Telix Pharmaceuticals Limited 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-PET 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 Brazil.

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