PSMA-PET imaging technology is leveraged to identify advanced prostate cancer. Credit: Korawat photo shoot / Shutterstock.

PSMA-PET成像技术被用于识别晚期前列腺癌。图片来源：Korawat photo shoot / Shutterstock。

Brazilian Health Regulatory Agency (ANVISA) has granted approval for Telix Pharmaceuticals’ Illuccix, a prostate cancer imaging agent.

巴西卫生监管局 (ANVISA) 已批准 Telix Pharmaceuticals 的 Illuccix，一种前列腺癌成像剂。

Illuccix claims to be the first prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging agent to receive full regulatory approval in Brazil.

Illuccix声称是巴西首个获得完全监管批准的前列腺特异性膜抗原-正电子发射断层扫描（PSMA-PET）成像剂。

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It is a kit that is used for preparing gallium-68 (⁶⁸Ga) gozetotide injection for PET imaging in conjunction with computerised tomography (CT) scan for identifying and localising recurrent cancerous lesions in situations where prostate cancer relapse is suspected in the adult male population.

这是一种用于制备镓-68（⁶⁸Ga）gozetotide注射剂的试剂盒，用于结合计算机断层扫描（CT）进行正电子发射断层扫描（PET）成像，以在怀疑成年男性前列腺癌复发的情况下识别和定位复发的癌性病灶。

According to the company, the imaging agent is indicated for detecting PSMA-positive lesions in individuals with suspected metastasis who are initial therapy candidates and for those with suspected recurrence depending on elevated serum-specific antigen levels.

据该公司称，该成像剂适用于检测疑似转移的初始治疗候选者中的PSMA阳性病灶，并适用于根据血清特异性抗原水平升高而疑似复发的患者。

Grupo GSH subsidiary and Telix’s Brazilian partner R2PHARMA secured the marketing authorisation for the imaging agent.

GSH集团子公司及Telix的巴西合作伙伴R2PHARMA获得了该成像剂的上市许可。

Known for its offerings in nuclear pharmacy and cyclotron networks, R2PHARMA is responsible for manufacturing, distributing, and marketing the imaging agent exclusively in Brazil under the licence provided by Telix.

R2PHARMA 以其在核药房和回旋加速器网络方面的优势而闻名，负责在巴西境内独家制造、分销和营销由 Telix 授权的成像剂。

PSMA-PET imaging technology is leveraged to identify advanced prostate cancer. ANVISA’s approval aligns with the global recognition of Illuccix, which is already available in the US, Canada, New Zealand, Australia, the UK, and several nations within the European Economic Area (EEA).

PSMA-PET成像技术被用于识别晚期前列腺癌。ANVISA的批准与Illuccix的全球认可一致，该技术已在美国、加拿大、新西兰、澳大利亚、英国和欧洲经济区（EEA）的多个国家上市。

Telix and R2PHARMA have announced a joint venture (JV) for commercialising and distributing the former’s therapeutic and diagnostic radiopharmaceutical products in the country, building upon their partnership established in 2019.

Telix和R2PHARMA宣布成立一家合资企业（JV），以在该国商业化和分销前者治疗性和诊断性放射性药物产品，这是基于双方自2019年建立的合作伙伴关系。

The Telix Innovations Brazil JV will carry the exclusive licence for commercialising Illuccix and Telix’s theranostic pipeline’s future product candidates in the country.

巴西特利克斯创新合资企业将独家拥有在该国商业化Illuccix和特利克斯治疗诊断管道未来产品候选物的许可。

Telix International CEO Raphaël Ortiz said: “Telix is pleased to bring Illuccix to Brazil and Latin America, with this new imaging modality now recognised in leading clinical practice guidelines and already being adopted in other parts of the world.

Telix国际首席执行官拉斐尔·奥尔蒂斯表示：“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纳入领先的临床实践指南，并已在世界其他地区逐渐应用。

“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.”

“我们要对我们的合作伙伴R2PHARMA表示感谢，感谢他们对基于镓的PSMA-PET的承诺，以及这为巴西前列腺癌患者带来的希望。”

In November 2024, Telix

2024年11月，Telix

dosed the first subject

给第一个受试者服药

in its Phase III ZIRCON-CP trial of TLX250-CDx, a PET imaging form tailored to examine clear cell renal cell carcinomas.

在其TLX250-CDx的III期ZIRCON-CP试验中，这是一种专门用于检查透明细胞肾细胞癌的PET成像形式。

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