Live Breaking News & Updates on 000 Chinese Men Will Be Diagnosed With Prostate Cancer

MELBOURNE, Australia, Oct. 17, 2022 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved an investigational new drug (IND) application to commence a pivotal Phase III registration study of TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), for the imaging of prostate cancer using Positron Emission Tomography (PET) that will bridge to the marketing authorisation granted to Illuccix by the United States Food and Drug Administration (FDA). The IND application was submitted in partnership with Grand Pharmaceutical Group Limited (Grand Pharma), Telix's partner in the Greater China region. The bridging study is required to provide data obtained in a Chinese population to establish that the diagnostic efficacy of TLX591-CDx is equivalent in Chinese and Western populations. This study will enroll up to 110 patients with suspected recurrent ....

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