Australian clinical stage biotechnology company Telix Pharmaceuticals Limited (ASX:TLX) (Nasdaq:TLX) announced on Tuesday that it has received approval from the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ANVISA) for Illuccix (kit for the preparation of gallium-68 (68Ga) gozetotide injection), the company's lead prostate cancer imaging agent.

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.

Illuccix is the first and only PSMA-PET prostate cancer imaging agent to receive full regulatory approval in Brazil.

The marketing authorisation was 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 licence to manufacture, distribute and market Illuccix in Brazil.

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 commercialise and distribute Illuccix as well as future product candidates from Telix's theranostic pipeline. Telix Innovations Brazil will leverage the local knowledge and expertise of R2PHARMA to obtain the necessary licences and governmental authorisations in Brazil.