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Telix APAC Report: Regulatory Progress for Prostate and Kidney Cancer Imaging

MELBOURNE, Australia, Aug. 2, 2022 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today reports on regulatory progress for the Company's core prostate and kidney cancer imaging programs in the Asia Pacific (APAC) Operating Region, including progress in the major market of China with its strategic partner Grand Pharmaceutical Group Limited (Grand Pharma). TLX591-CDx (Illuccix) for prostate cancer imaging China: An Investigational New Drug (IND) application has been submitted by Telix's partner in Greater China, Grand Pharma, to the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) - and accepted for review - for a pivotal Phase III registration study that will bridge to the United States Food and Drug Administration (FDA) approval of Illuccix. South Korea: As previously reported, an imported New Drug Application (NDA) has been submitted by Telix's partner in South Korea, DuChemBio Co, Ltd. (DuChemBio), to the Minist

Telix APAC Report: Regulatory Progress for Prostate and Kidney Cancer Imaging

Telix APAC Report: Regulatory Progress for Prostate and Kidney Cancer Imaging

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