![A global licensing agreement has been signed for the development and commercialization of SOFIE’s two investigational Gallium-68 and Fluorine-18 Fibroblast Activation Protein Inhibitors (FAPI) radiopharmaceutical diagnostics - [68Ga]FAPI-46 and outside-U.S. rights for [18F]FAPI-74](/sites/default/files/styles/content_large/public/Cancer_associated_fibroblasts_%28CAFs%29_and_the_tumour_microenvironment.jpeg?itok=BeB-GWoq)
Illustrative example: cancer associated fibroblasts (CAFs) and the tumor microenvironment. (Photo: Business Wire)
October 11, 2023 — GE HealthCare today announced an exclusive global licensing agreement with SOFIE Biosciences (SOFIE), a Virginia, U.S.-based company, to develop, manufacture and commercialize SOFIE’s Gallium-68 and Fluorine-18labelled diagnostics targeting fibroblast activation protein (FAP). Financial terms were not disclosed. Based on this agreement, GE HealthCare will take on global rights for [68Ga]FAPI-46 and outside-US rights for [18F]FAPI-74, originally developed at Heidelberg University in Germany, and both currently in Phase II clinical trials in the U.S. ([68Ga]FAPI-46 (NCT05262855)2 and [18F]FAPI-74 (NCT05641896)3). SOFIE will continue its clinical development and commercialization program with [18F]FAPI-74 in the U.S.
FAP is an enzyme highly expressed in cancer associated fibroblasts (CAF), a key component of the tumor microenvironment which supports the growth and spread of cancerous cells. With CAF present in most tumor types including, for example, breast, pancreatic, colorectal, lung, liver and gastric, the development of FAP-targeted diagnostics holds great potential in oncology as well as other conditions including inflammation, fibrosis and arthritis4.
Building on the momentum created by SOFIE’s sponsored trials in the U.S. and FAPI Global Outreach Program which engages with 130 academic institutions in 39 countries to unlock FAPI’s clinical utility, GE HealthCare aims to develop FAP imaging products through clinical trials and towards regulatory submission, and potential commercialization in various regions. SOFIE and GE HealthCare will collaborate on both the development and commercialization processes through a joint steering committee.
Usankar Thiru, Strategy & Evaluation Director with GE HealthCare’s Pharmaceutical Diagnostics segment said: “Working with SOFIE to add these FAPI assets to our next generation portfolio of investigational targets is a significant milestone and aligns with our vision to expand our innovation pipeline to enable precision care for personalized treatment decision making. As a standalone company, we are keen to collaborate with companies like SOFIE in this way – bringing our size, scale and unique perspective as a developer, of both radiopharmaceuticals and the scanners needed to utilize them, to drive innovation in healthcare to benefit patients and clinicians.”
Sherly Mosessian, Ph.D, SOFIE’s Chief Scientific Officer, added: “The FAPI family of compounds have shown to have tremendous potential in diagnostic and companion diagnostic use in various oncologic and non-oncologic indications. I am very excited that we are collaborating with GE HealthCare, on a worldwide scale, to help jointly unlock the full promise of these products.”
GE HealthCare’s Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology.
For more information: www.gehealthcare.com
November 13, 2025 
