​​ESMO Highlight: Domestic Radiopharmaceutical Selected As LBA​

Sep 25, 2025Leave a message

​The 2025 European Society for Medical Oncology (ESMO) Annual Meeting will be held from ​​October 17–21 in Berlin, Germany​​. As one of the most influential oncology conferences in Europe, it will showcase cutting-edge theories and advancements in the field of oncology worldwide.
In recent years, an increasing number of studies from China have been featured at this event, with some even selected as ​​Late-Breaking Abstracts (LBA)​​-a prestigious category reserved for groundbreaking research.
For instance, ​​XTR008​​, an innovative ​​radiopharmaceutical conjugate (RDC)​​ independently developed by ​​Sinotau Pharmaceutical​​, has been selected for the ​​LBA Proffered Paper Session​​, with its full ​​Phase III clinical trial results​​ set to be unveiled globally on ​​October 18​​.
​​XTR008​​ is a ​​¹⁷⁷Lu-labeled somatostatin receptor (SSTR)-targeting radioligand​​, sharing the same target as ​​Novartis' blockbuster drug Lutathera​​.
The selected study (​​XT-XTR008-3-01​​) is a ​​Phase III trial​​ comparing ​​¹⁷⁷Lu-Dotatate (XTR008)​​ with ​​high-dose long-acting octreotide (LAR)​​ in patients with ​​well-differentiated, grade 1-2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs)​​.
​​Interim analysis results​​ demonstrated that ​​XTR008​​ exhibits ​​significant efficacy and safety​​, with key metrics such as ​​progression-free survival (PFS)​​ and ​​objective response rate (ORR)​​ significantly outperforming the ​​high-dose LAR control group​​. Moreover, its performance was ​​comparable or even superior​​ to that observed in ​​Lutathera's Phase III NETTER-1 trial​​, suggesting ​​Best-in-Class (BIC) potential​​.
Based on these interim results, ​​Sinotau Pharmaceutical​​ submitted a ​​New Drug Application (NDA)​​ to China's ​​National Medical Products Administration (NMPA)​​ in ​​March 2025​​, which was accepted in ​​April 2025​​. The drug is ​​expected to be approved and launched in 2026​​.
As a ​​leading radiopharmaceutical company in China​​, Sinotau filed for an ​​IPO on the Hong Kong Stock Exchange in May 2025​​, potentially becoming the ​​first radiopharmaceutical firm listed under the HKEX's Chapter 18A​​.
Beyond ​​XTR008​​, Sinotau has a ​​robust pipeline​​ of radiopharmaceutical candidates, including:
​​XTR006​​: An ​​¹⁸F-labeled tau-targeting PET diagnostic radioligand​​ (developed in collaboration
​​XTR004​​: A ​​self-developed PET-MPI tracer​​
​​XTR003​​: A ​​PET tracer for myocardial fatty acid metabolism imaging​

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Image source: Pharma Intelligence - Global Drug Analysis System
​​Conclusion​​
The ​​ESMO Annual Meeting​​ is one of the ​​most influential international conferences in oncology​​, and the ​​LBA category​​ represents the ​​highest level of research​​, reserved only for ​​breakthrough studies that could reshape clinical practice or disease understanding​​.
This year, ​​23 studies from Chinese researchers​​ were selected as LBAs-a ​​notable increase from just 7 last year​​, reflecting the ​​growing prominence of China's innovative drugs on the global stage​​.
​​References:​​

1.https://mp.weixin.qq.com/s/2D6a5qdCYtb4S7LaWALXAg

2.https://mp.weixin.qq.com/s/4lXfy-3u40lKSgWKqf_Uyw

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