XellSmart secures fourth dual U.S/China regulatory nod for iPSC-derived cell therapy trials

XellSmart Pharmaceutical has secured its fourth U.S. FDA and China NMPA clearance for phase 1/2 registrational clinical trial entry with its ‘off-the-shelf’ allogeneic, iPSC-derived spinal neural progenitor cell therapy targeting multiple system atrophy-Parkinsonian type (MSA-P).

This joins the previous three consecutive FDA-NMPA registrational trial clearances for its universal iPSC-derived cell therapies targeting Parkinson's disease, spinal cord injury and ALS, reported Biopharma APAC.

MSA is a rare and fatal neurodegenerative disease with large unmet need, with the Parkinsonian type presenting with progressive bradykinesia (slowed movement), rigidity and gait disorders, accompanied by severe autonomic nerve dysfunction. Currently, there are no approved therapies that can effectively slow or reverse the disease progression.

Launched in 2021, Shanghai-based XellSmart has secured multiple rounds of financing, collectively led by VC firms including Eli Lilly Asia Ventures and Qiming Venture Partners. In July 2025, XellSmart dosed the world's first patient with its iPSC-derived spinal neural progenitor cell therapy in a China NMPA and U.S. FDA-approved registrational clinical trial.