Drug intelligence / Profile preview

XS-411

Development stage
Phase 2
Lead developer
XellSmart Biomedical
Modality
iPSCs → Pluripotent Stem Cells → Stem Cell Therapies → Cell Therapies
Administration
Intracerebral
01

Overview

XS-411 is an allogeneic, off-the-shelf cell therapy composed of induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cells. Developed by XellSmart Biomedical (Suzhou) Co., Ltd, this therapy is designed for the treatment of neurodegenerative diseases, primarily Parkinson's disease and amyotrophic lateral sclerosis (ALS). The iPSCs are derived from third-party donors and differentiated into dopaminergic neurons in the laboratory. These cells are then injected into affected brain regions such as the striatal putamen to replace lost or dysfunctional dopamine-producing neurons. Early clinical studies in China have shown that transplantation of GMP-grade XS-411 cells led to significant improvements in motor and non-motor symptoms in patients with moderate to severe Parkinson’s disease, with no reported adverse events over 6–12 months follow-up. The product has received Investigational New Drug (IND) approval from both the U.S. FDA and China's NMPA for Phase I clinical trials targeting Parkinson’s disease and ALS[1][3][5][6].

Other names
XS-411 InjectionXS411 InjectionXS 411 Injection

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