ShanghaiJune 3, 2026 /PRNewswire/ — On June 2, 2026, the “Parkinson’s Disease Early Diagnosis Achievements and Clinical Translation Conference & Launch of China’s First α-syn PET Tracer SST001 Entering Registered Clinical Study” was successfully held at Huashan Hospital, Fudan University. The event was jointly organized by Huashan Hospital, Fudan University; the Interdisciplinary Research Center on Biology and Chemistry, Chinese Academy of Sciences; and Shanghai Jiao Tong University, and hosted by Sinusai Biotechnology, an invested and incubated company of Mabwell. The conference brought together top experts and scholars from industry, academia, research, and medical fields to engage in in-depth exchanges on the translation of early diagnosis for Parkinson’s disease.
This conference focused on the clinical needs for early diagnosis and precise subtyping of neurodegenerative diseases such as Parkinson’s disease (PD) and multiple system atrophy (MSA). It highlighted progress in the clinical translation of α-syn PET molecular imaging and the latest research findings on the TPPP/p25-SAA fluid detection method for precise MSA diagnosis. Additionally, SST001 injection officially announced the initiation of its Phase I clinical study.
Leaders including Mao Ying, President of Huashan Hospital, Fudan University; Yuan Junying, Director of the Interdisciplinary Research Center on Biology and Chemistry, Chinese Academy of Sciences; Ding Kuiling, President of Shanghai Jiao Tong University; Lu Bai, President of the Shanghai Institute of Natural Sciences; Shen Hong, Head and Senior Vice President of Roche China Innovation Center; and Liu Datao, Chairman and CEO of Mabwell, attended the meeting and delivered speeches. Representatives from various fields, including Professor Guan Yihui, Professor Wang Jian, Professor Zhang Jing, and Professor Zuo Chuantao from Huashan Hospital, Fudan University; Researcher Liu Cong from the Interdisciplinary Research Center on Biology and Chemistry, Chinese Academy of Sciences; Professor Yu Chunjing from the Affiliated Hospital of Jiangnan University; Professor Li Dan from Shanghai Jiao Tong University; and Fan Mengqi, CEO of Sinusai Biotechnology, also attended the conference.
Focusing on Unmet Clinical Needs, Exploring New Pathways for α-syn In Vivo Visualization
PD and MSA are typical α-synucleinopathies, characterized pathologically by abnormal folding of α-syn and the formation of pathological aggregates. However, for a long time, there has been a lack of clinical tools to directly observe α-syn pathological deposits in living organisms. Addressing this need, the joint Parkinson’s disease research team, comprising the Interdisciplinary Research Center on Biology and Chemistry, Chinese Academy of Sciences; Shanghai Jiao Tong University; Huashan Hospital, Fudan University; and Sinusai Biotechnology, leveraged the synergistic advantages of basic research, clinical resources, and industrial translation. They advanced a collaborative innovation pathway of “basic research discovery—clinical need-driven—industrial translation validation,” accelerating the progression of original achievements toward clinical application. The translational outcome of this joint effort, SST001, is China’s first domestically developed α-syn PET tracer to enter registered clinical research. Labeled with the [18F] radionuclide, it specifically targets α-syn pathological proteins and can be used in conjunction with PET/CT for the auxiliary diagnosis and differential diagnosis of α-synucleinopathies such as PD and MSA.
At the conference, Researcher Liu Cong from the Interdisciplinary Research Center on Biology and Chemistry, Chinese Academy of Sciences, and Professor Wang Jian from Huashan Hospital, Fudan University, presented the results of SST001’s early preclinical studies and Investigator-Initiated Trial (IIT). The results showed that SST001 has good blood-brain barrier permeability and favorable pharmacokinetic characteristics for brain imaging, enabling effective brain uptake. It also achieves high pathological signal contrast through low non-specific retention and rapid brain clearance. In human PET studies, SST001 produced clear, stable, and interpretable α-syn-related imaging signals in pathological brain regions of PD and MSA patients, demonstrating a favorable disease-related spatial distribution pattern. These findings provide an important research foundation for its subsequent registered clinical development.
The Phase I clinical study of SST001 aims to systematically evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetic characteristics of SST001 injection in healthy volunteers, MSA patients, and PD patients. It will also preliminarily explore its PET imaging performance in different α-synucleinopathy populations, providing a basis for subsequent registered clinical development, standardization of imaging procedures, and establishment of an image interpretation system.
TPPP/p25-SAA Fluid Detection Method Offers New Insights for Precise MSA Diagnosis
The conference also introduced the latest research progress of the joint team in the field of precise MSA diagnosis. Recently, a collaborative study by Professor Li Dan’s team at Shanghai Jiao Tong University, Researcher Liu Cong’s team at the Interdisciplinary Research Center on Biology and Chemistry, Chinese Academy of Sciences, and Professor Wang Jian’s team at Huashan Hospital, Fudan University, was published in Cell, reporting significant advances in MSA-specific fluid detection methods. Professor Li Dan presented these research findings on behalf of the collaborative team at the conference.
TPPP/p25 is a microtubule-associated protein. The research team discovered that during the pathological process of MSA, TPPP/p25 can form disease-specific pathological amyloid seeds, which can be detected in patients’ cerebrospinal fluid. Based on this discovery, the team optimized the design using miniCORE as an amplification substrate to establish a TPPP/p25 seed amplification assay (TPPP/p25-SAA). This method enables the amplification and detection of trace amounts of TPPP/p25 pathological seeds in cerebrospinal fluid. The results showed that this method has good specificity for MSA-related pathological signals and can be used to distinguish MSA from PD, dementia with Lewy bodies (DLB), and healthy controls, providing a new technical approach for the early identification and molecular subtyping diagnosis of MSA.
It was stated at the conference that, leveraging Sinusai Biotechnology’s experience in diagnostic product development, clinical research, and translational advancement, the project will further promote the transition of TPPP/p25-SAA technology from scientific discovery to clinical validation, accelerating its development and application exploration in the field of MSA fluid detection technology.
The successful convening of this conference and clinical launch marks the official entry of the SST001 injection Phase I clinical study into the implementation phase. It also signifies a significant step forward for Sinusai Biotechnology in the fields of α-syn PET molecular imaging and precise diagnosis of neurodegenerative diseases. In the future, Sinusai Biotechnology will continue to be guided by clinical needs, leveraging the synergistic advantages of basic research, clinical resources, and industrial translation to help achieve earlier and more precise diagnostic subtyping for diseases such as PD and MSA.
About SST001
SST001 injection is a PET tracer developed by Sinusai Biotechnology, labeled with the [18F] radionuclide and specifically targeting α-syn pathological proteins. It is used in conjunction with PET/CT for the auxiliary diagnosis and differential diagnosis of α-synucleinopathies such as PD and MSA. This project focuses on the international frontier challenge of in vivo visualization of α-syn pathological aggregates. It systematically conducted early preclinical studies and Investigator-Initiated Trials (IIT), addressing key indicators such as tracer specificity, brain uptake, rapid clearance, imaging signal-to-noise ratio, and clinical applicability.
Based on a solid foundation of prior scientific research and clinical translation potential, SST001 received a research grant of $3.84 million from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to support its Research IND-related studies in the United States. The relevant clinical study was initiated in the U.S. in September 2025, with subject enrollment and dosing completed, and is currently in the data collection phase. In April 2026, SST001 received approval from the NMPA to conduct a Phase I clinical study.
About Mabwell
Mabwell (688062.SH, 02493.HK) is an innovative biopharmaceutical company with a full industry chain layout. Adhering to the vision of “Turning Innovation into Reality” and the mission of “Exploring Life, Benefiting Health,” the company is committed to providing patients with better and more accessible innovative biologics through source innovation, addressing unmet global clinical needs. Since its establishment in 2017, Mabwell has built an innovation system covering the entire drug R&D cycle, starting from antibody drug target discovery and molecular discovery, and encompassing druggability research, preclinical research, clinical research, and production translation, achieving a full industry chain layout integrating R&D, production, and marketing. The company focuses on oncology and age-related diseases, involving therapeutic areas such as oncology, autoimmune diseases, bone diseases, ophthalmology, hematology, and cardiovascular diseases. Leveraging its multi-field distinctive technology platforms and R&D innovation capabilities, Mabwell has established a rich and competitive pipeline. It currently has 16 key programs in preclinical, clinical, or marketing stages, including 12 innovative programs and 4 biosimilars. Among these, 4 programs have been launched, 1 is under marketing review, and 2 are in Phase III pivotal registration clinical studies. The company independently undertakes 1 major national “Major New Drug Creation” science and technology project, 2 national key R&D programs, and multiple provincial and municipal science and technology innovation projects. With innovation as its foundation, Mabwell emphasizes industrial translation. Its antibody and recombinant protein drug industrialization base, compliant with China NMPA, U.S. FDA, and EU EMA GMP standards, has been put into operation in Taizhou, Jiangsu Province, and has passed EU QP audits. Large-scale commercial production bases in Jinshan, Shanghai, and Taizhou, Jiangsu, are under construction. For more information, please visit: www.mabwell.com.
Forward-Looking Statements
The information released in this press release may contain certain forward-looking statements. These statements are inherently subject to significant risks and uncertainties. When using words such as “anticipate,” “believe,” “predict,” “expect,” “intend,” and other similar expressions, statements related to the company are intended to identify forward-looking statements. The company is under no obligation to continuously update these forward-looking statements.
These forward-looking statements are based on the company management’s current views, assumptions, expectations, estimates, predictions, and understanding of future events at the time the statements are made. These statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond the company’s control and difficult to predict. Therefore, actual results may differ materially from the information contained in the forward-looking statements due to future changes and developments in our business, competitive environment, and political, economic, legal, and social conditions.
The company, its directors, employees, and agents assume no obligation to (a) correct or update any forward-looking statements contained on this website; and (b) assume any liability arising from the failure of any forward-looking statement to materialize or becoming incorrect.