CN
About Us
About UniXell
Vision
History
About UniXell

UniXell Biotechnology, a leading company in the field of human PSC derived cell therapy for neurological diseases, was founded in 2021 with R&D center and GMP facility covering a total area of almost 4000 square meters. UniXell has developed four highly innovative and integrated technology: Reprogramming technology, Stem cell differentiation, SISBAR pedigree tracing technology, High-precision gene editing. These technological advantages enable UniXell to manufacture cell products of high purity and batch consistency, advancing toward the ultimate clinical goals of efficiency and safety.

UXDA001 is the lead investigational product of UniXell, designed as a midbrain dopaminergic neuronal precursor cell therapy for the treatment of Parkinson’s disease.

The program has received Investigational New Drug (IND) approvals from both the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA).

UniXell is currently conducting a Phase I clinical trial in collaboration with Ruijin Hospital, Shanghai.The first patient was successfully dosed on March 1, 2025, and is recovering well following surgery.

With a team of highly experienced CMC, R&D and clinical experts, UniXell will continue to drive innovative stem cell strategies and endeavour to create a heathier future based on cutting edge science.


Vision
Vision

Stem Cell Technology Creates A Healthy Future

Mission

Based on leading science and technology, develop innovative stem cell therapy strategies. Relieve patients' suffering and create well-being for human health.

Core Values

People-oriented

Scientific innovation

Pursuit of excellence

Win-win cooperation

Culture

Innovation

Excellence

Inclusiveness

Unity

History
UX-DA003
Dual IND Approvals in China and the U.S.
2026.6
UX-GIP001
Dual IND Approvals in China and the U.S.
2026.4
A+ series Nearly 130 million RMB
2026.2
UX-DA001
Received FDA Approval for IND Application
2025.2
UX-DA001
Received CDE Approval for IND Application
2024.12
A series Over 100 million RMB
2024
Founded in
Shanghai
2021.6
Investigator initiated Clinical Trial
at Ruijin hospital
2022.12
Angel round
Over ten million RMB
2021.8
First pipeline product
DA001 set up
2022
New location
2023
Pre-A series
Nearly 200 million RMB
2022.3
GMP faciliy
2800㎡ build
2022
Clinical Trials
UniXell is committed to discovering and developing next-generation cell therapies based on stem cell technologies, with the goal of providing innovative treatment options for patients of neurodegenerative and other serious diseases. We are conducting clinical trials to evaluate the safety and efficacy of our investigational therapies. We encourage eligible patients to consider participation in our clinical studies as the most appropriate and scientifically supported way to access our therapies at this stage of development.

Ongoing Clinical Trial
UX-DA001 Injection (Human Midbrain Dopaminergic Progenitor Cell Injection)
Indication: idiopathic Parkinson’s disease
Registration Number: CTR20244974, NCT06778265
Status: Active, Recruiting

Details:  Available on the clinical trials registration platform (http://www.chinadrugtrials.org.cn/index.html; https://clinicaltrials.gov/)


UX-DA003 Injection (Human Midbrain Dopaminergic Progenitor Cell Injection)
Indication: Parkinson’s disease
Registration Number: CTR20262508, NCT07733349
Status: Active, Not yet recruiting
Details:  Available on the clinical trials registration platform (http://www.chinadrugtrials.org.cn/index.html; https://clinicaltrials.gov/)


UX-GIP001 Injection  (Human GABAergic Interneuron Progenitor Cells Injection)
Indication: Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Registration Number: CTR20261520、NCT07572812、NCT07244328
Details:  The following links are available on the clinical trials registration platform.
CTR20261520-http://www.chinadrugtrials.org.cn/index.html
2) NCT07572812-Study Details | NCT07572812 | A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy | ClinicalTrials.gov
3) NCT07244328-Study Details | NCT07244328 | Exploratory Study of UX-GIP001 Cell Therapy in Adult Patients With Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE) | ClinicalTrials.gov

Expanded Access Policy (Compassionate Use)
UniXell understands the interest of patients in accessing UX-DA001 outside of clinical trials. However we do not currently offer any Expanded Access (compassionate use) for UX-DA001. In order to ensure patient safety and maintain the integrity of our clinical data, access to this investigational therapy is currently limited to participation in authorized clinical trials.

UniXell understands the interest of patients in accessing UX-GIP001 outside of clinical trials. However we do not currently offer any Expanded Access (compassionate use) for UX-GIP001. In order to ensure patient safety and maintain the integrity of our clinical data, access to this investigational therapy is currently limited to participation in authorized clinical trials.

UniXell understands the interest of patients in accessing UX-DA003 outside of clinical trials. However we do not currently offer any Expanded Access (compassionate use) for UX-DA003. In order to ensure patient safety and maintain the integrity of our clinical data, access to this investigational therapy is currently limited to participation in authorized clinical trials.