SynuSight's SST001 α-Synuclein PET Tracer Receives NMPA Approval for Phase I Clinical Trial in China
核心洞察
SynuSight Biotech (搜索)'s SST001 (搜索), an α-synuclein (搜索)-targeted PET tracer, has received NMPA approval to initiate Phase I clinical trials in China, marking a significant advancement in neurodegenerative disease diagnostics.
The non-randomized, open-label study will evaluate safety, tolerability, and pharmacokinetics in healthy volunteers and patients with Parkinson's disease (搜索) and multiple system atrophy (搜索) at two major Chinese hospitals.
SST001 (搜索) aims to provide objective, quantifiable imaging evidence for early diagnosis and disease subtyping of α-synucleinopathies (搜索), addressing current diagnostic limitations that rely primarily on clinical symptom assessment.
Mabwell (搜索)'s incubated company SynuSight Biotech (搜索) has achieved a significant regulatory milestone with the National Medical Products Administration (NMPA) approval of SST001 (搜索), an α-synuclein (搜索)-targeted PET tracer, to initiate Phase I clinical trials in China. The approval represents a major advancement in diagnostic imaging for neurodegenerative diseases, particularly Parkinson's disease (搜索) and multiple system atrophy (搜索).
Clinical Trial Design and Objectives
The approved Phase I study is designed as a non-randomized, open-label trial that will be conducted at two prominent medical institutions: Huashan Hospital at Fudan University and the Affiliated Hospital of Jiangnan University. The study protocol includes enrollment of healthy volunteers alongside patients diagnosed with multiple system atrophy (搜索) (MSA) and Parkinson's disease (搜索) (PD).
The primary objectives focus on comprehensive safety and pharmacological evaluation, including assessment of safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001 (搜索). These data will provide crucial support for subsequent clinical development phases.
Addressing Diagnostic Limitations in α-Synucleinopathies
Abnormal aggregation and deposition of α-synuclein (搜索) protein represent key pathological features of α-synucleinopathies (搜索), including PD and MSA. Current clinical diagnosis relies predominantly on clinical symptom assessment and indirect functional imaging biomarkers, creating significant limitations in early and accurate diagnosis.
SST001 (搜索), validated through Investigator-Initiated Trial (IIT) studies, enables in vivo, real-time, qualitative, and quantitative detection of α-synuclein (搜索) pathology. The tracer is expected to provide more objective and quantifiable imaging evidence for early diagnosis and disease subtyping of PD and MSA, while also offering potential imaging support for subject screening and efficacy evaluation in clinical trials of related therapeutic drugs.
Disease Burden and Market Need
According to data from the Global Burden of Disease (GBD) Study 1990-2021, approximately 11.8 million PD patients existed worldwide in 2021, with Chinese patients accounting for more than 40% of this population. In China specifically, the number of PD patients increased dramatically from 651,800 in 1990 to 5.077 million in 2021, driven primarily by population aging.
While MSA is classified as a rare disease, it presents particular clinical challenges due to its rapid progression and poor prognosis, with a median survival of only 6 to 10 years, resulting in significant disease burden for patients and healthcare systems.
International Development and Funding
SST001 (搜索) has garnered substantial international recognition and support. The tracer, developed in partnership with XingImaging (搜索), received a research grant of US$3.84 million from The Michael J. Fox Foundation (搜索) for Parkinson's Research (MJFF), specifically designated to support clinical research advancement in the United States.
In January 2026, SST001 (搜索) received Research IND clearance from the U.S. FDA, enabling the initiation of clinical studies with successful dosing of the first subject. Data collection is ongoing, and SST001 has now entered the clinical stage in both China and the United States, marking a new phase of global development.
Technology Platform and Company Background
SynuSight Biotech (搜索) specializes in studying the misfolding and pathological aggregation of proteins including alpha-synuclein, tau, and A-beta. The company integrates cutting-edge technologies such as Cryo-EM electron diffraction, helical filament imaging, and In-cell NMR spectroscopy to build expertise in key neurodegenerative disease targets.
Parent company Mabwell (搜索) (688062.SH) operates as an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain, focusing on oncology and aging-related diseases. The company's mission centers on "Explore Life, Benefit Health" with a vision of "Innovation, from Ideas to Reality."