SHANGHAI, CHINA, April 14, 2026
Mabwell (688062.SH) has announced that SST001 (18F-FD4), an innovative α-synuclein-targeted PET tracer developed by its incubated company SynuSight Biotech, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical trial. This milestone marks a significant step forward in the development of advanced molecular imaging technologies for neurodegenerative diseases, particularly Parkinson’s disease (PD) and multiple system atrophy (MSA). The approval underscores the growing importance of diagnostic innovation and regulatory pathways in accelerating early-stage clinical research.
Phase I Trial to Evaluate Safety and Imaging Performance
The upcoming Phase I study is designed as a non-randomized, open-label clinical trial, to be conducted at leading research institutions including Huashan Hospital, Fudan University and the Affiliated Hospital of Jiangnan University. The trial will enroll healthy volunteers, Parkinson’s disease patients, and individuals with multiple system atrophy, with primary endpoints focusing on safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001.
These evaluations are essential for establishing the tracer’s clinical safety profile and imaging capabilities, supporting its progression into later-stage trials. The study also highlights the importance of GCP-compliant clinical trial design and regulatory oversight in the development of novel diagnostic agents.
Targeting α-Synuclein for Early Disease Detection
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SST001 represents a next-generation PET molecular imaging agent specifically designed to target α-synuclein protein aggregates, which are a hallmark of neurodegenerative disorders such as PD and MSA. Unlike conventional diagnostic approaches that rely on clinical symptom assessment and indirect biomarkers, SST001 enables real-time, in vivo visualization and quantification of pathological protein deposition.
This capability has the potential to significantly improve early diagnosis, disease differentiation, and patient stratification, addressing a major unmet need in neurology. By providing objective imaging biomarkers, SST001 could also play a critical role in clinical trials of therapeutic drugs, supporting patient selection and treatment response evaluation.
Global Development Momentum and Clinical Expansion
SST001 has already demonstrated strong global momentum, having received Research IND clearance from the U.S. FDA earlier this year, with clinical studies initiated and the first subject dosed. The tracer has also gained recognition from the Michael J. Fox Foundation for Parkinson’s Research, securing a $3.84 million research grant to support its development. With clinical programs now underway in both China and the United States, SST001 is entering a global clinical development phase, reflecting increasing interest in precision diagnostics for neurodegenerative diseases. The expanding development footprint underscores the importance of international regulatory alignment and cross-border clinical research collaboration.
Addressing a Growing Global Disease Burden
Neurodegenerative diseases such as Parkinson’s disease represent a significant and growing global health burden, with approximately 11.8 million patients worldwide and a rapidly increasing prevalence driven by aging populations. In China alone, the number of PD patients has risen dramatically, exceeding 5 million cases, highlighting the urgent need for advanced diagnostic and therapeutic solutions.
Multiple system atrophy, although rarer, is associated with rapid disease progression and poor prognosis, further emphasizing the need for early and accurate diagnosis. Innovations such as SST001 are expected to play a crucial role in improving disease management, clinical research, and patient outcomes.
The NMPA approval for SST001 to enter Phase I clinical trials marks a pivotal advancement in the field of neurodegenerative disease diagnostics and molecular imaging. With its innovative mechanism targeting α-synuclein, strong regulatory support, and global development strategy, SST001 has the potential to transform how diseases like Parkinson’s and MSA are diagnosed and managed. As the healthcare industry continues to emphasize precision medicine and early detection, this development highlights the growing role of bio-pharmaceutical innovation and advanced diagnostic technologies in shaping the future of neurological care.
Source: Mabwell press release
