XellSmart’s universal cell therapy drug for Parkinson’s disease receives Fast Track designation from the US FDA
On July 28, 2026, XellSmart Bio‘s independently developed allogeneic universal “off-the-shelf” XS411 cell therapy injection, for the treatment of Parkinson’s disease, the world’s second most prevalent neurodegenerative disease, officially received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). This designation signifies that XS411 cell therapy has gained high recognition from U.S. regulatory agencies in addressing the severe unmet clinical needs of Parkinson’s disease, marking a significant milestone in the product’s international development.
FDA Fast Track designation accelerates clinical development in both China and the US.
Fast Track designation is an important special review pathway established by the FDA to accelerate the development of investigational drugs that treat serious diseases and fill clinical gaps.
According to FDA regulations, obtaining this designation will grant XellSmart several benefits: First, it will be able to communicate and exchange information with the FDA more frequently and in greater depth throughout the entire R&D cycle, optimizing clinical trial design and development pathways; second, it will be able to submit new drug applications in stages (i.e., rolling review), shortening the review time; and third, it will have the opportunity to obtain priority review status when conditions are met, accelerating the review process. These mechanisms will significantly accelerate the clinical development and market launch of XS411 injection for the treatment of Parkinson’s disease in the United States.
Previously, XS411 injection had already achieved “dual approval in China and the US.” In January 2025, the US FDA granted its IND application without any supplemental approvals and simultaneously granted it a Special New Drug Exemption (SDO). In April 2025, the China National Medical Products Administration (NMPA) also approved its new drug registration clinical trial application. This latest SDO approval signifies further recognition from US regulatory agencies of the potential of XS411 injection in addressing unmet clinical needs in Parkinson’s disease.
S411 clinical data continues to validate the results; the nationwide multicenter registration phase II clinical trial has completed full enrollment.
Parkinson’s disease is the second most common neurodegenerative disease worldwide, with over 10 million patients globally, including approximately 4 million in China, accounting for nearly 40% of the global total. With accelerating population aging, this number is projected to reach 5 million by 2030. The disease is characterized by the progressive degeneration and death of dopaminergic neurons in the substantia nigra of the midbrain, clinically manifesting as resting tremor, rigidity, bradykinesia, and postural and gait abnormalities, severely impacting patients’ quality of life. Currently, there are no drugs available to slow or reverse the progression of neurodegenerative diseases; existing treatments only alleviate symptoms, leaving a significant clinical gap.
XS411 injection is an innovative treatment strategy designed specifically for this cause of the disease. This product aims to restore neural function by transplanting healthy iPSC-derived dopaminergic progenitor cells into the patient’s brain to replace degenerated and dying dopaminergic neurons. The product is named after World Parkinson’s Day (April 11th), reflecting the Shize Biotechnology team’s commitment to prioritizing patient needs.
In terms of clinical research, XS411 injection has achieved solid interim data. In 2025, the Phase I clinical trial for XS411 injection, initiated by the National Neurological Disease Medical Center—Beijing Tiantan Hospital affiliated with Capital Medical University, will be conducted. Continuous follow-up data shows that the product has good safety and tolerability. After transplantation, the subjects’ “off” MDS-UPDRS III motor scores, “on” time, and quality of life scores were significantly improved compared to before transplantation. Molecular imaging examinations confirmed that the transplanted cells had engrafted, survived, differentiated, and produced dopamine neurotransmitter synthesis and metabolism capabilities in the brain.
Building on this foundation, the nationwide multicenter registration phase II clinical trial of XS411 for the treatment of Parkinson’s disease has been rapidly progressing. This trial, officially approved by the National Medical Products Administration, is led by the National Center for Neurological Diseases – Beijing Tiantan Hospital affiliated with Capital Medical University, with Professor Feng Tao, a leading domestic expert in Parkinson’s disease, serving as the principal investigator. It is a collaborative effort involving authoritative centers and research teams from Peking Union Medical College Hospital, the Second Affiliated Hospital of Soochow University, Jiangsu Provincial People’s Hospital, and West China Hospital of Sichuan University. This is the first domestic registration clinical trial of iPSC-derived cells for primary Parkinson’s disease led by the National Center for Neurological Diseases, and enrollment of all participants has been successfully completed.
The trial adopted the internationally recognized PROBE blinded assessment design (prospective, randomized, open-label, blinded endpoint assessment). Compared with traditional single-arm open-label clinical studies, it has significantly higher levels of evidence-based medicine. While taking into account the characteristics of clinical implementation of cell therapy, it can further improve the quality of the study through randomized controlled trials and blinded endpoint assessment, providing more reliable efficacy evidence for subsequent Phase III registration clinical trials and market approval.
Meanwhile, the XS411 cell injection project for the treatment of primary Parkinson’s disease has been supported by the National Science and Technology Major Project for Innovative Drug Development. Led by Shize Biotech, in conjunction with Tongji University, the National Institutes for Food and Drug Control, Beijing Tiantan Hospital, and Peking Union Medical College Hospital, it is China’s first National Science and Technology Major Project for the treatment of Parkinson’s disease with a novel drug derived from universal iPSCs.
To date, XellSmart has obtained approval for nine registration clinical trials in China and the United States, placing it in a globally leading or pioneering position in the fields of Parkinson’s disease, ALS, and other neurological diseases. With the steady progress of registration clinical trials in China and the United States, this domestically developed iPSC-derived cell therapy is expected to provide nearly ten million Parkinson’s disease patients worldwide with a novel treatment strategy that can significantly improve both symptoms and disease progression.
Founded by Dr. Xiang Li, who returned to China full-time, XellSmart has formed an internationally competitive, all-in professional team focused on the research and development of iPSC-derived cell-based drugs. The team covers the core aspects of the research and development and industrialization of iPSC-derived neural cell drugs. The core team members come from renowned universities at home and abroad or well-known companies in the cell therapy industry. The team possesses the most cutting-edge stem cell therapy technologies and translational experience in the international and industrial sectors.
Source: XellSmart Bio | Top Image: iStock
