October 17-21, 2025– The European Society for Medical Oncology (ESMO) Congress, Europe’s most influential oncology conference, will be held in Berlin, Germany. The full results of the China Phase III registration clinical trial for Sinotau’s self-developed innovative radioconjugate (RDC) drug, XTR008, have been successfully selected as a Late-Breaking Abstract (LBA) and will be globally presented on October 18.
The LBA session at the ESMO Congress is reserved for the highest level of research presentations, accepting only groundbreaking studies with the potential to change clinical practice or the understanding of diseases, such as Phase III randomized trials or major translational discoveries. The selection criteria are stringent, with a very low acceptance rate. This selection signifies that the XTR008 study has gained recognition from the global oncology community and fully demonstrates Sinotau’s innovation capabilities and global influence in the field of radiopharmaceuticals.
Title:
XT-XTR008-3-01: A Phase III Study of 177Lu-Dotatate Versus High-Dose Octreotide Long-Acting Repeatable (LAR) in Patients With Advanced Grade 1–2, Well-Differentiated, Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs)
Abstract Number:LBA63
Session:Proffered Paper Session
Presenter:Professor Rongrui Liu (Chinese PLA General Hospital)
Central European Summer Time (CEST):October 18, 2025, 11:15 – 11:25
Location:Karlsruhe Auditorium – Hall 5.2
As a potential first SSTR-targeting therapeutic radiopharmaceutical in China, the interim analysis results of the XTR008 China Phase III registration study demonstrated significant efficacy and safety. XTR008 showed superior efficacy compared to the control group receiving standard therapy with high-dose octreotide LAR across multiple endpoints, including Progression-Free Survival (PFS) and Objective Response Rate (ORR). Based on these interim results, a New Drug Application (NDA) was submitted to the National Medical Products Administration (NMPA) in March 2025 and was accepted in April 2025. XTR008 is expected to receive approval in 2026, potentially becoming the first radiopharmaceutical drug approved in China based on successful Phase III clinical trial results.
About Sinotau
Sinotau, founded in 2005, is a front-runner and leader in the Chinese radiopharmaceutical market, possessing end-to-end capabilities across the entire industry value chain, from radionuclide development and production to radiopharmaceutical R&D, manufacturing, and commercialization. Adhering to its mission of “Invent radiopharmaceuticals for lives”, Sinotau is rooted in China with a global vision. The company is headquartered in Beijing, with an R&D center in Shanghai, and modern radiopharmaceutical production bases in Jiangsu, Guangdong, and Sichuan; it also has a branch in the United States. Driven by unmet clinical needs, Sinotau focuses on three major therapeutic areas: neurodegenerative diseases, cardiovascular diseases, and oncology, having established a comprehensive, differentiated, and synergistic product portfolio with significant potential in radiopharmaceutical theranostics. Among its products, Florbetaben [18F] Injection is the first innovative PET tracer approved for marketing in China in nearly 20 years; its diverse pipeline, at various stages, broadly covers global innovative targets in radiopharmaceuticals, demonstrating the strong competitiveness of our pipeline and leading the new speed of innovative radiopharmaceutical development.
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