Next-generation fusion specialist SHINE Technologies has secured centralised marketing authorisation (CMA) in Europe for its radioisotope product Ilumira (non-carrier-added lutetium-177), allowing the company to sell Lu-177 across the European Union (EU).
The regulatory clearance enables access to a major market for the use of Lu-177 in targeted radioligand therapies.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The development coincides with several steps by SHINE Technologies to broaden its position in nuclear medicine.
In January, Shine acquired a US isotope manufacturing and distribution operation, which included an established range of diagnostic products such as Tc-99m generators, cardiac and neuroimaging agents, as well as xenon-133 for pulmonary imaging.
According to the company, these diagnostic isotopes are used in millions of medical procedures annually.
The combined offering aims to provide hospitals, imaging centres, and radiopharmaceutical developers with a single US-based supplier covering various nuclear medicine needs.
SHINE SPECT CEO Michael Rossi said: “For years, our customers have asked for a reliable partner that can deliver both the diagnostic and therapeutic side of nuclear medicine.
“EMA approval opens the door for Shine’s radioisotope Lu-177 to be used in developing radioligand therapies at scale, and ultimately support the expanded reach of nuclear medicine to patients.
“Combined with the isotope manufacturing and distribution operation we run for North American hospitals and imaging centres, SHINE now serves both sides of nuclear medicine.”
Ilumira is produced at Shine’s Cassiopeia facility in Janesville, Wisconsin, which the company describes as one of North America’s largest non-carrier-added Lu-177 production sites.
The facility uses a proprietary method and operates at commercial scale, with the ability to adjust output according to global demand.
Shine states that Ilumira is manufactured under current Good Manufacturing Practice and is compliant with European Pharmacopoeia standards, achieving a radionuclidic purity of at least 99.9% as a non-carrier-added product.
The company also recycles ytterbium (Yb-176), the starting material for non-carrier-added Lu-177, which it says reduces waste and helps create a domestic supply chain.
Shine has recently secured additional funding and partnerships, including a $240m Series E investment with strategic collaboration from NantWorks and a $263m conditional loan commitment from the US Department of Energy to complete a new isotope production site.
The fusion specialist has also expanded its leadership team and global distribution partnerships.
