Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that 18F-FD4 (R&D code: SST001), an α-synuclein (α-syn) targeted PET tracer independently developed by its incubated company SynuSight Biotech, has recently been approved by the National Medical Products Administration (NMPA) to initiate a Phase I clinical trial.

The clinical trial to be initiated is a non-randomized, open-label study to be conducted at Huashan Hospital, Fudan University and the Affiliated Hospital of Jiangnan University. The study plans to enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson's disease (PD). The primary objectives are to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001, thereby supporting subsequent clinical development.

Abnormal aggregation and deposition of α-syn protein are key pathological features of α-synucleinopathies such as PD and MSA. However, current clinical diagnosis still relies mainly on clinical symptom assessment and indirect functional imaging biomarkers. As an α-syn-specific PET molecular tracer validated through IIT (Investigator-Initiated Trial) studies, SST001 enables in vivo, real‑time, qualitative, and quantitative detection. It is expected to provide more objective and quantifiable imaging evidence for early diagnosis and disease subtyping of PD and MSA, as well as potential imaging support for subject screening and efficacy evaluation in clinical trials of related therapeutic drugs.

According to data from the Global Burden of Disease (GBD) Study 1990–2021, there were approximately 11.8 million PD patients worldwide in 2021, of which Chinese patients accounted for more than 40%. In China, the number of PD patients increased significantly from 651,800 in 1990 to 5.077 million in 2021, driven mainly by population aging. Although MSA is a rare disease, it progresses more rapidly and has a poorer prognosis, with a median survival of only 6 to 10 years, resulting in a significant disease burden.

Previously, SST001, partnering with XingImaging, has received high recognition from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and obtained a research grant of US$3.84 million, which will be specifically used to support its clinical research advancement in the United States. In January this year, SST001 received a Research IND clearance from the U.S. FDA, and clinical studies have been successfully initiated with the first subject dosed. Relevant data are being continuously collected. SST001 has now entered clinical stage in both China and the United States, entering a new phase of global development.

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.