Top Oncology Journal & ESMO LBA Concurrent Release: XTR008 Receives International Top-Level Dual Endorsement

Sinotau is pleased to announce that the results of the Phase III clinical trial in China for our self-developed radionuclide therapeutic drug, ¹⁷⁷Lu-Dotatate(XTR008), have been officially published in the prestigious international oncology journal Annals of Oncology (Impact Factor: 65.4). Concurrently, the latest analysis results from this study were successfully selected as a Late-Breaking Abstract (LBA) for this year’s ESMO Congress. During the Proffered Paper Session at the ESMO Annual Meeting, Professor Liu Rongrui from the Chinese PLA General Hospital delivered an oral presentation, showcasing the outstanding clinical performance of XTR008 as a monotherapy for neuroendocrine tumors to the global oncology community. This presentation garnered widespread attention and sparked lively discussions among attending experts and scholars. This achievement marks one of the few domestic studies to achieve concurrent release at the ESMO Congress and in a top-tier international academic journal, fully demonstrating the significant value and international influence of XTR008 in the field of neuroendocrine tumor treatment.

▲XTR008 China Phase III Clinical Trial Results Published in Prestigious International Oncology Journal Annals of Oncology

This clinical study is the world’s first Phase III clinical trial of Peptide Receptor Radionuclide Therapy (PRRT) conducted in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have failed prior standard-dose long-acting somatostatin analog therapy. It is also the first Phase III PRRT clinical study for neuroendocrine tumors conducted in China. The study aimed to evaluate the treatment of ¹⁷⁷Lu-Dotatate(XTR008) versus high dose octreotide long-acting repeatable (LAR) in patients with advanced grade 1–2, well-differentiated, gastroenteropancreatic neuroendocrine tumours (GEP-NETs)

▲Professor Liu Rongrui from Professor Xu Jianming’s team at the Chinese PLA General Hospital presenting on-site at ESMO

▲The on-site presentation attracted extensive attention and lively discussions among experts and scholars.

In a previous interim analysis, XTR008 had already demonstrated very significant efficacy. The latest data presented at the ESMO Congress 2025 further confirm the durable efficacy and survival benefit of XTR008.

Analysis showed that the median Progression-Free Survival (PFS) in the XTR008 group reached 24.77 months, significantly superior to the 5.78 months in the long-acting SSA group (HR=0.14, 95% CI: 0.090-0.219), indicating that XTR008 reduces the risk of disease progression or death by 86%.

Regarding tumor response, the Objective Response Rate (ORR) in the XTR008 group reached 55.6%, and the Disease Control Rate (DCR) was 94.9%, far exceeding the 2.1% and 72.2% observed in the control group, respectively, highlighting its significant advantage in shrinking tumors and controlling disease.

The study included patients with GEP-NETs originating from various primary sites such as the pancreas, rectum, and stomach, and a consistent trend of efficacy was observed across all subgroups, suggesting that XTR008, as a broad-spectrum and highly effective later-line treatment option, possesses significant clinical potential and application prospects.

Furthermore, XTR008 monotherapy demonstrated a favorable safety profile, with the vast majority of patients completing the full treatment course.

▲study results

Principal Investigator, Professor Xu Jianming from the Chinese PLA General Hospital, commented:

“Compared to the NETTER series of studies, this study design optimized the treatment regimen, enabling an unbiased evaluation of the monotherapy efficacy of XTR008 and providing the highest level of evidence for its therapeutic value. Simultaneously, for patients with non-functional GEP-NETs (without symptoms related to hormone secretion), it avoids the burden associated with long-term use of long-acting somatostatin analogs, significantly improving patients’ quality of life while also reducing their treatment burden and simplifying safety management.

This study enrolled patients from multiple centers across China, covering a wide geographical area, thus more accurately reflecting the disease characteristics and treatment needs of neuroendocrine tumors in China. Its excellent efficacy data and favorable safety profile provide Chinese patients with a more effective and reliable treatment option. It is expected to drive the earlier use of PRRT in the treatment sequence, potentially even becoming an important first-line treatment choice for GEP-NET patients in the future.”

The New Drug Application for XTR008 in China was accepted by the National Medical Products Administration (NMPA) in April 2025. XTR008 is expected to receive approval for marketing in China in 2026, potentially becoming the first SSTR-targeted Radioligand Therapy approved in China, offering a new treatment choice for Chinese patients with neuroendocrine tumors.
 

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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