On February 22, UniXell Bio's investigational autologous iPSC (induced pluripotent stem cell)-derived cell therapy UX-DA001 for Parkinson's disease received formal IND approval from the U.S. FDA, marking it as the world's first iPSC-based autologous cell therapy for Parkinson's to enter clinical stages in both China and the U.S. The approval was granted within the FDA's standard 30-day review cycle, demonstrating international recognition of UniXell Bio's R&D capabilities and injecting new momentum into global Parkinson's treatment paradigms.

As China's first clinical-stage autologous iPSC-derived cell therapy for Parkinson's, UX-DA001 had previously obtained CDE's implicit clinical trial approval in December 2024. The dual IND approvals within two months ("dual-filing, dual-approval") solidified UniXell Bio's global competitiveness and positioned UX-DA001 as a transformative treatment with broad clinical potential.

UX-DA001 is an autologous iPSC-derived cell product designed to replace lost dopamine-producing neurons in Parkinson's patients. During minimally invasive surgery, these neural precursors are transplanted into the brain, where they mature into functional dopamine neurons, rebuilding damaged neural circuits and restoring both motor and non-motor functions.

The cells are derived from the patient's own peripheral blood cells through reprogramming and differentiation, eliminating immune rejection risks and the need for immunosuppressants, thereby avoiding associated side effects like infection susceptibility, organ toxicity and metabolic disorders, resulting in safer and more effective treatment.

This personalized therapy is particularly suitable for advanced Parkinson's patients, offering long-term safety and quality-of-life improvements. The Phase I trial has recently commenced.

The dual-IND milestone (CDE to FDA) heralds a new era for Parkinson's treatment. As trials progress, UX-DA001 may offer hope for millions. UniXell Bio remains committed to advancing and  bringing safer and effective cell therapies to patients through rigorous innovation.