en.Wedoany.com Reported - SHINE Technologies' non-carrier-added lutetium-177 (Lu-177) product, Ilumira, has received a Centralized Marketing Authorization (CMA) from the European Union, allowing the company to sell this radioisotope within the EU.

This regulatory approval enables Lu-177 to enter a major market for targeted radioligand therapy. SHINE Technologies is expanding its presence in nuclear medicine through multiple initiatives. In January, the company acquired a U.S. isotope manufacturing and distribution business, with a product line including Tc-99m generators, cardiac and neuroimaging agents, and xenon-133 for lung imaging, among a range of established diagnostic products. According to the company, these diagnostic isotopes are used in millions of medical procedures annually. The combined portfolio aims to provide hospitals, imaging centers, and radiopharmaceutical developers with a single U.S. supplier to meet their diverse needs in nuclear medicine.

Michael Rossi, CEO of SHINE SPECT, stated that customers have long sought a reliable partner capable of addressing both diagnostic and therapeutic aspects of nuclear medicine. He believes that the European Medicines Agency (EMA) approval opens the door for Shine to develop radioligand therapies on a large scale with its Lu-177, ultimately supporting the expansion of nuclear medicine to more patients. Combined with its isotope manufacturing and distribution operations serving North American hospitals and imaging centers, SHINE now serves both realms of nuclear medicine. Ilumira is produced at Shine's Cassiopeia facility in Janesville, Wisconsin, which the company describes as one of the largest production sites for non-carrier-added Lu-177 in North America. The facility operates at commercial scale using proprietary methods and can adjust output based on global demand.

Shine states that Ilumira is manufactured in accordance with current Good Manufacturing Practices (cGMP) and meets European Pharmacopoeia standards. As a non-carrier-added product, it achieves a radionuclide purity of at least 99.9%. The company also recycles ytterbium (Yb-176), the starting material for non-carrier-added Lu-177, which is said to reduce waste and help establish a domestic supply chain. Shine recently secured additional funding and partnerships, including a $240 million Series E strategic investment from NantWorks and a $263 million conditional loan commitment from the U.S. Department of Energy to complete a new isotope production facility. The fusion technology specialist has also expanded its leadership team and global distribution partnerships.

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