The European approval lands alongside SHINE’s expansion into diagnostic radiopharmaceuticals. In January, the company acquired an established U.S. isotope manufacturing and distribution facility and product portfolio, adding decades of operational scale across diagnostic isotopes — Tc-99m generators, cardiac and neuroimaging agents, and Xe-133 for pulmonary imaging — used in millions of procedures each year. The combination gives hospitals, imaging centers, and radiopharmaceutical developers a single U.S.-based supplier across a wide spectrum of nuclear medicine.1
“For years, our customers have asked for a reliable partner that can deliver both the diagnostic and therapeutic side of nuclear medicine,” said Michael Rossi, CEO of SHINE SPECT LLC. “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 centers, SHINE now serves both sides of nuclear medicine.”
A U.S. Production Platform Built for Reliability and Scale
SHINE produces Ilumira at its Cassiopeia facility in Janesville, Wisconsin, one of North America’s largest n.c.a. Lu-177 production sites, using a proprietary process. The facility provides commercial-scale supply for the global radiopharmaceutical market, with the ability to adjust capacity according to demand for approved Lu-177 therapies.
Ilumira is produced under cGMP and meets European Pharmacopeia standards. As a non-carrier-added product, Ilumira achieves ≥99.9% radionuclidic purity and high specific activity, characteristics that distinguish n.c.a. Lu-177 from carrier-added alternatives.2,3 SHINE is one of the few lutetium producers that also recycles ytterbium (Yb-176), the starter material for all n.c.a. Lu-177. The result is less waste, improved efficiency, and a domestic supply chain radiopharmaceutical developers can plan around.
A New Era for Nuclear Medicine
The EMA approval is the latest in a series of major moves expanding SHINE’s nuclear medicine platform:
- SHINE acquired an established U.S. isotope manufacturing and distribution operation in January, expanding into diagnostic radiopharmaceuticals and adding immediate operational scale to its nuclear medicine platform
- The company closed a $240 million Series E led by Dr. Patrick Soon-Shiong in February. The investment included a strategic partnership with NantWorks featuring priority access to SHINE’s Lu-177 supply, positioning both companies to advance the next generation of targeted cancer treatment.
- SHINE received a $263 million conditional loan commitment from the U.S. Department of Energy in April to complete Chrysalis, designed to become the largest medical isotope production site in the world. The fusion-fission hybrid facility will produce molybdenum-99 — the parent isotope of the Tc-99m used in SHINE’s SPECT products — connecting the company’s isotope production to its diagnostic manufacturing under one supply chain.
- SHINE has also expanded its global distribution partnerships and built out its senior leadership team to support its next stage of growth.
With its integrated platform now spanning diagnostic and therapeutic radioisotopes from U.S. production, SHINE continues to scale capacity and expand global reach.
About Ilumira
Lu-177 is one of the most widely used isotopes in targeted cancer therapy. Paired with a targeting ligand, it delivers potent radiation to tumor cells while sparing healthy tissue. Lu-177 is currently used as the nuclear isotope precursor in several radiopharmaceuticals that have approved and investigational uses across prostate cancer and neuroendocrine tumors, and a growing list of indications.2
Global demand for Lu-177 is soaring, but supply has been unstable, and most Lu-177 produced today is carrier-added, with lower radionuclidic purity.2,3 Carrier-added Lu-177 contains non-therapeutic lutetium isotopes alongside the active material. Non-carrier-added Lu-177 separates them out for higher radionuclidic purity and a more concentrated source of active material.2,3
Note: Ilumira is a radiopharmaceutical precursor, not a finished drug. It is solely intended for radiolabeling of carrier molecules and is not for direct patient use.
References:
[1] World Nuclear Association. Radioisotopes in medicine. Updated January 21, 2026. Accessed April 10, 2026. https://world-nuclear.org/information-library/non-power-nuclear-applications/radioisotopes-research/radioisotopes-in-medicine
[2] Niu T, Fan M, Lin B, et al. Current clinical application of lutetium-177 in solid tumors (Review). Exp Ther Med. 2024;27(5):225. doi:10.3892/etm.2024.12514. PMID: 38596660; PMCID: PMC11002837. Accessed April 30, 2026. https://pmc.ncbi.nlm.nih.gov/articles/PMC11002837/
[3] Dash A, Pillai MRA, Knapp FF Jr. Production of ^177Lu for Targeted Radionuclide Therapy: Available Options. Nucl Med Mol Imaging. 2015;49(2):85–107. Available from: PubMed Central. Accessed April 10, 2026
About SHINE
Headquartered in Janesville, Wisconsin, SHINE is an industry leader in next-generation fusion, developing innovative fusion-based technology that combines safety, cost-efficiency and environmental responsibility.
SHINE has successfully commercialized fusion across multiple applications, including neutron testing markets such as neutron radiography, radiation-effects testing and fusion material research. It has commercialized and is scaling its proprietary medical isotope production processes, supplying high-quality radioisotopes essential for procedures including diagnosing heart disease and cancer as well as cancer therapy.
Beyond these applications, SHINE is pioneering nuclear waste recycling to make nuclear energy more sustainable. Its long-term purpose is to change the way humans make energy by commercializing fusion energy. Unlike other fusion companies, SHINE takes a commercially driven path mirroring successful deep-tech industries. Through this visionary approach, SHINE is advancing technology, healthcare, and sustainable energy, making a lasting impact across multiple sectors.
Learn more at www.shinefusion.com.
SOURCE SHINE Technologies, LLC
