates for definitive initial therapy treatment, and

怀疑有转移的患者，这些患者是进行初始确定性治疗的候选人，并且

With suspected recurrence based on an elevated specific antigen (PSA) level in the serum.

怀疑基于血清中特定抗原（PSA）水平升高而复发。

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 Participa??es S.A. (Grupo GSH). Telix has provided Grupo GSH with an exclusive license to manufacture, distribute and market Illuccix? in Brazil.

营销授权已授予Telix的合作伙伴R2PHARMA，该公司是巴西领先的冷套件制造商、核药房和回旋加速器网络，也是GSH Corp Participa??es S.A.（Grupo GSH）的子公司。Telix已向Grupo GSH授予了在巴西制造、分销和销售Illuccix?的独家许可。

PSMA-PET is a diagnostic technology demonstrated to detect advanced prostate cancer. ANVISA becomes the latest regulatory body worldwide to approve Illuccix?

PSMA-PET 是一种被证实能够检测晚期前列腺癌的诊断技术。ANVISA 成为全球最新批准 Illuccix? 的监管机构。

, 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).

，该产品已在澳大利亚、加拿大、新西兰和美国上市销售，并且最近在英国和欧洲经济区（EEA）的多个国家获得批准。

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.

巴西最大的综合医疗网络Rede D’Or的核医学专家塞尔吉奥·阿尔蒂诺·德·阿尔梅达博士表示：“Illuccix获得ANVISA批准，为巴西各地的男性提供了先进的前列腺癌成像技术，这是一个庞大且快速增长的基于镓-68的放射性药物市场。”

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.”.

“使用发生器生产的镓的‘冷盒’形式将促进生活在前列腺癌患者中的男性广泛获得平等的机会，无论他们身处地区、农村还是大都市区域。”

JV to manufacture and distribute radiopharmaceuticals for clinical and commercial use in Brazil

合资企业将在巴西生产和分销用于临床和商业用途的放射性药物

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..

Telix还宣布与R2PHARMA成立合资企业（JV），以在巴西商业化并分销Telix的治疗和诊断放射性药物产品，这建立在双方自2019年建立的现有合作伙伴关系基础之上。该合资企业进一步加强了这种关系，并承诺共同将创新且首屈一指的治疗性放射性药物和成像剂引入巴西市场。

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$330 million.

巴西放射性药物市场正经历显著增长，这得益于慢性疾病（如癌症）发病率的上升、成像技术的进步以及老年人口的不断增长。未来十年，巴西放射性药物市场预计将达到 3.3 亿美元。

, with this growth supported by rising investments in the healthcare industry, public health awareness, and the introduction of new and advanced radiopharmaceuticals.

，这一增长得益于医疗保健行业投资的增加、公共卫生意识的提高以及新型和先进的放射性药物的引入。

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.

根据协议，Telix和R2PHARMA将在巴西成立一家合资企业（Telix Innovations Brazil, Ltda.）。Telix Innovations Brazil将持有独家许可，负责商业化和分销Illuccix?以及Telix行业领先的诊疗产品线中的未来候选产品。

Telix Innovations Brazil will leverage the local knowledge and expertise of R2PHARMA to obtain the necessary licenses and governmental authorizations in Brazil.

Telix Innovations巴西公司将利用R2PHARMA的本地知识和专业技能，获取在巴西所需的许可证和政府授权。

Rapha?l 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.

拉斐尔·奥尔蒂斯，Telix国际公司首席执行官补充道：“Telix很高兴将Illuccix引入巴西和拉丁美洲，这种新的成像模式现已在领先的临床实践指南中得到认可，并已在世界其他地区逐渐应用。我们要感谢合作伙伴R2PHARMA对基于镓的PSMA-PET技术的投入，以及这为巴西的前列腺癌患者带来的希望。”

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.”.

这家合资企业将我们的合作推向了下一个阶段，目标是满足在一系列疾病领域中对治疗和诊断用放射性药物的未满足需求。

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.”.

R2PHARMA核医学与创新副总裁拉斐尔·马德克继续说道：“我们很高兴获得Illuccix在巴西的上市许可。Telix创新的诊疗产品线与R2PHARMA的生产和分销能力相结合，将为患者和医生广泛提供Illuccix及未来其他迄今在拉丁美洲尚未可用的产品。”

About Prostate Cancer in Brazil

关于巴西的前列腺癌

Prostate cancer is the most commonly diagnosed male cancer in Brazil with an estimated 71,730 new cases in 2023

前列腺癌是巴西最常见的男性癌症，预计2023年将有71,730例新病例。

. 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 2022

前列腺癌也是男性癌症死亡的第二大常见原因（仅次于肺癌），2022年约有2万名男性死于该疾病。据估计，2022年巴西有超过25万名男性患有前列腺癌。

About Illuccix?

关于Illuccix?

Illuccix? is a kit for the preparation of gallium-68 (

Illuccix? 是用于制备镓-68的试剂盒 (

Ga) 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.

镓) gozetotide（也称为 PSMA-11）注射剂，一种放射性诊断剂，用于在怀疑成年男性前列腺癌复发时结合计算机断层扫描 (CT) 进行 PET 成像，以检测和定位复发的癌性病灶。

Ga gozetotide injection targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix? enables gozetotide (PSMA-11) to be labelled with the radionuclide

戈泽托肽注射液靶向PSMA，这是一种在超过90%的原发性和转移性前列腺癌细胞表面过度表达的蛋白质。Illuccix? 使得戈泽托肽 (PSMA-11) 能够与放射性核素标记。

About R2PHARMA

关于R2PHARMA

Operating since 2002, R2PHARMA commercially delivers Cold Kits for

自2002年以来，R2PHARMA 商业化交付冷套件用于

Ga 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.

Ga为巴西市场做准备。R2PHARMA还拥有巴西唯一的私人全GMP（良好生产规范）核医学产品生产设施。R2PHARMA的产品在整个巴西销售，每天为超过420名客户提供服务，并将其产品出口到全球10多个国家。

R2PHARMA is also a pioneer of the nuclear pharmacy model in Brazil with two operating centers in S?o 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, S?o Paulo, Rio de Janeiro and Pernambuco.

R2PHARMA也是巴西核药房模式的先驱，在圣保罗和里约热内卢设有两个运营中心。该公司还拥有南美洲最大的回旋加速器生产网络，在巴拉那州、圣保罗州、里约热内卢州和伯南布哥州分布有五个基地。

The last installed facility will include, in addition to the production of .

最后一个安装的设施将包括，除了生产之外。

About

关于

Telix Pharmaceuticals Limited

特利克斯制药有限公司

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是一家生物制药公司，专注于治疗和诊断用放射性药物及相关医疗技术的开发和商业化。Telix总部位于澳大利亚墨尔本，在美国、巴西、加拿大、欧洲（比利时和瑞士）以及日本设有国际业务。

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)..

Telix正在开发一系列临床和商业化阶段的产品，旨在满足肿瘤学和罕见病领域显著未满足的医疗需求。Telix在澳大利亚证券交易所（ASX: TLX）和纳斯达克全球精选市场（Nasdaq: TLX）上市。