SINOTAU passes HKEX listing hearing: GF Securities, CICC and CITIC Securities joint sponsors, XTR008 expected to win approval in December 2026

NewTimeSpace News: According to the HKEX on October 28, Beijing Sinotau International Pharmaceutical Technology Co., Ltd. ("Sinotau") passed the HKEX listing hearing, with GF Securities, CICC and CITIC Securities as joint sponsors. Founded in 2005, the company is committed to developing and commercializing diagnostic and therapeutic radiopharmaceuticals with substantial market potential.

According to the prospectus, the company has established a staged, indication-oriented development pipeline comprising 13 assets, of which five were independently discovered and developed and three independently developed by the company. The pipeline includes core products XTR008 and XTR004, as well as major products XTR003 and XTR006. XTR008 is a 177Lu-labeled radioligand targeting somatostatin receptors at the registration stage for treating neuroendocrine neoplasms; as a generic version of Lutathera, it is the first in its class to submit an NDA to the NMPA as a Class 3 chemical drug, with approval expected in December 2026. XTR004 is an 18F-labeled diagnostic radioligand targeting mitochondrial complex I for PET-myocardial perfusion imaging. XTR003 is currently the world's first and only 18F-labeled imaging agent for myocardial fatty acid metabolism, while XTR006 is an 18F-labeled tau-targeted PET diagnostic radioligand for suspected Alzheimer's disease or related mild cognitive impairment.

The company focuses on oncology, neurodegenerative diseases and cardiovascular diseases, adopting a flexible R&D strategy that combines in-house development with licensing. It has established three in-house production facilities in Wuxi, Jiangsu; Zhongshan, Guangdong; and Mianyang, Sichuan, with a total gross floor area exceeding 40,000 square meters and 21 commercial-scale production lines, maintaining a stable and diversified supply of radionuclides through in-house capacity and partnerships with suppliers. For commercialization, it pursues a strategy combining direct sales and external collaboration.