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Illuccix China Phase 3 Study Completes Enrolment
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that the pivotal Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Chinese patients has completed patient enrolment.
About this update from Telix Pharmaceuticals Limited
[{"type":"text","content":"MELBOURNE, Australia and INDIANAPOLIS, May 13, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that the pivotal Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Chinese patients has completed patient enrolment.","length":373,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Telix Pharmaceuticals Limited)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Telix Pharmaceuticals Limited)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":166,"url":"https://media.zenfs.com/en/prnewswire.com/0260c8b822b865d6e9308370c79e16fb"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pLUSkugjGfNA5e2aFU4CYQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTI5MztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/0260c8b822b865d6e9308370c79e16fb","width":400,"height":166}},"href":"https://mma.prnewswire.com/media/1920208/Telix_Main_Logo_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The Phase 3 Illuccix China study[1] is a prospective, open-label, single-arm, multicenter study conducted in collaboration with Telix's strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The study, which enrolled 140 patients, aims to demonstrate equivalence of TLX591-CDx in imaging prostate cancer in Chinese and Western patients, in order to bridge to the marketing authorization granted to Illuccix by the United States (U.S.) Food and Drug Administration (FDA). The data will be used to file a marketing authorization application for TLX591-CDx with the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE).","length":715,"tagName":"p"},{"type":"text","content":"Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, "We are pleased to have completed this study in collaboration with Grand Pharma, which brings advanced PSMA-PET imaging one step closer for men living with prostate cancer in China. We extend our gratitude to the principal investigators, their clinical research teams, and the patients who participated in this important Phase 3 study."","length":412,"tagName":"p"},{"type":"text","content":"About Prostate Cancer in China",...