Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its incubated company SynuSight Biotech, has signed the non-exclusive clinical use license agreement of 18F-FD4 (“FD4”) with ABLi Therapeutics (“ABLi”).

ABLi will utilize FD4 in clinical trials for its c-Abl kinase inhibitor, risvodetinib, aiming to evaluate the aggregation levels of alpha-synuclein pathological protein in the brains of Parkinson’s disease (PD) patients before and after treatment. As part of this licensing collaboration, SynuSight Biotech will receive an upfront payment and subsequent license-related fees from ABLi. The ability of FD4 to visualize alpha-synuclein pathology in the central nervous system will be leveraged to complement the novel blood-borne and tissue biomarkers developed by ABLi and its collaborators, establishing an integrated framework for comprehensive evaluation of the therapeutic effects of risvodetinib in PD. Simultaneously, both parties have established a strategic collaboration with the professional imaging services company XingImaging, which will be responsible for the production of FD4 in the United States and PET imaging analysis work.

The development of PD therapies has long faced challenges due to the lack of assessment tools that can directly and objectively reflect the impact of drugs on the underlying pathology. SynuSight Biotech’s self-developed FD4 is a high-selectivity and high-affinity PET tracer designed to visualize and quantify alpha-synuclein pathological protein aggregation in human brain. ABLi plans to implement the FD4 PET tracer in two clinical trials in 2026—including a longitudinal biomarker study and a Phase 2b/3 efficacy study—to dynamically monitor or track changes in brain alpha-pathological burden before and after treatment, further validating the therapeutic potential of risvodetinib at the imaging biomarker level.

This collaboration represents a key milestone in the global development of FD4. By integrating molecular imaging technologies with rigorously designed clinical trials and longitudinal follow-up, the partnership aims to directly interrogate the disease-modifying potential at the pathological level. This approach is expected to overcome the limitations of relying solely on clinical scores to evaluate efficacy, providing more quantitative and pathologically relevant assessment tools for drug development in PD and related α-synucleinopathies.

About 18F-FD4

18F-FD4 is a selective, high-affinity PET tracer developed by SynuSight to image pathogenic α-synuclein in Parkinson’s disease and related α-synucleinopathies. 18F-FD4 has demonstrated efficient blood-brain barrier penetration, a clear and stable imaging window with rapid washout, low off-target binding, and favorable safety in both preclinical studies and investigator-initiated trials at Huashan Hospital. In patients with PD and MSA, 18F-FD4 has consistently produced high-contrast signals in pathology-relevant brain regions and shown robust disease-differentiation performance. Earlier in 2025, 18F‑FD4 received a $3.84 million research grant from the Michael J. Fox Foundation for Parkinson’s Research (MJFF)—the world’s largest nonprofit philanthropy of PD research—to support its U.S. clinical registration and development, underscoring the strong scientific rationale and clinical potential of this novel α-synuclein PET tracer. This funding award highlights the confidence of leading international research institutions in 18F-FD4 as a next-generation imaging biomarker, and clinical development is expected to begin in both the U.S. and China in the first quarter of 2026.

About SynuSight Biotech

SynuSight Biotech is committed to pioneering transformative diagnostic solutions for neurodegenerative diseases through cutting-edge scientific expertise and innovative technology platforms, ultimately benefiting millions of patients worldwide.  SynuSight specializes in studying the misfolding and pathological aggregation of proteins such as alpha-synuclein, tau, and A-beta. By integrating cutting-edge technologies like Cryo-EM electron diffraction, helical filament imaging, and In-cell NMR spectroscopy, we have built unparalleled expertise in key neurodegenerative disease targets, unlocking new possibilities for innovative therapeutic solutions development.

About ABLi Therapeutics

ABLi Therapeutics (“ABLi”) applies innovative medicinal chemistry and a deep understanding of disease biology to develop small molecule therapeutics that target the cause of diseases that arise from activation or dysfunction of the Abelson Tyrosine Kinases (c-Abl). Leveraging its expertise in drug design, ABLi utilizes clinically validated data of kinase inhibitors to design and develop novel product candidates with enhanced penetration into the brain, greater potency and target selectivity, and improved safety to treat diseases in which Abl kinase activation or dysfunction is implicated. The Company’s primary focus is on developing therapeutics for the treatment of neurodegenerative diseases like Parkinson’s disease and the Parkinson’s-related neurodegenerative diseases Multiple System Atrophy and Dementia with Lewy Body, that are all associated with Abl kinase activation or dysfunction. For more information visit www.ablitherapeutics.com or follow us on LinkedIn.

Developed by Abli, risvodetinib is a potent, selective small-molecule inhibitor of the non-receptor c-Abl kinases, designed for once-daily oral use that targets the underlying biological mechanisms driving Parkinson’s disease initiation and progression. Risvodetinib is believed to be a disease-modifying therapy that halts disease progression and reverses the functional loss arising from Parkinson’s disease inside and outside of the brain.