September 19, 2025 - MITRO's subsidiary XingImaging, in collaboration with SynuSight Biotech, announced today that they have received a $3.84 million research grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to support the development of ¹⁸F-FD4, an α-synuclein (α-syn)-targeted PET tracer. Based on preclinical data and Investigator-Initiated Trials (IIT), SynuSight's ¹⁸F-FD4 tracer has the potential to become the world's first α-syn-targeted PET tracer for Parkinson's disease (PD), multiple system atrophy (MSA), and rapid eye movement sleep behavior disorder (RBD).

XingImaging, a leading neuroimaging and radiopharmaceutical services company, serves as SynuSight's preclinical and clinical research partner. Under this grant framework, XingImaging will provide critical support for regulatory filings and clinical trial execution, while contributing essential scientific expertise to help drive the project toward clinical translation.

Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease, estimated to affect over 10 million people worldwide. PD is characterized by the progressive loss of dopamine neurons and the accumulation of pathological α-synuclein aggregates in the brain, leading to debilitating motor symptoms (such as tremors and rigidity) and non-motor symptoms (including cognitive decline and loss of smell).

Current diagnosis relies heavily on clinical symptom assessment, which often delays detection until significant neuronal damage has occurred. Early symptoms, such as subtle movement changes or sleep disturbances, frequently overlap with other conditions, complicating accurate diagnosis. Existing clinical imaging tools for PD (e.g., DATScan) provide valuable insights into dopaminergic dysfunction or metabolic changes but crucially lack molecular specificity for biomarkers. This limitation has hindered timely intervention and the development of disease-modifying therapies aimed at halting or reversing disease progression.

Leveraging structural biology approaches, SynuSight's R&D team systematically determined the molecular architecture of α-synuclein fibrils and investigated the binding specificity between candidate molecules and this pathological biomarker. ¹⁸F-FD4, independently developed by SynuSight based on strong scientific foundations from the Interdisciplinary Research Center on Biology and Chemistry at the Chinese Academy of Sciences, is a radioactive PET tracer designed to target pathological α-synuclein with high affinity and specificity. Preclinical and early clinical data demonstrate that ¹⁸F-FD4 exhibits robust and selective binding to α-synuclein fibrils, enabling the identification of α-syn pathology in the early stages of synucleinopathies and facilitating proactive treatment strategies.

Roger Gunn, Chief Scientific Officer and Principal Investigator at XingImaging, stated, "This represents a pivotal opportunity to advance one of the most promising alpha-synuclein PET tracers in humans, ensuring its comprehensive characterization and optimization for imaging in Parkinson's disease. We are deeply grateful for the support of The Michael J. Fox Foundation and share their commitment to developing a robust PET imaging biomarker targeting the core pathological hallmark of PD. Such a biomarker would significantly enhance our understanding of the disease and its progression and will play a central role in clinical trials evaluating new treatments."

Professor Junying Yuan, Director of the Interdisciplinary Research Center on Biology and Chemistry at the Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences, commented, "We thank the MJFF for its research support of the ¹⁸F-FD4 program. Based on previous extensive research at the Center, this project makes the previously invisible pathology in the brains of Parkinson's patients visible, offering new possibilities for treating this important neurodegenerative disease. The close collaboration between SynuSight Biotech and the Center has rapidly advanced the project to clinical validation, with the potential to benefit tens of millions of Parkinson's patients worldwide. This is a landmark case of translation from original discovery to clinical application."

Dr. Jamie Eberling, Senior Vice President of Research Resources at MJFF, said, "We continue to monitor the tremendous progress and advances in alpha-synuclein imaging. The research by XingImaging and SynuSight Biotech represents another hopeful step toward a urgently needed tool that could clearly measure, quantify and visualize brain pathology in Parkinson's disease."

About The Michael J. Fox Foundation
The Michael J. Fox Foundation (MJFF), founded by renowned actor Michael J. Fox, is the largest nonprofit organization dedicated to Parkinson's disease research globally. MJFF is committed to funding innovative, translatable research projects aimed significantly improving the quality of life for Parkinson's patients. As one of the world's leading drivers of Parkinson's research, MJFF actively collaborates with funded organizations to address key scientific challenges and accelerate the translation and clinical application of new technologies. To date, the foundation has invested over $2 billion in Parkinson's-related research, continually bringing hope and progress to patients worldwide.

About SynuSight Biotech
SynuSight Biotech, building upon the strong scientific foundation of the Interdisciplinary Research Center on Biology and Chemistry at the Chinese Academy of Sciences, is dedicated to leveraging solid research and pioneering technology platforms to enable transformative diagnostic and therapeutic solutions for neurodegenerative diseases, ultimately benefiting tens of millions of patients globally. The core team has extensive research experience in the field of pathological protein phase transition and aggregation, and utilizes platforms such as cryo-electron microscopy, artificial intelligence, and computational biology to develop first-in-class and best-in-class diagnostic molecules for key targets in various neurodegenerative diseases.

SynuSight has pioneered a new structure-driven drug discovery paradigm, conducting extensive structural analysis and ligand interaction mechanism studies on α-synuclein aggregates, the core pathological protein in Parkinson's disease. This effort resulted in the clinical candidate molecule ¹⁸F-FD4 (R&D code: SST001), which has demonstrated high sensitivity and specific recognition capability in IIT trials involving dozens of patients. It holds the potential to provide transformative solutions for the diagnosis and treatment of PD, MSA and other diseases.

About MITRO
Founded in 2012, MITRO specializes in providing professional and efficient radioactive isotope-labeled molecular imaging CRO and CDMO services to the global pharmaceutical and biotech industries. Using radiolabeling and molecular imaging technologies, MITRO offers drug screening, biodistribution, pharmacokinetic studies, and pharmacodynamic evaluation services to domestic and international pharmaceutical companies and research institutions. Additionally, it provides comprehensive one-stop solutions for radiopharmaceutical development, including labeling method development, pharmaceutical research, non-clinical studies, clinical research, and regulatory submissions.

About XingImaging
XingImaging, a leading neuroimaging and radiopharmaceutical services company, is a wholly-owned overseas subsidiary of MITRO Biotech Co., Ltd. The company's headquarters are located in New Haven, Connecticut, with over 24,000 square feet of research space and more than 40 staff members. The overseas team is organized into Clinical Research, Chemistry, and Imaging Sciences divisions, with administrative and project support including Regulatory Affairs, Quality Assurance, Imaging and Data Management Services, Information Technology, and Business Operations.