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Chinese NMPA Accepts New Drug Application for Illuccix for Prostate Cancer Imaging
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for TLX591-Px (Illuccix®, Kit for the preparation of 68Ga-PSMA-11), Telix's lead prostate cancer imaging agent.
About this update from Telix Pharmaceuticals Limited
[{"type":"text","content":"MELBOURNE, Australia and INDIANAPOLIS, Jan. 20, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for TLX591-Px (Illuccix®, Kit for the preparation of 68Ga-PSMA-11), Telix's lead prostate cancer imaging agent.","length":427,"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 NDA was submitted with Telix's strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (00512.HK, Grand Pharma). Seeking a broad label that reflects clinical utility at multiple stages of prostate cancer care, the submission includes data from the Illuccix China Pivotal Phase 3 Registration study[1], which reported positive top-line results in December 2025[2].","length":398,"tagName":"p"},{"type":"text","content":"The Illuccix China study met its primary endpoint, with an overall patient-level positive predictive value (PPV) of 94.8% for the detection of tumors in patients with biochemical recurrence (BCR) of prostate cancer with TLX591-Px[2],[3]. This confirmed that the clinical experience of TLX591-Px PSMA-PET[4] imaging in Chinese patients is comparable to studies in non-Chinese patients. The high PPV was demonstrated even in patients with very low PSA[5] values, and across differing metastatic locations. More than two-thirds (67.2%) of patients experienced a change in their treatment plan as a consequence of TLX591-Px PSMA-PET imaging compared with the initial plan at baseline[3], demonstrating a major impact on clinical decision-making in Chinese patien...