日本語 
Lantheus Holdings, Inc. GE HealthCare and another company have signed an exclusive licensing deal. This agreement allows GE HealthCare to develop, make, and sell piflufolastat F 18 (known as PYLARIFY® in the U.S.) in Japan. The PET imaging agent is now common in the U.S. and Europe. It helps find lesions that are positive for prostate-specific membrane antigen (PSMA) in men with prostate cancer. This agent is used for both diagnosis and as a companion diagnostic.
The agreement covers three main points:
- Transferring regulatory dossiers.
- Sharing manufacturing know-how.
- Providing technical support from Lantheus to GE HealthCare.
This partnership will help GE HealthCare expand clinical development in Japan. It sets the stage for regulatory submissions and a possible commercial launch. The initiative will tap into GE HealthCare’s vast manufacturing and research network. This network got even stronger after it acquired Nihon Medi-Physics Co., Ltd. in March 2025. (NMP), a leading radiopharmaceutical company in Japan.
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Prostate cancer is a big health issue worldwide. It ranks as the fourth most common cancer. Japan had the third highest rate of prostate cancer cases in 2022. Only the United States and China reported more. Under the licensing deal, GE HealthCare will pay Lantheus an upfront fee. They will provide milestone payments for development. Royalties will depend on sales in Japan. The companies plan to set up a Joint Steering Committee. This group will oversee development and commercialization efforts.
Piflufolastat F 18, or 18F-DCFPyL, got FDA approval in 2021. Since then, it has become the leading PSMA PET imaging agent in the U.S. Marketed as PYLARIFY, it has aided over 500,000 patient scans in 48 states. This shows its clinical value in real-world settings. In 2023, the agent got approval in the European Union as PYLCLARI™. Curium leads commercialization through a licensing deal with Progenics Pharmaceuticals, Inc., a Lantheus company.
This new partnership is an important step. It will make advanced prostate cancer diagnostics easier to access in Japan. It combines Lantheus Holdings’ advanced imaging technology with GE HealthCare ’s expertise in radiopharmaceuticals.
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